# Official Journal C 50/9 Fe

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 50 |
| | |
| English edition | Information and Notices | Volume 619 February 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 50

English edition

Information and Notices

Volume 619 February 2018

---

| Notice No | Contents | page |
| --- | --- | --- |
| | |
| | EUROPEAN PARLIAMENT
  2015-2016 SESSIONSitting of 7 March 2016
  The Minutes of this session have been published in
  OJ C 156, 18.5.2017 .2016-2017 SESSIONSittings of 8 to 10 March 2016
  The Minutes of this session have been published in
  OJ C 156, 18.5.2017 .TEXTS ADOPTED | 1 |

Notice No

Contents

page

EUROPEAN PARLIAMENT
  2015-2016 SESSIONSitting of 7 March 2016
  The Minutes of this session have been published in
  OJ C 156, 18.5.2017 .2016-2017 SESSIONSittings of 8 to 10 March 2016
  The Minutes of this session have been published in
  OJ C 156, 18.5.2017 .TEXTS ADOPTED

EUROPEAN PARLIAMENT

The Minutes of this session have been published in

OJ C 156, 18.5.2017

The Minutes of this session have been published in

OJ C 156, 18.5.2017

1

---

| | I   Resolutions, recommendations and opinions |
| --- | --- |
| | RESOLUTIONS |
| | European Parliament |
| | Tuesday 8 March 2016 |
| 2018/C 50/01 | European Parliament resolution of 8 March 2016 on the Annual Report 2014 on the Protection of the EU’s Financial Interests — Fight against fraud (2015/2128(INI)) | 2 |
| 2018/C 50/02 | European Parliament resolution of 8 March 2016 on Gender Mainstreaming in the work of the European Parliament (2015/2230(INI)) | 15 |
| 2018/C 50/03 | European Parliament resolution of 8 March 2016 on the situation of women refugees and asylum seekers in the EU (2015/2325(INI)) | 25 |
| | Wednesday 9 March 2016 |
| 2018/C 50/04 | European Parliament resolution of 9 March 2016 on the tobacco agreement (PMI agreement) (2016/2555(RSP)) | 35 |
| | Thursday 10 March 2016 |
| 2018/C 50/05 | European Parliament resolution of 10 March 2016 on freedom of expression in Kazakhstan (2016/2607(RSP)) | 38 |
| 2018/C 50/06 | European Parliament resolution of 10 March 2016 on Egypt, notably the case of Giulio Regeni (2016/2608(RSP)) | 42 |
| 2018/C 50/07 | European Parliament resolution of 10 March 2016 on the Democratic Republic of the Congo (2016/2609(RSP)) | 45 |
| 2018/C 50/08 | European Parliament resolution of 10 March 2016 on Towards a thriving data-driven economy (2015/2612(RSP)) | 50 |
| 2018/C 50/09 | European Parliament resolution of 10 March 2016 on the situation in Eritrea (2016/2568(RSP)) | 57 |
| 2018/C 50/10 | European Parliament resolution of 10 March 2016 on the 2015 Report on the former Yugoslav Republic of Macedonia (2015/2895(RSP)) | 64 |
| 2018/C 50/11 | European Parliament resolution of 10 March 2016 on the 2015 report on Montenegro (2015/2894(RSP)) | 73 |
| 2018/C 50/12 | European Parliament resolution of 10 March 2016 on the Banking Union — Annual Report 2015 (2015/2221(INI)) | 80 |

I   Resolutions, recommendations and opinions

RESOLUTIONS

European Parliament

Tuesday 8 March 2016

2018/C 50/01

European Parliament resolution of 8 March 2016 on the Annual Report 2014 on the Protection of the EU’s Financial Interests — Fight against fraud (2015/2128(INI))

2

2018/C 50/02

European Parliament resolution of 8 March 2016 on Gender Mainstreaming in the work of the European Parliament (2015/2230(INI))

15

2018/C 50/03

European Parliament resolution of 8 March 2016 on the situation of women refugees and asylum seekers in the EU (2015/2325(INI))

25

Wednesday 9 March 2016

2018/C 50/04

European Parliament resolution of 9 March 2016 on the tobacco agreement (PMI agreement) (2016/2555(RSP))

35

Thursday 10 March 2016

2018/C 50/05

European Parliament resolution of 10 March 2016 on freedom of expression in Kazakhstan (2016/2607(RSP))

38

2018/C 50/06

European Parliament resolution of 10 March 2016 on Egypt, notably the case of Giulio Regeni (2016/2608(RSP))

42

2018/C 50/07

European Parliament resolution of 10 March 2016 on the Democratic Republic of the Congo (2016/2609(RSP))

45

2018/C 50/08

European Parliament resolution of 10 March 2016 on Towards a thriving data-driven economy (2015/2612(RSP))

50

2018/C 50/09

European Parliament resolution of 10 March 2016 on the situation in Eritrea (2016/2568(RSP))

57

2018/C 50/10

European Parliament resolution of 10 March 2016 on the 2015 Report on the former Yugoslav Republic of Macedonia (2015/2895(RSP))

64

2018/C 50/11

European Parliament resolution of 10 March 2016 on the 2015 report on Montenegro (2015/2894(RSP))

73

2018/C 50/12

European Parliament resolution of 10 March 2016 on the Banking Union — Annual Report 2015 (2015/2221(INI))

80

---

| | II   Information |
| --- | --- |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Parliament |
| | Wednesday 9 March 2016 |
| 2018/C 50/13 | European Parliament decision of 9 March 2016 on the conclusion of an Interinstitutional Agreement on Better Law-Making between the European Parliament, the Council of the European Union and the European Commission (2016/2005(ACI)) | 91 |

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Parliament

Wednesday 9 March 2016

2018/C 50/13

European Parliament decision of 9 March 2016 on the conclusion of an Interinstitutional Agreement on Better Law-Making between the European Parliament, the Council of the European Union and the European Commission (2016/2005(ACI))

91

---

| | III   Preparatory acts |
| --- | --- |
| | EUROPEAN PARLIAMENT |
| | Tuesday 8 March 2016 |
| 2018/C 50/14 | European Parliament legislative resolution of 8 March 2016 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law) (11779/1/2015 — C8-0008/2016 — 2013/0136(COD)) | 98 |
| 2018/C 50/15 | P8_TA(2016)0068Aid scheme for the supply of fruit and vegetables, bananas and milk in the educational establishments ***IEuropean Parliament legislative resolution of 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 1308/2013 and Regulation (EU) No 1306/2013 as regards the aid scheme for the supply of fruit and vegetables, bananas and milk in the educational establishments (COM(2014)0032 — C7-0025/2014 — 2014/0014(COD))P8_TC1-COD(2014)0014Position of the European Parliament adopted at first reading on 8 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council amending Regulations (EU) No 1308/2013 and (EU) No 1306/2013 as regards the aid scheme for the supply of fruit and vegetables, bananas and milk in educational establishments | 101 |
| 2018/C 50/16 | Amendments adopted by the European Parliament on 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council establishing a framework on market access to port services and financial transparency of ports (COM(2013)0296 — C7-0144/2013 — 2013/0157(COD)) | 102 |
| 2018/C 50/17 | P8_TA(2016)0070Harmonised indices of consumer prices ***IEuropean Parliament legislative resolution of 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council on harmonised indices of consumer prices and repealing Regulation (EC) No 2494/95 (COM(2014)0724 — C8-0283/2014 — 2014/0346(COD))P8_TC1-COD(2014)0346Position of the European Parliament adopted at first reading on 8 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council on harmonised indices of consumer prices and the house price index, and repealing Council Regulation (EC) No 2494/95 | 149 |
| | Wednesday 9 March 2016 |
| 2018/C 50/18 | European Parliament decision to raise no objections to the draft Commission regulation amending Commission Regulation (EU) No 1178/2011 as regards pilot training, testing and periodic checking for performance-based navigation (D042244/03 — 2016/2545(RPS)) | 150 |
| 2018/C 50/19 | P8_TA(2016)0075Reduction in the sulphur content of certain liquid fuels ***IEuropean Parliament legislative resolution of 9 March 2016 on the proposal for a directive of the European Parliament and of the Council relating to a reduction in the sulphur content of certain liquid fuels (codified text) (COM(2014)0466 — C8-0107/2014 — 2014/0216(COD))P8_TC1-COD(2014)0216Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Directive (EU) 2016/... of the European Parliament and of the Council relating to a reduction in the sulphur content of certain liquid fuels (codification) | 152 |
| 2018/C 50/20 | P8_TA(2016)0076Trade diversion into the European Union of certain key medicines ***IEuropean Parliament legislative resolution of 9 March 2016 on the proposal for a regulation of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codified text) (COM(2014)0319 — C8-0015/2014 — 2014/0165(COD))P8_TC1-COD(2014)0165Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codification) | 153 |
| 2018/C 50/21 | European Parliament legislative resolution of 9 March 2016 on the proposal for a Council decision on the conclusion, on behalf of the European Union, of the Amending Protocol to the Agreement between the European Community and the Principality of Andorra providing for measures equivalent to those laid down in Council Directive 2003/48/EC on taxation of savings income in the form of interest payments (COM(2015)0631 — C8-0028/2016 — 2015/0285(NLE)) | 154 |
| 2018/C 50/22 | European Parliament decision of 9 March 2016 on the proposal for the appointment of the Executive Director of the European Insurance and Occupational Pensions Authority (EIOPA) (C8-0023/2016 — 2016/0902(NLE)) | 155 |
| 2018/C 50/23 | P8_TA(2016)0079Procedural safeguards for children suspected or accused in criminal proceedings ***IEuropean Parliament legislative resolution of 9 March 2016 on the proposal for a directive of the European Parliament and of the Council on procedural safeguards for children suspected or accused in criminal proceedings (COM(2013)0822 — C7-0428/2013 — 2013/0408(COD))P8_TC1-COD(2013)0408Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Directive (EU) 2016/... of the European Parliament and of the Council on procedural safeguards for children who are suspects or accused persons in criminal proceedings | 156 |
| 2018/C 50/24 | European Parliament resolution of 9 March 2016 on general guidelines for the preparation of the 2017 budget, Section III — Commission (2016/2004(BUD)) | 157 |
| | Thursday 10 March 2016 |
| 2018/C 50/25 | P8_TA(2016)0086Introduction of emergency autonomous trade measures for Tunisia ***IEuropean Parliament legislative resolution of 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia (COM(2015)0460 — C8-0273/2015 — 2015/0218(COD))P8_TC1-COD(2015)0218Position of the European Parliament adopted at first reading on 10 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia | 165 |
| 2018/C 50/26 | Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014)0558 — C8-0164/2014 — 2014/0257(COD)) | 166 |
| 2018/C 50/27 | Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (COM(2014)0557 — C8-0142/2014 — 2014/0256(COD)) | 280 |

III   Preparatory acts

EUROPEAN PARLIAMENT

Tuesday 8 March 2016

2018/C 50/14

European Parliament legislative resolution of 8 March 2016 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law) (11779/1/2015 — C8-0008/2016 — 2013/0136(COD))

98

2018/C 50/15

P8_TA(2016)0068Aid scheme for the supply of fruit and vegetables, bananas and milk in the educational establishments ***IEuropean Parliament legislative resolution of 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 1308/2013 and Regulation (EU) No 1306/2013 as regards the aid scheme for the supply of fruit and vegetables, bananas and milk in the educational establishments (COM(2014)0032 — C7-0025/2014 — 2014/0014(COD))P8_TC1-COD(2014)0014Position of the European Parliament adopted at first reading on 8 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council amending Regulations (EU) No 1308/2013 and (EU) No 1306/2013 as regards the aid scheme for the supply of fruit and vegetables, bananas and milk in educational establishments

101

2018/C 50/16

Amendments adopted by the European Parliament on 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council establishing a framework on market access to port services and financial transparency of ports (COM(2013)0296 — C7-0144/2013 — 2013/0157(COD))

102

2018/C 50/17

P8_TA(2016)0070Harmonised indices of consumer prices ***IEuropean Parliament legislative resolution of 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council on harmonised indices of consumer prices and repealing Regulation (EC) No 2494/95 (COM(2014)0724 — C8-0283/2014 — 2014/0346(COD))P8_TC1-COD(2014)0346Position of the European Parliament adopted at first reading on 8 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council on harmonised indices of consumer prices and the house price index, and repealing Council Regulation (EC) No 2494/95

149

Wednesday 9 March 2016

2018/C 50/18

European Parliament decision to raise no objections to the draft Commission regulation amending Commission Regulation (EU) No 1178/2011 as regards pilot training, testing and periodic checking for performance-based navigation (D042244/03 — 2016/2545(RPS))

150

2018/C 50/19

P8_TA(2016)0075Reduction in the sulphur content of certain liquid fuels ***IEuropean Parliament legislative resolution of 9 March 2016 on the proposal for a directive of the European Parliament and of the Council relating to a reduction in the sulphur content of certain liquid fuels (codified text) (COM(2014)0466 — C8-0107/2014 — 2014/0216(COD))P8_TC1-COD(2014)0216Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Directive (EU) 2016/... of the European Parliament and of the Council relating to a reduction in the sulphur content of certain liquid fuels (codification)

152

2018/C 50/20

P8_TA(2016)0076Trade diversion into the European Union of certain key medicines ***IEuropean Parliament legislative resolution of 9 March 2016 on the proposal for a regulation of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codified text) (COM(2014)0319 — C8-0015/2014 — 2014/0165(COD))P8_TC1-COD(2014)0165Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codification)

153

2018/C 50/21

European Parliament legislative resolution of 9 March 2016 on the proposal for a Council decision on the conclusion, on behalf of the European Union, of the Amending Protocol to the Agreement between the European Community and the Principality of Andorra providing for measures equivalent to those laid down in Council Directive 2003/48/EC on taxation of savings income in the form of interest payments (COM(2015)0631 — C8-0028/2016 — 2015/0285(NLE))

154

2018/C 50/22

European Parliament decision of 9 March 2016 on the proposal for the appointment of the Executive Director of the European Insurance and Occupational Pensions Authority (EIOPA) (C8-0023/2016 — 2016/0902(NLE))

155

2018/C 50/23

P8_TA(2016)0079Procedural safeguards for children suspected or accused in criminal proceedings ***IEuropean Parliament legislative resolution of 9 March 2016 on the proposal for a directive of the European Parliament and of the Council on procedural safeguards for children suspected or accused in criminal proceedings (COM(2013)0822 — C7-0428/2013 — 2013/0408(COD))P8_TC1-COD(2013)0408Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Directive (EU) 2016/... of the European Parliament and of the Council on procedural safeguards for children who are suspects or accused persons in criminal proceedings

156

2018/C 50/24

European Parliament resolution of 9 March 2016 on general guidelines for the preparation of the 2017 budget, Section III — Commission (2016/2004(BUD))

157

Thursday 10 March 2016

2018/C 50/25

P8_TA(2016)0086Introduction of emergency autonomous trade measures for Tunisia ***IEuropean Parliament legislative resolution of 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia (COM(2015)0460 — C8-0273/2015 — 2015/0218(COD))P8_TC1-COD(2015)0218Position of the European Parliament adopted at first reading on 10 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia

165

2018/C 50/26

Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014)0558 — C8-0164/2014 — 2014/0257(COD))

166

2018/C 50/27

Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (COM(2014)0557 — C8-0142/2014 — 2014/0256(COD))

280

---

| Key to symbols used






  - | Consultation procedure |
| --- | --- |
| *** | Consent procedure |
| ***I | Ordinary legislative procedure: first reading |
| ***II | Ordinary legislative procedure: second reading |
| ***III | Ordinary legislative procedure: third reading |

Key to symbols used

*

Consultation procedure

***

Consent procedure

***I

Ordinary legislative procedure: first reading

***II

Ordinary legislative procedure: second reading

***III

Ordinary legislative procedure: third reading

(The type of procedure depends on the legal basis proposed by the draft act.)

Amendments by Parliament:

New text is highlighted in
  bold italics
  . Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in
  bold italics
  and by deleting or striking out the text that has been replaced.

bold italics

bold italics

| EN | |
| --- | --- |

EN

---

9.2.2018

| 9.2.2018 | EN | Official Journal of the European Union | C 50/1 |
| --- | --- | --- | --- |

EN

Official Journal of the European Union

C 50/1

---

EUROPEAN PARLIAMENT

2015-2016 SESSION

Sitting of 7 March 2016

The Minutes of this session have been published in

  OJ C 156, 18.5.2017
  .

2016-2017 SESSION

Sittings of 8 to 10 March 2016

The Minutes of this session have been published in

  OJ C 156, 18.5.2017
  .

TEXTS ADOPTED

---

I Resolutions, recommendations and opinions

RESOLUTIONS

European Parliament

Tuesday 8 March 2016

| 9.2.2018 | EN | Official Journal of the European Union | C 50/2 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/2

---

P8_TA(2016)0071

Annual report 2014 on the Protection of the EU’s financial interests — Fight against fraud

European Parliament resolution of 8 March 2016 on the Annual Report 2014 on the Protection of the EU’s Financial Interests — Fight against fraud (2015/2128(INI))

(2018/C 050/01)

The European Parliament,

| — | having regard to Article 325(5) of the Treaty on the Functioning of the European Union (TFEU), |
| --- | --- |

—

having regard to Article 325(5) of the Treaty on the Functioning of the European Union (TFEU),

| — | having regard to its resolutions on previous annual reports of the Commission and of the European Anti-Fraud Office (OLAF), |
| --- | --- |

—

having regard to its resolutions on previous annual reports of the Commission and of the European Anti-Fraud Office (OLAF),

| — | having regard to the Commission report of 31 July 2015 entitled ‘Protection of the European Union’s financial interests — Fight against fraud — 2014 Annual Report’ (COM(2015)0386) and the accompanying staff working documents (SWD(2015)0151, SWD(2015)0152, SWD(2015)0153, SWD(2015)0154, SWD(2015)0155 and SWD(2015)0156), |
| --- | --- |

—

having regard to the Commission report of 31 July 2015 entitled ‘Protection of the European Union’s financial interests — Fight against fraud — 2014 Annual Report’ (COM(2015)0386) and the accompanying staff working documents (SWD(2015)0151, SWD(2015)0152, SWD(2015)0153, SWD(2015)0154, SWD(2015)0155 and SWD(2015)0156),

| — | having regard to the OLAF annual report 2014, |
| --- | --- |

—

having regard to the OLAF annual report 2014,

| — | having regard to the 2014 Activity Report of the OLAF Supervisory Committee, |
| --- | --- |

—

having regard to the 2014 Activity Report of the OLAF Supervisory Committee,

| — | having regard to the annual report of the Court of Auditors on the implementation of the budget concerning the financial year 2014, together with the institutions’ replies, |
| --- | --- |

—

having regard to the annual report of the Court of Auditors on the implementation of the budget concerning the financial year 2014, together with the institutions’ replies,

| — | having regard to the Commission communication of 8 October 2015 entitled ‘Protection of the EU budget to end 2014’ (COM(2015)0503), |
| --- | --- |

—

having regard to the Commission communication of 8 October 2015 entitled ‘Protection of the EU budget to end 2014’ (COM(2015)0503),

| — | having regard to the opinion of the European Economic and Social Committee of 16 September 2015 entitled ‘Fighting corruption in the EU: meeting business and civil society concerns’ (CCMI/132), |
| --- | --- |

—

having regard to the opinion of the European Economic and Social Committee of 16 September 2015 entitled ‘Fighting corruption in the EU: meeting business and civil society concerns’ (CCMI/132),

| — | having regard to the Commission report of 3 February 2014 entitled ‘EU anti-corruption report’ (COM(2014)0038), |
| --- | --- |

—

having regard to the Commission report of 3 February 2014 entitled ‘EU anti-corruption report’ (COM(2014)0038),

| — | having regard to Regulation (EU) No 250/2014 of the European Parliament and of the Council of 26 February 2014 establishing a programme to promote activities in the field of the protection of the financial interests of the European Union (Hercule III programme) and repealing Decision No 804/2004/EC (1), |
| --- | --- |

—

having regard to Regulation (EU) No 250/2014 of the European Parliament and of the Council of 26 February 2014 establishing a programme to promote activities in the field of the protection of the financial interests of the European Union (Hercule III programme) and repealing Decision No 804/2004/EC (1),

| — | having regard to the Commission proposal of 17 July 2013 for a Council regulation on the establishment of the European Public Prosecutor’s Office (COM(2013)0534), |
| --- | --- |

—

having regard to the Commission proposal of 17 July 2013 for a Council regulation on the establishment of the European Public Prosecutor’s Office (COM(2013)0534),

| — | having regard to Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and replacing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (2), |
| --- | --- |

—

having regard to Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and replacing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (2),

| — | having regard to the Commission proposal of 11 July 2012 for a directive of the European Parliament and of the Council on the fight against fraud to the Union’s financial interests by means of criminal law (COM(2012)0363), |
| --- | --- |

—

having regard to the Commission proposal of 11 July 2012 for a directive of the European Parliament and of the Council on the fight against fraud to the Union’s financial interests by means of criminal law (COM(2012)0363),

| — | having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3), |
| --- | --- |

—

having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3),

| — | having regard to its resolution of 15 September 2011 on the EU’s efforts to combat corruption (4), its declaration of 18 May 2010 on the Union’s efforts in combatting corruption (5) and the Commission communication of 6 June 2011 entitled ‘Fighting Corruption in the EU’ (COM(2011)0308), |
| --- | --- |

—

having regard to its resolution of 15 September 2011 on the EU’s efforts to combat corruption (4), its declaration of 18 May 2010 on the Union’s efforts in combatting corruption (5) and the Commission communication of 6 June 2011 entitled ‘Fighting Corruption in the EU’ (COM(2011)0308),

| — | having regard to Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities’ financial interests (6), |
| --- | --- |

—

having regard to Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities’ financial interests (6),

| — | having regard to the 2015 Report on the VAT Gap commissioned by the European Commission, |
| --- | --- |

—

having regard to the 2015 Report on the VAT Gap commissioned by the European Commission,

| — | having regard to the special report of the European Court of Auditors on public procurement in EU cohesion expenditure, |
| --- | --- |

—

having regard to the special report of the European Court of Auditors on public procurement in EU cohesion expenditure,

| — | having regard to the judgment of the European Court of Justice in Case C-105/14, Taricco and Others, |
| --- | --- |

—

having regard to the judgment of the European Court of Justice in Case C-105/14, Taricco and Others,

| — | having regard to Rule 52 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 52 of its Rules of Procedure,

| — | having regard to the report of the Committee on Budgetary Control and the opinions of the Committee on International Trade, the Committee on Regional Development, the Committee on Civil Liberties, Justice and Home Affairs and the Committee on Constitutional Affairs (A8-0026/2016), |
| --- | --- |

—

having regard to the report of the Committee on Budgetary Control and the opinions of the Committee on International Trade, the Committee on Regional Development, the Committee on Civil Liberties, Justice and Home Affairs and the Committee on Constitutional Affairs (A8-0026/2016),

| A. | whereas the Member States and the Commission have shared responsibility for implementing approximately 80 % of the Union’s budget; whereas Member States are primarily responsible for the collection of own resources, inter alia in the form of VAT and customs duties; |
| --- | --- |

A.

whereas the Member States and the Commission have shared responsibility for implementing approximately 80 % of the Union’s budget; whereas Member States are primarily responsible for the collection of own resources, inter alia in the form of VAT and customs duties;

| B. | whereas sound public spending and the protection of the EU’s financial interests should be key elements of the EU’s policy to increase the confidence of citizens by ensuring that their money is used properly, efficiently and effectively; whereas this sound financial management should be combined with a ‘best use of every euro’ approach; |
| --- | --- |

B.

whereas sound public spending and the protection of the EU’s financial interests should be key elements of the EU’s policy to increase the confidence of citizens by ensuring that their money is used properly, efficiently and effectively; whereas this sound financial management should be combined with a ‘best use of every euro’ approach;

| C. | whereas achieving good performance involves inputs, outputs, results and impacts which are regularly assessed through performance audits; |
| --- | --- |

C.

whereas achieving good performance involves inputs, outputs, results and impacts which are regularly assessed through performance audits;

| D. | whereas the diversity of legal and administrative systems in the Member States presents a challenging environment in which to overcome irregularities and combat fraud, and whereas the Commission should therefore step up its efforts to ensure that the fight against fraud is implemented effectively and produces more tangible and more satisfactory results; |
| --- | --- |

D.

whereas the diversity of legal and administrative systems in the Member States presents a challenging environment in which to overcome irregularities and combat fraud, and whereas the Commission should therefore step up its efforts to ensure that the fight against fraud is implemented effectively and produces more tangible and more satisfactory results;

| E. | whereas the European Anti-Fraud Office (OLAF) has responsibility for protecting the Union’s financial interests by investigating fraud, corruption and any other illegal activities; whereas its Supervisory Committee was established in order to reinforce and guarantee OLAF’s independence by regularly monitoring the implementation of its investigative function; whereas, in particular, the Supervisory Committee monitors developments as regards the application of procedural guarantees and the duration of investigations in the light of the information supplied by the Director-General in accordance with Article 7(8) of Regulation (EU, Euratom) No 883/2013; |
| --- | --- |

E.

whereas the European Anti-Fraud Office (OLAF) has responsibility for protecting the Union’s financial interests by investigating fraud, corruption and any other illegal activities; whereas its Supervisory Committee was established in order to reinforce and guarantee OLAF’s independence by regularly monitoring the implementation of its investigative function; whereas, in particular, the Supervisory Committee monitors developments as regards the application of procedural guarantees and the duration of investigations in the light of the information supplied by the Director-General in accordance with Article 7(8) of Regulation (EU, Euratom) No 883/2013;

| F. | whereas corruption affects all Member States and costs the EU economy around EUR 120 billion per year, as stated in the Commission’s first report on the EU’s anti-corruption policy, published in February 2014; |
| --- | --- |

F.

whereas corruption affects all Member States and costs the EU economy around EUR 120 billion per year, as stated in the Commission’s first report on the EU’s anti-corruption policy, published in February 2014;

| G. | whereas corruption can help to finance the activities of organised crime or terrorism networks in Europe; whereas corruption also undermines citizens’ trust in institutions and democratic processes; |
| --- | --- |

G.

whereas corruption can help to finance the activities of organised crime or terrorism networks in Europe; whereas corruption also undermines citizens’ trust in institutions and democratic processes;

| H. | whereas, in addition to the civilisational assumption based on ethical principles inherent in the rule of law, combating fraud and corruption contributes to the Union’s competitiveness in the global economy; |
| --- | --- |

H.

whereas, in addition to the civilisational assumption based on ethical principles inherent in the rule of law, combating fraud and corruption contributes to the Union’s competitiveness in the global economy;

| 1. | Takes note of the Commission report entitled ‘Protection of the European Union’s financial interests — Fight against fraud — Annual Report 2014’; asks that the Commission, in its annual reports on the protection of the EU’s financial interests (PIF reports), respond to Parliament’s requests in a more timely manner; |
| --- | --- |

1.

Takes note of the Commission report entitled ‘Protection of the European Union’s financial interests — Fight against fraud — Annual Report 2014’; asks that the Commission, in its annual reports on the protection of the EU’s financial interests (PIF reports), respond to Parliament’s requests in a more timely manner;

Detection and reporting of irregularities

| 2. | Notes that all the irregularities reported involve a total amount of around EUR 3,24 billion; emphasises that the overall financial impact of fraudulent and non-fraudulent irregularities reported in 2014 is 36 % greater than in 2013, while the number of such irregularities increased by 48 %; emphasises that EUR 2,27 billion of the reported irregularities relates to expenditure, representing 1,8 % of total payments; |
| --- | --- |

2.

Notes that all the irregularities reported involve a total amount of around EUR 3,24 billion; emphasises that the overall financial impact of fraudulent and non-fraudulent irregularities reported in 2014 is 36 % greater than in 2013, while the number of such irregularities increased by 48 %; emphasises that EUR 2,27 billion of the reported irregularities relates to expenditure, representing 1,8 % of total payments;

| 3. | Stresses that 1 649 out of a total of 16 473 irregularities reported to the Commission in 2014 were fraudulent, involving an amount of EUR 538,2 million; notes that fraudulent irregularities related to expenditure involved EUR 362 million, representing 0,26 % of total payments, and that those related to revenue involved EUR 176,2 million, representing 0,88 % of the gross amount of traditional own resources (TOR) collected in 2014; |
| --- | --- |

3.

Stresses that 1 649 out of a total of 16 473 irregularities reported to the Commission in 2014 were fraudulent, involving an amount of EUR 538,2 million; notes that fraudulent irregularities related to expenditure involved EUR 362 million, representing 0,26 % of total payments, and that those related to revenue involved EUR 176,2 million, representing 0,88 % of the gross amount of traditional own resources (TOR) collected in 2014;

| 4. | Emphasises that the overall financial impact of non-fraudulent irregularities reported in 2014 is 47 % greater than in 2013, while their number decreased by 5 %; also notes that non-fraudulent irregularities related to expenditure affected 1,54 % of total payments, and that those related to revenue affected 3,66 % of TOR collected in 2014; |
| --- | --- |

4.

Emphasises that the overall financial impact of non-fraudulent irregularities reported in 2014 is 47 % greater than in 2013, while their number decreased by 5 %; also notes that non-fraudulent irregularities related to expenditure affected 1,54 % of total payments, and that those related to revenue affected 3,66 % of TOR collected in 2014;

| 5. | Urges the Commission to assume full responsibility for the recovery of funds unduly paid from the EU budget, as well as for the better levying of own resources, and to establish uniform reporting principles in all Member States for the purpose of collecting appropriate, comparable and accurate data; |
| --- | --- |

5.

Urges the Commission to assume full responsibility for the recovery of funds unduly paid from the EU budget, as well as for the better levying of own resources, and to establish uniform reporting principles in all Member States for the purpose of collecting appropriate, comparable and accurate data;

| 6. | Emphasises that non-fraudulent irregularities are often linked to insufficient knowledge of complex rules and requirements; believes that the simplification of rules and procedures by the Member States and the Commission will decrease the number of such irregularities; considers that the fight against irregularities, including fraud, requires awareness among all institutional bodies at the European, national, regional and local levels and among the general public; notes that the establishment of a culture conducive to preventing and combating fraud is of vital importance in all the institutions and bodies involved in implementing the Funds, and calls on the Member States to encourage exchanges of good practices; |
| --- | --- |

6.

Emphasises that non-fraudulent irregularities are often linked to insufficient knowledge of complex rules and requirements; believes that the simplification of rules and procedures by the Member States and the Commission will decrease the number of such irregularities; considers that the fight against irregularities, including fraud, requires awareness among all institutional bodies at the European, national, regional and local levels and among the general public; notes that the establishment of a culture conducive to preventing and combating fraud is of vital importance in all the institutions and bodies involved in implementing the Funds, and calls on the Member States to encourage exchanges of good practices;

| 7. | Recalls that, with the objective of bringing finances onto a more sustainable footing, Member States are involved in ongoing fiscal consolidation and restraint, and firmly believes that all available resources are needed for investment in the Member States with the objective of stimulating sustainable economic growth; believes that all necessary steps must be taken to prevent and stop any fraudulent activities in the field of trade policy and its associated appropriations, combining all relevant policy instruments (such as criminal investigations, the development of reliable analysis models, and efforts to tackle shortcomings and failures related to deficient Commission policy); calls on the Member States to put even more effort into ensuring that money from the EU budget is used correctly for projects that contribute to growth and jobs in Europe, and into recovering customs debt following the discovery of fraud; stresses, more generally, that the fight against illicit trade and illicit financial flows should remain a high priority for the EU as well as for the Member States; |
| --- | --- |

7.

Recalls that, with the objective of bringing finances onto a more sustainable footing, Member States are involved in ongoing fiscal consolidation and restraint, and firmly believes that all available resources are needed for investment in the Member States with the objective of stimulating sustainable economic growth; believes that all necessary steps must be taken to prevent and stop any fraudulent activities in the field of trade policy and its associated appropriations, combining all relevant policy instruments (such as criminal investigations, the development of reliable analysis models, and efforts to tackle shortcomings and failures related to deficient Commission policy); calls on the Member States to put even more effort into ensuring that money from the EU budget is used correctly for projects that contribute to growth and jobs in Europe, and into recovering customs debt following the discovery of fraud; stresses, more generally, that the fight against illicit trade and illicit financial flows should remain a high priority for the EU as well as for the Member States;

| 8. | Welcomes the adoption by the Commission of a multiannual anti-fraud strategy which is helping to correct significant differences in the number of irregularities notified by each Member State; |
| --- | --- |

8.

Welcomes the adoption by the Commission of a multiannual anti-fraud strategy which is helping to correct significant differences in the number of irregularities notified by each Member State;

Revenue — own resources

| 9. | Notes with concern that the amount of TOR affected by fraud in 2014 was 191 % higher than in 2013, and the amount affected by non-fraudulent irregularities was 146 % higher in 2014 than in the previous year; |
| --- | --- |

9.

Notes with concern that the amount of TOR affected by fraud in 2014 was 191 % higher than in 2013, and the amount affected by non-fraudulent irregularities was 146 % higher in 2014 than in the previous year;

| 10. | Is concerned that the average TOR recovery rate per Member State for both fraudulent and non-fraudulent irregularities for 2014 is, at 24 %, at its historic lowest point; urges the Member States to recover the amounts due more quickly, and especially urges those Member States which need to recover the largest amounts to improve their recovery; |
| --- | --- |

10.

Is concerned that the average TOR recovery rate per Member State for both fraudulent and non-fraudulent irregularities for 2014 is, at 24 %, at its historic lowest point; urges the Member States to recover the amounts due more quickly, and especially urges those Member States which need to recover the largest amounts to improve their recovery;

| 11. | Is concerned about the VAT gap and the estimated losses on VAT collection, which amounted to EUR 168 billion in 2013; underlines the fact that in 13 of the 26 Member States examined in 2014, the average estimated VAT loss exceeded 15,2 %; points out that the Commission does not have access to the information exchanged between Member States with a view to preventing and combating so-called ‘carousel’ fraud; calls on all the Member States to participate in all of Eurofisc’s fields of activity so as to facilitate the exchange of information with the aim of helping to combat fraud; reiterates that the Commission has the competence to control and supervise measures taken by the Member States; calls on the Commission to make full use of its executive powers in order to both control and help the Member States in their fight against VAT fraud and tax avoidance; acknowledges that since 2013 the Commission has been using the Quick Reaction Mechanism to deal with massive and sudden VAT fraud; |
| --- | --- |

11.

Is concerned about the VAT gap and the estimated losses on VAT collection, which amounted to EUR 168 billion in 2013; underlines the fact that in 13 of the 26 Member States examined in 2014, the average estimated VAT loss exceeded 15,2 %; points out that the Commission does not have access to the information exchanged between Member States with a view to preventing and combating so-called ‘carousel’ fraud; calls on all the Member States to participate in all of Eurofisc’s fields of activity so as to facilitate the exchange of information with the aim of helping to combat fraud; reiterates that the Commission has the competence to control and supervise measures taken by the Member States; calls on the Commission to make full use of its executive powers in order to both control and help the Member States in their fight against VAT fraud and tax avoidance; acknowledges that since 2013 the Commission has been using the Quick Reaction Mechanism to deal with massive and sudden VAT fraud;

| 12. | Encourages the Commission to develop a mechanism that would motivate companies to pay regular taxes rather than avoiding them; |
| --- | --- |

12.

Encourages the Commission to develop a mechanism that would motivate companies to pay regular taxes rather than avoiding them;

| 13. | Notes the increasing number of coordination centres supported by Eurojust and Europol; welcomes the results of cross-border operations Vertigo 2 and 3 and the efficient cooperation between law enforcement and judicial authorities in Germany, Poland, the Netherlands, the UK, Belgium, Spain, the Czech Republic and Switzerland, leading to the neutralisation of criminal networks responsible for defrauding approximately EUR 320 million in tax revenues, including VAT; |
| --- | --- |

13.

Notes the increasing number of coordination centres supported by Eurojust and Europol; welcomes the results of cross-border operations Vertigo 2 and 3 and the efficient cooperation between law enforcement and judicial authorities in Germany, Poland, the Netherlands, the UK, Belgium, Spain, the Czech Republic and Switzerland, leading to the neutralisation of criminal networks responsible for defrauding approximately EUR 320 million in tax revenues, including VAT;

| 14. | Expresses concern with regard to customs inspections and the related collection of customs duties, which are one of the own resources under the EU budget; points out that it is the customs authorities of the Member States that conduct inspections to check that importers are complying with the rules on tariffs and imports, and stresses that the Court of Auditors has found the quality of those inspections to vary from one Member State to another; calls on the Commission to update the Customs Audit Guide, published in 2014, in order to eliminate the shortcomings detected by the Court of Auditors, such as the issues surrounding the handling of imports cleared through customs in another Member State; |
| --- | --- |

14.

Expresses concern with regard to customs inspections and the related collection of customs duties, which are one of the own resources under the EU budget; points out that it is the customs authorities of the Member States that conduct inspections to check that importers are complying with the rules on tariffs and imports, and stresses that the Court of Auditors has found the quality of those inspections to vary from one Member State to another; calls on the Commission to update the Customs Audit Guide, published in 2014, in order to eliminate the shortcomings detected by the Court of Auditors, such as the issues surrounding the handling of imports cleared through customs in another Member State;

Expenditure

| 15. | Notes with concern that the number of irregularities related to expenditure reported as fraudulent in 2014 dropped by only 4 %, after a 76 % increase in 2013; urges the competent authorities to take all necessary measures to decrease the number of fraudulent irregularities, although not at the expense of control standards; |
| --- | --- |

15.

Notes with concern that the number of irregularities related to expenditure reported as fraudulent in 2014 dropped by only 4 %, after a 76 % increase in 2013; urges the competent authorities to take all necessary measures to decrease the number of fraudulent irregularities, although not at the expense of control standards;

| 16. | Is concerned by the steady increase in the number of reported non-fraudulent irregularities related to directly managed EU funds, in terms of both the number of cases and the sums involved; is surprised that the number of fraudulent irregularities reported in 2014 quadrupled compared with the previous year, and asks the Commission to provide detailed explanations and to take the necessary action to counter this trend; |
| --- | --- |

16.

Is concerned by the steady increase in the number of reported non-fraudulent irregularities related to directly managed EU funds, in terms of both the number of cases and the sums involved; is surprised that the number of fraudulent irregularities reported in 2014 quadrupled compared with the previous year, and asks the Commission to provide detailed explanations and to take the necessary action to counter this trend;

| 17. | Is concerned, therefore, that in 2014 the rural development sector accounted for the largest number of reported fraudulent irregularities, showing the biggest increase in comparison with 2013; points out that about 71 % of the total number of fraudulent irregularities notified for natural resources (agriculture, rural development and fisheries) came from Hungary, Italy, Poland and Romania; |
| --- | --- |

17.

Is concerned, therefore, that in 2014 the rural development sector accounted for the largest number of reported fraudulent irregularities, showing the biggest increase in comparison with 2013; points out that about 71 % of the total number of fraudulent irregularities notified for natural resources (agriculture, rural development and fisheries) came from Hungary, Italy, Poland and Romania;

| 18. | Acknowledges that the Member States’ recovery rate for the European Agricultural Guarantee Fund (EAGF) is below the overall average, and that fewer than half of the irregularities detected in 2009 had been recovered by the end of 2014; points to significant differences in the ability of Member States to recover sums in respect of irregular payments detected under the Common Agricultural Policy, and urges Bulgaria, France, Greece and Slovakia to improve their results significantly; acknowledges that the clearance mechanism (the 50/50 rule) provides a strong incentive for Member States to recover undue payments under the EAGF from beneficiaries as quickly as possible; regrets that 2014 was the third consecutive year marked by growth in the number of cases of fraudulent irregularities in respect of the EAGF, and the fourth consecutive year marked by growth in the number of fraudulent cases reported in respect of rural development; stresses the need for faster recovery of funds; |
| --- | --- |

18.

Acknowledges that the Member States’ recovery rate for the European Agricultural Guarantee Fund (EAGF) is below the overall average, and that fewer than half of the irregularities detected in 2009 had been recovered by the end of 2014; points to significant differences in the ability of Member States to recover sums in respect of irregular payments detected under the Common Agricultural Policy, and urges Bulgaria, France, Greece and Slovakia to improve their results significantly; acknowledges that the clearance mechanism (the 50/50 rule) provides a strong incentive for Member States to recover undue payments under the EAGF from beneficiaries as quickly as possible; regrets that 2014 was the third consecutive year marked by growth in the number of cases of fraudulent irregularities in respect of the EAGF, and the fourth consecutive year marked by growth in the number of fraudulent cases reported in respect of rural development; stresses the need for faster recovery of funds;

| 19. | Notes that the irregularities linked to the Common Fisheries Policy in 2014 returned to a level comparable to 2012 after a one-year peak in 2013; notes that the most frequently detected category of irregularity during the 2010-2014 period was ‘Non-eligibility for aid of the action/project’, followed by ‘Infringements of public procurement rules’; |
| --- | --- |

19.

Notes that the irregularities linked to the Common Fisheries Policy in 2014 returned to a level comparable to 2012 after a one-year peak in 2013; notes that the most frequently detected category of irregularity during the 2010-2014 period was ‘Non-eligibility for aid of the action/project’, followed by ‘Infringements of public procurement rules’;

| 20. | Notes that in respect of the 2007-2013 cohesion policy programming period the number of irregularities reported as fraudulent decreased by 5 % in 2014 compared with 2013, with 306 cases reported; is seriously concerned about the increase of over EUR 115 million (76 %) in the amounts affected by fraudulent irregularities in 2014 compared with 2013, which is due mainly to a sharp increase (660 %) in the amounts involved under the Cohesion Fund; notes that out of 74 cases of established fraud in respect of cohesion policy between 2008 and 2014, 61 (82 %) were reported by three Member States — Germany (42 cases), Poland (11 cases) and Slovenia (8 cases); expresses concern that 14 Member States have an established fraud ratio of 0 % for that period, which may raise questions as to the efficiency of their control systems; |
| --- | --- |

20.

Notes that in respect of the 2007-2013 cohesion policy programming period the number of irregularities reported as fraudulent decreased by 5 % in 2014 compared with 2013, with 306 cases reported; is seriously concerned about the increase of over EUR 115 million (76 %) in the amounts affected by fraudulent irregularities in 2014 compared with 2013, which is due mainly to a sharp increase (660 %) in the amounts involved under the Cohesion Fund; notes that out of 74 cases of established fraud in respect of cohesion policy between 2008 and 2014, 61 (82 %) were reported by three Member States — Germany (42 cases), Poland (11 cases) and Slovenia (8 cases); expresses concern that 14 Member States have an established fraud ratio of 0 % for that period, which may raise questions as to the efficiency of their control systems;

| 21. | Is worried, furthermore, that the overall time lapse in the cohesion field between the occurrence of an irregularity, its detection and its final reporting to the Commission has increased to 3 years and 4 months; recalls that further procedures kick in once an irregularity has been detected (recovery orders, OLAF investigations, etc.); urges the Commission to work with Member States to improve the efficiency of their detection and reporting; |
| --- | --- |

21.

Is worried, furthermore, that the overall time lapse in the cohesion field between the occurrence of an irregularity, its detection and its final reporting to the Commission has increased to 3 years and 4 months; recalls that further procedures kick in once an irregularity has been detected (recovery orders, OLAF investigations, etc.); urges the Commission to work with Member States to improve the efficiency of their detection and reporting;

| 22. | Welcomes the overall drop in reported irregularities in Pre-Accession Assistance (PAA); regrets the steadily increasing trend concerning irregularities related to the Instrument for Pre-Accession (IPA) since 2010, in terms of both amounts and the number of cases, with Turkey being the main contributor to this negative development, and calls on the Commission to do everything it can to improve the situation, in particular in the context of the upcoming efforts to enhance EU-Turkey cooperation; |
| --- | --- |

22.

Welcomes the overall drop in reported irregularities in Pre-Accession Assistance (PAA); regrets the steadily increasing trend concerning irregularities related to the Instrument for Pre-Accession (IPA) since 2010, in terms of both amounts and the number of cases, with Turkey being the main contributor to this negative development, and calls on the Commission to do everything it can to improve the situation, in particular in the context of the upcoming efforts to enhance EU-Turkey cooperation;

Problems identified and measures required

Better reporting

| 23. | Notes with concern that, despite the numerous calls from Parliament for the establishment of uniform reporting principles in all Member States, the situation remains highly unsatisfactory and there are still significant differences in the number of fraudulent and non-fraudulent irregularities reported by each Member State; considers that this problem creates a distorted picture of the real situation regarding the level of infringements and the protection of the EU’s financial interests; urges the Commission to make serious efforts to resolve the problem of differing approaches by Member States to detecting irregularities, and non-homogeneous interpretations when applying the EU legal framework; |
| --- | --- |

23.

Notes with concern that, despite the numerous calls from Parliament for the establishment of uniform reporting principles in all Member States, the situation remains highly unsatisfactory and there are still significant differences in the number of fraudulent and non-fraudulent irregularities reported by each Member State; considers that this problem creates a distorted picture of the real situation regarding the level of infringements and the protection of the EU’s financial interests; urges the Commission to make serious efforts to resolve the problem of differing approaches by Member States to detecting irregularities, and non-homogeneous interpretations when applying the EU legal framework;

| 24. | Welcomes the Commission’s commitment to publish an EU Anti-Corruption report biannually, and looks forward to reading the next report in early 2016; asks the Commission to add a chapter on the performance of the EU institutions in fighting corruption, with further analysis being carried out at the level of the EU institutions as to the policies implemented, in order to identify inherent critical factors, vulnerable areas and risk factors conducive to corruption; |
| --- | --- |

24.

Welcomes the Commission’s commitment to publish an EU Anti-Corruption report biannually, and looks forward to reading the next report in early 2016; asks the Commission to add a chapter on the performance of the EU institutions in fighting corruption, with further analysis being carried out at the level of the EU institutions as to the policies implemented, in order to identify inherent critical factors, vulnerable areas and risk factors conducive to corruption;

| 25. | Calls on the Commission to harmonise the framework for the reporting of ‘suspected fraud’ and to establish rules on the reporting of all judicial action undertaken in the Member States in relation to potential fraudulent use of EU resources, requiring the reporting to indicate specifically the judicial actions taken on the basis of OLAF’s judicial recommendations; |
| --- | --- |

25.

Calls on the Commission to harmonise the framework for the reporting of ‘suspected fraud’ and to establish rules on the reporting of all judicial action undertaken in the Member States in relation to potential fraudulent use of EU resources, requiring the reporting to indicate specifically the judicial actions taken on the basis of OLAF’s judicial recommendations;

| 26. | Invites the Commission to develop a system of strict indicators and easily applicable, uniform criteria, based on the requirements set out in the Stockholm Programme, to measure the level of corruption in the Member States and evaluate the Member States’ anti-corruption policies; is concerned about the reliability and quality of the data coming from the Member States; calls on the Commission, therefore, to work closely with the Member States to guarantee the provision of comprehensive, accurate and reliable data, keeping in mind the goal of full implementation of the Single Audit Scheme; invites the Commission to develop a corruption index in order to categorise the Member States; |
| --- | --- |

26.

Invites the Commission to develop a system of strict indicators and easily applicable, uniform criteria, based on the requirements set out in the Stockholm Programme, to measure the level of corruption in the Member States and evaluate the Member States’ anti-corruption policies; is concerned about the reliability and quality of the data coming from the Member States; calls on the Commission, therefore, to work closely with the Member States to guarantee the provision of comprehensive, accurate and reliable data, keeping in mind the goal of full implementation of the Single Audit Scheme; invites the Commission to develop a corruption index in order to categorise the Member States;

| 27. | Calls on the Commission, as part of the annual evaluation of the results achieved in the fight against corruption, to give the Member States precise guidelines as to how to facilitate the gradual and continuous implementation of the obligations taken on by each Member State as regards combating corruption; |
| --- | --- |

27.

Calls on the Commission, as part of the annual evaluation of the results achieved in the fight against corruption, to give the Member States precise guidelines as to how to facilitate the gradual and continuous implementation of the obligations taken on by each Member State as regards combating corruption;

| 28. | Reiterates its call on the Commission to swiftly promote legislation on the minimum level of protection for whistle-blowers in the EU; calls on the European institutions to amend the Staff Regulations to ensure that these not only formally oblige officials to report irregularities, but also lay down adequate protection for whistle-blowers; calls on those European institutions that have not done so, and on other bodies, to implement Article 22(c) of the Staff Regulations without delay; calls firmly for all EU institutions to adopt internal rules concerning whistle-blowing by employees and the obligations of the latter, focusing on protection for whistle-blowers; believes that these rules should be explicitly extended to whistle-blowers who reveal fraud in respect of international agreements, including trade agreements; |
| --- | --- |

28.

Reiterates its call on the Commission to swiftly promote legislation on the minimum level of protection for whistle-blowers in the EU; calls on the European institutions to amend the Staff Regulations to ensure that these not only formally oblige officials to report irregularities, but also lay down adequate protection for whistle-blowers; calls on those European institutions that have not done so, and on other bodies, to implement Article 22(c) of the Staff Regulations without delay; calls firmly for all EU institutions to adopt internal rules concerning whistle-blowing by employees and the obligations of the latter, focusing on protection for whistle-blowers; believes that these rules should be explicitly extended to whistle-blowers who reveal fraud in respect of international agreements, including trade agreements;

| 29. | Underlines the importance of access to information and the transparency of lobbying, and of using EU funding to support the work of independent organisations in this area; |
| --- | --- |

29.

Underlines the importance of access to information and the transparency of lobbying, and of using EU funding to support the work of independent organisations in this area;

| 30. | Believes that the level of transparency could be raised through the creation of a legislative footprint for EU lobbying, with the objective of switching from a voluntary to a mandatory EU register for all lobbying activities vis-à-vis any of the EU institutions; |
| --- | --- |

30.

Believes that the level of transparency could be raised through the creation of a legislative footprint for EU lobbying, with the objective of switching from a voluntary to a mandatory EU register for all lobbying activities vis-à-vis any of the EU institutions;

| 31. | Urges the Commission to maintain its strict policy on interruption and suspension of payments in accordance with the relevant legal basis; welcomes the fact that the Commission has adopted a new decision on the Early Warning Mechanism (EWS); looks forward to the creation of a comprehensive system of early detection and exclusion to be proposed by the Commission; calls on the Commission to better inform the Member States and local authorities about the implementation of its policy, bearing in mind that this process should not be undermined by political considerations; |
| --- | --- |

31.

Urges the Commission to maintain its strict policy on interruption and suspension of payments in accordance with the relevant legal basis; welcomes the fact that the Commission has adopted a new decision on the Early Warning Mechanism (EWS); looks forward to the creation of a comprehensive system of early detection and exclusion to be proposed by the Commission; calls on the Commission to better inform the Member States and local authorities about the implementation of its policy, bearing in mind that this process should not be undermined by political considerations;

| 32. | Calls, therefore, for Article 325 TFEU to be implemented right across the spectrum of EU policies, and for action not just in response to cases of fraud but also to prevent them; calls for compliance with Article 325 TFEU, and particularly with paragraph 5 on annual reports, which is currently facing a year’s delay; calls for simplification, especially, of the way in which EU subsidies are used in cohesion policy; calls for adherence to agreed procedures and for the ratification of the agreements on combating fraud at regional and international level which have been concluded between the Union and third countries or third-party organisations; calls for follow-up to the recommendations for an action plan set out in Parliament’s resolution of 23 October 2013 on ‘organised crime, corruption and money laundering: recommendations on action and initiatives to be taken’ (7), especially recommendation 130 on the visibility of measures by the Member States to combat organised fraud and crime, and paragraph 131 on a general action plan for the 2014-2019 period to eradicate organised crime, corruption and money laundering (points i-xxi); calls for the initial results of the implementation of the Currency Counterfeiting Directive to be made available; calls, furthermore, for more information to be provided about the anti-corruption instruments used by OLAF and about the coordination of Member States’ procedures for recovering monies disbursed as a result of fraud; |
| --- | --- |

32.

Calls, therefore, for Article 325 TFEU to be implemented right across the spectrum of EU policies, and for action not just in response to cases of fraud but also to prevent them; calls for compliance with Article 325 TFEU, and particularly with paragraph 5 on annual reports, which is currently facing a year’s delay; calls for simplification, especially, of the way in which EU subsidies are used in cohesion policy; calls for adherence to agreed procedures and for the ratification of the agreements on combating fraud at regional and international level which have been concluded between the Union and third countries or third-party organisations; calls for follow-up to the recommendations for an action plan set out in Parliament’s resolution of 23 October 2013 on ‘organised crime, corruption and money laundering: recommendations on action and initiatives to be taken’ (7), especially recommendation 130 on the visibility of measures by the Member States to combat organised fraud and crime, and paragraph 131 on a general action plan for the 2014-2019 period to eradicate organised crime, corruption and money laundering (points i-xxi); calls for the initial results of the implementation of the Currency Counterfeiting Directive to be made available; calls, furthermore, for more information to be provided about the anti-corruption instruments used by OLAF and about the coordination of Member States’ procedures for recovering monies disbursed as a result of fraud;

| 33. | Calls for the EU to apply for membership of the Council of Europe Group of States against Corruption (GRECO); |
| --- | --- |

33.

Calls for the EU to apply for membership of the Council of Europe Group of States against Corruption (GRECO);

| 34. | Welcomes the fact that in 2014 there were 48 agreements in place that encompassed mutual administrative assistance, covering 71 countries, with another 49 countries in negotiations, including major trading partners such as the USA and Japan, and asks that Parliament be kept constantly informed of developments in these negotiations; emphasises that the top priority in terms of protecting the EU’s financial interests and combating fraud effectively is to ensure that legislation is applied and that all parties observe the relevant international agreements, including relevant anti-fraud and anti-corruption clauses providing for sanctions; encourages the Commission to continue to cooperate with other countries on anti-fraud measures and to establish new administrative cooperation arrangements; invites the Commission to continue to include anti-fraud and anti-corruption provisions in all EU international agreements so as to pave the way for enhanced cooperation in combating organised crime, trafficking and other illegal or illicit trade; |
| --- | --- |

34.

Welcomes the fact that in 2014 there were 48 agreements in place that encompassed mutual administrative assistance, covering 71 countries, with another 49 countries in negotiations, including major trading partners such as the USA and Japan, and asks that Parliament be kept constantly informed of developments in these negotiations; emphasises that the top priority in terms of protecting the EU’s financial interests and combating fraud effectively is to ensure that legislation is applied and that all parties observe the relevant international agreements, including relevant anti-fraud and anti-corruption clauses providing for sanctions; encourages the Commission to continue to cooperate with other countries on anti-fraud measures and to establish new administrative cooperation arrangements; invites the Commission to continue to include anti-fraud and anti-corruption provisions in all EU international agreements so as to pave the way for enhanced cooperation in combating organised crime, trafficking and other illegal or illicit trade;

| 35. | Welcomes the key role played by the EU’s macro-financial assistance (MFA) programme in encouraging reform on the part of the EU’s closest trading partners; requests that the Commission continue to report to Parliament and the Member States with a view to ensuring that all funds are spent in full compliance with the basic regulation and in a manner consistent with regional cohesion and the promotion of regional stability, thereby limiting the risk of misuse of repayable loans; requests a long-term assessment of the effect of MFA programmes on efforts to tackle corruption and fraud in recipient countries; |
| --- | --- |

35.

Welcomes the key role played by the EU’s macro-financial assistance (MFA) programme in encouraging reform on the part of the EU’s closest trading partners; requests that the Commission continue to report to Parliament and the Member States with a view to ensuring that all funds are spent in full compliance with the basic regulation and in a manner consistent with regional cohesion and the promotion of regional stability, thereby limiting the risk of misuse of repayable loans; requests a long-term assessment of the effect of MFA programmes on efforts to tackle corruption and fraud in recipient countries;

| 36. | Reiterates its call for each Member State’s court of auditors to make public national declarations accounting for the spending of EU funds; |
| --- | --- |

36.

Reiterates its call for each Member State’s court of auditors to make public national declarations accounting for the spending of EU funds;

| 37. | Calls on the Commission and the Member States to develop, at their respective levels, interlinked databases on irregularities in the area of cohesion policy, including those arising from public procurement, as such databases are able to provide a basis for meaningful and comprehensive analysis of the frequency, seriousness and causes of irregularities, and of the amounts involved in fraudulent irregularities; emphasises the need for the Member States to ensure that accurate and comparable data are provided to the Commission in an appropriate and timely manner, without a disproportionate increase in administrative burden; |
| --- | --- |

37.

Calls on the Commission and the Member States to develop, at their respective levels, interlinked databases on irregularities in the area of cohesion policy, including those arising from public procurement, as such databases are able to provide a basis for meaningful and comprehensive analysis of the frequency, seriousness and causes of irregularities, and of the amounts involved in fraudulent irregularities; emphasises the need for the Member States to ensure that accurate and comparable data are provided to the Commission in an appropriate and timely manner, without a disproportionate increase in administrative burden;

Better controls

| 38. | Emphasises the complex nature of irregularities; takes the view that the Commission and the Member States must take firm action against fraudulent irregularities; believes that non-fraudulent irregularities should be tackled by means of administrative measures, and in particular through more transparent and simpler requirements, more technical assistance from the Commission to the Member States, and enhanced exchanges of good practices and lessons learned; believes that the methodology for calculating error rates must be harmonised at EU and Member State level; |
| --- | --- |

38.

Emphasises the complex nature of irregularities; takes the view that the Commission and the Member States must take firm action against fraudulent irregularities; believes that non-fraudulent irregularities should be tackled by means of administrative measures, and in particular through more transparent and simpler requirements, more technical assistance from the Commission to the Member States, and enhanced exchanges of good practices and lessons learned; believes that the methodology for calculating error rates must be harmonised at EU and Member State level;

| 39. | Welcomes the fact that the ex-ante and ex-post ‘Community Controls’ are detecting more and more cases of irregularities, and considers, therefore, that these controls should be further promoted; |
| --- | --- |

39.

Welcomes the fact that the ex-ante and ex-post ‘Community Controls’ are detecting more and more cases of irregularities, and considers, therefore, that these controls should be further promoted;

| 40. | Calls on the relevant authorities in the Member States to perform better controls and to use all available information to avoid errors and irregular payments involving EU funds; |
| --- | --- |

40.

Calls on the relevant authorities in the Member States to perform better controls and to use all available information to avoid errors and irregular payments involving EU funds;

| 41. | Encourages the Commission to further enhance its supervisory role through audit, control and inspection activities, remedial action plans and early warning letters; calls on the Member States to intensify their efforts and to tap their potential to detect and correct errors prior to claiming reimbursement from the Commission; underlines, in this regard, the particular value of preventive action in forestalling disbursements and thus eliminating the need for subsequent action to recover misappropriated funds; |
| --- | --- |

41.

Encourages the Commission to further enhance its supervisory role through audit, control and inspection activities, remedial action plans and early warning letters; calls on the Member States to intensify their efforts and to tap their potential to detect and correct errors prior to claiming reimbursement from the Commission; underlines, in this regard, the particular value of preventive action in forestalling disbursements and thus eliminating the need for subsequent action to recover misappropriated funds;

| 42. | Repeats its call on the Commission to develop a system for the exchange of information among the competent authorities so as to enable the cross-checking of accounting entries between two or more Member States in order to prevent transnational fraud in respect of the Structural and Investment Funds, hence ensuring a cross-cutting approach to the protection of the EU’s financial interests; |
| --- | --- |

42.

Repeats its call on the Commission to develop a system for the exchange of information among the competent authorities so as to enable the cross-checking of accounting entries between two or more Member States in order to prevent transnational fraud in respect of the Structural and Investment Funds, hence ensuring a cross-cutting approach to the protection of the EU’s financial interests;

| 43. | Welcomes the fact that all of the Commission’s services developed and implemented their anti-fraud strategies in 2014; invites the EU agencies, executive agencies and joint undertakings to do the same; emphasises the role of the Anti-Fraud Coordination Services (AFCOSs) in fighting fraud; welcomes the adoption of national anti-fraud strategies by Bulgaria, Greece, Croatia, Malta and Slovakia, and calls on the Member States concerned to submit their national anti-fraud strategies (NAFSs) as soon as possible; calls on the Commission to monitor closely the implementation of the NAFSs; |
| --- | --- |

43.

Welcomes the fact that all of the Commission’s services developed and implemented their anti-fraud strategies in 2014; invites the EU agencies, executive agencies and joint undertakings to do the same; emphasises the role of the Anti-Fraud Coordination Services (AFCOSs) in fighting fraud; welcomes the adoption of national anti-fraud strategies by Bulgaria, Greece, Croatia, Malta and Slovakia, and calls on the Member States concerned to submit their national anti-fraud strategies (NAFSs) as soon as possible; calls on the Commission to monitor closely the implementation of the NAFSs;

| 44. | Is eager, in addition, to see closer cooperation between the Member States and the Commission on the ways funds are managed; asks for comprehensive training to be provided for staff of the authorities involved in managing the funds, in particular staff of the AFCOSs, so that they can develop their own national anti-fraud strategies; |
| --- | --- |

44.

Is eager, in addition, to see closer cooperation between the Member States and the Commission on the ways funds are managed; asks for comprehensive training to be provided for staff of the authorities involved in managing the funds, in particular staff of the AFCOSs, so that they can develop their own national anti-fraud strategies;

| 45. | Welcomes the positive results of the first annual overview of the Hercule III programme; expresses concern that the budget reserved for it may be insufficient; requests additional performance-based information, in particular on the contribution of the 55 conferences and training sessions to the effectiveness of the actions taken by Member States to counter fraud, corruption and any other illegal activities affecting the EU’s financial interests; |
| --- | --- |

45.

Welcomes the positive results of the first annual overview of the Hercule III programme; expresses concern that the budget reserved for it may be insufficient; requests additional performance-based information, in particular on the contribution of the 55 conferences and training sessions to the effectiveness of the actions taken by Member States to counter fraud, corruption and any other illegal activities affecting the EU’s financial interests;

| 46. | Reiterates that, according to Article 325(2) TFEU, Member States ‘shall take the same measures to counter fraud affecting the financial interests of the Union as they take to counter fraud affecting their own financial interests’; is of the opinion that this provision is not met in the EU; is of the opinion that the Commission should develop a horizontal policy on the fight against fraud and corruption; emphasises that the Commission is also responsible for the effective spending of funds, and calls, therefore, on the Commission to put in place internal performance requirements; |
| --- | --- |

46.

Reiterates that, according to Article 325(2) TFEU, Member States ‘shall take the same measures to counter fraud affecting the financial interests of the Union as they take to counter fraud affecting their own financial interests’; is of the opinion that this provision is not met in the EU; is of the opinion that the Commission should develop a horizontal policy on the fight against fraud and corruption; emphasises that the Commission is also responsible for the effective spending of funds, and calls, therefore, on the Commission to put in place internal performance requirements;

| 47. | Considers that greater involvement of EU citizens is necessary at the programming and control stages, through easily accessible information tools, especially where major infrastructure is being financed; calls on the Commission to consider the idea of participatory budgeting in order to involve citizens in monitoring the spending of EU funds, and to establish an accessible electronic desk for reporting cases of fraud; |
| --- | --- |

47.

Considers that greater involvement of EU citizens is necessary at the programming and control stages, through easily accessible information tools, especially where major infrastructure is being financed; calls on the Commission to consider the idea of participatory budgeting in order to involve citizens in monitoring the spending of EU funds, and to establish an accessible electronic desk for reporting cases of fraud;

| 48. | Notes that the definition, classification and detection of, and reporting on, irregularities continue to vary between and within Member States, mainly on account of differing definitions of irregularities; takes the view that further harmonisation is necessary, and welcomes, in this context, the Commission delegated regulation of 8 July 2015 on the reporting of irregularities, which supplements the Common Provisions Regulation; calls on the Commission and the Member States to establish coherent strategies for the treatment of irregularities and for the fight against fraud in cohesion policy; highlights the preventive and corrective measures taken by the Commission to avoid fraudulent irregularities, including the interruption of 193 payments under cohesion policy; |
| --- | --- |

48.

Notes that the definition, classification and detection of, and reporting on, irregularities continue to vary between and within Member States, mainly on account of differing definitions of irregularities; takes the view that further harmonisation is necessary, and welcomes, in this context, the Commission delegated regulation of 8 July 2015 on the reporting of irregularities, which supplements the Common Provisions Regulation; calls on the Commission and the Member States to establish coherent strategies for the treatment of irregularities and for the fight against fraud in cohesion policy; highlights the preventive and corrective measures taken by the Commission to avoid fraudulent irregularities, including the interruption of 193 payments under cohesion policy;

| 49. | Recalls that the Common Provisions Regulation requires managing authorities to put in place effective and proportionate anti-fraud measures, which should be embedded in national anti-fraud strategies; calls on the Commission to reinforce its preventive action; welcomes, in this connection, the establishment of a system for the early detection of risks, and calls in particular for the technical and administrative capacities of managing authorities to be strengthened so as to ensure more robust control systems that are able to reduce the risks of fraud and increase detection capacity, including in less developed regions, without imposing undue financial and administrative burden; stresses that prevention should involve constant training and support for staff responsible for the management and control of funds within the competent authorities, as well as exchanges of information and best practices; recalls the crucial role of local and regional authorities and partners in fighting fraud, ensuring transparency and preventing conflicts of interest; |
| --- | --- |

49.

Recalls that the Common Provisions Regulation requires managing authorities to put in place effective and proportionate anti-fraud measures, which should be embedded in national anti-fraud strategies; calls on the Commission to reinforce its preventive action; welcomes, in this connection, the establishment of a system for the early detection of risks, and calls in particular for the technical and administrative capacities of managing authorities to be strengthened so as to ensure more robust control systems that are able to reduce the risks of fraud and increase detection capacity, including in less developed regions, without imposing undue financial and administrative burden; stresses that prevention should involve constant training and support for staff responsible for the management and control of funds within the competent authorities, as well as exchanges of information and best practices; recalls the crucial role of local and regional authorities and partners in fighting fraud, ensuring transparency and preventing conflicts of interest;

| 50. | Appreciates the Commission’s decision to carry out a mid-term assessment in 2018 in order to establish whether the new regulatory architecture for cohesion policy further prevents and reduces the risk of irregularities, including fraud, and looks forward to receiving detailed information on the impact of the new rules on management and control systems, both as regards the risk of irregularities and fraud and as regards the general implementation of the policy; |
| --- | --- |

50.

Appreciates the Commission’s decision to carry out a mid-term assessment in 2018 in order to establish whether the new regulatory architecture for cohesion policy further prevents and reduces the risk of irregularities, including fraud, and looks forward to receiving detailed information on the impact of the new rules on management and control systems, both as regards the risk of irregularities and fraud and as regards the general implementation of the policy;

| 51. | Calls for the Commission and the Court of Auditors to facilitate the transparency of audit data by releasing more detailed information as regards the best- and worst-performing Member States in each policy area and sector, so as to allow actors to identify the areas in which help is most needed and to design actions accordingly; |
| --- | --- |

51.

Calls for the Commission and the Court of Auditors to facilitate the transparency of audit data by releasing more detailed information as regards the best- and worst-performing Member States in each policy area and sector, so as to allow actors to identify the areas in which help is most needed and to design actions accordingly;

PIF directive and EPPO regulation

| 52. | Welcomes the Commission’s statement in its 2014 annual report on the protection of the EU’s financial interests (PIF report) that both the PIF directive and the European Public Prosecutor’s Office regulation (EPPO regulation) ‘would complement and strengthen the legal framework and would considerably reinforce the fight against fraud’; reiterates its view that there is an urgent need to adopt the PIF directive, which should include VAT in its scope and set out a clear definition of PIF offences, minimum rules for maximum applicable imprisonment penalties, and minimum rules on the statute of limitations, as soon as possible; recalls the Taricco case, in which the Court of Justice draws attention to the fact that VAT fraud is indeed included in the 1995 PIF Convention’s definition of PIF fraud; |
| --- | --- |

52.

Welcomes the Commission’s statement in its 2014 annual report on the protection of the EU’s financial interests (PIF report) that both the PIF directive and the European Public Prosecutor’s Office regulation (EPPO regulation) ‘would complement and strengthen the legal framework and would considerably reinforce the fight against fraud’; reiterates its view that there is an urgent need to adopt the PIF directive, which should include VAT in its scope and set out a clear definition of PIF offences, minimum rules for maximum applicable imprisonment penalties, and minimum rules on the statute of limitations, as soon as possible; recalls the Taricco case, in which the Court of Justice draws attention to the fact that VAT fraud is indeed included in the 1995 PIF Convention’s definition of PIF fraud;

| 53. | Stresses that the EPPO regulation should also be adopted swiftly, and demands that the Council explain its reasons for delaying the negotiations; |
| --- | --- |

53.

Stresses that the EPPO regulation should also be adopted swiftly, and demands that the Council explain its reasons for delaying the negotiations;

Public procurement

| 54. | Notes that the level of irregularities due to non-compliance with public procurement rules remains high; calls on the Member States to transpose rapidly into national law Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement (8), which makes e-procurement mandatory and introduces monitoring and reporting obligations to curb procurement fraud and other serious irregularities; calls on the Commission to make it compulsory to publish all documentation relating to beneficiaries, and in particular to subcontractors; |
| --- | --- |

54.

Notes that the level of irregularities due to non-compliance with public procurement rules remains high; calls on the Member States to transpose rapidly into national law Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement (8), which makes e-procurement mandatory and introduces monitoring and reporting obligations to curb procurement fraud and other serious irregularities; calls on the Commission to make it compulsory to publish all documentation relating to beneficiaries, and in particular to subcontractors;

| 55. | Asks the Commission to apply strictly the measures pertaining to discretion and exclusion in respect of public procurement, with proper background checks being carried out in every instance, and to apply the exclusion criteria in order to debar companies in the event of any conflict of interest, this being essential to protect the credibility of the institutions; |
| --- | --- |

55.

Asks the Commission to apply strictly the measures pertaining to discretion and exclusion in respect of public procurement, with proper background checks being carried out in every instance, and to apply the exclusion criteria in order to debar companies in the event of any conflict of interest, this being essential to protect the credibility of the institutions;

| 56. | Emphasises that failure to comply with public procurement rules was a significant source of error for the 2007-2013 programming period, including the avoidance of public procurement by splitting contracts into smaller tenders in order to avoid exceeding thresholds, and the use of inappropriate procedures; points out that the new public procurement directives have to be implemented by April 2016; emphasises that reducing the incidence of irregularities requires correct implementation of the directives by the Member States; calls on the Commission, therefore, to work out guidelines for the proper implementation of the directives; calls on the Commission to monitor closely the implementation of the directives; believes that ex-ante conditionalities have the potential to improve public procurement; emphasises the need for transparent and accessible rules; |
| --- | --- |

56.

Emphasises that failure to comply with public procurement rules was a significant source of error for the 2007-2013 programming period, including the avoidance of public procurement by splitting contracts into smaller tenders in order to avoid exceeding thresholds, and the use of inappropriate procedures; points out that the new public procurement directives have to be implemented by April 2016; emphasises that reducing the incidence of irregularities requires correct implementation of the directives by the Member States; calls on the Commission, therefore, to work out guidelines for the proper implementation of the directives; calls on the Commission to monitor closely the implementation of the directives; believes that ex-ante conditionalities have the potential to improve public procurement; emphasises the need for transparent and accessible rules;

| 57. | Expresses its concern about the lack of full transparency concerning the financing of large infrastructure projects; calls on the Commission to consider submitting a proposal that would make compulsory the publication of all financial reports and projects relating to major public works, including documentation on subcontractors; |
| --- | --- |

57.

Expresses its concern about the lack of full transparency concerning the financing of large infrastructure projects; calls on the Commission to consider submitting a proposal that would make compulsory the publication of all financial reports and projects relating to major public works, including documentation on subcontractors;

| 58. | Asks the Commission to make public all documentation relating to the Lyon-Turin high-speed rail project and its funding; |
| --- | --- |

58.

Asks the Commission to make public all documentation relating to the Lyon-Turin high-speed rail project and its funding;

| 59. | Calls on the Commission to develop a database on irregularities that is capable of providing a basis for meaningful and comprehensive analysis of the frequency, seriousness and causes of public procurement errors; calls on the relevant authorities in the Member States to develop and analyse their own databases on irregularities, including those arising in public procurement, and to cooperate with the Commission in order to provide such data in a form and at a time that facilitates the Commission’s work; |
| --- | --- |

59.

Calls on the Commission to develop a database on irregularities that is capable of providing a basis for meaningful and comprehensive analysis of the frequency, seriousness and causes of public procurement errors; calls on the relevant authorities in the Member States to develop and analyse their own databases on irregularities, including those arising in public procurement, and to cooperate with the Commission in order to provide such data in a form and at a time that facilitates the Commission’s work;

| 60. | Questions the non-fraudulent nature of the increasing number of serious errors made in the context of public procurement procedures, and asks the Commission to be particularly vigilant in this regard, not only by engaging in a dialogue with Member States with a view to better application of existing and new public procurement directives, but also by submitting relevant cases to OLAF for further consideration; |
| --- | --- |

60.

Questions the non-fraudulent nature of the increasing number of serious errors made in the context of public procurement procedures, and asks the Commission to be particularly vigilant in this regard, not only by engaging in a dialogue with Member States with a view to better application of existing and new public procurement directives, but also by submitting relevant cases to OLAF for further consideration;

| 61. | Points out that in emergency situations, such as the use of funds for refugees, there are often exemptions from normal procurement procedures, involving direct access to funds; regrets that, for this reason, there have often been cases of misconduct; calls on the Commission to supervise more effectively the use of such exemptions and the widespread practice of splitting procurement contracts so as not to exceed the thresholds, thereby avoiding regular procurement procedures; |
| --- | --- |

61.

Points out that in emergency situations, such as the use of funds for refugees, there are often exemptions from normal procurement procedures, involving direct access to funds; regrets that, for this reason, there have often been cases of misconduct; calls on the Commission to supervise more effectively the use of such exemptions and the widespread practice of splitting procurement contracts so as not to exceed the thresholds, thereby avoiding regular procurement procedures;

| 62. | Notes that, in its Special Report No 10/2015 entitled ‘Efforts to address problems with public procurement in EU cohesion expenditure should be intensified’, the Court of Auditors analyses procedures connected with public procurement; notes that failure to comply with public procurement rules leads to errors, which may result in implementation delays and financial corrections; calls on the Commission and the Member States to ensure full compliance with the ex-ante conditionality regarding effective application of public procurement law by the end of 2016; calls on the Member States to ensure appropriate and quick transposition of the 2014 package of public procurement directives; |
| --- | --- |

62.

Notes that, in its Special Report No 10/2015 entitled ‘Efforts to address problems with public procurement in EU cohesion expenditure should be intensified’, the Court of Auditors analyses procedures connected with public procurement; notes that failure to comply with public procurement rules leads to errors, which may result in implementation delays and financial corrections; calls on the Commission and the Member States to ensure full compliance with the ex-ante conditionality regarding effective application of public procurement law by the end of 2016; calls on the Member States to ensure appropriate and quick transposition of the 2014 package of public procurement directives;

| 63. | Urges the Member States and the Commission to exploit fully the opportunities afforded by information technology (IT) tools in public procurement, including tools for e-procurement, the exchange of good practices and preventive risk-scoring; appreciates the web-based fraud alert tool Arachne developed by the Commission, which is aimed at identifying the most risky projects on the basis of a set of risk indicators, and calls on the Member States to use this tool; |
| --- | --- |

63.

Urges the Member States and the Commission to exploit fully the opportunities afforded by information technology (IT) tools in public procurement, including tools for e-procurement, the exchange of good practices and preventive risk-scoring; appreciates the web-based fraud alert tool Arachne developed by the Commission, which is aimed at identifying the most risky projects on the basis of a set of risk indicators, and calls on the Member States to use this tool;

Performance-based budgeting and the ‘value for money’ approach

| 64. | Stresses the importance of leading by example, and warmly welcomes the interinstitutional approach to implementing performance-based budgeting; calls on the Commission to adopt the planning, implementation and control phase of the multiannual financial framework in accordance with the principle of performance-based budgeting; |
| --- | --- |

64.

Stresses the importance of leading by example, and warmly welcomes the interinstitutional approach to implementing performance-based budgeting; calls on the Commission to adopt the planning, implementation and control phase of the multiannual financial framework in accordance with the principle of performance-based budgeting;

| 65. | Notes the importance of further and continuous measures to avoid fraudulent irregularities, but also reiterates its call for the adoption of a new methodology focused on performance rather than on the formalistic evaluation of programmes, in line with the principle of an EU budget focused on results; calls on Commission to reinforce its activities in relation to applying efficiency and effectiveness indicators in all its programmes, and not to concentrate only on the error rate; calls on the Commission, furthermore, not to work only on the three main categories — economy, efficiency and effectiveness — but to start focusing also on the new triptych (ecology, equality and ethics); |
| --- | --- |

65.

Notes the importance of further and continuous measures to avoid fraudulent irregularities, but also reiterates its call for the adoption of a new methodology focused on performance rather than on the formalistic evaluation of programmes, in line with the principle of an EU budget focused on results; calls on Commission to reinforce its activities in relation to applying efficiency and effectiveness indicators in all its programmes, and not to concentrate only on the error rate; calls on the Commission, furthermore, not to work only on the three main categories — economy, efficiency and effectiveness — but to start focusing also on the new triptych (ecology, equality and ethics);

| 66. | Calls for the mandatory inclusion of ex-ante assessments of environmental, economic and social added value in the process for selecting projects for funding, both within and outside the Union, and for the results of those assessments and the indicators used to be made public and to be fully accessible; |
| --- | --- |

66.

Calls for the mandatory inclusion of ex-ante assessments of environmental, economic and social added value in the process for selecting projects for funding, both within and outside the Union, and for the results of those assessments and the indicators used to be made public and to be fully accessible;

| 67. | Notes that reporting on performance is still weak, and that there is a need to assess regularly input parameters (the financial, human, material, organisational or regulatory means needed to implement a programme), outputs (the programme’s deliverables), results (the programme’s immediate effects) and impacts (long-term changes in society); |
| --- | --- |

67.

Notes that reporting on performance is still weak, and that there is a need to assess regularly input parameters (the financial, human, material, organisational or regulatory means needed to implement a programme), outputs (the programme’s deliverables), results (the programme’s immediate effects) and impacts (long-term changes in society);

| 68. | Welcomes the setting-up of a network of Member State National Contact Points and the incorporation of anti-corruption objectives into the European Semester process of economic governance; |
| --- | --- |

68.

Welcomes the setting-up of a network of Member State National Contact Points and the incorporation of anti-corruption objectives into the European Semester process of economic governance;

| 69. | Urges the Commission to publish immediately its assessment of all agreements with tobacco companies, with a view to establishing their efficiency in combating fraud and counterfeiting activities, which affect the financial interests of the EU, and to evaluate the appropriateness of renewing these kinds of agreement; |
| --- | --- |

69.

Urges the Commission to publish immediately its assessment of all agreements with tobacco companies, with a view to establishing their efficiency in combating fraud and counterfeiting activities, which affect the financial interests of the EU, and to evaluate the appropriateness of renewing these kinds of agreement;

| 70. | Emphasises the role of the Court of Auditors, the Supreme Audit Institutions (SAIs), the Commission and the Managing Authorities in controlling the regularity and performance of public spending; calls on the Court of Auditors and the Commission to further improve their cooperation with SAIs in Member States in order to broaden the scope and proportion of funds and projects audited; |
| --- | --- |

70.

Emphasises the role of the Court of Auditors, the Supreme Audit Institutions (SAIs), the Commission and the Managing Authorities in controlling the regularity and performance of public spending; calls on the Court of Auditors and the Commission to further improve their cooperation with SAIs in Member States in order to broaden the scope and proportion of funds and projects audited;

Tobacco smuggling


  and counterfeit goods

| 71. | Is worried about the finding by the European Ombudsman (9) that, with the exception of DG Health, the Commission was ‘not fully implementing UN WHO rules and guidelines governing transparency and tobacco lobbying’; is of the opinion, therefore, that the Commission’s credibility and seriousness have been endangered; |
| --- | --- |

71.

Is worried about the finding by the European Ombudsman (9) that, with the exception of DG Health, the Commission was ‘not fully implementing UN WHO rules and guidelines governing transparency and tobacco lobbying’; is of the opinion, therefore, that the Commission’s credibility and seriousness have been endangered;

| 72. | Urges all the relevant EU institutions to implement Article 5(3) of the WHO Framework Convention on Tobacco Control (FCTC) in accordance with the recommendations contained in the guidelines thereto; urges the Commission to publish immediately its assessment of agreements with tobacco companies and an impact assessment on the implementation of the FCTC; calls on the Commission to provide complete transparency concerning agreements on tobacco and their possible renewal, and urges the Member States to report regularly on expenditure incurred in respect of the funds received as a result of such agreements; |
| --- | --- |

72.

Urges all the relevant EU institutions to implement Article 5(3) of the WHO Framework Convention on Tobacco Control (FCTC) in accordance with the recommendations contained in the guidelines thereto; urges the Commission to publish immediately its assessment of agreements with tobacco companies and an impact assessment on the implementation of the FCTC; calls on the Commission to provide complete transparency concerning agreements on tobacco and their possible renewal, and urges the Member States to report regularly on expenditure incurred in respect of the funds received as a result of such agreements;

| 73. | Welcomes the successful outcomes of numerous joint customs operations (JCOs) involving the cooperation of OLAF and Member States with various third-country services, which have resulted in the seizure of, inter alia, 1,2 million counterfeit goods, including perfumes, vehicle spare parts, electronic devices and 130 million cigarettes; underlines the fact that the smuggling of heavily taxed goods causes significant losses of revenue to the budgets of the EU and the Member States, and that direct losses in customs revenue as a result of cigarette smuggling alone are estimated at more than EUR 10 billion a year; points out that trafficking in counterfeit goods inflicts damage on the revenue of the EU and its Member States and on European companies; |
| --- | --- |

73.

Welcomes the successful outcomes of numerous joint customs operations (JCOs) involving the cooperation of OLAF and Member States with various third-country services, which have resulted in the seizure of, inter alia, 1,2 million counterfeit goods, including perfumes, vehicle spare parts, electronic devices and 130 million cigarettes; underlines the fact that the smuggling of heavily taxed goods causes significant losses of revenue to the budgets of the EU and the Member States, and that direct losses in customs revenue as a result of cigarette smuggling alone are estimated at more than EUR 10 billion a year; points out that trafficking in counterfeit goods inflicts damage on the revenue of the EU and its Member States and on European companies;

| 74. | Is very concerned about the increasing incidence of smuggling, trafficking and other forms of illegal and illicit trade, which not only have an impact on Member States’ collection of customs duties and consequently on the EU budget, but are also strongly associated with organised international crime, threats to consumers and negative effects on the functioning of the single market, and which undermine a level playing field for all competing companies, particularly SMEs; requests, therefore, better coordination between OLAF, customs authorities and market surveillance authorities in order not only to combat these problems but also to curb the trade in products that infringe intellectual property laws in the EU; |
| --- | --- |

74.

Is very concerned about the increasing incidence of smuggling, trafficking and other forms of illegal and illicit trade, which not only have an impact on Member States’ collection of customs duties and consequently on the EU budget, but are also strongly associated with organised international crime, threats to consumers and negative effects on the functioning of the single market, and which undermine a level playing field for all competing companies, particularly SMEs; requests, therefore, better coordination between OLAF, customs authorities and market surveillance authorities in order not only to combat these problems but also to curb the trade in products that infringe intellectual property laws in the EU;

| 75. | Stresses the importance of distinguishing between legitimate generic medicines and fraudulent counterfeit drugs so as to avoid interrupting the production and legitimate trade of generic medicines, and invites, once again, all those Member States which have signed but not yet ratified the UN Protocol to Eliminate Illicit Trade in Tobacco Products to complete the ratification process as soon as possible; |
| --- | --- |

75.

Stresses the importance of distinguishing between legitimate generic medicines and fraudulent counterfeit drugs so as to avoid interrupting the production and legitimate trade of generic medicines, and invites, once again, all those Member States which have signed but not yet ratified the UN Protocol to Eliminate Illicit Trade in Tobacco Products to complete the ratification process as soon as possible;

Investigations and the role of OLAF

| 76. | Notes OLAF’s role within different JCOs in preventing losses for the EU budget, and asks OLAF to include in its future annual reports more information and concrete figures concerning its contribution to protecting the revenue side of the EU budget; |
| --- | --- |

76.

Notes OLAF’s role within different JCOs in preventing losses for the EU budget, and asks OLAF to include in its future annual reports more information and concrete figures concerning its contribution to protecting the revenue side of the EU budget;

| 77. | Welcomes the annual interinstitutional meetings between the Council, the Commission, Parliament, OLAF and its Supervisory Committee; insists on the presidency rotating between the three European institutions; invites the Commission to support Parliament’s initiative, and urges the Council to reconsider its negative position on this matter; |
| --- | --- |

77.

Welcomes the annual interinstitutional meetings between the Council, the Commission, Parliament, OLAF and its Supervisory Committee; insists on the presidency rotating between the three European institutions; invites the Commission to support Parliament’s initiative, and urges the Council to reconsider its negative position on this matter;

| 78. | Reiterates its call relating to the Annual Report 2013 on the Protection of the EU’s Financial Interests (10) for a speedy resolution of the remaining issues between OLAF and its Supervisory Committee; reiterates that neither OLAF nor its Supervisory Committee can fulfil their legal duties effectively under the conditions of their current limited cooperation; notes with concern the lack of progress, and thus considers the current situation unacceptable; calls on the Commission to play its role fully and to work actively on a long-term solution to be put in place without delay; |
| --- | --- |

78.

Reiterates its call relating to the Annual Report 2013 on the Protection of the EU’s Financial Interests (10) for a speedy resolution of the remaining issues between OLAF and its Supervisory Committee; reiterates that neither OLAF nor its Supervisory Committee can fulfil their legal duties effectively under the conditions of their current limited cooperation; notes with concern the lack of progress, and thus considers the current situation unacceptable; calls on the Commission to play its role fully and to work actively on a long-term solution to be put in place without delay;

| 79. | Is of the opinion that the Supervisory Committee should, as a matter of consistency with its mandate, have autonomous staff who are detached from the OLAF administration and enjoy financial autonomy; calls on OLAF to grant the Supervisory Committee access to documents that the Supervisory Committee deems necessary in order to fulfil its task in accordance with its remit; urges the Commission to put forward a proposal to change the OLAF Regulation accordingly; |
| --- | --- |

79.

Is of the opinion that the Supervisory Committee should, as a matter of consistency with its mandate, have autonomous staff who are detached from the OLAF administration and enjoy financial autonomy; calls on OLAF to grant the Supervisory Committee access to documents that the Supervisory Committee deems necessary in order to fulfil its task in accordance with its remit; urges the Commission to put forward a proposal to change the OLAF Regulation accordingly;

| 80. | Notes that there is a discrepancy between the information collected by OLAF from public and private sources in the Member States concerning fraud (OLAF Report 2014) and the highly uneven financial recovery recommended by OLAF to the Member States; calls on the Commission to support initiatives aimed at increasing the recovery rate in fraud cases; |
| --- | --- |

80.

Notes that there is a discrepancy between the information collected by OLAF from public and private sources in the Member States concerning fraud (OLAF Report 2014) and the highly uneven financial recovery recommended by OLAF to the Member States; calls on the Commission to support initiatives aimed at increasing the recovery rate in fraud cases;

| 81. | Urges the Commission to provide full transparency regarding all requests by national prosecutors to lift the immunity of OLAF staff, including its Director-General; |
| --- | --- |

81.

Urges the Commission to provide full transparency regarding all requests by national prosecutors to lift the immunity of OLAF staff, including its Director-General;

| 82. | Welcomes the proven effectiveness of OLAF’s origin investigations concerning the eligibility of preferential tariff measures, and calls on the Member States to give consideration to these findings and to take all necessary and appropriate measures in accordance with the provisions of EU customs legislation; calls on the Commission, with a view to preventing losses from the EU budget arising from the import of goods not entitled to preferential tariff treatment under preferential trade agreements (PTAs), to continue to verify that Member States improve the effectiveness of their risk management systems and control strategies on the basis of the mutual assistance communications; asks the Commission, furthermore, to follow up on its commitment to carrying out ex-post evaluations of PTAs with significant economic, social and environmental impact, including a periodic system of reporting by beneficiary countries on their management and control of preferential origin; |
| --- | --- |

82.

Welcomes the proven effectiveness of OLAF’s origin investigations concerning the eligibility of preferential tariff measures, and calls on the Member States to give consideration to these findings and to take all necessary and appropriate measures in accordance with the provisions of EU customs legislation; calls on the Commission, with a view to preventing losses from the EU budget arising from the import of goods not entitled to preferential tariff treatment under preferential trade agreements (PTAs), to continue to verify that Member States improve the effectiveness of their risk management systems and control strategies on the basis of the mutual assistance communications; asks the Commission, furthermore, to follow up on its commitment to carrying out ex-post evaluations of PTAs with significant economic, social and environmental impact, including a periodic system of reporting by beneficiary countries on their management and control of preferential origin;

| 83. | Notes that the comprehensive prosecution of crime, including fraud, corruption, money laundering, related organised crime and other illegal activities affecting the financial interests of the EU, is a conditio sine qua non for the effective functioning of the EU; emphasises the need for systemic follow-up to OLAF recommendations; is of the opinion that following up those recommendations requires procedural rights for OLAF in national legislations to make sure that recommendations are respected and taken into account by national authorities; |
| --- | --- |

83.

Notes that the comprehensive prosecution of crime, including fraud, corruption, money laundering, related organised crime and other illegal activities affecting the financial interests of the EU, is a conditio sine qua non for the effective functioning of the EU; emphasises the need for systemic follow-up to OLAF recommendations; is of the opinion that following up those recommendations requires procedural rights for OLAF in national legislations to make sure that recommendations are respected and taken into account by national authorities;

| 84. | Calls for the Commission to clarify the main reasons that Member States are not following up alleged cases of fraud affecting the EU’s financial interests, as submitted to them by OLAF; |
| --- | --- |

84.

Calls for the Commission to clarify the main reasons that Member States are not following up alleged cases of fraud affecting the EU’s financial interests, as submitted to them by OLAF;

o

o o

| 85. | Instructs its President to forward this resolution to the Council and the Commission, the Court of Justice of the European Union, the European Court of Auditors, the European Anti-Fraud Office (OLAF) and the OLAF Supervisory Committee. |
| --- | --- |

85.

Instructs its President to forward this resolution to the Council and the Commission, the Court of Justice of the European Union, the European Court of Auditors, the European Anti-Fraud Office (OLAF) and the OLAF Supervisory Committee.

---

(1)  OJ L 84, 20.3.2014, p. 6.

(2)  OJ L 248, 18.9.2013, p. 1.

(3)  OJ L 298, 26.10.2012, p. 1.

(4)  OJ C 51 E, 22.2.2013, p. 121.

(5)  OJ C 161 E, 31.5.2011, p. 62.

(6)  OJ L 312, 23.12.1995, p. 1.

(7)  Texts adopted, P7_TA(2013)0444.

(8)  OJ L 94, 28.3.2014, p. 65.

(9)  http://www.ombudsman.europa.eu/en/press/release.faces/en/61027/html.bookmark

(10)  Texts adopted of 11 March 2015, P8_TA(2015)0062.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/15 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/15

---

P8_TA(2016)0072

Gender mainstreaming in the work of the European Parliament

European Parliament resolution of 8 March 2016 on Gender Mainstreaming in the work of the European Parliament (2015/2230(INI))

(2018/C 050/02)

The European Parliament,

| — | having regard to Article 2 and Article 3(3), second subparagraph, of the Treaty on European Union (TEU) and Article 8 of the Treaty on the Functioning of the European Union (TFEU), |
| --- | --- |

—

having regard to Article 2 and Article 3(3), second subparagraph, of the Treaty on European Union (TEU) and Article 8 of the Treaty on the Functioning of the European Union (TFEU),

| — | having regard to Article 23 of the Charter of Fundamental Rights of the European Union, |
| --- | --- |

—

having regard to Article 23 of the Charter of Fundamental Rights of the European Union,

| — | having regard to the Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR), |
| --- | --- |

—

having regard to the Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR),

| — | having regard to the 1948 Universal Declaration of Human Rights, |
| --- | --- |

—

having regard to the 1948 Universal Declaration of Human Rights,

| — | having regard to the 1979 UN Convention on the Elimination of All Forms of Discrimination against Women (CEDAW), |
| --- | --- |

—

having regard to the 1979 UN Convention on the Elimination of All Forms of Discrimination against Women (CEDAW),

| — | having regard to the Beijing Declaration and Platform for Action adopted by the Fourth World Conference on Women on 15 September 1995, to the subsequent outcome documents adopted at the United Nations Beijing + 5 (2000), Beijing + 10 (2005) and Beijing + 15 (2010) special sessions and on the outcome document of the Beijing + 20 review conference, |
| --- | --- |

—

having regard to the Beijing Declaration and Platform for Action adopted by the Fourth World Conference on Women on 15 September 1995, to the subsequent outcome documents adopted at the United Nations Beijing + 5 (2000), Beijing + 10 (2005) and Beijing + 15 (2010) special sessions and on the outcome document of the Beijing + 20 review conference,

| — | having regard to the Council conclusions of 26 May 2015 on Gender in Development, |
| --- | --- |

—

having regard to the Council conclusions of 26 May 2015 on Gender in Development,

| — | having regard to the joint staff working document of 21 September 2015 entitled ‘Gender Equality and Women’s Empowerment: Transforming the Lives of Girls and Women through EU External Relations 2016-2020’ (SWD(2015)0182), and the Council conclusions of 26 October 2015 on the Gender Action Plan 2016-2020, |
| --- | --- |

—

having regard to the joint staff working document of 21 September 2015 entitled ‘Gender Equality and Women’s Empowerment: Transforming the Lives of Girls and Women through EU External Relations 2016-2020’ (SWD(2015)0182), and the Council conclusions of 26 October 2015 on the Gender Action Plan 2016-2020,

| — | having regard to Article 3 of the Council of Europe Convention on preventing and combating violence against women and domestic violence, which defines ‘gender’ as ‘the socially constructed roles, behaviours, activities and attributes that a given society considers appropriate for women and men’, |
| --- | --- |

—

having regard to Article 3 of the Council of Europe Convention on preventing and combating violence against women and domestic violence, which defines ‘gender’ as ‘the socially constructed roles, behaviours, activities and attributes that a given society considers appropriate for women and men’,

| — | having regard to the European Pact for Gender Equality (2011-2020), adopted by the European Council in March 2011, |
| --- | --- |

—

having regard to the European Pact for Gender Equality (2011-2020), adopted by the European Council in March 2011,

| — | having regard to the Commission communication of 5 March 2010 entitled ‘A Strengthened Commitment to Equality between Women and Men: A Women’s Charter’ (COM(2010)0078), |
| --- | --- |

—

having regard to the Commission communication of 5 March 2010 entitled ‘A Strengthened Commitment to Equality between Women and Men: A Women’s Charter’ (COM(2010)0078),

| — | having regard to the Commission communication of 21 September 2010 entitled ‘Strategy for equality between women and men 2010-2015’ (COM(2010)0491), |
| --- | --- |

—

having regard to the Commission communication of 21 September 2010 entitled ‘Strategy for equality between women and men 2010-2015’ (COM(2010)0491),

| — | having regard to the Commission staff working document entitled ‘Strategic engagement for gender equality 2016-2019’ (SWD(2015)0278), |
| --- | --- |

—

having regard to the Commission staff working document entitled ‘Strategic engagement for gender equality 2016-2019’ (SWD(2015)0278),

| — | having regard to the Commission’s research report entitled ‘Evaluation of the strengths and weaknesses of the strategy for equality between women and men 2010-2015’, |
| --- | --- |

—

having regard to the Commission’s research report entitled ‘Evaluation of the strengths and weaknesses of the strategy for equality between women and men 2010-2015’,

| — | having regard to the Council of Europe’s Gender Equality Strategy 2014-2017, |
| --- | --- |

—

having regard to the Council of Europe’s Gender Equality Strategy 2014-2017,

| — | having regard to European Institute for Gender Equality (EIGE) study on ‘Advancing women in political decision-making — Way forward’, published in 2015, |
| --- | --- |

—

having regard to European Institute for Gender Equality (EIGE) study on ‘Advancing women in political decision-making — Way forward’, published in 2015,

| — | having regard to the conclusions and recommendations of EIGE’s report on ‘Gender-Sensitive Parliaments: A Global Review of Good Practice’, published in 2011, |
| --- | --- |

—

having regard to the conclusions and recommendations of EIGE’s report on ‘Gender-Sensitive Parliaments: A Global Review of Good Practice’, published in 2011,

| — | having regard to its resolutions of 10 February 2010 on equality between women and men in the European Union — 2009 (1), of 8 March 2011 on equality between women and men in the European Union — 2010 (2), of 13 March 2012 on equality between women and men in the European Union — 2011 (3), and of 10 March 2015 on progress on equality between women and men in the European Union in 2013 (4), |
| --- | --- |

—

having regard to its resolutions of 10 February 2010 on equality between women and men in the European Union — 2009 (1), of 8 March 2011 on equality between women and men in the European Union — 2010 (2), of 13 March 2012 on equality between women and men in the European Union — 2011 (3), and of 10 March 2015 on progress on equality between women and men in the European Union in 2013 (4),

| — | having regard to its resolution of 13 March 2003 on gender mainstreaming in the European Parliament (5), |
| --- | --- |

—

having regard to its resolution of 13 March 2003 on gender mainstreaming in the European Parliament (5),

| — | having regard to its resolution of 18 January 2007 on gender mainstreaming in the work of the committees (6), |
| --- | --- |

—

having regard to its resolution of 18 January 2007 on gender mainstreaming in the work of the committees (6),

| — | having regard to its resolution of 22 April 2009 on gender mainstreaming in the work of its committees and delegations (7), |
| --- | --- |

—

having regard to its resolution of 22 April 2009 on gender mainstreaming in the work of its committees and delegations (7),

| — | having regard to its resolution of 7 May 2009 on gender mainstreaming in EU external relations and peace-building/nation-building (8), |
| --- | --- |

—

having regard to its resolution of 7 May 2009 on gender mainstreaming in EU external relations and peace-building/nation-building (8),

| — | having regard to its resolution of 13 March 2012 on women in political decision-making — quality and equality (9), |
| --- | --- |

—

having regard to its resolution of 13 March 2012 on women in political decision-making — quality and equality (9),

| — | having regard to its resolution of 9 June 2015 on the EU Strategy for equality between women and men post 2015 (10), |
| --- | --- |

—

having regard to its resolution of 9 June 2015 on the EU Strategy for equality between women and men post 2015 (10),

| — | having regard to its resolution of 3 February 2016 on the new Strategy for Women’s Rights and Gender Equality in Europe post-2015 (11), |
| --- | --- |

—

having regard to its resolution of 3 February 2016 on the new Strategy for Women’s Rights and Gender Equality in Europe post-2015 (11),

| — | having regard to the Commission communication of 21 February 1996 entitled ‘Incorporating equal opportunities for women and men into all Community policies and activities’ (COM(1996)0067) committing itself to ‘[promoting] equality between women and men in all [its] activities and policies at all levels’, effectively specifying the gender mainstreaming principle, |
| --- | --- |

—

having regard to the Commission communication of 21 February 1996 entitled ‘Incorporating equal opportunities for women and men into all Community policies and activities’ (COM(1996)0067) committing itself to ‘[promoting] equality between women and men in all [its] activities and policies at all levels’, effectively specifying the gender mainstreaming principle,

| — | having regard to the study entitled ‘Evaluation of the Strategy for Equality between women and men 2010-2015 as a contribution to achieve the goals of the Beijing Platform for Action’, published in 2014 by European Parliament Policy Department C, |
| --- | --- |

—

having regard to the study entitled ‘Evaluation of the Strategy for Equality between women and men 2010-2015 as a contribution to achieve the goals of the Beijing Platform for Action’, published in 2014 by European Parliament Policy Department C,

| — | having regard to the study entitled ‘Gender Mainstreaming in Committees and Delegations of the European Parliament’, published in 2014 by European Parliament Policy Department C, |
| --- | --- |

—

having regard to the study entitled ‘Gender Mainstreaming in Committees and Delegations of the European Parliament’, published in 2014 by European Parliament Policy Department C,

| — | having regard to the study entitled ‘The EU Budget for Gender Equality’, published in 2015 by European Parliament Policy Department D, |
| --- | --- |

—

having regard to the study entitled ‘The EU Budget for Gender Equality’, published in 2015 by European Parliament Policy Department D,

| — | having regard to the note entitled ‘Guidance on the development of gender equality and the empowerment of women policies’, published by UN Women in May 2014, |
| --- | --- |

—

having regard to the note entitled ‘Guidance on the development of gender equality and the empowerment of women policies’, published by UN Women in May 2014,

| — | having regard to the paper entitled ‘Advances in EU Gender Equality: Missing the mark?’ published in 2014 by the European Policy Institutes Network, |
| --- | --- |

—

having regard to the paper entitled ‘Advances in EU Gender Equality: Missing the mark?’ published in 2014 by the European Policy Institutes Network,

| — | having regard to the Human Resources Annual Report 2014 published by the European Parliament’s Directorate-General for Personnel, |
| --- | --- |

—

having regard to the Human Resources Annual Report 2014 published by the European Parliament’s Directorate-General for Personnel,

| — | having regard to Rule 52 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 52 of its Rules of Procedure,

| — | having regard to the report of the Committee on Women’s Rights and Gender Equality (A8-0034/2016), |
| --- | --- |

—

having regard to the report of the Committee on Women’s Rights and Gender Equality (A8-0034/2016),

| A. | whereas Article 8 of the Treaty on the Functioning of the European Union (TFUE) lays down gender mainstreaming as a horizontal principle and Article 2 of the Treaty on European Union (TUE) lays down the principle of gender equality as a value of the Union; |
| --- | --- |

A.

whereas Article 8 of the Treaty on the Functioning of the European Union (TFUE) lays down gender mainstreaming as a horizontal principle and Article 2 of the Treaty on European Union (TUE) lays down the principle of gender equality as a value of the Union;

| B. | whereas the Charter of Fundamental Rights contains specific provisions on the horizontal principle of gender equality, and Article 6 TEU recognises that the Charter has the same legal values as the Treaties; |
| --- | --- |

B.

whereas the Charter of Fundamental Rights contains specific provisions on the horizontal principle of gender equality, and Article 6 TEU recognises that the Charter has the same legal values as the Treaties;

| C. | whereas achieving gender equality is central to the protection of human rights, the functioning of democracy, respect for the rule of law, and economic growth, social inclusion and sustainability; |
| --- | --- |

C.

whereas achieving gender equality is central to the protection of human rights, the functioning of democracy, respect for the rule of law, and economic growth, social inclusion and sustainability;

| D. | whereas progress in achieving gender equality in the EU is stagnating and at this pace will not be achieved for some time yet; |
| --- | --- |

D.

whereas progress in achieving gender equality in the EU is stagnating and at this pace will not be achieved for some time yet;

| E. | whereas, in the Strategic engagement for gender equality 2016-2019, the Commission undertook to continue gender mainstreaming actions, including through evaluation and monitoring exercises; whereas the Commission has downgraded its strategic engagement for gender equality post 2015 to a staff working document; |
| --- | --- |

E.

whereas, in the Strategic engagement for gender equality 2016-2019, the Commission undertook to continue gender mainstreaming actions, including through evaluation and monitoring exercises; whereas the Commission has downgraded its strategic engagement for gender equality post 2015 to a staff working document;

| F. | whereas the fifth objective of the Sustainable Development Goals is the achievement of gender equality by 2030; |
| --- | --- |

F.

whereas the fifth objective of the Sustainable Development Goals is the achievement of gender equality by 2030;

| G. | whereas gender mainstreaming means ‘the integration of a gender perspective into every aspect of EU policy — preparation, design, implementation, monitoring and evaluation of policies, legal measures and spending programmes — with a view to achieving equality between women and men’ (12); |
| --- | --- |

G.

whereas gender mainstreaming means ‘the integration of a gender perspective into every aspect of EU policy — preparation, design, implementation, monitoring and evaluation of policies, legal measures and spending programmes — with a view to achieving equality between women and men’ (12);

| H. | whereas gender mainstreaming must include the rights, perspectives and well-being of LGBTIQ people and people of all gender identities; |
| --- | --- |

H.

whereas gender mainstreaming must include the rights, perspectives and well-being of LGBTIQ people and people of all gender identities;

| I. | whereas gender mainstreaming should be a proactive and reactive tool to achieve gender equality; |
| --- | --- |

I.

whereas gender mainstreaming should be a proactive and reactive tool to achieve gender equality;

| J. | whereas gender mainstreaming is not a policy goal in itself, but a key means of achieving gender equality, always in combination with other specific actions and policies targeted at advancing gender equality; |
| --- | --- |

J.

whereas gender mainstreaming is not a policy goal in itself, but a key means of achieving gender equality, always in combination with other specific actions and policies targeted at advancing gender equality;

| K. | whereas one of the competences of the committee responsible is to contribute to the implementation and further development of gender mainstreaming in all policy areas; |
| --- | --- |

K.

whereas one of the competences of the committee responsible is to contribute to the implementation and further development of gender mainstreaming in all policy areas;

| L. | whereas the majority of parliamentary committees generally give importance to gender mainstreaming (e.g. in their legislative work, in their working relations with the Committee on Women’s Rights and Gender Equality and when drawing up action plans on equality), while some committees exhibit little or no interest in this matter; |
| --- | --- |

L.

whereas the majority of parliamentary committees generally give importance to gender mainstreaming (e.g. in their legislative work, in their working relations with the Committee on Women’s Rights and Gender Equality and when drawing up action plans on equality), while some committees exhibit little or no interest in this matter;

| M. | whereas, since the previous parliamentary term, the committee responsible has developed a practice of making focused contributions to the reports of other committees through ‘gender mainstreaming amendments’ (GMAs); whereas according to a study published in 2014 (13), 85 % of the GMAs tabled between July 2011 and February 2013 have been incorporated in the final reports adopted by lead committees; whereas further data from February 2013 onwards is necessary for an updated assessment to be made of the gender mainstreaming situation in Parliament; |
| --- | --- |

M.

whereas, since the previous parliamentary term, the committee responsible has developed a practice of making focused contributions to the reports of other committees through ‘gender mainstreaming amendments’ (GMAs); whereas according to a study published in 2014 (13), 85 % of the GMAs tabled between July 2011 and February 2013 have been incorporated in the final reports adopted by lead committees; whereas further data from February 2013 onwards is necessary for an updated assessment to be made of the gender mainstreaming situation in Parliament;

| N. | whereas, following the 2003 resolution on gender mainstreaming, each parliamentary committee appoints one of its members as responsible for gender mainstreaming, thus establishing ‘the gender mainstreaming network’; whereas subsequent resolutions on this topic called for the continuous development of this network and for a similar network to be established in the interparliamentary delegations; whereas the network is supported by a network at staff level in the committee secretariats; |
| --- | --- |

N.

whereas, following the 2003 resolution on gender mainstreaming, each parliamentary committee appoints one of its members as responsible for gender mainstreaming, thus establishing ‘the gender mainstreaming network’; whereas subsequent resolutions on this topic called for the continuous development of this network and for a similar network to be established in the interparliamentary delegations; whereas the network is supported by a network at staff level in the committee secretariats;

| O. | whereas a questionnaire was filled in by members of the network in order to assess the state of play of gender mainstreaming in their respective policy areas; |
| --- | --- |

O.

whereas a questionnaire was filled in by members of the network in order to assess the state of play of gender mainstreaming in their respective policy areas;

| P. | whereas the MFF (multiannual financial framework) is accompanied by a joint declaration by the three institutions, which agreed that ‘the annual budgetary procedures applied for the MFF 2014-2020 will integrate, as appropriate, gender-responsive elements, taking into account the ways in which the overall financial framework of the Union contributes to increased gender equality (and ensures gender mainstreaming)’; whereas, despite this, the actual commitment to continuing gender mainstreaming and empowering women needs to be bolstered, since existing policies have only been implemented to a modest extent and insufficient budgetary resources have been allocated specifically for gender matters; |
| --- | --- |

P.

whereas the MFF (multiannual financial framework) is accompanied by a joint declaration by the three institutions, which agreed that ‘the annual budgetary procedures applied for the MFF 2014-2020 will integrate, as appropriate, gender-responsive elements, taking into account the ways in which the overall financial framework of the Union contributes to increased gender equality (and ensures gender mainstreaming)’; whereas, despite this, the actual commitment to continuing gender mainstreaming and empowering women needs to be bolstered, since existing policies have only been implemented to a modest extent and insufficient budgetary resources have been allocated specifically for gender matters;

| Q. | whereas gender budgeting has not been consistently applied by any of the EU institutions; |
| --- | --- |

Q.

whereas gender budgeting has not been consistently applied by any of the EU institutions;

| R. | whereas the European Institute for Gender Equality (EIGE) has been established to contribute to and strengthen the promotion of gender equality, including gender mainstreaming in all EU policies and the resulting national policies; whereas EIGE has developed a Platform on Gender Mainstreaming and a Gender Equality Glossary and Thesaurus to support decision makers, the staff of the EU institutions and governmental bodies with the integration of a gender perspective in their work; |
| --- | --- |

R.

whereas the European Institute for Gender Equality (EIGE) has been established to contribute to and strengthen the promotion of gender equality, including gender mainstreaming in all EU policies and the resulting national policies; whereas EIGE has developed a Platform on Gender Mainstreaming and a Gender Equality Glossary and Thesaurus to support decision makers, the staff of the EU institutions and governmental bodies with the integration of a gender perspective in their work;

| S. | whereas gender mainstreaming involves both integrating a gender perspective into the content of the different policies and addressing the issue of the representation of women, men and people of all gender identities in the given policy areas; whereas both dimensions need to be taken into consideration in all phases of the policy-making process; |
| --- | --- |

S.

whereas gender mainstreaming involves both integrating a gender perspective into the content of the different policies and addressing the issue of the representation of women, men and people of all gender identities in the given policy areas; whereas both dimensions need to be taken into consideration in all phases of the policy-making process;

| T. | whereas all internal and external EU policies should be designed to benefit boys and girls, and men and women, as well as all other gender identities equally; |
| --- | --- |

T.

whereas all internal and external EU policies should be designed to benefit boys and girls, and men and women, as well as all other gender identities equally;

| U. | whereas the implementation of gender mainstreaming is listed among the main weaknesses in the Commission’s evaluation of the gender equality strategy 2010-2015; |
| --- | --- |

U.

whereas the implementation of gender mainstreaming is listed among the main weaknesses in the Commission’s evaluation of the gender equality strategy 2010-2015;

| V. | whereas a gender-sensitive parliament has a crucial role to play in redressing gender imbalances, promoting parity of economic, social and political participation for women and men and expanding the gender equality policy framework; |
| --- | --- |

V.

whereas a gender-sensitive parliament has a crucial role to play in redressing gender imbalances, promoting parity of economic, social and political participation for women and men and expanding the gender equality policy framework;

| W. | whereas gender mainstreaming training for MEPs and Parliament staff, particularly those in management positions, is key to promoting a gender perspective in all policy areas and stages; |
| --- | --- |

W.

whereas gender mainstreaming training for MEPs and Parliament staff, particularly those in management positions, is key to promoting a gender perspective in all policy areas and stages;

| X. | whereas insufficient funds and human resources are being allocated to ensure real progress in gender mainstreaming of Parliament’s activities; |
| --- | --- |

X.

whereas insufficient funds and human resources are being allocated to ensure real progress in gender mainstreaming of Parliament’s activities;

| Y. | whereas the systematic and periodic collection of gender-disaggregated data and statistics in policy impact assessments and in the policy-making process is indispensable for analysing the advancement of gender equality; whereas more qualitative research must be carried out within Parliament in order to establish the significance and impact of gender mainstreaming tools on policy outcomes, resolutions and legislative texts; |
| --- | --- |

Y.

whereas the systematic and periodic collection of gender-disaggregated data and statistics in policy impact assessments and in the policy-making process is indispensable for analysing the advancement of gender equality; whereas more qualitative research must be carried out within Parliament in order to establish the significance and impact of gender mainstreaming tools on policy outcomes, resolutions and legislative texts;

| Z. | whereas female representation in key decision-making positions at political and administrative level, including within Parliament’s political groups, remains low; whereas women tend to chair the committees which are less connected to resource allocation and economic decision making; whereas in order to improve the quality of decisions made, Parliament needs to ensure that the allocation of decision-making positions is evenly spread between genders; whereas men must commit to promoting gender equality in all areas and at all levels and male MEPs must be encouraged to engage with gender mainstreaming in their work; |
| --- | --- |

Z.

whereas female representation in key decision-making positions at political and administrative level, including within Parliament’s political groups, remains low; whereas women tend to chair the committees which are less connected to resource allocation and economic decision making; whereas in order to improve the quality of decisions made, Parliament needs to ensure that the allocation of decision-making positions is evenly spread between genders; whereas men must commit to promoting gender equality in all areas and at all levels and male MEPs must be encouraged to engage with gender mainstreaming in their work;

| AA. | whereas Parliament has the organisational structure in place to promote gender mainstreaming within its activities, and this structure must be better coordinated, reinforced and expanded, with fresh political and administrative will, in order to achieve a higher degree of gender mainstreaming; |
| --- | --- |

AA.

whereas Parliament has the organisational structure in place to promote gender mainstreaming within its activities, and this structure must be better coordinated, reinforced and expanded, with fresh political and administrative will, in order to achieve a higher degree of gender mainstreaming;

| AB. | whereas greater interinstitutional cooperation on gender mainstreaming between Parliament, the Council and the Commission is needed in order to ensure that gender perspectives can be introduced at all stages of the policy cycle, which would facilitate Parliament’s own gender mainstreaming work; |
| --- | --- |

AB.

whereas greater interinstitutional cooperation on gender mainstreaming between Parliament, the Council and the Commission is needed in order to ensure that gender perspectives can be introduced at all stages of the policy cycle, which would facilitate Parliament’s own gender mainstreaming work;

| AC. | whereas input from external stakeholders, such as civil society organisations, grassroots women’s rights and gender equality groups, international institutions, academia and national parliaments, is important in improving Parliament’s gender mainstreaming processes, and in fostering reciprocal exchanges to promote best practice; |
| --- | --- |

AC.

whereas input from external stakeholders, such as civil society organisations, grassroots women’s rights and gender equality groups, international institutions, academia and national parliaments, is important in improving Parliament’s gender mainstreaming processes, and in fostering reciprocal exchanges to promote best practice;

| AD. | whereas Parliament’s gender mainstreaming resolution, adopted in 2007, called for an assessment to be conducted every two years on gender mainstreaming in its work; |
| --- | --- |

AD.

whereas Parliament’s gender mainstreaming resolution, adopted in 2007, called for an assessment to be conducted every two years on gender mainstreaming in its work;

General assessment of the existing institutional framework

| 1. | Takes the view that, in order to integrate a gender perspective into a policy process, different aspects should be considered: the content of the policy and gender representation in the administration and in decision making; also notes that clear data on the impacts of policy are vital to the continuing improvement of gender equality; |
| --- | --- |

1.

Takes the view that, in order to integrate a gender perspective into a policy process, different aspects should be considered: the content of the policy and gender representation in the administration and in decision making; also notes that clear data on the impacts of policy are vital to the continuing improvement of gender equality;

| 2. | Notes that within the Parliament’s organisational structure different bodies are in charge of developing and implementing gender mainstreaming both at policy and working life level:






  — | the High-Level Group on Gender Equality and Diversity, which is responsible for promoting full equality between women and men in all aspects of working life in Parliament’s Secretariat; |
| --- | --- | --- |

2.

Notes that within the Parliament’s organisational structure different bodies are in charge of developing and implementing gender mainstreaming both at policy and working life level:

—

the High-Level Group on Gender Equality and Diversity, which is responsible for promoting full equality between women and men in all aspects of working life in Parliament’s Secretariat;

| — | the committee responsible for specific action aimed at integrating a gender perspective into the work of the other committees and delegations; |
| --- | --- |

—

the committee responsible for specific action aimed at integrating a gender perspective into the work of the other committees and delegations;

| — | the gender mainstreaming network; |
| --- | --- |

—

the gender mainstreaming network;

| — | the services responsible for the successful implementation of balanced gender representation with regard to all posts in the organisation chart; |
| --- | --- |

—

the services responsible for the successful implementation of balanced gender representation with regard to all posts in the organisation chart;

| 3. | Regrets that the activities of these different bodies responsible for gender mainstreaming are not being coordinated or integrated within Parliament or with other institutions (no interinstitutional cooperation mechanism for gender mainstreaming); undertakes to establish effective cooperation between all actors in this institutional framework, based on specific mechanisms such as monitoring and performance feedback; |
| --- | --- |

3.

Regrets that the activities of these different bodies responsible for gender mainstreaming are not being coordinated or integrated within Parliament or with other institutions (no interinstitutional cooperation mechanism for gender mainstreaming); undertakes to establish effective cooperation between all actors in this institutional framework, based on specific mechanisms such as monitoring and performance feedback;

| 4. | Reiterates its commitment to regularly adopt and implement a policy plan for gender mainstreaming within Parliament, with the overall objective of promoting gender equality through effective incorporation of the gender perspective in policies and activities, including decision-making structures and the administration; |
| --- | --- |

4.

Reiterates its commitment to regularly adopt and implement a policy plan for gender mainstreaming within Parliament, with the overall objective of promoting gender equality through effective incorporation of the gender perspective in policies and activities, including decision-making structures and the administration;

| 5. | Calls for ongoing development of the gender mainstreaming network, representing committees but also interparliamentary delegations, and its full involvement in regular monitoring of the state of play of gender mainstreaming across policy areas; notes the need for greater and active participation by MEPs in the network and calls for substitute MEPs to be added to the network in order to increase participation, as is the case for committees and delegations; |
| --- | --- |

5.

Calls for ongoing development of the gender mainstreaming network, representing committees but also interparliamentary delegations, and its full involvement in regular monitoring of the state of play of gender mainstreaming across policy areas; notes the need for greater and active participation by MEPs in the network and calls for substitute MEPs to be added to the network in order to increase participation, as is the case for committees and delegations;

| 6. | Stresses that, according to the aforementioned 2014 study on this issue, the most effective tool for including a gender equality perspective in the policy process has been the use of procedures involving cooperation with other committees; emphasises the need for the other committees to support the gender mainstreaming work and to implement it in their activities; |
| --- | --- |

6.

Stresses that, according to the aforementioned 2014 study on this issue, the most effective tool for including a gender equality perspective in the policy process has been the use of procedures involving cooperation with other committees; emphasises the need for the other committees to support the gender mainstreaming work and to implement it in their activities;

| 7. | Invites the services responsible to continue working on specific measures to promote work life balance; regrets that among EP officials women remain in the majority in the assistants’ function group (AST); calls for a yearly analysis of the state of play of gender equality within Parliament, based on gender disaggregated data, at all levels of staff and political bodies, including parliamentary assistants, and for this reporting to be made public; |
| --- | --- |

7.

Invites the services responsible to continue working on specific measures to promote work life balance; regrets that among EP officials women remain in the majority in the assistants’ function group (AST); calls for a yearly analysis of the state of play of gender equality within Parliament, based on gender disaggregated data, at all levels of staff and political bodies, including parliamentary assistants, and for this reporting to be made public;

| 8. | Calls for the structural barriers to be addressed, and for the creation of an enabling environment for women to take part in decision-making positions at all levels, such as measures for the reconciliation of work and private life and positive action measures, through which the number of the underrepresented gender can be increased in positions which are dominated by either women or men; calls for political parties to recognise their responsibility in the promotion of women, as the power to recruit, select and nominate candidates is in the hands of these parties; |
| --- | --- |

8.

Calls for the structural barriers to be addressed, and for the creation of an enabling environment for women to take part in decision-making positions at all levels, such as measures for the reconciliation of work and private life and positive action measures, through which the number of the underrepresented gender can be increased in positions which are dominated by either women or men; calls for political parties to recognise their responsibility in the promotion of women, as the power to recruit, select and nominate candidates is in the hands of these parties;

| 9. | Deplores the fact that the targets for gender balance at senior and middle management level adopted by the Bureau in 2006 (Kaufmann report) were not reached by the 2009 deadline, nor have they been reached to date; notes that these targets have been subsequently confirmed by the High Level Group on Gender Equality and Diversity for the subsequent years; urges for effective, corrective and far-reaching measures to be taken so as to reach these gender equality targets within the shortest possible time frame; |
| --- | --- |

9.

Deplores the fact that the targets for gender balance at senior and middle management level adopted by the Bureau in 2006 (Kaufmann report) were not reached by the 2009 deadline, nor have they been reached to date; notes that these targets have been subsequently confirmed by the High Level Group on Gender Equality and Diversity for the subsequent years; urges for effective, corrective and far-reaching measures to be taken so as to reach these gender equality targets within the shortest possible time frame;

| 10. | Notes that the High Level Group on Gender Equality and Diversity is responsible for adopting an Action Plan for the Promotion of Equality and Diversity in Parliament and ensuring its implementation; calls on the high level group, with the support of the competent services, to submit a comprehensive gender equality roadmap indicating how to increase the representation of women in middle and senior management positions to 40 % by 2020; invites the Directorate-General for Personnel and the political groups to consider proposing both a woman and a man for Head of Unit positions when posts are vacant; |
| --- | --- |

10.

Notes that the High Level Group on Gender Equality and Diversity is responsible for adopting an Action Plan for the Promotion of Equality and Diversity in Parliament and ensuring its implementation; calls on the high level group, with the support of the competent services, to submit a comprehensive gender equality roadmap indicating how to increase the representation of women in middle and senior management positions to 40 % by 2020; invites the Directorate-General for Personnel and the political groups to consider proposing both a woman and a man for Head of Unit positions when posts are vacant;

| 11. | Recommends that the standing rapporteur on gender mainstreaming, once that post has been established, should work together with the High Level Group to ensure that gender mainstreaming targets for Parliament’s secretariat and staff are met; |
| --- | --- |

11.

Recommends that the standing rapporteur on gender mainstreaming, once that post has been established, should work together with the High Level Group to ensure that gender mainstreaming targets for Parliament’s secretariat and staff are met;

| 12. | Invites the political groups to consider proposing both a woman and a man for the position of Chair in committees and groups; |
| --- | --- |

12.

Invites the political groups to consider proposing both a woman and a man for the position of Chair in committees and groups;

| 13. | Notes that equal gender representation in each committee is desirable, to the extent that circumstances allow; invites the political groups to consider nominating MEPs from the underrepresented gender in each committee, in a coordinated fashion; invites the political groups to nominate an equal number of male and female MEPs as members and substitutes of the Committee on Women’s Rights and Gender Equality, in order to encourage the involvement of men in gender equality policy; |
| --- | --- |

13.

Notes that equal gender representation in each committee is desirable, to the extent that circumstances allow; invites the political groups to consider nominating MEPs from the underrepresented gender in each committee, in a coordinated fashion; invites the political groups to nominate an equal number of male and female MEPs as members and substitutes of the Committee on Women’s Rights and Gender Equality, in order to encourage the involvement of men in gender equality policy;

Gender mainstreaming tools

| 14. | Stresses that the practice of using GMAs has proved to be more effective than opinions as they are more concise, can be more rapidly submitted and relate to key, specific and delimited issues; reiterates its call on the competent committee to include this practice of GMAs in the Rules of Procedure, taking into account the specific role of the Committee on Women’s Rights and Gender Equality in gender mainstreaming as a horizontal principle; calls for closer cooperation among committees and for effective coordination between the gender mainstreaming network and the competent committee at both political and administrative levels, aimed at bringing a substantial gender dimension into the reports; highlights the importance of the role of the network members in each committee in facilitating effective input from the competent committee through GMAs and opinions, and calls for effective coordination between the responsible members of the Committee on Women’s Rights and Gender Equality and the network members in the GMA procedure; reiterates the need for close coordination between the competent committee and lead committees on GMAs and opinions, to ensure optimal scheduling and planning for effective input into the lead committee report; |
| --- | --- |

14.

Stresses that the practice of using GMAs has proved to be more effective than opinions as they are more concise, can be more rapidly submitted and relate to key, specific and delimited issues; reiterates its call on the competent committee to include this practice of GMAs in the Rules of Procedure, taking into account the specific role of the Committee on Women’s Rights and Gender Equality in gender mainstreaming as a horizontal principle; calls for closer cooperation among committees and for effective coordination between the gender mainstreaming network and the competent committee at both political and administrative levels, aimed at bringing a substantial gender dimension into the reports; highlights the importance of the role of the network members in each committee in facilitating effective input from the competent committee through GMAs and opinions, and calls for effective coordination between the responsible members of the Committee on Women’s Rights and Gender Equality and the network members in the GMA procedure; reiterates the need for close coordination between the competent committee and lead committees on GMAs and opinions, to ensure optimal scheduling and planning for effective input into the lead committee report;

| 15. | Regrets that despite the interinstitutional declaration on ensuring gender mainstreaming annexed to the MFF, no measures concerning gender budgeting have so far been taken; underlines, in this connection, the need to closely monitor how the principles of the joint declaration have been implemented as regards annual budgetary procedures, and calls for the committee responsible to be given a formal role in the MFF revision; |
| --- | --- |

15.

Regrets that despite the interinstitutional declaration on ensuring gender mainstreaming annexed to the MFF, no measures concerning gender budgeting have so far been taken; underlines, in this connection, the need to closely monitor how the principles of the joint declaration have been implemented as regards annual budgetary procedures, and calls for the committee responsible to be given a formal role in the MFF revision;

| 16. | Stresses that gender-responsive budgeting in the form of planning, programming and budgeting that contributes to the advancement of gender equality and the fulfilment of women’s rights is one of the key tools used by policy-makers to tackle the gender gaps; deplores that the gender budgeting exercise has revealed that the gender perspective is far from being assumed in all policies, at all levels and at every stage of the policy-making process; notes that, in this context, it is particularly crucial to build up in-house capacity on gender-responsive budgeting in order to enhance Parliament’s scrutiny role on these matters; notes that the implications of spending and revenue decisions have an extremely different impact on women and men and underlines that MEPs on the relevant committees should take these different effects into consideration in the design of budgets; stresses that gender-responsive budgeting promotes accountability and transparency in respect of Parliament’s commitment to gender equality; |
| --- | --- |

16.

Stresses that gender-responsive budgeting in the form of planning, programming and budgeting that contributes to the advancement of gender equality and the fulfilment of women’s rights is one of the key tools used by policy-makers to tackle the gender gaps; deplores that the gender budgeting exercise has revealed that the gender perspective is far from being assumed in all policies, at all levels and at every stage of the policy-making process; notes that, in this context, it is particularly crucial to build up in-house capacity on gender-responsive budgeting in order to enhance Parliament’s scrutiny role on these matters; notes that the implications of spending and revenue decisions have an extremely different impact on women and men and underlines that MEPs on the relevant committees should take these different effects into consideration in the design of budgets; stresses that gender-responsive budgeting promotes accountability and transparency in respect of Parliament’s commitment to gender equality;

| 17. | Takes note that the Commission has undertaken to continue gender mainstreaming by incorporating gender-equality considerations in impact assessments and evaluations in line with the Better Regulation principles and is considering issuing a report on gender mainstreaming in the Commission in 2017; |
| --- | --- |

17.

Takes note that the Commission has undertaken to continue gender mainstreaming by incorporating gender-equality considerations in impact assessments and evaluations in line with the Better Regulation principles and is considering issuing a report on gender mainstreaming in the Commission in 2017;

| 18. | Reaffirms the need for sufficient allocation of resources also at Parliament level in order to develop gender impact assessments and gender-based analysis; calls on the Commission to perform systematic gender impact assessments on new legislative or policy proposals, on the basis of its reinforced assessment of their impact on fundamental rights and in order to guarantee that the EU is upholding women’s rights; emphasises that such analyses and the data collection methods used need to be sensitive to the experiences of LGBTIQ persons; underlines that committees are to be encouraged to take advantage of internal expertise as well as the external expertise of other institutions and bodies from the public or private sector which are active in promoting gender mainstreaming; |
| --- | --- |

18.

Reaffirms the need for sufficient allocation of resources also at Parliament level in order to develop gender impact assessments and gender-based analysis; calls on the Commission to perform systematic gender impact assessments on new legislative or policy proposals, on the basis of its reinforced assessment of their impact on fundamental rights and in order to guarantee that the EU is upholding women’s rights; emphasises that such analyses and the data collection methods used need to be sensitive to the experiences of LGBTIQ persons; underlines that committees are to be encouraged to take advantage of internal expertise as well as the external expertise of other institutions and bodies from the public or private sector which are active in promoting gender mainstreaming;

| 19. | Calls on EIGE to regularly submit information to every committee in order to underline the gender perspective in every sector of policy making and to make available the data and tools it has developed, such as the gender mainstreaming platform, as part of a broader capacity-building exercise, addressed also to staff and parliamentary assistants; calls on the Research Service to carry out regular detailed qualitative and quantitative research on the progress of gender mainstreaming in Parliament and the functioning of the organisational structure dedicated to it; |
| --- | --- |

19.

Calls on EIGE to regularly submit information to every committee in order to underline the gender perspective in every sector of policy making and to make available the data and tools it has developed, such as the gender mainstreaming platform, as part of a broader capacity-building exercise, addressed also to staff and parliamentary assistants; calls on the Research Service to carry out regular detailed qualitative and quantitative research on the progress of gender mainstreaming in Parliament and the functioning of the organisational structure dedicated to it;

| 20. | Regrets that, at present, EIGE does not have sufficient resources to conduct all the work it is asked to perform, and therefore stresses that there is a need to ensure that EIGE’s budget is amended in accordance with its broad mandate; |
| --- | --- |

20.

Regrets that, at present, EIGE does not have sufficient resources to conduct all the work it is asked to perform, and therefore stresses that there is a need to ensure that EIGE’s budget is amended in accordance with its broad mandate;

| 21. | Notes that, in the replies to the questionnaires on the state of gender mainstreaming in the parliamentary committees, specific tools were highlighted as being effective in integrating a gender perspective in the work of committees, including:






  — | distribution of key documents and inclusion of gender equality issues in the terms of reference of studies commissioned; |
| --- | --- | --- |

21.

Notes that, in the replies to the questionnaires on the state of gender mainstreaming in the parliamentary committees, specific tools were highlighted as being effective in integrating a gender perspective in the work of committees, including:

—

distribution of key documents and inclusion of gender equality issues in the terms of reference of studies commissioned;

| — | focusing attention on the use of specific terminology and definitions in relation to gender equality issues; |
| --- | --- |

—

focusing attention on the use of specific terminology and definitions in relation to gender equality issues;

| — | promoting ex-ante and ex-post assessment of draft proposals for legislation and for future agreements; |
| --- | --- |

—

promoting ex-ante and ex-post assessment of draft proposals for legislation and for future agreements;

| — | training and awareness-raising activities for Members, staff, political advisers and assistants; |
| --- | --- |

—

training and awareness-raising activities for Members, staff, political advisers and assistants;

and strongly recommends the further development and implementation of these tools in the work of Parliament;

| 22. | Recalls that gender mainstreaming evaluations and programmes also require an effective follow-up measure to be conducted in order to address the effectiveness and possible problems of each action; underlines that it is important to implement corrective measures where needed, and to develop gender mainstreaming if lack of progress is detected after the implementation of corrective measures; |
| --- | --- |

22.

Recalls that gender mainstreaming evaluations and programmes also require an effective follow-up measure to be conducted in order to address the effectiveness and possible problems of each action; underlines that it is important to implement corrective measures where needed, and to develop gender mainstreaming if lack of progress is detected after the implementation of corrective measures;

| 23. | Recommends that Parliament’s Directorate-General for Communication include a stronger gender perspective in its reporting of Parliament’s policy-making; |
| --- | --- |

23.

Recommends that Parliament’s Directorate-General for Communication include a stronger gender perspective in its reporting of Parliament’s policy-making;

| 24. | Expresses its full support for developing targeted and regular gender mainstreaming training, with adequate resources and tailor-made for Parliament specific needs, addressed to all Parliament staff working in policy fields, with more extensive training provided for middle and senior management, specifically Heads of Unit; calls for gender mainstreaming training to be made available for MEPs, parliamentary assistants and political group staff; calls for leadership training to be organised for women, and for women to be offered experience of leadership positions; recommends that training sessions include information on the multiple and intersectional forms of discrimination; highlights the need to ensure that all its services are aware of their responsibilities in implementing gender mainstreaming, including those in charge of human resources, security and facilities; suggests the introduction of specific human resources guidelines effectively implementing gender mainstreaming in order to improve the well-being of all staff, including LGBTIQ people, in the workplace; |
| --- | --- |

24.

Expresses its full support for developing targeted and regular gender mainstreaming training, with adequate resources and tailor-made for Parliament specific needs, addressed to all Parliament staff working in policy fields, with more extensive training provided for middle and senior management, specifically Heads of Unit; calls for gender mainstreaming training to be made available for MEPs, parliamentary assistants and political group staff; calls for leadership training to be organised for women, and for women to be offered experience of leadership positions; recommends that training sessions include information on the multiple and intersectional forms of discrimination; highlights the need to ensure that all its services are aware of their responsibilities in implementing gender mainstreaming, including those in charge of human resources, security and facilities; suggests the introduction of specific human resources guidelines effectively implementing gender mainstreaming in order to improve the well-being of all staff, including LGBTIQ people, in the workplace;

Gender mainstreaming in the work of committees

| 25. | Reiterates the call for the commitment to delivering a biannual report on gender mainstreaming in the work of Parliament to be met; is aware of the role that the gender mainstreaming network plays in assessing the state of play of gender mainstreaming in each policy area and recommends that the questionnaire that serves as a basis for the aforementioned report become an annual monitoring method; |
| --- | --- |

25.

Reiterates the call for the commitment to delivering a biannual report on gender mainstreaming in the work of Parliament to be met; is aware of the role that the gender mainstreaming network plays in assessing the state of play of gender mainstreaming in each policy area and recommends that the questionnaire that serves as a basis for the aforementioned report become an annual monitoring method;

| 26. | Notes that, in their answers to the questionnaires, the members of the network generally replied that, in their specific policy area, gender-specific needs were taken into account in various activities such as reports, amendments on gender equality, studies, hearings, missions and exchanges of views; |
| --- | --- |

26.

Notes that, in their answers to the questionnaires, the members of the network generally replied that, in their specific policy area, gender-specific needs were taken into account in various activities such as reports, amendments on gender equality, studies, hearings, missions and exchanges of views;

| 27. | Welcomes the specific initiatives taken by several parliamentary committees in this field; regrets that a large majority of the committees have neither adopted nor discussed an action plan on gender equality for their work; stresses how important it is for the competent bodies to work with all committees and delegations in order to share best practices, including through the gender mainstreaming network, and to establish a clear procedure, to be incorporated into Parliament’s Rules of Procedure, on the adoption of a gender action plan by each committee and delegation; recommends that each committee hold a hearing on gender mainstreaming in its policy area once every two years, to coincide with the drafting of the gender mainstreaming report; |
| --- | --- |

27.

Welcomes the specific initiatives taken by several parliamentary committees in this field; regrets that a large majority of the committees have neither adopted nor discussed an action plan on gender equality for their work; stresses how important it is for the competent bodies to work with all committees and delegations in order to share best practices, including through the gender mainstreaming network, and to establish a clear procedure, to be incorporated into Parliament’s Rules of Procedure, on the adoption of a gender action plan by each committee and delegation; recommends that each committee hold a hearing on gender mainstreaming in its policy area once every two years, to coincide with the drafting of the gender mainstreaming report;

| 28. | Underlines the need to thoroughly assess the functioning of the GM network and identify ways of ensuring closer involvement of and greater awareness among the network members; recommends that members and substitutes of the gender mainstreaming network be committed to gender equality, but points out that they do not necessarily have to be members of the Committee on Women’s Rights and Gender Equality as this would allow a larger pool of MEPs to work on gender mainstreaming; recommends regular contact and exchanges between the committee responsible and the network; |
| --- | --- |

28.

Underlines the need to thoroughly assess the functioning of the GM network and identify ways of ensuring closer involvement of and greater awareness among the network members; recommends that members and substitutes of the gender mainstreaming network be committed to gender equality, but points out that they do not necessarily have to be members of the Committee on Women’s Rights and Gender Equality as this would allow a larger pool of MEPs to work on gender mainstreaming; recommends regular contact and exchanges between the committee responsible and the network;

| 29. | Recommends that the gender mainstreaming network be co-chaired by the committee responsible with another member of the network, the latter being appointed on a rota basis from among the different committees in order to signal that gender mainstreaming involves all the committees; |
| --- | --- |

29.

Recommends that the gender mainstreaming network be co-chaired by the committee responsible with another member of the network, the latter being appointed on a rota basis from among the different committees in order to signal that gender mainstreaming involves all the committees;

| 30. | Takes the view that an internal monitoring body needs to be created in order to follow up and evaluate ex-post the implementation of tools and actions; calls for the formulation of specific job descriptions for members of staff responsible for gender mainstreaming in committees; calls on the competent authorities to evaluate the progress of gender mainstreaming in the committees and delegations biannually; |
| --- | --- |

30.

Takes the view that an internal monitoring body needs to be created in order to follow up and evaluate ex-post the implementation of tools and actions; calls for the formulation of specific job descriptions for members of staff responsible for gender mainstreaming in committees; calls on the competent authorities to evaluate the progress of gender mainstreaming in the committees and delegations biannually;

Interinstitutional cooperation to support gender mainstreaming

| 31. | Believes that stronger interinstitutional relations will improve the gender balance in EU policy-making; notes that no structured cooperation on gender mainstreaming has yet been established with other institutional partners, such as the Commission, the Council and EIGE; calls on the Commission to propose an appropriate framework for establishing interinstitutional gender mainstreaming cooperation and also involving other stakeholders in this field; |
| --- | --- |

31.

Believes that stronger interinstitutional relations will improve the gender balance in EU policy-making; notes that no structured cooperation on gender mainstreaming has yet been established with other institutional partners, such as the Commission, the Council and EIGE; calls on the Commission to propose an appropriate framework for establishing interinstitutional gender mainstreaming cooperation and also involving other stakeholders in this field;

| 32. | Calls on the Commission to follow up on the results of the public consultation and the positions of Parliament and of the Council by immediately adopting a communication on a new Strategy for Gender Equality and Women’s Rights post-2015 which addresses gender equality issues in line with the international agenda; |
| --- | --- |

32.

Calls on the Commission to follow up on the results of the public consultation and the positions of Parliament and of the Council by immediately adopting a communication on a new Strategy for Gender Equality and Women’s Rights post-2015 which addresses gender equality issues in line with the international agenda;

| 33. | Recommends that data be provided annually by the European Ombudsman to Parliament’s High Level Group on Gender Equality and Diversity, as regards complaints about maladministration relating to gender equality in Parliament, with due respect for the Decision of the European Parliament on the regulations and general conditions governing the performance of the Ombudsman’s duties; |
| --- | --- |

33.

Recommends that data be provided annually by the European Ombudsman to Parliament’s High Level Group on Gender Equality and Diversity, as regards complaints about maladministration relating to gender equality in Parliament, with due respect for the Decision of the European Parliament on the regulations and general conditions governing the performance of the Ombudsman’s duties;

| 34. | Believes that the exchange of best practice with other organisations will strengthen Parliament’s capacity building and effectiveness in the implementation of gender mainstreaming; calls for exchanges of best practice to be organised at all levels with other institutions and organisations such as UN Women, the Council of Europe, the EU institutions and stakeholders involved in promoting gender equality, such as gender equality bodies, the social partners and NGOs; encourages participation in the specific capacity-building programmes of other international organisations and in gaining their support for organising tailor-made gender mainstreaming programmes; |
| --- | --- |

34.

Believes that the exchange of best practice with other organisations will strengthen Parliament’s capacity building and effectiveness in the implementation of gender mainstreaming; calls for exchanges of best practice to be organised at all levels with other institutions and organisations such as UN Women, the Council of Europe, the EU institutions and stakeholders involved in promoting gender equality, such as gender equality bodies, the social partners and NGOs; encourages participation in the specific capacity-building programmes of other international organisations and in gaining their support for organising tailor-made gender mainstreaming programmes;

| 35. | Requests that the Directorate-General for Personnel exchange gender equality and diversity best practices and technical assistance, for instance with the US Congress and national equality bodies, on promoting underrepresented racial and ethnic minority communities in short-term recruitment procedures and EPSO competitions; calls for a focus on trainees, and for developing initiatives and programmes dedicated to promoting youth traineeships for young people, particularly women, from underrepresented racial and ethnic minority groups; |
| --- | --- |

35.

Requests that the Directorate-General for Personnel exchange gender equality and diversity best practices and technical assistance, for instance with the US Congress and national equality bodies, on promoting underrepresented racial and ethnic minority communities in short-term recruitment procedures and EPSO competitions; calls for a focus on trainees, and for developing initiatives and programmes dedicated to promoting youth traineeships for young people, particularly women, from underrepresented racial and ethnic minority groups;

| 36. | Underlines the need to have an open and ongoing dialogue with national parliaments in order to establish regular exchanges of views, exchange new techniques and report back on policy impact assessments, with a view to promoting a shared approach and further developing best practices in advancing gender mainstreaming; recommends organising regular interparliamentary meetings on gender mainstreaming; |
| --- | --- |

36.

Underlines the need to have an open and ongoing dialogue with national parliaments in order to establish regular exchanges of views, exchange new techniques and report back on policy impact assessments, with a view to promoting a shared approach and further developing best practices in advancing gender mainstreaming; recommends organising regular interparliamentary meetings on gender mainstreaming;

o

o o

| 37. | Instructs its President to forward this resolution to the Council, the Commission and the governments of the Member States. |
| --- | --- |

37.

Instructs its President to forward this resolution to the Council, the Commission and the governments of the Member States.

---

(1)  OJ C 341 E, 16.12.2010, p. 35.

(2)  OJ C 199 E, 7.7.2012, p. 65.

(3)  OJ C 251 E, 31.8.2013, p. 1.

(4)  Texts adopted, P8_TA(2015)0050.

(5)  OJ C 61 E, 10.3.2004, p. 384.

(6)  OJ C 244 E, 18.10.2007, p. 225.

(7)  OJ C 184 E, 8.7.2010, p. 18.

(8)  OJ C 212 E, 5.8.2010, p. 32.

(9)  OJ C 251 E, 31.8.2013, p. 11.

(10)  Texts adopted, P8_TA(2015)0218.

(11)  Texts adopted, P8_TA(2016)0042.

(12)  SWD(2015)0278.

(13)  ‘Gender Mainstreaming in Committees and Delegations of the European Parliament’, European Parliament Policy Department C.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/25 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/25

---

P8_TA(2016)0073

The situation of women refugees and asylum seekers in the EU

European Parliament resolution of 8 March 2016 on the situation of women refugees and asylum seekers in the EU (2015/2325(INI))

(2018/C 050/03)

The European Parliament,

| — | having regard to Article 2 and Article 3(3), second subparagraph, of the Treaty on European Union (TEU), |
| --- | --- |

—

having regard to Article 2 and Article 3(3), second subparagraph, of the Treaty on European Union (TEU),

| — | having regard to Article 8 and Article 78 of the Treaty on the Functioning of the European Union (TFEU), |
| --- | --- |

—

having regard to Article 8 and Article 78 of the Treaty on the Functioning of the European Union (TFEU),

| — | having regard to Article 23 of the Charter of Fundamental Rights of the European Union, |
| --- | --- |

—

having regard to Article 23 of the Charter of Fundamental Rights of the European Union,

| — | having regard to the 1951 Convention and the 1967 Protocol relating to the Status of Refugees, |
| --- | --- |

—

having regard to the 1951 Convention and the 1967 Protocol relating to the Status of Refugees,

| — | having regard to the 1948 Universal Declaration of Human Rights, |
| --- | --- |

—

having regard to the 1948 Universal Declaration of Human Rights,

| — | having regard to the 1979 UN Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) and to General Recommendation No 32 of the CEDAW Committee on the gender-related dimensions of refugee status, asylum, nationality and the statelessness of women of 14 November 2014, |
| --- | --- |

—

having regard to the 1979 UN Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) and to General Recommendation No 32 of the CEDAW Committee on the gender-related dimensions of refugee status, asylum, nationality and the statelessness of women of 14 November 2014,

| — | having regard to the Council of Europe Convention on preventing and combating violence against women and domestic violence (Istanbul Convention), |
| --- | --- |

—

having regard to the Council of Europe Convention on preventing and combating violence against women and domestic violence (Istanbul Convention),

| — | having regard to the Beijing Declaration and Platform for Action adopted by the Fourth World Conference on Women on 15 September 1995, and to the subsequent outcome documents adopted at the United Nations Beijing + 5, Beijing + 10, Beijing + 15 and Beijing + 20 special sessions, |
| --- | --- |

—

having regard to the Beijing Declaration and Platform for Action adopted by the Fourth World Conference on Women on 15 September 1995, and to the subsequent outcome documents adopted at the United Nations Beijing + 5, Beijing + 10, Beijing + 15 and Beijing + 20 special sessions,

| — | having regard to the Commission communication of 13 May 2015 entitled ‘A European Agenda on Migration’ (COM(2015)0240), |
| --- | --- |

—

having regard to the Commission communication of 13 May 2015 entitled ‘A European Agenda on Migration’ (COM(2015)0240),

| — | having regard to the Commission communication of 27 May 2015 entitled ‘EU Action Plan against migrant smuggling (2015-2020)’ (COM(2015)0285), |
| --- | --- |

—

having regard to the Commission communication of 27 May 2015 entitled ‘EU Action Plan against migrant smuggling (2015-2020)’ (COM(2015)0285),

| — | having regard to the Council conclusions on migration of 12 October 2015, and particularly the commitment expressed therein to the human rights of women and girls, |
| --- | --- |

—

having regard to the Council conclusions on migration of 12 October 2015, and particularly the commitment expressed therein to the human rights of women and girls,

| — | having regard to Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims and replacing Council Framework Decision 2002/629/JHA, |
| --- | --- |

—

having regard to Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims and replacing Council Framework Decision 2002/629/JHA,

| — | having regard to Directive 2012/29/EU of the European Parliament and of the Council of 25 October 2012 establishing minimum standards on the rights, support and protection of victims of crime, and replacing Council Framework Decision 2001/220/JHA, |
| --- | --- |

—

having regard to Directive 2012/29/EU of the European Parliament and of the Council of 25 October 2012 establishing minimum standards on the rights, support and protection of victims of crime, and replacing Council Framework Decision 2001/220/JHA,

| — | having regard to Directive 2013/33/EU of the European Parliament and of the Council of 26 June 2013 laying down standards for the reception of applicants for international protection, |
| --- | --- |

—

having regard to Directive 2013/33/EU of the European Parliament and of the Council of 26 June 2013 laying down standards for the reception of applicants for international protection,

| — | having regard to Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals, |
| --- | --- |

—

having regard to Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals,

| — | having regard to Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection, |
| --- | --- |

—

having regard to Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection,

| — | having regard to the Commission proposal for a Regulation of the European Parliament and of the Council establishing an EU common list of safe countries of origin for the purposes of Directive 2013/32/EU of the European Parliament and of the Council on common procedures for granting and withdrawing international protection, and amending Directive 2013/32/EU (COM(2015)0452), |
| --- | --- |

—

having regard to the Commission proposal for a Regulation of the European Parliament and of the Council establishing an EU common list of safe countries of origin for the purposes of Directive 2013/32/EU of the European Parliament and of the Council on common procedures for granting and withdrawing international protection, and amending Directive 2013/32/EU (COM(2015)0452),

| — | having regard to Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection, |
| --- | --- |

—

having regard to Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection,

| — | having regard to Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person, |
| --- | --- |

—

having regard to Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person,

| — | having regard to the Council conclusions entitled ‘Gender Action Plan 2016-2020’ of 26 October 2015, |
| --- | --- |

—

having regard to the Council conclusions entitled ‘Gender Action Plan 2016-2020’ of 26 October 2015,

| — | having regard to the joint staff working document of the Commission and the High Representative of the European Union for foreign affairs and security policy of 25 March 2015 entitled ‘Implementation of the European Neighbourhood Policy in 2014’ (SWD(2015)0076), |
| --- | --- |

—

having regard to the joint staff working document of the Commission and the High Representative of the European Union for foreign affairs and security policy of 25 March 2015 entitled ‘Implementation of the European Neighbourhood Policy in 2014’ (SWD(2015)0076),

| — | having regard to United Nations Security Council resolutions (UNSCR) 1325 and 1820 on women, peace and security, |
| --- | --- |

—

having regard to United Nations Security Council resolutions (UNSCR) 1325 and 1820 on women, peace and security,

| — | having regard to its resolution of 2 December 2015 on the Special Report of the European Ombudsman in own-initiative inquiry OI/5/2012/BEH-MHZ concerning Frontex (1), |
| --- | --- |

—

having regard to its resolution of 2 December 2015 on the Special Report of the European Ombudsman in own-initiative inquiry OI/5/2012/BEH-MHZ concerning Frontex (1),

| — | having regard to Rule 52 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 52 of its Rules of Procedure,

| — | having regard to the report of the Committee on Women’s Rights and Gender Equality (A8-0024/2016), |
| --- | --- |

—

having regard to the report of the Committee on Women’s Rights and Gender Equality (A8-0024/2016),

| A. | whereas an unprecedented and increasing number of men, women and children are seeking international protection in the EU as a result of ongoing conflicts, regional instability and human rights violations, including gender-based violence and rape as a weapon of war; |
| --- | --- |

A.

whereas an unprecedented and increasing number of men, women and children are seeking international protection in the EU as a result of ongoing conflicts, regional instability and human rights violations, including gender-based violence and rape as a weapon of war;

| B. | whereas there is a great degree of gender inequality for asylum applicants across the European Union; whereas women account on average for one third of people who apply for asylum; whereas between the start of 2015 and November of the same year, some 900 000 people crossed the Mediterranean to reach Europe’s coasts, and women and children accounted for around 38 % of the total; whereas the United Nations High Commissioner for Refugees (UNHCR) has reported that, as of January 2016, women and children account for 55 % of those reaching Greece to seek asylum in the EU; whereas too many people have already lost their lives during these journeys of hope and many of them have been women; |
| --- | --- |

B.

whereas there is a great degree of gender inequality for asylum applicants across the European Union; whereas women account on average for one third of people who apply for asylum; whereas between the start of 2015 and November of the same year, some 900 000 people crossed the Mediterranean to reach Europe’s coasts, and women and children accounted for around 38 % of the total; whereas the United Nations High Commissioner for Refugees (UNHCR) has reported that, as of January 2016, women and children account for 55 % of those reaching Greece to seek asylum in the EU; whereas too many people have already lost their lives during these journeys of hope and many of them have been women;

| C. | whereas women and LGBTI people are subject to specific forms of gender-based persecution, which is still too often not recognised in asylum procedures; |
| --- | --- |

C.

whereas women and LGBTI people are subject to specific forms of gender-based persecution, which is still too often not recognised in asylum procedures;

| D. | whereas UN Security Council resolution 1325 on women, peace and security has not achieved its primary objective of protecting women and substantially increasing their participation in political and decision-making processes; |
| --- | --- |

D.

whereas UN Security Council resolution 1325 on women, peace and security has not achieved its primary objective of protecting women and substantially increasing their participation in political and decision-making processes;

| E. | whereas an estimated 20 000 women and girls from countries of origin practising female genital mutilation (FGM) seek asylum in EU Member States every year according to the UNHCR; whereas a significant number of women presenting an asylum claim are doing so based on a fear of FGM; |
| --- | --- |

E.

whereas an estimated 20 000 women and girls from countries of origin practising female genital mutilation (FGM) seek asylum in EU Member States every year according to the UNHCR; whereas a significant number of women presenting an asylum claim are doing so based on a fear of FGM;

| F. | whereas the UNHCR has estimated that 71 % of female EU asylum applicants from FGM-practising countries are survivors of FGM; whereas the European Court of Human Rights has issued rulings halting the expulsion of girls in danger of being forced to undergo genital mutilation, in view of the irreparable harm likely to be done to their physical and psychological health; |
| --- | --- |

F.

whereas the UNHCR has estimated that 71 % of female EU asylum applicants from FGM-practising countries are survivors of FGM; whereas the European Court of Human Rights has issued rulings halting the expulsion of girls in danger of being forced to undergo genital mutilation, in view of the irreparable harm likely to be done to their physical and psychological health;

| G. | whereas women and girls seeking asylum have specific protection needs and different concerns from men which require that the implementation of all asylum policies and procedures, including the assessment of the asylum claims, be gender sensitive and individual; whereas violence-related asylum claims should be dealt with in a way that protects women from secondary victimisation during the asylum process; |
| --- | --- |

G.

whereas women and girls seeking asylum have specific protection needs and different concerns from men which require that the implementation of all asylum policies and procedures, including the assessment of the asylum claims, be gender sensitive and individual; whereas violence-related asylum claims should be dealt with in a way that protects women from secondary victimisation during the asylum process;

| H. | whereas the integration process and rights of women and girls are undermined when their legal status is dependent upon their spouse; |
| --- | --- |

H.

whereas the integration process and rights of women and girls are undermined when their legal status is dependent upon their spouse;

| I. | whereas the relevant acts making up the Common European Asylum System must be transposed and implemented in accordance with the Geneva Convention relating to the Status of Refugees and other relevant instruments; |
| --- | --- |

I.

whereas the relevant acts making up the Common European Asylum System must be transposed and implemented in accordance with the Geneva Convention relating to the Status of Refugees and other relevant instruments;

| J. | whereas the treatment of women and girls seeking asylum across Member States differs hugely, and very significant shortcomings remain; |
| --- | --- |

J.

whereas the treatment of women and girls seeking asylum across Member States differs hugely, and very significant shortcomings remain;

| K. | whereas women refugees and asylum seekers are often subjected to multiple forms of discrimination and are more vulnerable to sexual and gender-based violence in their countries of origin, transit and destination; whereas unaccompanied women and girls, women heads of household, pregnant women, people with disabilities and the elderly are particularly vulnerable; |
| --- | --- |

K.

whereas women refugees and asylum seekers are often subjected to multiple forms of discrimination and are more vulnerable to sexual and gender-based violence in their countries of origin, transit and destination; whereas unaccompanied women and girls, women heads of household, pregnant women, people with disabilities and the elderly are particularly vulnerable;

| L. | whereas women refugees not only face threats to their personal safety (long and dangerous journeys into exile, harassment, official indifference and, frequently, sexual abuse and violence, even once they have reached a place that seems safe and the resulting social stigmatisation), but are also responsible for the physical safety, welfare and survival of their families; |
| --- | --- |

L.

whereas women refugees not only face threats to their personal safety (long and dangerous journeys into exile, harassment, official indifference and, frequently, sexual abuse and violence, even once they have reached a place that seems safe and the resulting social stigmatisation), but are also responsible for the physical safety, welfare and survival of their families;

| M. | whereas many refugees who have arrived in Europe live in makeshift conditions in camps or on the streets, and women and girls are especially vulnerable; |
| --- | --- |

M.

whereas many refugees who have arrived in Europe live in makeshift conditions in camps or on the streets, and women and girls are especially vulnerable;

| N. | whereas criminal networks are taking advantage of the lack of safe passage into the EU for asylum seekers and refugees, regional instability, conflict and the vulnerability of women and girls trying to flee, in order to exploit them through trafficking and sexual exploitation; |
| --- | --- |

N.

whereas criminal networks are taking advantage of the lack of safe passage into the EU for asylum seekers and refugees, regional instability, conflict and the vulnerability of women and girls trying to flee, in order to exploit them through trafficking and sexual exploitation;

| O. | whereas women who are subjected to violence and trafficking are more exposed to the risk of sexually transmitted diseases; |
| --- | --- |

O.

whereas women who are subjected to violence and trafficking are more exposed to the risk of sexually transmitted diseases;

| P. | whereas the Office of the UNHCR has reported instances of violence and abuse, including sexual violence, against refugee women and children, throughout their journey and including in overcrowded reception centres in the EU; |
| --- | --- |

P.

whereas the Office of the UNHCR has reported instances of violence and abuse, including sexual violence, against refugee women and children, throughout their journey and including in overcrowded reception centres in the EU;

| Q. | whereas women and girls seeking refuge in the EU often flee from regimes that are oppressive towards women, do not recognise women’s equality with men, tolerate violence against women, abuse, and child, early and forced marriages; |
| --- | --- |

Q.

whereas women and girls seeking refuge in the EU often flee from regimes that are oppressive towards women, do not recognise women’s equality with men, tolerate violence against women, abuse, and child, early and forced marriages;

| R. | whereas very often, reception hubs do not contain any internal areas that are suitable for mothers housed there who have to support and look after their children; whereas, in addition, legal assistance facilities do not give adequate support in providing information and helping in the search for family members; |
| --- | --- |

R.

whereas very often, reception hubs do not contain any internal areas that are suitable for mothers housed there who have to support and look after their children; whereas, in addition, legal assistance facilities do not give adequate support in providing information and helping in the search for family members;

| S. | whereas the most basic needs to prevent gender based violence, which are separate bathrooms, showers and sleeping arrangements for women, are not met in reception nor transit facilities across the European Union; |
| --- | --- |

S.

whereas the most basic needs to prevent gender based violence, which are separate bathrooms, showers and sleeping arrangements for women, are not met in reception nor transit facilities across the European Union;

| T. | whereas girls fleeing conflict and persecution are at a heightened risk of child, early and forced marriage, rape, sexual and physical abuse, and prostitution; |
| --- | --- |

T.

whereas girls fleeing conflict and persecution are at a heightened risk of child, early and forced marriage, rape, sexual and physical abuse, and prostitution;

| U. | whereas separation from family members, including when detained, exposes women and children to greater risks; |
| --- | --- |

U.

whereas separation from family members, including when detained, exposes women and children to greater risks;

| V. | whereas family reunification, although a basic human right, is systematically delayed and even violated, and whereas women and children are the first victims of this right being denied or delayed; |
| --- | --- |

V.

whereas family reunification, although a basic human right, is systematically delayed and even violated, and whereas women and children are the first victims of this right being denied or delayed;

| W. | whereas women are often forced to accept undeclared work in degrading conditions so that they can stay in their country of arrival; |
| --- | --- |

W.

whereas women are often forced to accept undeclared work in degrading conditions so that they can stay in their country of arrival;

| X. | whereas the Beijing Platform for Action highlighted the need to increase the participation of women in conflict resolution at decision-making levels and the need for refugee, displaced and migrant women to be appropriately involved in decisions that affect them; |
| --- | --- |

X.

whereas the Beijing Platform for Action highlighted the need to increase the participation of women in conflict resolution at decision-making levels and the need for refugee, displaced and migrant women to be appropriately involved in decisions that affect them;

| Y. | whereas Sustainable Development Goal No 5 seeks to achieve gender equality and improve living conditions for women by 2030; |
| --- | --- |

Y.

whereas Sustainable Development Goal No 5 seeks to achieve gender equality and improve living conditions for women by 2030;

| 1. | Believes that, to improve the security and safety of women and girl refugees, safe and legal routes to the EU must be made available for those fleeing conflict and persecution, and that gender should be taken into account; stresses in particular that more Member States should participate in the EU Resettlement Programmes; believes that legislation and policies relating to irregular migration should not prevent access to EU asylum procedures; stresses that the right to asylum is enshrined in Article 18 of the EU Charter of Fundamental Rights; |
| --- | --- |

1.

Believes that, to improve the security and safety of women and girl refugees, safe and legal routes to the EU must be made available for those fleeing conflict and persecution, and that gender should be taken into account; stresses in particular that more Member States should participate in the EU Resettlement Programmes; believes that legislation and policies relating to irregular migration should not prevent access to EU asylum procedures; stresses that the right to asylum is enshrined in Article 18 of the EU Charter of Fundamental Rights;

| 2. | Emphasises the urgent need to immediately open safe and legal asylum routes, in order to counter smuggling networks and to increasingly enable women, children, the elderly and people with disabilities to seek refuge without risking their lives; is deeply concerned about deaths, pushbacks and grave human rights violations at the EU external borders; takes the view that responsibilities and costs and benefits should be shared by all 28 Member States and not just by the countries of first arrival; regrets the lack of solidarity among Member States; |
| --- | --- |

2.

Emphasises the urgent need to immediately open safe and legal asylum routes, in order to counter smuggling networks and to increasingly enable women, children, the elderly and people with disabilities to seek refuge without risking their lives; is deeply concerned about deaths, pushbacks and grave human rights violations at the EU external borders; takes the view that responsibilities and costs and benefits should be shared by all 28 Member States and not just by the countries of first arrival; regrets the lack of solidarity among Member States;

| 3. | Emphasises the importance of women refugees being registered individually and issued with the documents which guarantee their personal safety, freedom of movement and access to essential services, as required by the UNHCR; |
| --- | --- |

3.

Emphasises the importance of women refugees being registered individually and issued with the documents which guarantee their personal safety, freedom of movement and access to essential services, as required by the UNHCR;

| 4. | Stresses that the principle of gender parity should be observed in coordination committees and any other kind of body representing refugees, whether in urban or rural areas, and in the refugee camps, including in areas to which refugees are returned, so as to ensure that the rights of women refugees and asylum seekers are upheld and their needs are met; |
| --- | --- |

4.

Stresses that the principle of gender parity should be observed in coordination committees and any other kind of body representing refugees, whether in urban or rural areas, and in the refugee camps, including in areas to which refugees are returned, so as to ensure that the rights of women refugees and asylum seekers are upheld and their needs are met;

| 5. | Reiterates its call for all Member States and the European Union to sign and ratify the Council of Europe Convention on preventing and combating violence against women (Istanbul Convention); |
| --- | --- |

5.

Reiterates its call for all Member States and the European Union to sign and ratify the Council of Europe Convention on preventing and combating violence against women (Istanbul Convention);

| 6. | Asks all Member States, in collaboration with the EU, to guarantee specialised trauma counselling and psychosocial care for women who have experienced gender-based harm, with the direct involvement of qualified women who are specialists in the field, and which is available at all stages of the asylum process; |
| --- | --- |

6.

Asks all Member States, in collaboration with the EU, to guarantee specialised trauma counselling and psychosocial care for women who have experienced gender-based harm, with the direct involvement of qualified women who are specialists in the field, and which is available at all stages of the asylum process;

| 7. | Expresses its deep concern at reports that women and children are engaging in survival sex to pay smugglers to continue their journey to seek asylum in the EU; reemphasises that safe and legal routes to Europe are key to effectively preventing this reality; |
| --- | --- |

7.

Expresses its deep concern at reports that women and children are engaging in survival sex to pay smugglers to continue their journey to seek asylum in the EU; reemphasises that safe and legal routes to Europe are key to effectively preventing this reality;

| 8. | Urges the EU to include a gender-sensitive perspective when establishing a complaint mechanism within the office of the Frontex Fundamental Rights officer and to address human rights violations committed by Frontex, Member States and officers of third countries when cooperating with Frontex, as called for in Parliament’s resolution of 2 December 2015 on the Special Report of the European Ombudsman in own-initiative inquiry OI/5/2012/BEH-MHZ concerning Frontex; |
| --- | --- |

8.

Urges the EU to include a gender-sensitive perspective when establishing a complaint mechanism within the office of the Frontex Fundamental Rights officer and to address human rights violations committed by Frontex, Member States and officers of third countries when cooperating with Frontex, as called for in Parliament’s resolution of 2 December 2015 on the Special Report of the European Ombudsman in own-initiative inquiry OI/5/2012/BEH-MHZ concerning Frontex;

| 9. | Calls for targeted measures to ensure the full integration of women refugees and asylum seekers, by preventing all forms of exploitation, abuse, violence and trafficking; |
| --- | --- |

9.

Calls for targeted measures to ensure the full integration of women refugees and asylum seekers, by preventing all forms of exploitation, abuse, violence and trafficking;

| 10. | Stresses that all EU migration and asylum policies and measures should take into account gender in their design, implementation and evaluation; |
| --- | --- |

10.

Stresses that all EU migration and asylum policies and measures should take into account gender in their design, implementation and evaluation;

Gender dimension of refugee status determination

| 11. | Calls for a new, comprehensive set of EU-wide gender guidelines to be adopted as part of wider reforms to migration and asylum policy, which take full account of the social, cultural and political dimensions of persecution and include reception and integration measures; |
| --- | --- |

11.

Calls for a new, comprehensive set of EU-wide gender guidelines to be adopted as part of wider reforms to migration and asylum policy, which take full account of the social, cultural and political dimensions of persecution and include reception and integration measures;

| 12. | Underlines that, even in countries deemed safe, women may suffer gender-based persecution, while LGBTI people may also be subjected to abuse, and thus have a legitimate request for protection; calls on all Member States to adopt asylum procedures and endeavour to develop training programmes which are sensitive to the needs of women with multiple marginalised identities, including LGBTI women; urges all Member States to combat harmful stereotypes about the behaviour and characteristics of LGBTI women and to fully apply the EU Charter of Fundamental Rights in respect of their asylum claims; stresses the need for LGBTI-sensitive reception facilities across all Member States; highlights that violence against LGBTI individuals is common in reception facilities; |
| --- | --- |

12.

Underlines that, even in countries deemed safe, women may suffer gender-based persecution, while LGBTI people may also be subjected to abuse, and thus have a legitimate request for protection; calls on all Member States to adopt asylum procedures and endeavour to develop training programmes which are sensitive to the needs of women with multiple marginalised identities, including LGBTI women; urges all Member States to combat harmful stereotypes about the behaviour and characteristics of LGBTI women and to fully apply the EU Charter of Fundamental Rights in respect of their asylum claims; stresses the need for LGBTI-sensitive reception facilities across all Member States; highlights that violence against LGBTI individuals is common in reception facilities;

| 13. | Highlights that gendered forms of violence and discrimination, including but not limited to rape and sexual violence, FGM, forced marriage, domestic violence, so-called honour crimes and state-sanctioned gender discrimination, constitute persecution and should be valid reasons for seeking asylum in the EU and that this should be reflected in new gender guidelines; |
| --- | --- |

13.

Highlights that gendered forms of violence and discrimination, including but not limited to rape and sexual violence, FGM, forced marriage, domestic violence, so-called honour crimes and state-sanctioned gender discrimination, constitute persecution and should be valid reasons for seeking asylum in the EU and that this should be reflected in new gender guidelines;

| 14. | Calls on the Commission to gather thorough statistics on migration and international protection with a view to adding more gender disaggregated data categories, particularly in relation to stages in the asylum process after an initial decision has been made; |
| --- | --- |

14.

Calls on the Commission to gather thorough statistics on migration and international protection with a view to adding more gender disaggregated data categories, particularly in relation to stages in the asylum process after an initial decision has been made;

| 15. | Urges the Commission to develop interpretative guidelines on FGM which give full consideration to the UNHCR Guidelines on gender-based persecution and Guidance Note on FGM and which clearly outline Member States’ obligations, with a particular focus on identifying and communicating with vulnerable asylum seekers; stresses that FGM survivors may have difficulty in expressing their trauma from FGM; calls on the Member States to take measures to ensure that all forms of violence against women, including FGM, can be recognised as a form of persecution and that the victims can thus avail themselves of the protection offered by the 1951 Convention relating to the Status of Refugees, in line with Article 60 of the Istanbul Convention; |
| --- | --- |

15.

Urges the Commission to develop interpretative guidelines on FGM which give full consideration to the UNHCR Guidelines on gender-based persecution and Guidance Note on FGM and which clearly outline Member States’ obligations, with a particular focus on identifying and communicating with vulnerable asylum seekers; stresses that FGM survivors may have difficulty in expressing their trauma from FGM; calls on the Member States to take measures to ensure that all forms of violence against women, including FGM, can be recognised as a form of persecution and that the victims can thus avail themselves of the protection offered by the 1951 Convention relating to the Status of Refugees, in line with Article 60 of the Istanbul Convention;

| 16. | Calls on the Member States to ensure that asylum procedures at borders comply with the UNHCR Guidelines on International Protection, in particular with regard to gender-related persecution, and with the UNHCR Guidelines on Claims to Refugee Status based on Sexual Orientation and/or Gender Identity, which clearly outline the Member States’ obligations; |
| --- | --- |

16.

Calls on the Member States to ensure that asylum procedures at borders comply with the UNHCR Guidelines on International Protection, in particular with regard to gender-related persecution, and with the UNHCR Guidelines on Claims to Refugee Status based on Sexual Orientation and/or Gender Identity, which clearly outline the Member States’ obligations;

| 17. | Calls on the Commission, in view of the situation described, to review the increased funding for and wider scope of the Daphne and Odysseus programmes and to assess whether these programmes could be adapted to the current situation, in order to protect women refugees; |
| --- | --- |

17.

Calls on the Commission, in view of the situation described, to review the increased funding for and wider scope of the Daphne and Odysseus programmes and to assess whether these programmes could be adapted to the current situation, in order to protect women refugees;

| 18. | Notes the Commission’s proposal to establish a common EU list of safe countries of origin; demands that all appropriate steps be taken to ensure that this approach is consistent with the principle of non-refoulement and that the rights of women, children and other vulnerable groups are not undermined; calls for gender differentiation to be applied; believes that any list of safe countries of origin should not result in less favourable procedural treatment for women whose claims for asylum are based on fear or experience of gender-based violence; stresses the need to avoid hasty decisions which do not take due account of the dangers, and even the threat of death, facing women who have suffered gender-based violence if their application is rejected and they are forced to return to their own country; |
| --- | --- |

18.

Notes the Commission’s proposal to establish a common EU list of safe countries of origin; demands that all appropriate steps be taken to ensure that this approach is consistent with the principle of non-refoulement and that the rights of women, children and other vulnerable groups are not undermined; calls for gender differentiation to be applied; believes that any list of safe countries of origin should not result in less favourable procedural treatment for women whose claims for asylum are based on fear or experience of gender-based violence; stresses the need to avoid hasty decisions which do not take due account of the dangers, and even the threat of death, facing women who have suffered gender-based violence if their application is rejected and they are forced to return to their own country;

| 19. | Calls for more objective and gender-sensitive approaches to credibility assessment in all Member States, and enhanced training on credibility assessment for decision-makers which incorporates a gender dimension; highlights that credibility assessments can never be completely accurate and should not be used as the only basis for a negative asylum decision; recommends that when assessing asylum claims from women, cultural, social and psychological profiles including cultural background, education, trauma, fear, shame and/or cultural inequalities between men and women should be taking into account; |
| --- | --- |

19.

Calls for more objective and gender-sensitive approaches to credibility assessment in all Member States, and enhanced training on credibility assessment for decision-makers which incorporates a gender dimension; highlights that credibility assessments can never be completely accurate and should not be used as the only basis for a negative asylum decision; recommends that when assessing asylum claims from women, cultural, social and psychological profiles including cultural background, education, trauma, fear, shame and/or cultural inequalities between men and women should be taking into account;

| 20. | Calls on the Member States to give reasons for positive asylum decisions in order to make available useful data on the consideration given to gender-based violence and to ensure transparency as to the grounds on which asylum claims have been granted under the Convention; |
| --- | --- |

20.

Calls on the Member States to give reasons for positive asylum decisions in order to make available useful data on the consideration given to gender-based violence and to ensure transparency as to the grounds on which asylum claims have been granted under the Convention;

| 21. | Urges the Member States to provide women with information on asylum procedures, their rights and the specific services available to women applying for asylum; underlines the right of women to lodge a claim for asylum independent of their spouse as key to women’s empowerment and the principle of non-refoulement; urges the Member States to inform all women of their right to make an independent claim for asylum, thus enabling women to apply for and maintain the status of refugee or asylum seeker regardless of the situation of other members of their family; |
| --- | --- |

21.

Urges the Member States to provide women with information on asylum procedures, their rights and the specific services available to women applying for asylum; underlines the right of women to lodge a claim for asylum independent of their spouse as key to women’s empowerment and the principle of non-refoulement; urges the Member States to inform all women of their right to make an independent claim for asylum, thus enabling women to apply for and maintain the status of refugee or asylum seeker regardless of the situation of other members of their family;

| 22. | Calls on the Member states to fully implement Directive 2011/36/EU on preventing and combating trafficking in human beings and protecting its victims and Directive 2012/29/EU on establishing minimum standards on the rights, support and protection of victims of crime; |
| --- | --- |

22.

Calls on the Member states to fully implement Directive 2011/36/EU on preventing and combating trafficking in human beings and protecting its victims and Directive 2012/29/EU on establishing minimum standards on the rights, support and protection of victims of crime;

| 23. | Takes the view that prompt action should be taken in terms of humanitarian assistance whenever gender-based violence is suspected, given the extremely high exposure of vulnerable groups such as women and children to forms of physical violence and moral coercion along illegal migration routes, where all kinds of rights are denied; |
| --- | --- |

23.

Takes the view that prompt action should be taken in terms of humanitarian assistance whenever gender-based violence is suspected, given the extremely high exposure of vulnerable groups such as women and children to forms of physical violence and moral coercion along illegal migration routes, where all kinds of rights are denied;

| 24. | Stresses that women and girls are particularly vulnerable to exploitation by smugglers; calls therefore on Member States to increase their police and judicial cooperation, including with Europol, Frontex, Eurojust and the European Asylum Support Office (EASO) in order to effectively combat smuggling and trafficking of migrants; |
| --- | --- |

24.

Stresses that women and girls are particularly vulnerable to exploitation by smugglers; calls therefore on Member States to increase their police and judicial cooperation, including with Europol, Frontex, Eurojust and the European Asylum Support Office (EASO) in order to effectively combat smuggling and trafficking of migrants;

| 25. | Stresses the crucial importance of providing childcare and care for dependants during screening and asylum interviews, in order to ensure a fair opportunity to make an asylum claim; |
| --- | --- |

25.

Stresses the crucial importance of providing childcare and care for dependants during screening and asylum interviews, in order to ensure a fair opportunity to make an asylum claim;

Needs of women in asylum procedures

| 26. | Urges the Member States to duly inform women seeking asylum about their rights and in particular about the right to request a female interviewer and interpreter and to have a personal interview separately from any third parties; urges the Member States to deliver comprehensive and mandatory training for interviewers and interpreters on sexual violence, trauma and memory; urges the Member States to ensure that these rights are being respected; urges the Member States to comply with Article 15(3) of the Asylum Procedures Directive; |
| --- | --- |

26.

Urges the Member States to duly inform women seeking asylum about their rights and in particular about the right to request a female interviewer and interpreter and to have a personal interview separately from any third parties; urges the Member States to deliver comprehensive and mandatory training for interviewers and interpreters on sexual violence, trauma and memory; urges the Member States to ensure that these rights are being respected; urges the Member States to comply with Article 15(3) of the Asylum Procedures Directive;

| 27. | Notes with concern that many asylum case workers in the EU are not familiar with FGM; calls on the Member States to work at national level with their asylum authorities to establish better procedures to help support and assist women and girls who have undergone or who are at risk of FGM; |
| --- | --- |

27.

Notes with concern that many asylum case workers in the EU are not familiar with FGM; calls on the Member States to work at national level with their asylum authorities to establish better procedures to help support and assist women and girls who have undergone or who are at risk of FGM;

| 28. | Urges all Member States to provide up to date and accessible information about the asylum process, rights and entitlements specific to women seeking asylum; |
| --- | --- |

28.

Urges all Member States to provide up to date and accessible information about the asylum process, rights and entitlements specific to women seeking asylum;

| 29. | Urges the Commission and the Member States to guarantee full access to sexual and reproductive health and rights, including access to safe abortion, and to allocate additional resources to healthcare provision as a matter of urgency; |
| --- | --- |

29.

Urges the Commission and the Member States to guarantee full access to sexual and reproductive health and rights, including access to safe abortion, and to allocate additional resources to healthcare provision as a matter of urgency;

| 30. | Urges the Commission and the Member States to guarantee women’s protection and assistance during their stay in refugee camps, at border controls and of course after entering into the EU; |
| --- | --- |

30.

Urges the Commission and the Member States to guarantee women’s protection and assistance during their stay in refugee camps, at border controls and of course after entering into the EU;

| 31. | Urges all Member States to sign and ratify the Council of Europe Istanbul Convention on preventing and combating violence against women and domestic violence and to apply Article 59 thereof, which clearly states that the parties should take the necessary measures to suspend expulsion proceedings and/or to grant an autonomous residence permit in the event of a dissolution of marriage to those women migrants whose residence status depends on their spouse; |
| --- | --- |

31.

Urges all Member States to sign and ratify the Council of Europe Istanbul Convention on preventing and combating violence against women and domestic violence and to apply Article 59 thereof, which clearly states that the parties should take the necessary measures to suspend expulsion proceedings and/or to grant an autonomous residence permit in the event of a dissolution of marriage to those women migrants whose residence status depends on their spouse;

| 32. | Calls for women asylum seekers and migrants to be granted an independent legal status from that of their spouse, in order to avoid exploitation, decrease vulnerability and achieve greater equality; |
| --- | --- |

32.

Calls for women asylum seekers and migrants to be granted an independent legal status from that of their spouse, in order to avoid exploitation, decrease vulnerability and achieve greater equality;

| 33. | Stresses that undocumented migrant women and girls should have full access to their basic fundamental rights and that channels for legal migration should be developed; |
| --- | --- |

33.

Stresses that undocumented migrant women and girls should have full access to their basic fundamental rights and that channels for legal migration should be developed;

| 34. | Stresses the need for family reunification procedures to afford individual rights to women and girls joining their families in the EU, so that they do not have to depend on a possibly abusive relationship with the male family member for access to health, education or work; |
| --- | --- |

34.

Stresses the need for family reunification procedures to afford individual rights to women and girls joining their families in the EU, so that they do not have to depend on a possibly abusive relationship with the male family member for access to health, education or work;

| 35. | Strongly condemns the use of sexual violence against women as a weapon of war; considers that special attention should be given to migrant women and girls abused in conflicts by ensuring access to medical and psychological support; |
| --- | --- |

35.

Strongly condemns the use of sexual violence against women as a weapon of war; considers that special attention should be given to migrant women and girls abused in conflicts by ensuring access to medical and psychological support;

| 36. | Welcomes the development of a new training module on Gender, Gender Identity and Sexual Orientation by the EASO; calls for the full incorporation of gender mainstreaming and gender budgeting into the work of the EASO through gender focal points and formal liaison with the European Institute for Gender Equality (EIGE); calls for country of origin information which includes the situation of women, both legally and de facto, including information about the persecution of women, or threat thereof, by non-state actors; |
| --- | --- |

36.

Welcomes the development of a new training module on Gender, Gender Identity and Sexual Orientation by the EASO; calls for the full incorporation of gender mainstreaming and gender budgeting into the work of the EASO through gender focal points and formal liaison with the European Institute for Gender Equality (EIGE); calls for country of origin information which includes the situation of women, both legally and de facto, including information about the persecution of women, or threat thereof, by non-state actors;

| 37. | Encourages all Member States to make full use of the Dublin Regulation to ensure that families are able to be together and have their asylum claims processed by the same authorities; |
| --- | --- |

37.

Encourages all Member States to make full use of the Dublin Regulation to ensure that families are able to be together and have their asylum claims processed by the same authorities;

Reception and detention

| 38. | Calls for all detention of children in the EU to stop, and for parents to be able to live with their children in appropriate tailored facilities while awaiting their asylum decision; |
| --- | --- |

38.

Calls for all detention of children in the EU to stop, and for parents to be able to live with their children in appropriate tailored facilities while awaiting their asylum decision;

| 39. | Underlines that the detention of asylum seekers should be avoided, and can only be applied where it pursues a legitimate purpose and has been determined to be both necessary and proportionate in each individual case, and can never be justified in the case of anyone under 18 years of age; considers that respecting the right to seek asylum entails instituting open and humane reception arrangements for asylum seekers, including safe, dignified and human-rights-compatible treatment; stresses the need to develop alternatives to detention, including engagement-focused approaches which meet the needs of vulnerable groups; |
| --- | --- |

39.

Underlines that the detention of asylum seekers should be avoided, and can only be applied where it pursues a legitimate purpose and has been determined to be both necessary and proportionate in each individual case, and can never be justified in the case of anyone under 18 years of age; considers that respecting the right to seek asylum entails instituting open and humane reception arrangements for asylum seekers, including safe, dignified and human-rights-compatible treatment; stresses the need to develop alternatives to detention, including engagement-focused approaches which meet the needs of vulnerable groups;

| 40. | Highlights that many women asylum seekers and refugees have experienced extreme violence and that detention may exacerbate their trauma; highlights that detention of asylum seekers for mere administrative convenience violates the right to liberty as enshrined in Article 6 of the EU Charter of Fundamental Rights; calls for an immediate end, in all Member States, to the detention of children, pregnant and nursing women and survivors of rape, sexual violence and trafficking, and for appropriate psychological support to be made available; |
| --- | --- |

40.

Highlights that many women asylum seekers and refugees have experienced extreme violence and that detention may exacerbate their trauma; highlights that detention of asylum seekers for mere administrative convenience violates the right to liberty as enshrined in Article 6 of the EU Charter of Fundamental Rights; calls for an immediate end, in all Member States, to the detention of children, pregnant and nursing women and survivors of rape, sexual violence and trafficking, and for appropriate psychological support to be made available;

| 41. | Urges all Member States to reduce the maximum limits on the duration of detention prior to removal to below the limit stipulated in the Return Directive; considers that prolonged detention disproportionately harms vulnerable groups; |
| --- | --- |

41.

Urges all Member States to reduce the maximum limits on the duration of detention prior to removal to below the limit stipulated in the Return Directive; considers that prolonged detention disproportionately harms vulnerable groups;

| 42. | Urges that women asylum seekers in detention who have been subjected to sexual abuse receive appropriate medical advice and counselling, including in cases resulting in pregnancy, and be provided with the necessary physical and mental health care, support and legal aid; demands that the Commission and the Member States take immediate measures to ensure that reception, transit and detention conditions are safe, humane and adequate, with separate accommodation and sanitation facilities for women and families; points out that the provision of appropriate basic hygiene kits for all women and girls should be standard practice in assistance programmes; |
| --- | --- |

42.

Urges that women asylum seekers in detention who have been subjected to sexual abuse receive appropriate medical advice and counselling, including in cases resulting in pregnancy, and be provided with the necessary physical and mental health care, support and legal aid; demands that the Commission and the Member States take immediate measures to ensure that reception, transit and detention conditions are safe, humane and adequate, with separate accommodation and sanitation facilities for women and families; points out that the provision of appropriate basic hygiene kits for all women and girls should be standard practice in assistance programmes;

| 43. | Points out that involving women refugees directly and indirectly in managing the distribution of food and non-food items will ensure that the goods in question are distributed and controlled directly by adult women members of households, thereby guaranteeing that they are distributed fairly; |
| --- | --- |

43.

Points out that involving women refugees directly and indirectly in managing the distribution of food and non-food items will ensure that the goods in question are distributed and controlled directly by adult women members of households, thereby guaranteeing that they are distributed fairly;

| 44. | Calls on the Commission and the Member States to equip reception hubs for refugees and asylum seekers with appropriate areas enabling them to support and look after their children; |
| --- | --- |

44.

Calls on the Commission and the Member States to equip reception hubs for refugees and asylum seekers with appropriate areas enabling them to support and look after their children;

| 45. | Calls on the Member States to implement or strengthen mechanisms to monitor overcrowded reception centres in the EU, in which minimum standards to mitigate gender-based violence do not necessarily apply, in order to prevent the harassment of women and children from continuing also in the country of arrival; |
| --- | --- |

45.

Calls on the Member States to implement or strengthen mechanisms to monitor overcrowded reception centres in the EU, in which minimum standards to mitigate gender-based violence do not necessarily apply, in order to prevent the harassment of women and children from continuing also in the country of arrival;

| 46. | Stresses that the needs of vulnerable people such as women victims of violence and girls, in particular unaccompanied girls, should be prioritised in the reception procedures; |
| --- | --- |

46.

Stresses that the needs of vulnerable people such as women victims of violence and girls, in particular unaccompanied girls, should be prioritised in the reception procedures;

| 47. | Highlights the importance of equipping reception facilities with appropriate legal assistance for women in order to provide them with valuable support in terms of information and the search for family members; |
| --- | --- |

47.

Highlights the importance of equipping reception facilities with appropriate legal assistance for women in order to provide them with valuable support in terms of information and the search for family members;

| 48. | Calls on the Commission and the Member States to take measures to prevent forced marriages from being imposed on women and girls once they have obtained refugee status by men hoping to secure safe access for themselves and who would otherwise not be entitled to such access; |
| --- | --- |

48.

Calls on the Commission and the Member States to take measures to prevent forced marriages from being imposed on women and girls once they have obtained refugee status by men hoping to secure safe access for themselves and who would otherwise not be entitled to such access;

| 49. | Stresses the urgent need for independent investigations into all allegations, including sexual abuse and gender-based violence, at places of immigration detention or at the borders, and for access to be granted to journalists and appropriate civil society organisations; |
| --- | --- |

49.

Stresses the urgent need for independent investigations into all allegations, including sexual abuse and gender-based violence, at places of immigration detention or at the borders, and for access to be granted to journalists and appropriate civil society organisations;

| 50. | Considers that, when women asylum seekers are detained, facilities and materials are required to meet women’s specific hygiene needs, the use of female guards and warders should be promoted and all staff assigned to work with women detainees should receive training relating to the gender-specific needs and human rights of women; |
| --- | --- |

50.

Considers that, when women asylum seekers are detained, facilities and materials are required to meet women’s specific hygiene needs, the use of female guards and warders should be promoted and all staff assigned to work with women detainees should receive training relating to the gender-specific needs and human rights of women;

| 51. | Is of the opinion that women asylum seekers in detention who report abuse are to be provided with immediate protection, support and counselling, and their claims must be investigated by competent and independent authorities, with full respect for the principle of confidentiality, including where women are detained together with their husbands/partners/other relatives; considers that protection measures should take into account specifically the risks of retaliation; |
| --- | --- |

51.

Is of the opinion that women asylum seekers in detention who report abuse are to be provided with immediate protection, support and counselling, and their claims must be investigated by competent and independent authorities, with full respect for the principle of confidentiality, including where women are detained together with their husbands/partners/other relatives; considers that protection measures should take into account specifically the risks of retaliation;

| 52. | Calls on the Commission, the Member States and local authorities to work together with civil society and human rights organisations to alleviate the plight of refugees surviving in makeshift conditions, particularly in respect of vulnerable women and girls; |
| --- | --- |

52.

Calls on the Commission, the Member States and local authorities to work together with civil society and human rights organisations to alleviate the plight of refugees surviving in makeshift conditions, particularly in respect of vulnerable women and girls;

Social inclusion and integration

| 53. | Calls on the Member States to develop and implement specific measures to facilitate labour market participation of women refugees and asylum seekers, including language classes, literacy programmes, lifelong learning and training; calls on the Commission, the Member States and local authorities to guarantee the right of refugee girls to access statutory education; highlights the importance of informal and non-formal education and cultural exchange in including and empowering young women and girls; stresses the importance of widening access to higher education for women refugees; calls for robust and transparent procedures for recognising qualifications obtained abroad; |
| --- | --- |

53.

Calls on the Member States to develop and implement specific measures to facilitate labour market participation of women refugees and asylum seekers, including language classes, literacy programmes, lifelong learning and training; calls on the Commission, the Member States and local authorities to guarantee the right of refugee girls to access statutory education; highlights the importance of informal and non-formal education and cultural exchange in including and empowering young women and girls; stresses the importance of widening access to higher education for women refugees; calls for robust and transparent procedures for recognising qualifications obtained abroad;

| 54. | Calls on the Commission and the Member States to make funding and other resources available for civil society and human rights organisations that provide assistance, promote inclusion, and monitor the situation of refugees and asylum seekers in the EU, particularly in respect of addressing the barriers and vulnerabilities experienced by women and girls; |
| --- | --- |

54.

Calls on the Commission and the Member States to make funding and other resources available for civil society and human rights organisations that provide assistance, promote inclusion, and monitor the situation of refugees and asylum seekers in the EU, particularly in respect of addressing the barriers and vulnerabilities experienced by women and girls;

| 55. | Calls on the Member States and the Commission to give women leaders who were persecuted in their countries of origin and are now refugees assurances that they can carry on their political and social activities in favour of women’s rights and gender equality in safety in the EU; |
| --- | --- |

55.

Calls on the Member States and the Commission to give women leaders who were persecuted in their countries of origin and are now refugees assurances that they can carry on their political and social activities in favour of women’s rights and gender equality in safety in the EU;

| 56. | Highlights the critical importance of accessible, high-quality childcare and care for other dependants in enabling the economic and social empowerment of women refugees; |
| --- | --- |

56.

Highlights the critical importance of accessible, high-quality childcare and care for other dependants in enabling the economic and social empowerment of women refugees;

| 57. | Encourages the Member States to make use of the Structural and Investment Funds in addition to the Asylum, Migration and Integration Fund to promote refugees’ integration into the labour market, with a particular focus on childcare; |
| --- | --- |

57.

Encourages the Member States to make use of the Structural and Investment Funds in addition to the Asylum, Migration and Integration Fund to promote refugees’ integration into the labour market, with a particular focus on childcare;

| 58. | Calls for swifter, more efficient family reunification procedures and the collection of gender-disaggregated data on decisions relating to family reunification; stresses the importance of access to legal aid in family reunification cases; |
| --- | --- |

58.

Calls for swifter, more efficient family reunification procedures and the collection of gender-disaggregated data on decisions relating to family reunification; stresses the importance of access to legal aid in family reunification cases;

| 59. | Believes that mutual recognition of positive asylum decisions would enable better opportunities for jobs, integration and family reunification; |
| --- | --- |

59.

Believes that mutual recognition of positive asylum decisions would enable better opportunities for jobs, integration and family reunification;

| 60. | Stresses that full access to the right to free public quality education, healthcare services, especially sexual and reproductive health and rights, employment that matches the needs and abilities of refugee women, and housing that meets the needs of refugee women and girls, should be guaranteed by the host countries; emphasises that welfare policies are key to integration; |
| --- | --- |

60.

Stresses that full access to the right to free public quality education, healthcare services, especially sexual and reproductive health and rights, employment that matches the needs and abilities of refugee women, and housing that meets the needs of refugee women and girls, should be guaranteed by the host countries; emphasises that welfare policies are key to integration;

| 61. | Calls for comprehensive and adequately resourced programmes to address the unmet short- and long-term health needs of women refugees, including psychosocial and trauma counselling; |
| --- | --- |

61.

Calls for comprehensive and adequately resourced programmes to address the unmet short- and long-term health needs of women refugees, including psychosocial and trauma counselling;

| 62. | Emphasises the important positive role that social enterprises and alternative business models such as mutuals and cooperatives can play in economically empowering women refugees and integrating them into labour markets, as well as the social and cultural spheres; |
| --- | --- |

62.

Emphasises the important positive role that social enterprises and alternative business models such as mutuals and cooperatives can play in economically empowering women refugees and integrating them into labour markets, as well as the social and cultural spheres;

| 63. | Encourages the sharing of best practice among Member States as regards the involvement of grassroots community-based organisations and the direct participation of refugees, in representing the views of refugee and asylum-seeking women to policymakers; |
| --- | --- |

63.

Encourages the sharing of best practice among Member States as regards the involvement of grassroots community-based organisations and the direct participation of refugees, in representing the views of refugee and asylum-seeking women to policymakers;

| 64. | Takes the view that local and regional authorities play a vital role in the inclusion of women refugees and asylum seekers, especially with regard to their inclusion in the labour market; encourages those authorities to foster dialogue and debate between women refugees and local women; |
| --- | --- |

64.

Takes the view that local and regional authorities play a vital role in the inclusion of women refugees and asylum seekers, especially with regard to their inclusion in the labour market; encourages those authorities to foster dialogue and debate between women refugees and local women;

o

o o

| 65. | Instructs its President to forward this resolution to the Council, the Commission and the UNHCR. |
| --- | --- |

65.

Instructs its President to forward this resolution to the Council, the Commission and the UNHCR.

---

(1)  Texts adopted, P8_TA(2015)0422.

---

Wednesday 9 March 2016

| 9.2.2018 | EN | Official Journal of the European Union | C 50/35 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/35

---

P8_TA(2016)0082

Tobacco agreement (PMI agreement)

European Parliament resolution of 9 March 2016 on the tobacco agreement (PMI agreement) (2016/2555(RSP))

(2018/C 050/04)

The European Parliament,

| — | having regard to the Anti-Contraband and Anti-Counterfeit Agreement and General Release of 9 July 2004 among Philip Morris International (PMI) and affiliates, the Union and its Member States, |
| --- | --- |

—

having regard to the Anti-Contraband and Anti-Counterfeit Agreement and General Release of 9 July 2004 among Philip Morris International (PMI) and affiliates, the Union and its Member States,

| — | having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (1), |
| --- | --- |

—

having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (1),

| — | having regard to the World Health Organisation Framework Convention on Tobacco Control (the ‘WHO FCTC’) and to the Protocol to Eliminate Illicit Trade in Tobacco Products, adopted during the fifth session of the Conference of the Parties to the WHO FCTC by Decision FCTC/COP5(1) of 12 November 2012, |
| --- | --- |

—

having regard to the World Health Organisation Framework Convention on Tobacco Control (the ‘WHO FCTC’) and to the Protocol to Eliminate Illicit Trade in Tobacco Products, adopted during the fifth session of the Conference of the Parties to the WHO FCTC by Decision FCTC/COP5(1) of 12 November 2012,

| — | having regard to the Commission proposal of 4 May 2015 for a Council decision on the conclusion, on behalf of the European Union, of the Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation’s Framework Convention on Tobacco Control, in so far as the provisions of the Protocol which fall under Title V of Part III of the Treaty on the Functioning of the European Union are concerned (COM(2015)0193), |
| --- | --- |

—

having regard to the Commission proposal of 4 May 2015 for a Council decision on the conclusion, on behalf of the European Union, of the Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation’s Framework Convention on Tobacco Control, in so far as the provisions of the Protocol which fall under Title V of Part III of the Treaty on the Functioning of the European Union are concerned (COM(2015)0193),

| — | having regard to the Commission staff working document of 24 February 2016 entitled ‘Technical assessment of the experience made with the Anti-Contraband and Anti-Counterfeit Agreement and General Release of 9 July 2004 among Philip Morris International and affiliates, the Union and its Member States’ (SWD(2016)0044), |
| --- | --- |

—

having regard to the Commission staff working document of 24 February 2016 entitled ‘Technical assessment of the experience made with the Anti-Contraband and Anti-Counterfeit Agreement and General Release of 9 July 2004 among Philip Morris International and affiliates, the Union and its Member States’ (SWD(2016)0044),

| — | having regard to its resolution of 11 October 2007 on the implications of the agreement between the Community, Member States and Philip Morris on intensifying the fight against fraud and cigarette smuggling and progress made in implementing the recommendations of Parliament’s Committee of Inquiry into the Community Transit System (2), |
| --- | --- |

—

having regard to its resolution of 11 October 2007 on the implications of the agreement between the Community, Member States and Philip Morris on intensifying the fight against fraud and cigarette smuggling and progress made in implementing the recommendations of Parliament’s Committee of Inquiry into the Community Transit System (2),

| — | having regard to the question to the Commission on the tobacco agreement (PMI agreement) (O-000010/2016 — B8-0109/2016), |
| --- | --- |

—

having regard to the question to the Commission on the tobacco agreement (PMI agreement) (O-000010/2016 — B8-0109/2016),

| — | having regard to Rules 128(5) and 123(4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 128(5) and 123(4) of its Rules of Procedure,

| A. | whereas protection of the EU’s financial interests is one of the Commission’s key priorities, and whereas illicit trade in tobacco products, in particular smuggling of contraband and counterfeit cigarettes, costs national and EU budgets, at a conservative estimate, more than EUR 10 billion in lost public revenue per year; |
| --- | --- |

A.

whereas protection of the EU’s financial interests is one of the Commission’s key priorities, and whereas illicit trade in tobacco products, in particular smuggling of contraband and counterfeit cigarettes, costs national and EU budgets, at a conservative estimate, more than EUR 10 billion in lost public revenue per year;

| B. | whereas illicit trade is a serious crime that contributes to the funding of other international organised criminal activities, including human, drugs and arms trafficking, and, in some cases, terrorist groups; |
| --- | --- |

B.

whereas illicit trade is a serious crime that contributes to the funding of other international organised criminal activities, including human, drugs and arms trafficking, and, in some cases, terrorist groups;

| C. | whereas the core aim of the PMI agreement is to reduce the prevalence of PMI contraband on the illicit EU tobacco market; |
| --- | --- |

C.

whereas the core aim of the PMI agreement is to reduce the prevalence of PMI contraband on the illicit EU tobacco market;

| D. | whereas the PMI agreement is set to expire on 9 July 2016; |
| --- | --- |

D.

whereas the PMI agreement is set to expire on 9 July 2016;

| E. | whereas the Commission’s technical assessment of the PMI agreement concludes that this core objective has been met effectively, but questions the causality of this result and points out that the reduction in PMI contraband has not led to an overall reduction in the number of illicit products on the EU market; |
| --- | --- |

E.

whereas the Commission’s technical assessment of the PMI agreement concludes that this core objective has been met effectively, but questions the causality of this result and points out that the reduction in PMI contraband has not led to an overall reduction in the number of illicit products on the EU market;

| F. | whereas the PMI agreement has provided financial benefits to public revenue of approximately USD 1 billion in annual payments and EUR 68,2 million in seizure payments, divided between the Commission (approximately 10 %) and the Member States (approximately 90 %); whereas there are no data on how the Member States have spent the revenue received under the agreement; |
| --- | --- |

F.

whereas the PMI agreement has provided financial benefits to public revenue of approximately USD 1 billion in annual payments and EUR 68,2 million in seizure payments, divided between the Commission (approximately 10 %) and the Member States (approximately 90 %); whereas there are no data on how the Member States have spent the revenue received under the agreement;

| G. | whereas both the legal framework and the market environment of the illicit tobacco trade have changed substantially since the signing of the agreement, in particular as regards the increased presence of non-branded cigarettes, often referred to as ‘cheap whites’, and the development of the new area of liquid nicotine sales for e-cigarettes; |
| --- | --- |

G.

whereas both the legal framework and the market environment of the illicit tobacco trade have changed substantially since the signing of the agreement, in particular as regards the increased presence of non-branded cigarettes, often referred to as ‘cheap whites’, and the development of the new area of liquid nicotine sales for e-cigarettes;

| H. | whereas Cases C-358/14 Poland v Parliament and Council, C-477/14 Pillbox 38 (UK) Limited and C-547/14 Philip Morris Brands SARL and Others, which challenge Directive 2014/40/EU, are currently before the Court of Justice and should be withdrawn by the tobacco manufacturers in question at the earliest opportunity; |
| --- | --- |

H.

whereas Cases C-358/14 Poland v Parliament and Council, C-477/14 Pillbox 38 (UK) Limited and C-547/14 Philip Morris Brands SARL and Others, which challenge Directive 2014/40/EU, are currently before the Court of Justice and should be withdrawn by the tobacco manufacturers in question at the earliest opportunity;

| I. | whereas the Commission has committed to ratification of the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products, which is a major step towards strengthening the legal framework for the fight against illicit trade in tobacco products; whereas the Commission has undertaken to invite third countries to ratify the Protocol; |
| --- | --- |

I.

whereas the Commission has committed to ratification of the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products, which is a major step towards strengthening the legal framework for the fight against illicit trade in tobacco products; whereas the Commission has undertaken to invite third countries to ratify the Protocol;

| J. | whereas tobacco smuggling undermines EU public health policies and means that illicit tobacco products are available — including to young people — at a substantial illegal discount in many places; whereas not only are counterfeit cigarettes illegally manufactured and imported, but they contain unknown ingredients, thus constituting a serious health risk; |
| --- | --- |

J.

whereas tobacco smuggling undermines EU public health policies and means that illicit tobacco products are available — including to young people — at a substantial illegal discount in many places; whereas not only are counterfeit cigarettes illegally manufactured and imported, but they contain unknown ingredients, thus constituting a serious health risk;

| 1. | Welcomes the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products, and calls for the ratification process to be completed as soon as possible; |
| --- | --- |

1.

Welcomes the WHO FCTC Protocol to Eliminate Illicit Trade in Tobacco Products, and calls for the ratification process to be completed as soon as possible;

| 2. | Welcomes the Commission’s proposal to ratify the Protocol, and its undertaking to invite Member States and third countries to ratify it; notes that 15 countries have ratified the Protocol so far, including five EU Member States, and that the EU is currently preparing to ratify it; |
| --- | --- |

2.

Welcomes the Commission’s proposal to ratify the Protocol, and its undertaking to invite Member States and third countries to ratify it; notes that 15 countries have ratified the Protocol so far, including five EU Member States, and that the EU is currently preparing to ratify it;

| 3. | Urges the Commission to pursue prompt ratification of the Protocol; believes, however, that renewal of the agreement would send a damaging and counterproductive message to third countries that the EU engages in inappropriate interactions with the tobacco industry even though the Protocol clearly prohibits such interactions; |
| --- | --- |

3.

Urges the Commission to pursue prompt ratification of the Protocol; believes, however, that renewal of the agreement would send a damaging and counterproductive message to third countries that the EU engages in inappropriate interactions with the tobacco industry even though the Protocol clearly prohibits such interactions;

| 4. | Expresses its belief that renewal of the PMI agreement may not be compatible with the EU’s obligations under Article 5.3 of the WHO FCTC, which could damage the EU’s reputation as a global leader on tobacco control; |
| --- | --- |

4.

Expresses its belief that renewal of the PMI agreement may not be compatible with the EU’s obligations under Article 5.3 of the WHO FCTC, which could damage the EU’s reputation as a global leader on tobacco control;

| 5. | Points out that the Guidelines for implementation of Article 5.3 of the WHO FCTC state that ‘[t]here is a fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests’; |
| --- | --- |

5.

Points out that the Guidelines for implementation of Article 5.3 of the WHO FCTC state that ‘[t]here is a fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests’;

| 6. | Welcomes the adoption of Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (the Tobacco Products Directive); stresses that the Tobacco Products Directive already provides for a legal requirement for tobacco companies to introduce and maintain a track-and-trace system which must be operational for cigarettes and roll-your-own tobacco products from 20 May 2019, and for other tobacco products from 20 May 2024; |
| --- | --- |

6.

Welcomes the adoption of Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (the Tobacco Products Directive); stresses that the Tobacco Products Directive already provides for a legal requirement for tobacco companies to introduce and maintain a track-and-trace system which must be operational for cigarettes and roll-your-own tobacco products from 20 May 2019, and for other tobacco products from 20 May 2024;

| 7. | Emphasises that the Commission must take immediate steps to ensure the full transposition of the Tobacco Products Directive in all Member States; notes that several Member States have informally indicated to the Commission that the transposition process for the directive has been completed; calls on the Commission to provide full information on the state of play of transposition following the expiry of the deadline of 20 May 2016; |
| --- | --- |

7.

Emphasises that the Commission must take immediate steps to ensure the full transposition of the Tobacco Products Directive in all Member States; notes that several Member States have informally indicated to the Commission that the transposition process for the directive has been completed; calls on the Commission to provide full information on the state of play of transposition following the expiry of the deadline of 20 May 2016;

| 8. | Recalls that in May 2015 the Commission promised to deliver its assessment of the agreement with PMI as soon as possible; stresses that the Commission postponed the publication of the assessment several times and that it was finally published on 24 February 2016, one day before a plenary debate on the issue in Parliament; firmly considers such delayed publication to constitute a serious failure on the part of the Commission to meet its obligations of transparency, both to Parliament and to citizens, thus undermining Parliament’s capacity to express its view in a timely manner on this complex and delicate matter; |
| --- | --- |

8.

Recalls that in May 2015 the Commission promised to deliver its assessment of the agreement with PMI as soon as possible; stresses that the Commission postponed the publication of the assessment several times and that it was finally published on 24 February 2016, one day before a plenary debate on the issue in Parliament; firmly considers such delayed publication to constitute a serious failure on the part of the Commission to meet its obligations of transparency, both to Parliament and to citizens, thus undermining Parliament’s capacity to express its view in a timely manner on this complex and delicate matter;

| 9. | Takes note of the Commission’s assessment that the PMI agreement has met effectively its objective of reducing the prevalence of PMI contraband on the illicit EU tobacco market, as shown by a drop of around 85 % in the volume of genuine PMI cigarettes seized by Member States between 2006 and 2014; notes, however, that the Commission questions the causality of this result, and also highlights the fact that the reduction in PMI contraband has not led to an overall reduction in the number of illicit products on the EU market; notes that contraband consisting of smuggled products from the large manufacturers has been increasingly replaced by other products, including non-branded cigarettes (‘cheap whites’) typically produced in third countries; |
| --- | --- |

9.

Takes note of the Commission’s assessment that the PMI agreement has met effectively its objective of reducing the prevalence of PMI contraband on the illicit EU tobacco market, as shown by a drop of around 85 % in the volume of genuine PMI cigarettes seized by Member States between 2006 and 2014; notes, however, that the Commission questions the causality of this result, and also highlights the fact that the reduction in PMI contraband has not led to an overall reduction in the number of illicit products on the EU market; notes that contraband consisting of smuggled products from the large manufacturers has been increasingly replaced by other products, including non-branded cigarettes (‘cheap whites’) typically produced in third countries;

| 10. | Is deeply concerned that the budget of the European Anti-Fraud Office (OLAF) is partly financed by yearly payments from the tobacco industry, as mentioned in the tobacco agreements, since this could lead to a certain conflict of interest; |
| --- | --- |

10.

Is deeply concerned that the budget of the European Anti-Fraud Office (OLAF) is partly financed by yearly payments from the tobacco industry, as mentioned in the tobacco agreements, since this could lead to a certain conflict of interest;

| 11. | Emphasises that, when first concluded in 2004, the PMI agreement was an innovative instrument in tackling the illicit tobacco trade, but stresses that the market and regulatory environment have experienced substantial changes since then; stresses that the agreement does not address important characteristics of the illicit tobacco trade today, in particular the high proportion of the trade that is now made up of ‘cheap whites’; is therefore of the opinion that all the elements covered in the agreement with PMI will be covered by the new legal framework made up of the Tobacco Products Directive and the WHO FCTC Protocol; |
| --- | --- |

11.

Emphasises that, when first concluded in 2004, the PMI agreement was an innovative instrument in tackling the illicit tobacco trade, but stresses that the market and regulatory environment have experienced substantial changes since then; stresses that the agreement does not address important characteristics of the illicit tobacco trade today, in particular the high proportion of the trade that is now made up of ‘cheap whites’; is therefore of the opinion that all the elements covered in the agreement with PMI will be covered by the new legal framework made up of the Tobacco Products Directive and the WHO FCTC Protocol;

| 12. | Concludes, therefore, that the agreement with PMI should not be renewed, extended or renegotiated; asks the Commission not to renew, extend or renegotiate it beyond its current date of expiry; |
| --- | --- |

12.

Concludes, therefore, that the agreement with PMI should not be renewed, extended or renegotiated; asks the Commission not to renew, extend or renegotiate it beyond its current date of expiry;

| 13. | Urges the Commission to put in place, at EU level and by the date of expiry of the PMI agreement, all the necessary measures to track and trace PMI tobacco products, and to bring legal action for any illegal seizures of this manufacturer’s products until all provisions of the Tobacco Products Directive are fully enforceable, so that there is no regulatory gap between the expiry of the PMI agreement and the entry into force of the TPD and FCTC; |
| --- | --- |

13.

Urges the Commission to put in place, at EU level and by the date of expiry of the PMI agreement, all the necessary measures to track and trace PMI tobacco products, and to bring legal action for any illegal seizures of this manufacturer’s products until all provisions of the Tobacco Products Directive are fully enforceable, so that there is no regulatory gap between the expiry of the PMI agreement and the entry into force of the TPD and FCTC;

| 14. | Calls on PMI to continue to apply the track-and-trace and due diligence (‘know your customer’) provisions contained in the current agreement, regardless of whether or not it is extended; |
| --- | --- |

14.

Calls on PMI to continue to apply the track-and-trace and due diligence (‘know your customer’) provisions contained in the current agreement, regardless of whether or not it is extended;

| 15. | Expresses concern that the four agreements with tobacco manufacturers do not deal with the issue of ‘cheap whites’; calls on the Commission, therefore, to come forward with an action plan setting out new measures to tackle this problem as a matter of urgency; |
| --- | --- |

15.

Expresses concern that the four agreements with tobacco manufacturers do not deal with the issue of ‘cheap whites’; calls on the Commission, therefore, to come forward with an action plan setting out new measures to tackle this problem as a matter of urgency;

| 16. | Calls on the Commission to bring forward a new, additional regulation establishing an independent track-and-trace system and applying due diligence (‘know your customer’) provisions to raw cut tobacco, filters and papers used by the tobacco industry, as an additional tool to combat contraband and counterfeit products; |
| --- | --- |

16.

Calls on the Commission to bring forward a new, additional regulation establishing an independent track-and-trace system and applying due diligence (‘know your customer’) provisions to raw cut tobacco, filters and papers used by the tobacco industry, as an additional tool to combat contraband and counterfeit products;

| 17. | Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States, and the Secretariat of the World Health Organisation Framework Convention on Tobacco Control. |
| --- | --- |

17.

Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States, and the Secretariat of the World Health Organisation Framework Convention on Tobacco Control.

---

(1)  OJ L 127, 29.4.2014, p. 1.

(2)  OJ C 227 E, 4.9.2008, p. 147.

---

Thursday 10 March 2016

| 9.2.2018 | EN | Official Journal of the European Union | C 50/38 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/38

---

P8_TA(2016)0083

Freedom of expression in Kazakhstan

European Parliament resolution of 10 March 2016 on freedom of expression in Kazakhstan (2016/2607(RSP))

(2018/C 050/05)

The European Parliament,

| — | having regard to its previous resolutions on Kazakhstan, including those of 18 April 2013 (1), of 15 March 2012 (2), of 22 November 2012 containing the European Parliament’s recommendations to the Council, the Commission and the European External Action Service on the negotiations for an EU-Kazakhstan Enhanced Partnership and Cooperation Agreement (3), of 15 December 2011 on the state of implementation of the EU Strategy for Central Asia (4), and of 17 September 2009 on the case of Yevgeny Zhovtis in Kazakhstan (5), |
| --- | --- |

—

having regard to its previous resolutions on Kazakhstan, including those of 18 April 2013 (1), of 15 March 2012 (2), of 22 November 2012 containing the European Parliament’s recommendations to the Council, the Commission and the European External Action Service on the negotiations for an EU-Kazakhstan Enhanced Partnership and Cooperation Agreement (3), of 15 December 2011 on the state of implementation of the EU Strategy for Central Asia (4), and of 17 September 2009 on the case of Yevgeny Zhovtis in Kazakhstan (5),

| — | having regard to remarks made by the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, Federica Mogherini, following the signing of the EU-Kazakhstan Enhanced Partnership and Cooperation Agreement (EPCA) on 21 December 2015, |
| --- | --- |

—

having regard to remarks made by the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, Federica Mogherini, following the signing of the EU-Kazakhstan Enhanced Partnership and Cooperation Agreement (EPCA) on 21 December 2015,

| — | having regard to the seventh round of the annual EU-Kazakhstan Human Rights Dialogue in Astana on 26 November 2015, |
| --- | --- |

—

having regard to the seventh round of the annual EU-Kazakhstan Human Rights Dialogue in Astana on 26 November 2015,

| — | having regard to the Council conclusions of 22 June 2015 on the EU Strategy for Central Asia, |
| --- | --- |

—

having regard to the Council conclusions of 22 June 2015 on the EU Strategy for Central Asia,

| — | having regard to the fourth progress report of 13 January 2015 on the implementation of the EU Strategy for Central Asia adopted in 2007, |
| --- | --- |

—

having regard to the fourth progress report of 13 January 2015 on the implementation of the EU Strategy for Central Asia adopted in 2007,

| — | having regard to the report of the Special Rapporteur on the rights to freedom of peaceful assembly and of association, Maina Kiai, following his mission to Kazakhstan and presented on 16 June 2015, |
| --- | --- |

—

having regard to the report of the Special Rapporteur on the rights to freedom of peaceful assembly and of association, Maina Kiai, following his mission to Kazakhstan and presented on 16 June 2015,

| — | having regard to the Enhanced Partnership and Cooperation Agreement signed on 21 December 2015, |
| --- | --- |

—

having regard to the Enhanced Partnership and Cooperation Agreement signed on 21 December 2015,

| — | having regard to Article 19 of the International Covenant on Civil and Political Rights, |
| --- | --- |

—

having regard to Article 19 of the International Covenant on Civil and Political Rights,

| — | having regard to the 1948 Universal Declaration of Human Rights, |
| --- | --- |

—

having regard to the 1948 Universal Declaration of Human Rights,

| — | having regard to Article 20 of the Constitution of Kazakhstan, |
| --- | --- |

—

having regard to Article 20 of the Constitution of Kazakhstan,

| — | having regard to Rules 135(5) and 123(4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

| A. | whereas on 21 December 2015 the European Union and Kazakhstan signed an Enhanced Partnership and Cooperation Agreement (EPCA) aimed at providing a broad framework for reinforced political dialogue and cooperation in justice and home affairs and many other areas; whereas this agreement puts a strong emphasis on democracy and the rule of law, human rights and fundamental freedoms, and sustainable development, and on civil society cooperation; |
| --- | --- |

A.

whereas on 21 December 2015 the European Union and Kazakhstan signed an Enhanced Partnership and Cooperation Agreement (EPCA) aimed at providing a broad framework for reinforced political dialogue and cooperation in justice and home affairs and many other areas; whereas this agreement puts a strong emphasis on democracy and the rule of law, human rights and fundamental freedoms, and sustainable development, and on civil society cooperation;

| B. | whereas Kazakhstan is an important international actor and plays an important role in the political and socio-economic development, and in the security situation, of the whole region; whereas Kazakhstan has played a positive role in Central Asia, making efforts to develop good neighbourly relations with bordering countries, to resume regional cooperation and to resolve all bilateral issues by peaceful means; whereas the EU has a vital interest in stepping up political, economic and security cooperation with the Central Asia region via a strong, open and strategic EU-Kazakhstan relationship; |
| --- | --- |

B.

whereas Kazakhstan is an important international actor and plays an important role in the political and socio-economic development, and in the security situation, of the whole region; whereas Kazakhstan has played a positive role in Central Asia, making efforts to develop good neighbourly relations with bordering countries, to resume regional cooperation and to resolve all bilateral issues by peaceful means; whereas the EU has a vital interest in stepping up political, economic and security cooperation with the Central Asia region via a strong, open and strategic EU-Kazakhstan relationship;

| C. | whereas the EPCA will need to be ratified by the parliaments of all 28 EU Member States and by the European Parliament; whereas this agreement will not only strengthen political dialogue between the EU and Kazakhstan and serve to promote mutual trade and investment, but also puts a strong emphasis on international obligations; whereas it can be acknowledged that during the course of the EPCA negotiations improvements were made in terms of civil society engagement through measures taken to involve civil society in public policymaking; |
| --- | --- |

C.

whereas the EPCA will need to be ratified by the parliaments of all 28 EU Member States and by the European Parliament; whereas this agreement will not only strengthen political dialogue between the EU and Kazakhstan and serve to promote mutual trade and investment, but also puts a strong emphasis on international obligations; whereas it can be acknowledged that during the course of the EPCA negotiations improvements were made in terms of civil society engagement through measures taken to involve civil society in public policymaking;

| D. | whereas the general situation with regard to freedom of expression has deteriorated in recent years; whereas in December 2015 the Kazakh authorities detained Guzal Baidalinova, a journalist and the owner of the Nakanune.kz online news site, in connection with a criminal case on charges of ‘deliberately publishing false information’; whereas concerns were expressed after the arrest of Guzal Baidalinova about the harassment of independent media in Kazakhstan; whereas on 29 February 2016 a court acquitted journalist Yulia Kozlova, who writes for Nakanune.kz; |
| --- | --- |

D.

whereas the general situation with regard to freedom of expression has deteriorated in recent years; whereas in December 2015 the Kazakh authorities detained Guzal Baidalinova, a journalist and the owner of the Nakanune.kz online news site, in connection with a criminal case on charges of ‘deliberately publishing false information’; whereas concerns were expressed after the arrest of Guzal Baidalinova about the harassment of independent media in Kazakhstan; whereas on 29 February 2016 a court acquitted journalist Yulia Kozlova, who writes for Nakanune.kz;

| E. | whereas there is an ongoing criminal investigation against Seytkazy Matayev, the head of the National Press Club and journalists’ union, who is accused of embezzling millions of Kazakh tenge in public funds; whereas on 22 February 2016 Seytkazy Matayev, who denies the charges, and his son Aset Matayev, who is the director of the KazTag independent news agency, were detained; whereas Aset Matayev was released after questioning; |
| --- | --- |

E.

whereas there is an ongoing criminal investigation against Seytkazy Matayev, the head of the National Press Club and journalists’ union, who is accused of embezzling millions of Kazakh tenge in public funds; whereas on 22 February 2016 Seytkazy Matayev, who denies the charges, and his son Aset Matayev, who is the director of the KazTag independent news agency, were detained; whereas Aset Matayev was released after questioning;

| F. | whereas on 22 January 2016 a court convicted Ermek Narymbaev and Serikzhan Mambetalin — bloggers who had been arrested in October 2015 on charges of ‘inciting national discord’– and sentenced them to three years and two years in prison respectively; whereas blogger Bolatbek Blyalov was put under limited house arrest; |
| --- | --- |

F.

whereas on 22 January 2016 a court convicted Ermek Narymbaev and Serikzhan Mambetalin — bloggers who had been arrested in October 2015 on charges of ‘inciting national discord’– and sentenced them to three years and two years in prison respectively; whereas blogger Bolatbek Blyalov was put under limited house arrest;

| G. | whereas the Kazakh authorities have closed down independent and opposition media outlets, including the Assandi Times, Pravdivaya and the ADAM bol and ADAM journals; whereas in late 2012 the Kazakh authorities sued independent and opposition media outlets, in particular the Golos Respubliki and Vzglyad newspapers, as well as their affiliate newspapers and websites, and the K+ and Stan.TV online television portals; |
| --- | --- |

G.

whereas the Kazakh authorities have closed down independent and opposition media outlets, including the Assandi Times, Pravdivaya and the ADAM bol and ADAM journals; whereas in late 2012 the Kazakh authorities sued independent and opposition media outlets, in particular the Golos Respubliki and Vzglyad newspapers, as well as their affiliate newspapers and websites, and the K+ and Stan.TV online television portals;

| H. | whereas in October 2014 a court in Almaty imposed a fine of KZT 34 million on Havas Worldwide Kazakhstan; |
| --- | --- |

H.

whereas in October 2014 a court in Almaty imposed a fine of KZT 34 million on Havas Worldwide Kazakhstan;

| I. | whereas the European Instrument for Democracy and Human Rights (EIDHR) is an important financing tool that aims to support civil society organisations and democratisation in both the country and the region; |
| --- | --- |

I.

whereas the European Instrument for Democracy and Human Rights (EIDHR) is an important financing tool that aims to support civil society organisations and democratisation in both the country and the region;

| J. | whereas according to ILGA (the International Lesbian, Gay, Bisexual, Trans and Intersex Association), LGBTI persons in Kazakhstan face legal challenges and discrimination not experienced by non-LGBTI residents; whereas both male and female same-sex sexual activity is legal in Kazakhstan, but same-sex couples and households headed by same-sex couples are not eligible for the same legal protections available to opposite-sex married couples; |
| --- | --- |

J.

whereas according to ILGA (the International Lesbian, Gay, Bisexual, Trans and Intersex Association), LGBTI persons in Kazakhstan face legal challenges and discrimination not experienced by non-LGBTI residents; whereas both male and female same-sex sexual activity is legal in Kazakhstan, but same-sex couples and households headed by same-sex couples are not eligible for the same legal protections available to opposite-sex married couples;

| K. | whereas on 20 March 2016 Kazakhstan will hold early parliamentary elections which should be preceded by guarantees regarding freedom of expression in society and the easy and transparent registration of political parties that are considered free and fair; whereas, according to the Organisation for Security and Cooperation in Europe (OSCE) Election Observation Mission Final Report of 3 April 2012, the 2012 elections were marred by ‘significant irregularities’ (6); |
| --- | --- |

K.

whereas on 20 March 2016 Kazakhstan will hold early parliamentary elections which should be preceded by guarantees regarding freedom of expression in society and the easy and transparent registration of political parties that are considered free and fair; whereas, according to the Organisation for Security and Cooperation in Europe (OSCE) Election Observation Mission Final Report of 3 April 2012, the 2012 elections were marred by ‘significant irregularities’ (6);

| L. | whereas a new Criminal Code, a new Code of Administrative Offences and a new Criminal Procedure Code came into force on 1 January 2015; |
| --- | --- |

L.

whereas a new Criminal Code, a new Code of Administrative Offences and a new Criminal Procedure Code came into force on 1 January 2015;

| M. | whereas Kazakhstan is ranked 160th out of 180 countries in the 2015 Reporters Without Borders press freedom index; |
| --- | --- |

M.

whereas Kazakhstan is ranked 160th out of 180 countries in the 2015 Reporters Without Borders press freedom index;

| N. | whereas the EU has consistently worked with Kazakhstan on its WTO accession path, which has now resulted in the completion of negotiations to join the WTO; whereas it is important that Kazakhstan follow the rule of law, uphold its international obligations and guarantee legal certainty for international companies operating in the country, together with the protection of their investments; |
| --- | --- |

N.

whereas the EU has consistently worked with Kazakhstan on its WTO accession path, which has now resulted in the completion of negotiations to join the WTO; whereas it is important that Kazakhstan follow the rule of law, uphold its international obligations and guarantee legal certainty for international companies operating in the country, together with the protection of their investments;

| O. | whereas development cooperation with Kazakhstan focuses on strengthening the capacity of regional and local government, supporting the reform of the justice sector and improving the capacity of the public sector to introduce social and economic reforms; |
| --- | --- |

O.

whereas development cooperation with Kazakhstan focuses on strengthening the capacity of regional and local government, supporting the reform of the justice sector and improving the capacity of the public sector to introduce social and economic reforms;

| 1. | Stresses the importance of relations between the EU and Kazakhstan and of strengthening economic and political cooperation in all areas; highlights the great interest the EU has in a sustainable relationship with Kazakhstan in terms of political and economic cooperation; |
| --- | --- |

1.

Stresses the importance of relations between the EU and Kazakhstan and of strengthening economic and political cooperation in all areas; highlights the great interest the EU has in a sustainable relationship with Kazakhstan in terms of political and economic cooperation;

| 2. | Expresses its concerns about the climate for media and free speech in Kazakhstan; is very concerned about the pressure on independent media outlets and the possible negative implications of new draft legislation on the funding of civil society organisations; points out that freedom of speech for independent media, bloggers and individual citizens is a universal value that cannot be bargained away; |
| --- | --- |

2.

Expresses its concerns about the climate for media and free speech in Kazakhstan; is very concerned about the pressure on independent media outlets and the possible negative implications of new draft legislation on the funding of civil society organisations; points out that freedom of speech for independent media, bloggers and individual citizens is a universal value that cannot be bargained away;

| 3. | Regrets the indiscriminate blocking of news, social media and other websites on the grounds that they feature unlawful content, and calls on the Kazakh authorities to ensure that any measure to restrict access to internet resources is based on law; is concerned about the amendments to the Communications Law adopted in 2014; |
| --- | --- |

3.

Regrets the indiscriminate blocking of news, social media and other websites on the grounds that they feature unlawful content, and calls on the Kazakh authorities to ensure that any measure to restrict access to internet resources is based on law; is concerned about the amendments to the Communications Law adopted in 2014;

| 4. | Is deeply worried about the disrespect and violation of prisoners’ rights in Kazakhstan’s prison system; is concerned about the physical and mental well-being of prisoners Vladimir Kozlov, Vadim Kuramshin (who won the Ludovic Trarieux International Human Rights Prize 2013) and Aron Atabek, who have been convicted on political grounds, and demands that they receive immediate access to necessary medical treatment and are allowed regular visits, including by family members, legal representatives and representatives of human rights and prisoners’ rights organisations; |
| --- | --- |

4.

Is deeply worried about the disrespect and violation of prisoners’ rights in Kazakhstan’s prison system; is concerned about the physical and mental well-being of prisoners Vladimir Kozlov, Vadim Kuramshin (who won the Ludovic Trarieux International Human Rights Prize 2013) and Aron Atabek, who have been convicted on political grounds, and demands that they receive immediate access to necessary medical treatment and are allowed regular visits, including by family members, legal representatives and representatives of human rights and prisoners’ rights organisations;

| 5. | Recognises the ‘100-step programme’ as an attempt to address urgent reforms in Kazakhstan; calls on Kazakhstan to implement the National Torture Prevention Mechanism and to open a debate on the new Penal and Criminal Codes; |
| --- | --- |

5.

Recognises the ‘100-step programme’ as an attempt to address urgent reforms in Kazakhstan; calls on Kazakhstan to implement the National Torture Prevention Mechanism and to open a debate on the new Penal and Criminal Codes;

| 6. | Stresses that deeper political and economic relations with the EU as envisaged by the recently signed Enhanced Partnership and Cooperation Agreement must be based on shared values and correspond to an active and concrete engagement by Kazakhstan to conduct political and democratic reforms stemming from its international obligations and commitments; |
| --- | --- |

6.

Stresses that deeper political and economic relations with the EU as envisaged by the recently signed Enhanced Partnership and Cooperation Agreement must be based on shared values and correspond to an active and concrete engagement by Kazakhstan to conduct political and democratic reforms stemming from its international obligations and commitments;

| 7. | Welcomes the release, since the last Human Rights Dialogue, of a number of imprisoned human rights and labour activists; |
| --- | --- |

7.

Welcomes the release, since the last Human Rights Dialogue, of a number of imprisoned human rights and labour activists;

| 8. | Emphasises that the legitimate fight against terrorism and extremism should not be used as an excuse to ban opposition activity, hinder the freedom of expression or hamper the independence of the judiciary; |
| --- | --- |

8.

Emphasises that the legitimate fight against terrorism and extremism should not be used as an excuse to ban opposition activity, hinder the freedom of expression or hamper the independence of the judiciary;

| 9. | Calls for a review of the articles of the Criminal Code that can be used to criminalise lawful behaviour protected by human rights law, in particular Article 174 on ‘inciting social, national, clan, racial, class or religious discord’; |
| --- | --- |

9.

Calls for a review of the articles of the Criminal Code that can be used to criminalise lawful behaviour protected by human rights law, in particular Article 174 on ‘inciting social, national, clan, racial, class or religious discord’;

| 10. | Calls on the Kazakh authorities to quash the convictions of bloggers, including Ermek Narymbaev, Serikzhan Mambetalin and Bolatbek Blyalov; calls for the release of Guzal Baidalinova; calls for an end to the harassment of Seytkazy and Aset Matayev; points out, in this connection, that cases involving journalists should be public and that there should be no harassment during the proceedings; |
| --- | --- |

10.

Calls on the Kazakh authorities to quash the convictions of bloggers, including Ermek Narymbaev, Serikzhan Mambetalin and Bolatbek Blyalov; calls for the release of Guzal Baidalinova; calls for an end to the harassment of Seytkazy and Aset Matayev; points out, in this connection, that cases involving journalists should be public and that there should be no harassment during the proceedings;

| 11. | Calls for the release of the opposition leader Vladimir Kozlov, who is currently being held under strict prison conditions, pending an independent and impartial review of his case; |
| --- | --- |

11.

Calls for the release of the opposition leader Vladimir Kozlov, who is currently being held under strict prison conditions, pending an independent and impartial review of his case;

| 12. | Expresses its deep concerns regarding the Law on NGOs, which undermines the existence and independence of NGOs in Kazakhstan; urges the Kazakh authorities to guarantee in all circumstances that all human rights activists and NGOs in Kazakhstan are able to carry out their legitimate human rights activities without fear of reprisals, and free of all restrictions; |
| --- | --- |

12.

Expresses its deep concerns regarding the Law on NGOs, which undermines the existence and independence of NGOs in Kazakhstan; urges the Kazakh authorities to guarantee in all circumstances that all human rights activists and NGOs in Kazakhstan are able to carry out their legitimate human rights activities without fear of reprisals, and free of all restrictions;

| 13. | Welcomes Kazakhstan’s ambition to engage actively as a mediator/facilitator in international security issues concerning the wider region; urges the Kazakh authorities to honour the international commitments they have signed up to, including those relating to the rule of law and the independence of the judiciary; |
| --- | --- |

13.

Welcomes Kazakhstan’s ambition to engage actively as a mediator/facilitator in international security issues concerning the wider region; urges the Kazakh authorities to honour the international commitments they have signed up to, including those relating to the rule of law and the independence of the judiciary;

| 14. | Welcomes the regular EU-Kazakhstan Human Rights Dialogues; underlines the importance of human rights dialogues between the EU and the Kazakh authorities; calls for the dialogues to be strengthened to make them conducive to the establishment of a forum in which issues can be openly addressed; stresses that these dialogues should be effective and results-oriented; |
| --- | --- |

14.

Welcomes the regular EU-Kazakhstan Human Rights Dialogues; underlines the importance of human rights dialogues between the EU and the Kazakh authorities; calls for the dialogues to be strengthened to make them conducive to the establishment of a forum in which issues can be openly addressed; stresses that these dialogues should be effective and results-oriented;

| 15. | Calls on the EU, and in particular on the European External Action Service, to monitor closely developments in Kazakhstan, to raise concerns with the Kazakh authorities where necessary, to offer assistance, and to report regularly to Parliament; calls on the EU Delegation in Astana to continue to play an active role in monitoring the situation and to raise the issue of freedom of expression in all relevant bilateral meetings with Kazakhstan; |
| --- | --- |

15.

Calls on the EU, and in particular on the European External Action Service, to monitor closely developments in Kazakhstan, to raise concerns with the Kazakh authorities where necessary, to offer assistance, and to report regularly to Parliament; calls on the EU Delegation in Astana to continue to play an active role in monitoring the situation and to raise the issue of freedom of expression in all relevant bilateral meetings with Kazakhstan;

| 16. | Urges the Kazakh authorities to implement fully the recommendations of the OSCE/Office for Democratic Institutions and Human Rights before the next parliamentary elections, and to take concrete steps to implement the recommendations made by the UN Special Rapporteur on freedom of peaceful assembly and of association; reminds Kazakhstan of its ambition to be a candidate for a non-permanent seat on the UN Security Council in 2017-2018; |
| --- | --- |

16.

Urges the Kazakh authorities to implement fully the recommendations of the OSCE/Office for Democratic Institutions and Human Rights before the next parliamentary elections, and to take concrete steps to implement the recommendations made by the UN Special Rapporteur on freedom of peaceful assembly and of association; reminds Kazakhstan of its ambition to be a candidate for a non-permanent seat on the UN Security Council in 2017-2018;

| 17. | Calls on the Kazakh authorities to commit to the achievements of the Sustainable Development Goals recently adopted at international level; |
| --- | --- |

17.

Calls on the Kazakh authorities to commit to the achievements of the Sustainable Development Goals recently adopted at international level;

| 18. | Instructs its President to forward this resolution to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the Council, the Commission, the EU Special Representative for Human Rights, the governments and parliaments of the Member States, the Organisation for Security and Cooperation in Europe, the UN Human Rights Council and the Government and Parliament of Kazakhstan. |
| --- | --- |

18.

Instructs its President to forward this resolution to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the Council, the Commission, the EU Special Representative for Human Rights, the governments and parliaments of the Member States, the Organisation for Security and Cooperation in Europe, the UN Human Rights Council and the Government and Parliament of Kazakhstan.

---

(1)  OJ C 45, 5.2.2016, p. 85.

(2)  OJ C 251 E, 31.8.2013, p. 93.

(3)  OJ C 419, 16.12.2015, p. 159.

(4)  OJ C 168 E, 14.6.2013, p. 91.

(5)  OJ C 224 E, 19.8.2010, p. 30.

(6)  http://www.osce.org/odihr/elections/89401?download=true

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/42 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/42

---

P8_TA(2016)0084

Egypt, notably the case of Giulio Regeni

European Parliament resolution of 10 March 2016 on Egypt, notably the case of Giulio Regeni (2016/2608(RSP))

(2018/C 050/06)

The European Parliament,

| — | having regard to its previous resolutions on Egypt, in particular those of 17 December 2015 (1) and 15 January 2015 (2), |
| --- | --- |

—

having regard to its previous resolutions on Egypt, in particular those of 17 December 2015 (1) and 15 January 2015 (2),

| — | having regard to the EU Foreign Affairs Council (FAC) conclusions on Egypt of 21 August 2013 and of 10 February 2014, |
| --- | --- |

—

having regard to the EU Foreign Affairs Council (FAC) conclusions on Egypt of 21 August 2013 and of 10 February 2014,

| — | having regard to the EU-Egypt Association Agreement, |
| --- | --- |

—

having regard to the EU-Egypt Association Agreement,

| — | having regard to the EU Guidelines on the Death Penalty, on Torture, on Freedom of Expression and on Human Rights Defenders, |
| --- | --- |

—

having regard to the EU Guidelines on the Death Penalty, on Torture, on Freedom of Expression and on Human Rights Defenders,

| — | having regard to the response of 27 October 2015 by the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy (VP/HR) to Written Question E-010476/2015 on EU and Member State military support to Egypt, |
| --- | --- |

—

having regard to the response of 27 October 2015 by the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy (VP/HR) to Written Question E-010476/2015 on EU and Member State military support to Egypt,

| — | having regard to the Egyptian Constitution, in particular Articles 52 (on torture) and 93 (on the binding nature of international human rights law), |
| --- | --- |

—

having regard to the Egyptian Constitution, in particular Articles 52 (on torture) and 93 (on the binding nature of international human rights law),

| — | having regard to the International Covenant on Civil and Political Rights and the UN Convention against Torture, to which Egypt is a party, |
| --- | --- |

—

having regard to the International Covenant on Civil and Political Rights and the UN Convention against Torture, to which Egypt is a party,

| — | having regard to the statement by the Egyptian Commission for Rights and Freedoms, which reported the disappearance of 1 700 people at the hands of the state security forces in 2015, |
| --- | --- |

—

having regard to the statement by the Egyptian Commission for Rights and Freedoms, which reported the disappearance of 1 700 people at the hands of the state security forces in 2015,

| — | having regard to Rules 135(5) and 123(4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

| A. | whereas, according to information available, Giulio Regeni, a 28-year-old Italian doctoral student at Cambridge University, disappeared on 25 January 2016 after leaving his home in Cairo; whereas his body was found on 3 February 2016 next to a road on the outskirts of Cairo; |
| --- | --- |

A.

whereas, according to information available, Giulio Regeni, a 28-year-old Italian doctoral student at Cambridge University, disappeared on 25 January 2016 after leaving his home in Cairo; whereas his body was found on 3 February 2016 next to a road on the outskirts of Cairo;

| B. | whereas the Egyptian authorities ordered a post-mortem examination before repatriating his body to Italy, where Italian investigators performed their own post-mortem; whereas the results have yet to be made public; whereas the Egyptian authorities have affirmed that they have nothing to hide regarding this murder, that they are equally interested in finding the truth and that they are ready to cooperate fully with their Italian counterparts in the ongoing investigation; |
| --- | --- |

B.

whereas the Egyptian authorities ordered a post-mortem examination before repatriating his body to Italy, where Italian investigators performed their own post-mortem; whereas the results have yet to be made public; whereas the Egyptian authorities have affirmed that they have nothing to hide regarding this murder, that they are equally interested in finding the truth and that they are ready to cooperate fully with their Italian counterparts in the ongoing investigation;

| C. | whereas, according to media reports and to the Italian ambassador to Cairo, Mr Regeni’s body was found to have been subjected to severe beating and multiple forms of torture; whereas the Italian Interior Minister said that the body showed signs of ‘something inhuman, animal-like, an unacceptable violence’; |
| --- | --- |

C.

whereas, according to media reports and to the Italian ambassador to Cairo, Mr Regeni’s body was found to have been subjected to severe beating and multiple forms of torture; whereas the Italian Interior Minister said that the body showed signs of ‘something inhuman, animal-like, an unacceptable violence’;

| D. | whereas Mr Regeni was conducting research in Cairo on the development of independent trade unions in post-Mubarak and post-Morsi Egypt, and had contact with opponents of the government; |
| --- | --- |

D.

whereas Mr Regeni was conducting research in Cairo on the development of independent trade unions in post-Mubarak and post-Morsi Egypt, and had contact with opponents of the government;

| E. | whereas the case of Giulio Regeni follows a long list of enforced disappearances that have occurred in Egypt since July 2013; whereas these disappearances are met with impunity; |
| --- | --- |

E.

whereas the case of Giulio Regeni follows a long list of enforced disappearances that have occurred in Egypt since July 2013; whereas these disappearances are met with impunity;

| F. | whereas the current Egyptian Government has conducted a large-scale campaign of arbitrary detention of critics of the government, including journalists, human rights defenders and members of political and social movements; whereas, since July 2013, more than 22 000 people have been detained, according to the Egyptian authorities; |
| --- | --- |

F.

whereas the current Egyptian Government has conducted a large-scale campaign of arbitrary detention of critics of the government, including journalists, human rights defenders and members of political and social movements; whereas, since July 2013, more than 22 000 people have been detained, according to the Egyptian authorities;

| G. | whereas the El Nadeem Center for the Management and Rehabilitation of Victims of Violence is under threat of closure by the authorities as a result of false accusations pertaining to health violations; whereas the centre’s role has been critical in treating victims of violence and torture, and has been crucial to the provision of information on torture, killings and the worst abuses in detention; |
| --- | --- |

G.

whereas the El Nadeem Center for the Management and Rehabilitation of Victims of Violence is under threat of closure by the authorities as a result of false accusations pertaining to health violations; whereas the centre’s role has been critical in treating victims of violence and torture, and has been crucial to the provision of information on torture, killings and the worst abuses in detention;

| H. | whereas Egypt is a long-standing strategic partner of the European Union; whereas the EU’s level of engagement with Egypt should be incentive-based, in line with the ‘more for more’ principle of the European Neighbourhood Policy, and depend on progress in reforming democratic institutions and in relation to the rule of law and human rights; whereas on 21 August 2013 the EU Foreign Affairs Council (FAC) tasked the VP/HR with reviewing EU assistance to Egypt; whereas the FAC decided that the EU’s cooperation with Egypt would be readjusted in line with developments on the ground; |
| --- | --- |

H.

whereas Egypt is a long-standing strategic partner of the European Union; whereas the EU’s level of engagement with Egypt should be incentive-based, in line with the ‘more for more’ principle of the European Neighbourhood Policy, and depend on progress in reforming democratic institutions and in relation to the rule of law and human rights; whereas on 21 August 2013 the EU Foreign Affairs Council (FAC) tasked the VP/HR with reviewing EU assistance to Egypt; whereas the FAC decided that the EU’s cooperation with Egypt would be readjusted in line with developments on the ground;

| I. | whereas the FAC conclusions of 21 August 2013 stated that, ‘Member States also agreed to suspend export licences to Egypt of any equipment which might be used for internal repression and to reassess export licences of equipment covered by Common Position 2008/944/CFSP and review their security assistance with Egypt’; whereas these conclusions were reiterated by the FAC in February 2014; whereas the VP/HR confirmed in her response of 27 October 2015 to Written Question E-010476/2015 that these conclusions constituted ‘a political commitment against any military support to Egypt’; |
| --- | --- |

I.

whereas the FAC conclusions of 21 August 2013 stated that, ‘Member States also agreed to suspend export licences to Egypt of any equipment which might be used for internal repression and to reassess export licences of equipment covered by Common Position 2008/944/CFSP and review their security assistance with Egypt’; whereas these conclusions were reiterated by the FAC in February 2014; whereas the VP/HR confirmed in her response of 27 October 2015 to Written Question E-010476/2015 that these conclusions constituted ‘a political commitment against any military support to Egypt’;

| J. | whereas the Egyptian Constitution adopted in 2014 enshrines fundamental rights and freedoms; |
| --- | --- |

J.

whereas the Egyptian Constitution adopted in 2014 enshrines fundamental rights and freedoms;

| K. | whereas Egypt faces terrorism from various jihadi organisations which are active in Egypt, in particular in Sinai, and which have links to Islamic State and other terrorist organisations active in the Libyan crisis; whereas the ongoing conflict in Libya has a direct influence on Egypt’s security; whereas the ongoing crisis is of serious concern to the European Union, and Italy in particular; |
| --- | --- |

K.

whereas Egypt faces terrorism from various jihadi organisations which are active in Egypt, in particular in Sinai, and which have links to Islamic State and other terrorist organisations active in the Libyan crisis; whereas the ongoing conflict in Libya has a direct influence on Egypt’s security; whereas the ongoing crisis is of serious concern to the European Union, and Italy in particular;

| 1. | Strongly condemns the torture and assassination under suspicious circumstances of EU citizen Giulio Regeni, and expresses its deep sympathy and condolences to the family; |
| --- | --- |

1.

Strongly condemns the torture and assassination under suspicious circumstances of EU citizen Giulio Regeni, and expresses its deep sympathy and condolences to the family;

| 2. | Calls on the Egyptian authorities to provide the Italian authorities with all the documents and information necessary to enable a swift, transparent and impartial joint investigation into the case of Mr Regeni in accordance with international obligations, and for every effort to be made to bring the perpetrators of the crime to justice as soon as possible; |
| --- | --- |

2.

Calls on the Egyptian authorities to provide the Italian authorities with all the documents and information necessary to enable a swift, transparent and impartial joint investigation into the case of Mr Regeni in accordance with international obligations, and for every effort to be made to bring the perpetrators of the crime to justice as soon as possible;

| 3. | Underlines with grave concern that the case of Giulio Regeni is not an isolated incident, but that it occurred within a context of torture, death in custody and enforced disappearances across Egypt in recent years, in clear violation of Article 2 of the EU-Egypt Association Agreement, which states that the relations between the EU and Egypt are to be based on respect for democratic principles and fundamental human rights as set out in the Universal Declaration on Human Rights, which is an essential element of the agreement; calls, therefore, on the European External Action Service (EEAS) and the Member States to raise with the Egyptian authorities the routine practice of enforced disappearances and torture and to press for effective reform of Egypt’s security apparatus and judiciary; |
| --- | --- |

3.

Underlines with grave concern that the case of Giulio Regeni is not an isolated incident, but that it occurred within a context of torture, death in custody and enforced disappearances across Egypt in recent years, in clear violation of Article 2 of the EU-Egypt Association Agreement, which states that the relations between the EU and Egypt are to be based on respect for democratic principles and fundamental human rights as set out in the Universal Declaration on Human Rights, which is an essential element of the agreement; calls, therefore, on the European External Action Service (EEAS) and the Member States to raise with the Egyptian authorities the routine practice of enforced disappearances and torture and to press for effective reform of Egypt’s security apparatus and judiciary;

| 4. | Is deeply concerned about the imminent threat of forced closure of the El Nadeem Center for the Management and Rehabilitation of Victims of Violence and Torture; calls for the swift withdrawal of the order for its administrative closure; |
| --- | --- |

4.

Is deeply concerned about the imminent threat of forced closure of the El Nadeem Center for the Management and Rehabilitation of Victims of Violence and Torture; calls for the swift withdrawal of the order for its administrative closure;

| 5. | Expresses concern at the continuous harassment of the Egyptian Commission for Rights and Freedoms for its apparent role in the ‘Stop Enforced Disappearance’ campaign in Egypt; |
| --- | --- |

5.

Expresses concern at the continuous harassment of the Egyptian Commission for Rights and Freedoms for its apparent role in the ‘Stop Enforced Disappearance’ campaign in Egypt;

| 6. | Reminds the Egyptian authorities of their national and international legal obligations, and calls on them to prioritise the protection and promotion of human rights and to ensure accountability for violations of such rights; calls, once again, for the immediate and unconditional release of all individuals detained and sentenced solely for exercising their right to freedom of expression and peaceful assembly, including human rights defenders, media professionals and bloggers; calls on the Egyptian authorities to ensure the right to a fair trial in accordance with international standards; |
| --- | --- |

6.

Reminds the Egyptian authorities of their national and international legal obligations, and calls on them to prioritise the protection and promotion of human rights and to ensure accountability for violations of such rights; calls, once again, for the immediate and unconditional release of all individuals detained and sentenced solely for exercising their right to freedom of expression and peaceful assembly, including human rights defenders, media professionals and bloggers; calls on the Egyptian authorities to ensure the right to a fair trial in accordance with international standards;

| 7. | Calls on the Government of Egypt to guarantee that domestic and international civil society organisations and independent trade unions can operate freely without government interference or intimidation in the country; calls on the Egyptian authorities to withdraw the travel bans imposed on a number of Egypt’s leading human rights defenders; |
| --- | --- |

7.

Calls on the Government of Egypt to guarantee that domestic and international civil society organisations and independent trade unions can operate freely without government interference or intimidation in the country; calls on the Egyptian authorities to withdraw the travel bans imposed on a number of Egypt’s leading human rights defenders;

| 8. | Expects the new Constitution, approved on 14 and 15 January 2014, in particular Articles 52, 73 and 93 thereof, to constitute an important step forward in the country’s transition to democracy; |
| --- | --- |

8.

Expects the new Constitution, approved on 14 and 15 January 2014, in particular Articles 52, 73 and 93 thereof, to constitute an important step forward in the country’s transition to democracy;

| 9. | Takes note of the formation of the new People’s Assembly, and calls on it to review as a matter of urgency the repressive Protest Law of November 2013, which has been used to clamp down on all forms of peaceful dissent, as well as the Assembly Law of 1914; calls also for the review of all other repressive legislation adopted in violation of Egypt’s Constitution, including the Law on Terrorist Acts and the Law on Terrorist Entities, which could be misused for internal repression rather than to improve collective security; stresses its readiness, in partnership with the country’s authorities, to study the possibility of developing a capacity-building programme for the Egyptian parliament; |
| --- | --- |

9.

Takes note of the formation of the new People’s Assembly, and calls on it to review as a matter of urgency the repressive Protest Law of November 2013, which has been used to clamp down on all forms of peaceful dissent, as well as the Assembly Law of 1914; calls also for the review of all other repressive legislation adopted in violation of Egypt’s Constitution, including the Law on Terrorist Acts and the Law on Terrorist Entities, which could be misused for internal repression rather than to improve collective security; stresses its readiness, in partnership with the country’s authorities, to study the possibility of developing a capacity-building programme for the Egyptian parliament;

| 10. | Insists that only by building a truly pluralistic society, respectful of the diversity of views and lifestyles, can long-term stability and security in Egypt be ensured, and calls on the Egyptian authorities to commit to a reconciliation dialogue bringing together all non-violent forces, including non-violent Islamists, in order to rebuild trust in politics and the economy in an inclusive political process; |
| --- | --- |

10.

Insists that only by building a truly pluralistic society, respectful of the diversity of views and lifestyles, can long-term stability and security in Egypt be ensured, and calls on the Egyptian authorities to commit to a reconciliation dialogue bringing together all non-violent forces, including non-violent Islamists, in order to rebuild trust in politics and the economy in an inclusive political process;

| 11. | Underlines the importance that the European Union attaches to cooperation with Egypt as an important neighbour and partner, and Egypt’s role in ensuring stability in the region; shares the concerns of the Egyptian people about the economic, political and security challenges facing their country and the region; condemns the terrorists’ attacks on Egyptian civilians and military; |
| --- | --- |

11.

Underlines the importance that the European Union attaches to cooperation with Egypt as an important neighbour and partner, and Egypt’s role in ensuring stability in the region; shares the concerns of the Egyptian people about the economic, political and security challenges facing their country and the region; condemns the terrorists’ attacks on Egyptian civilians and military;

| 12. | Calls for the EU, in particular the VP/HR and the EU Delegation in Cairo, to ensure regular exchanges with human rights defenders and other voices of dissent, to support those at risk or in detention and to monitor their trials in a comprehensive manner; |
| --- | --- |

12.

Calls for the EU, in particular the VP/HR and the EU Delegation in Cairo, to ensure regular exchanges with human rights defenders and other voices of dissent, to support those at risk or in detention and to monitor their trials in a comprehensive manner;

| 13. | Urges the Member States to adhere fully to the FAC conclusions of August 2013 concerning the export of military technology and equipment and security cooperation; calls for exports of surveillance equipment to be suspended when there is evidence that such equipment would be used for human rights violations; calls on the VP/HR to report on the current state of military and security cooperation by EU Member States with Egypt, and to develop a roadmap in close consultation with the European Parliament outlining concrete steps to be taken by the Egyptian authorities to improve significantly the human rights situation and achieve comprehensive judicial reform before a reassessment of the FAC conclusions of August 2013 can be considered; |
| --- | --- |

13.

Urges the Member States to adhere fully to the FAC conclusions of August 2013 concerning the export of military technology and equipment and security cooperation; calls for exports of surveillance equipment to be suspended when there is evidence that such equipment would be used for human rights violations; calls on the VP/HR to report on the current state of military and security cooperation by EU Member States with Egypt, and to develop a roadmap in close consultation with the European Parliament outlining concrete steps to be taken by the Egyptian authorities to improve significantly the human rights situation and achieve comprehensive judicial reform before a reassessment of the FAC conclusions of August 2013 can be considered;

| 14. | Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the parliaments and governments of the Member States, the President and Government of the Arab Republic of Egypt and the African Commission on Human and Peoples’ Rights. |
| --- | --- |

14.

Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the parliaments and governments of the Member States, the President and Government of the Arab Republic of Egypt and the African Commission on Human and Peoples’ Rights.

---

(1)  Texts adopted, P8_TA(2015)0463.

(2)  Texts adopted, P8_TA(2015)0012.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/45 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/45

---

P8_TA(2016)0085

Democratic Republic of the Congo

European Parliament resolution of 10 March 2016 on the Democratic Republic of the Congo (2016/2609(RSP))

(2018/C 050/07)

The European Parliament,

| — | having regard to its previous resolutions on the Democratic Republic of the Congo (DRC), in particular those of 9 July 2015 (1) and of 17 December 2015 (2), |
| --- | --- |

—

having regard to its previous resolutions on the Democratic Republic of the Congo (DRC), in particular those of 9 July 2015 (1) and of 17 December 2015 (2),

| — | having regard to the joint press release of 16 February 2016 by the African Union, the United Nations, the European Union and the International Organisation of La Francophonie on the necessity of an inclusive political dialogue in the DRC and their commitment to supporting Congolese actors in their efforts towards the consolidation of democracy in the country, |
| --- | --- |

—

having regard to the joint press release of 16 February 2016 by the African Union, the United Nations, the European Union and the International Organisation of La Francophonie on the necessity of an inclusive political dialogue in the DRC and their commitment to supporting Congolese actors in their efforts towards the consolidation of democracy in the country,

| — | having regard to the EU’s local statement of 19 November 2015 following the launch of the national dialogue in the DRC, |
| --- | --- |

—

having regard to the EU’s local statement of 19 November 2015 following the launch of the national dialogue in the DRC,

| — | having regard to the statement of 9 November 2015 by the President of the UN Security Council on the situation concerning the DRC, |
| --- | --- |

—

having regard to the statement of 9 November 2015 by the President of the UN Security Council on the situation concerning the DRC,

| — | having regard to the EU’s local statement of 21 October 2015 on the human rights situation in the DRC, |
| --- | --- |

—

having regard to the EU’s local statement of 21 October 2015 on the human rights situation in the DRC,

| — | having regard to the statement of 12 October 2015 by the Spokesperson for the European External Action Service on the resignation of the head of the Electoral Commission in the DRC, |
| --- | --- |

—

having regard to the statement of 12 October 2015 by the Spokesperson for the European External Action Service on the resignation of the head of the Electoral Commission in the DRC,

| — | having regard to the UN Security Council resolutions on the DRC, in particular resolutions 2198 (2015) on renewing the DRC sanctions regime and the mandate of the Group of Experts and 2211 (2013), which renewed the mandate of the UN Stabilisation Mission in the DRC (MONUSCO), |
| --- | --- |

—

having regard to the UN Security Council resolutions on the DRC, in particular resolutions 2198 (2015) on renewing the DRC sanctions regime and the mandate of the Group of Experts and 2211 (2013), which renewed the mandate of the UN Stabilisation Mission in the DRC (MONUSCO),

| — | having regard to the joint press statement of 2 September 2015 by the Team of International Envoys and Representatives for the Great Lakes region of Africa on Elections in the DRC, |
| --- | --- |

—

having regard to the joint press statement of 2 September 2015 by the Team of International Envoys and Representatives for the Great Lakes region of Africa on Elections in the DRC,

| — | having regard to the annual report of the UN High Commissioner for Human Rights of 27 July 2015 on the situation of human rights and the activities of the UN Joint Human Rights Office in the DRC (UNJHRO), |
| --- | --- |

—

having regard to the annual report of the UN High Commissioner for Human Rights of 27 July 2015 on the situation of human rights and the activities of the UN Joint Human Rights Office in the DRC (UNJHRO),

| — | having regard to the statement of 25 January 2015 by the Vice-President of the Union/High Representative for Foreign Affairs and Security Policy (VP/HR), Federica Mogherini, following the adoption of the new electoral law in the DRC, |
| --- | --- |

—

having regard to the statement of 25 January 2015 by the Vice-President of the Union/High Representative for Foreign Affairs and Security Policy (VP/HR), Federica Mogherini, following the adoption of the new electoral law in the DRC,

| — | having regard to the report of 12 January 2015 of the UN Group of Experts on the DRC, |
| --- | --- |

—

having regard to the report of 12 January 2015 of the UN Group of Experts on the DRC,

| — | having regard to the Nairobi Declarations of December 2013, |
| --- | --- |

—

having regard to the Nairobi Declarations of December 2013,

| — | having regard to the Peace, Security and Cooperation Framework Agreement for the DRC and the Region signed in Addis Ababa in February 2013, |
| --- | --- |

—

having regard to the Peace, Security and Cooperation Framework Agreement for the DRC and the Region signed in Addis Ababa in February 2013,

| — | having regard to the African Charter of Human and Peoples’ Rights of June 1981, |
| --- | --- |

—

having regard to the African Charter of Human and Peoples’ Rights of June 1981,

| — | having regard to the African Charter on Democracy, Elections and Governance, |
| --- | --- |

—

having regard to the African Charter on Democracy, Elections and Governance,

| — | having regard to the Congolese Constitution of 18 February 2006, |
| --- | --- |

—

having regard to the Congolese Constitution of 18 February 2006,

| — | having regard to the Cotonou Agreement, |
| --- | --- |

—

having regard to the Cotonou Agreement,

| — | having regard to Rules 135(5) and 123(4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

| A. | whereas the next presidential and legislative elections, which are scheduled to be held in November 2016, could represent a further opportunity for a democratic transition of power; |
| --- | --- |

A.

whereas the next presidential and legislative elections, which are scheduled to be held in November 2016, could represent a further opportunity for a democratic transition of power;

| B. | whereas the mandate of the President of the DRC is constitutionally limited to two terms; |
| --- | --- |

B.

whereas the mandate of the President of the DRC is constitutionally limited to two terms;

| C. | whereas President Joseph Kabila, in power since 2001, has been accused by his opponents of using administrative and technical means to try to delay the election and remain in power beyond the end of his mandate, and has yet to declare publicly that he will step down at the end of his term; whereas this has caused growing political tension, unrest and violence across the country; |
| --- | --- |

C.

whereas President Joseph Kabila, in power since 2001, has been accused by his opponents of using administrative and technical means to try to delay the election and remain in power beyond the end of his mandate, and has yet to declare publicly that he will step down at the end of his term; whereas this has caused growing political tension, unrest and violence across the country;

| D. | whereas doubts have been expressed as to the independence and impartiality of the Independent National Electoral Commission (CENI); |
| --- | --- |

D.

whereas doubts have been expressed as to the independence and impartiality of the Independent National Electoral Commission (CENI);

| E. | whereas since January 2015 Congolese security and intelligence officials have clamped down on peaceful activists, political leaders and others who oppose attempts to allow President Kabila to modify the constitution in order to stay in power past his constitutionally mandated two-term limit; whereas human rights groups continually report on the worsening of the situation with regard to human rights and freedom of expression and assembly in the DRC, including the use of excessive force against peaceful demonstrators and an increase in the number of politically motivated trials; whereas MONUSCO has registered more than 260 election-related human rights violations, mainly against political opponents, civil society and journalists, during the past year; whereas the UNJHRO in the DRC has stated that it has documented more than 400 cases of human rights violations, including 52 arrests, since the beginning of 2016; |
| --- | --- |

E.

whereas since January 2015 Congolese security and intelligence officials have clamped down on peaceful activists, political leaders and others who oppose attempts to allow President Kabila to modify the constitution in order to stay in power past his constitutionally mandated two-term limit; whereas human rights groups continually report on the worsening of the situation with regard to human rights and freedom of expression and assembly in the DRC, including the use of excessive force against peaceful demonstrators and an increase in the number of politically motivated trials; whereas MONUSCO has registered more than 260 election-related human rights violations, mainly against political opponents, civil society and journalists, during the past year; whereas the UNJHRO in the DRC has stated that it has documented more than 400 cases of human rights violations, including 52 arrests, since the beginning of 2016;

| F. | whereas in June 2015 President Kabila announced the launch of a national dialogue; whereas formal preparations for such a dialogue have not yet begun, as two major opposition groups decided not to participate because they consider this to be a delaying tactic; |
| --- | --- |

F.

whereas in June 2015 President Kabila announced the launch of a national dialogue; whereas formal preparations for such a dialogue have not yet begun, as two major opposition groups decided not to participate because they consider this to be a delaying tactic;

| G. | whereas in September 2015 seven senior political figures were expelled from the DRC’s ruling coalition for signing a letter urging President Kabila to comply with the constitution and not to cling to power after his term expires; whereas violent clashes broke out the same month in Kinshasa, where a rally opposing any bid for an unconstitutional third term was violently attacked; |
| --- | --- |

G.

whereas in September 2015 seven senior political figures were expelled from the DRC’s ruling coalition for signing a letter urging President Kabila to comply with the constitution and not to cling to power after his term expires; whereas violent clashes broke out the same month in Kinshasa, where a rally opposing any bid for an unconstitutional third term was violently attacked;

| H. | whereas those arbitrarily detained include Fred Bauma and Yves Makwambala, human rights activists from the Filimbi (‘Whistle’) movement, both of whom were arrested for participating in a workshop intended to encourage Congolese young people to perform their civic duties peacefully and responsibly, and who have now been jailed for 11 months, their release having already been demanded by the European Parliament in its aforementioned resolution of 9 July 2015; |
| --- | --- |

H.

whereas those arbitrarily detained include Fred Bauma and Yves Makwambala, human rights activists from the Filimbi (‘Whistle’) movement, both of whom were arrested for participating in a workshop intended to encourage Congolese young people to perform their civic duties peacefully and responsibly, and who have now been jailed for 11 months, their release having already been demanded by the European Parliament in its aforementioned resolution of 9 July 2015;

| I. | whereas leaders of Congo’s main opposition parties, non-governmental organisations and pro-democracy youth movements called on Congolese citizens to stay home from work and school on 16 February 2016 for ‘Ville Morte’ (‘Dead City Day’) in commemoration of those killed during a pro-democracy march on 16 February 1992, and to protest against the delays in organising presidential elections and the government’s alleged failure to comply with the constitution; |
| --- | --- |

I.

whereas leaders of Congo’s main opposition parties, non-governmental organisations and pro-democracy youth movements called on Congolese citizens to stay home from work and school on 16 February 2016 for ‘Ville Morte’ (‘Dead City Day’) in commemoration of those killed during a pro-democracy march on 16 February 1992, and to protest against the delays in organising presidential elections and the government’s alleged failure to comply with the constitution;

| J. | whereas eight youth activists and at least 30 political opposition supporters were detained on or around 16 February 2016 in connection with this national strike, while other activists received text message threats from unknown phone numbers and Employment Minister Willy Makiashi prohibited public employees from participating in the strike; whereas six members of the LUCHA movement were sentenced to six months in prison; whereas traders and officials who had observed ‘Dead City Day’ saw their shops sealed or were the subject of disciplinary sanctions; |
| --- | --- |

J.

whereas eight youth activists and at least 30 political opposition supporters were detained on or around 16 February 2016 in connection with this national strike, while other activists received text message threats from unknown phone numbers and Employment Minister Willy Makiashi prohibited public employees from participating in the strike; whereas six members of the LUCHA movement were sentenced to six months in prison; whereas traders and officials who had observed ‘Dead City Day’ saw their shops sealed or were the subject of disciplinary sanctions;

| K. | whereas the African Union, the UN, the EU and the International Organisation of La Francophonie have jointly underscored the importance of dialogue and the search for an agreement between political actors that respects democracy and the rule of law, and have urged all Congolese political actors to extend their full cooperation to the mediators designated by the international community; |
| --- | --- |

K.

whereas the African Union, the UN, the EU and the International Organisation of La Francophonie have jointly underscored the importance of dialogue and the search for an agreement between political actors that respects democracy and the rule of law, and have urged all Congolese political actors to extend their full cooperation to the mediators designated by the international community;

| L. | whereas the situation is worsened by the persistence and consolidation of impunity in the DRC; whereas the security situation in the DRC continues to deteriorate, in particular in the eastern part of the country, owing to violence caused by more than 30 foreign and domestic armed groups, with constant reports of abuses of human rights and international law, including targeted attacks against civilians, widespread sexual and gender-based violence, systematic recruitment and abuse of children by armed groups, and extrajudicial executions; |
| --- | --- |

L.

whereas the situation is worsened by the persistence and consolidation of impunity in the DRC; whereas the security situation in the DRC continues to deteriorate, in particular in the eastern part of the country, owing to violence caused by more than 30 foreign and domestic armed groups, with constant reports of abuses of human rights and international law, including targeted attacks against civilians, widespread sexual and gender-based violence, systematic recruitment and abuse of children by armed groups, and extrajudicial executions;

| M. | whereas there has recently been a deterioration in the freedom of the media in the DRC; whereas government officials have blocked free speech by shutting down media outlets (specifically targeting those that aired messages about the protests), text messaging services and the internet; whereas in February 2016 the government closed two private TV channels in Lubumbashi; whereas in its last annual report, released in November 2015, Journalists in Danger, the partner organisation of Reporters Without Borders, listed 72 cases of attacks against journalists and media in the DRC and revealed that 60 % of violations of press freedom are perpetrated by military or security service agents, the National Intelligence Agency (ANR) or the police; whereas transmission of Radio France International broadcasts was suspended to coincide with the ‘Dead City Day’ protest; |
| --- | --- |

M.

whereas there has recently been a deterioration in the freedom of the media in the DRC; whereas government officials have blocked free speech by shutting down media outlets (specifically targeting those that aired messages about the protests), text messaging services and the internet; whereas in February 2016 the government closed two private TV channels in Lubumbashi; whereas in its last annual report, released in November 2015, Journalists in Danger, the partner organisation of Reporters Without Borders, listed 72 cases of attacks against journalists and media in the DRC and revealed that 60 % of violations of press freedom are perpetrated by military or security service agents, the National Intelligence Agency (ANR) or the police; whereas transmission of Radio France International broadcasts was suspended to coincide with the ‘Dead City Day’ protest;

| N. | whereas the 2014-2020 National Indicative Programme for the DRC, with EUR 620 million in funding under the 11th European Development Fund, prioritises strengthening governance and the rule of law, including reforms of the judiciary, police and army; |
| --- | --- |

N.

whereas the 2014-2020 National Indicative Programme for the DRC, with EUR 620 million in funding under the 11th European Development Fund, prioritises strengthening governance and the rule of law, including reforms of the judiciary, police and army;

| 1. | Calls on the authorities of the DRC to expressly undertake to comply with the constitution and to ensure the timely holding of elections by the end of 2016, in full accordance with the African Charter on Democracy, Elections and Governance, and to guarantee an environment conducive to transparent, credible and inclusive elections; stresses that the successful holding of elections will be crucial to the long-term stability and development of the country; |
| --- | --- |

1.

Calls on the authorities of the DRC to expressly undertake to comply with the constitution and to ensure the timely holding of elections by the end of 2016, in full accordance with the African Charter on Democracy, Elections and Governance, and to guarantee an environment conducive to transparent, credible and inclusive elections; stresses that the successful holding of elections will be crucial to the long-term stability and development of the country;

| 2. | Expresses deep concern about the deteriorating security and human rights situation in the DRC, and in particular about the continual reports of increasing political violence and the severe restrictions and intimidation faced by human rights defenders, political opponents and journalists ahead of the upcoming electoral cycle; insists on the government’s responsibility to prevent any deepening of the current political crisis or escalation of violence and to respect, protect and promote the civil and political rights of its citizens; |
| --- | --- |

2.

Expresses deep concern about the deteriorating security and human rights situation in the DRC, and in particular about the continual reports of increasing political violence and the severe restrictions and intimidation faced by human rights defenders, political opponents and journalists ahead of the upcoming electoral cycle; insists on the government’s responsibility to prevent any deepening of the current political crisis or escalation of violence and to respect, protect and promote the civil and political rights of its citizens;

| 3. | Strongly condemns any use of force against peaceful, unarmed demonstrators; recalls that freedom of expression, association and assembly is the basis of a dynamic political and democratic life; strongly condemns the increasing restrictions of the democratic space and the targeted repression of members of the opposition, civil society and the media; calls for the immediate and unconditional release of all political prisoners, including Yves Makwambala, Fred Bauma and other Filimbi and LUCHA activists and supporters, and the human rights defender Christopher Ngoyi; |
| --- | --- |

3.

Strongly condemns any use of force against peaceful, unarmed demonstrators; recalls that freedom of expression, association and assembly is the basis of a dynamic political and democratic life; strongly condemns the increasing restrictions of the democratic space and the targeted repression of members of the opposition, civil society and the media; calls for the immediate and unconditional release of all political prisoners, including Yves Makwambala, Fred Bauma and other Filimbi and LUCHA activists and supporters, and the human rights defender Christopher Ngoyi;

| 4. | Considers the fight against impunity to be a prerequisite for re-establishing peace in the DRC; asks for a full, thorough and transparent investigation to be launched by the DRC Government, together with international partners, into the human rights violations that took place during the election-related protests, with the aim of identifying any illegal actions or denial of rights or freedoms; urges that measures be taken to ensure that perpetrators of human rights violations, war crimes, crimes against humanity and sexual violence against women, together with those responsible for recruiting child soldiers, are reported, identified, prosecuted and punished in accordance with national and international criminal law; |
| --- | --- |

4.

Considers the fight against impunity to be a prerequisite for re-establishing peace in the DRC; asks for a full, thorough and transparent investigation to be launched by the DRC Government, together with international partners, into the human rights violations that took place during the election-related protests, with the aim of identifying any illegal actions or denial of rights or freedoms; urges that measures be taken to ensure that perpetrators of human rights violations, war crimes, crimes against humanity and sexual violence against women, together with those responsible for recruiting child soldiers, are reported, identified, prosecuted and punished in accordance with national and international criminal law;

| 5. | Calls on the VP/HR and the Member States to make full use of all policy instruments, including the recommendations issued in the final report of the 2011 EU Electoral Observation Mission and in the report of the follow-up mission of 2014, and to exert political pressure at the highest level, in order to prevent the spread of electoral violence in the DRC and any further destabilisation of the Great Lakes region; |
| --- | --- |

5.

Calls on the VP/HR and the Member States to make full use of all policy instruments, including the recommendations issued in the final report of the 2011 EU Electoral Observation Mission and in the report of the follow-up mission of 2014, and to exert political pressure at the highest level, in order to prevent the spread of electoral violence in the DRC and any further destabilisation of the Great Lakes region;

| 6. | Takes note of the willingness of the EU and the international community to support the Congolese electoral process, provided that a valid electoral calendar is published and that constitutional provisions are complied with; considers that this support should concentrate on voter registration, training and election securitisation; insists that the nature and amount of EU support to the electoral process in the DRC must depend on the progress made in implementing the recommendations of the Electoral Observation Missions of 2011 and 2014, in particular as regards guarantees of the CENI’s independence, the revision of the electoral roll, budgetary requirements and compliance with the constitutional timeframe; |
| --- | --- |

6.

Takes note of the willingness of the EU and the international community to support the Congolese electoral process, provided that a valid electoral calendar is published and that constitutional provisions are complied with; considers that this support should concentrate on voter registration, training and election securitisation; insists that the nature and amount of EU support to the electoral process in the DRC must depend on the progress made in implementing the recommendations of the Electoral Observation Missions of 2011 and 2014, in particular as regards guarantees of the CENI’s independence, the revision of the electoral roll, budgetary requirements and compliance with the constitutional timeframe;

| 7. | Calls on the Congolese authorities to ratify the African Charter on Democracy, Elections and Governance at the earliest |
| --- | --- |

7.

Calls on the Congolese authorities to ratify the African Charter on Democracy, Elections and Governance at the earliest

| 8. | Highlights the crucial role of the African Union (AU) in preventing a political crisis in Central Africa and invites the AU member states, in particular South Africa, to engage in favour of compliance with the constitution of the DRC; urges the EU to use all its diplomatic and economic tools, including the forthcoming signing of the Economic Partnership Agreements, to reach this goal; |
| --- | --- |

8.

Highlights the crucial role of the African Union (AU) in preventing a political crisis in Central Africa and invites the AU member states, in particular South Africa, to engage in favour of compliance with the constitution of the DRC; urges the EU to use all its diplomatic and economic tools, including the forthcoming signing of the Economic Partnership Agreements, to reach this goal;

| 9. | Recalls that full participation of the opposition, independent civil society and electoral experts in the CENI is an important factor in legitimising the electoral process; recalls that the CENI should be an impartial institution; stresses that the authorities should make available to the CENI the necessary financial resources to allow a comprehensive and transparent process; |
| --- | --- |

9.

Recalls that full participation of the opposition, independent civil society and electoral experts in the CENI is an important factor in legitimising the electoral process; recalls that the CENI should be an impartial institution; stresses that the authorities should make available to the CENI the necessary financial resources to allow a comprehensive and transparent process;

| 10. | Calls on the VP/HR to intensify the dialogue with the DCR authorities under Article 8 of the Cotonou Agreement, with the objective of obtaining definitive clarification concerning the electoral process; recalls the commitment made by the DRC under the Cotonou Agreement to respecting democracy, the rule of law and human rights principles, which include freedom of expression and of the media, good governance and transparency in political office; urges the Government of the DRC to uphold these provisions in accordance with Articles 11b, 96 and 97 of the Cotonou Agreement, and, failing that, asks the Commission to launch the relevant procedure in accordance with Articles 8, 9 and 96 of the Cotonou Agreement; |
| --- | --- |

10.

Calls on the VP/HR to intensify the dialogue with the DCR authorities under Article 8 of the Cotonou Agreement, with the objective of obtaining definitive clarification concerning the electoral process; recalls the commitment made by the DRC under the Cotonou Agreement to respecting democracy, the rule of law and human rights principles, which include freedom of expression and of the media, good governance and transparency in political office; urges the Government of the DRC to uphold these provisions in accordance with Articles 11b, 96 and 97 of the Cotonou Agreement, and, failing that, asks the Commission to launch the relevant procedure in accordance with Articles 8, 9 and 96 of the Cotonou Agreement;

| 11. | Calls for the EU to consider imposing targeted sanctions on those responsible for the violent crackdown in the DRC, including travel bans and asset freezes, so as to help prevent further violence; |
| --- | --- |

11.

Calls for the EU to consider imposing targeted sanctions on those responsible for the violent crackdown in the DRC, including travel bans and asset freezes, so as to help prevent further violence;

| 12. | Urges the EU Delegation to monitor developments and to use all appropriate tools and instruments, including the European Instrument for Democracy and Human Rights, to support human rights defenders and pro-democracy movements; |
| --- | --- |

12.

Urges the EU Delegation to monitor developments and to use all appropriate tools and instruments, including the European Instrument for Democracy and Human Rights, to support human rights defenders and pro-democracy movements;

| 13. | Calls for the reinstatement of a UN rapporteur on human rights in the DRC; |
| --- | --- |

13.

Calls for the reinstatement of a UN rapporteur on human rights in the DRC;

| 14. | Recalls that peace and security are preconditions for a successful election; notes, in this connection, the renewal of MONUSCO’s mandate, and calls for the reinforcement of its competences in the field of civilian protection in the electoral context; |
| --- | --- |

14.

Recalls that peace and security are preconditions for a successful election; notes, in this connection, the renewal of MONUSCO’s mandate, and calls for the reinforcement of its competences in the field of civilian protection in the electoral context;

| 15. | Reiterates its deep concern regarding the alarming humanitarian situation in the DRC, caused in particular by the violent armed conflicts in the country’s eastern provinces; calls for the EU and its Member States to continue their assistance to the people of the DRC with a view to improving the living conditions of the most vulnerable populations and tackling the consequences of displacement, food insecurity, epidemics and natural disasters; |
| --- | --- |

15.

Reiterates its deep concern regarding the alarming humanitarian situation in the DRC, caused in particular by the violent armed conflicts in the country’s eastern provinces; calls for the EU and its Member States to continue their assistance to the people of the DRC with a view to improving the living conditions of the most vulnerable populations and tackling the consequences of displacement, food insecurity, epidemics and natural disasters;

| 16. | Condemns the ongoing acts of sexual violence in the eastern Congo; notes that the Congolese authorities have held 20 trials in recent months in respect of sexual violence in the eastern Congo, convicting 19 army officers, and that much more needs to be done; strongly encourages the Congolese authorities to continue their fight against impunity by investigating cases of sexual violence and prosecuting the perpetrators; |
| --- | --- |

16.

Condemns the ongoing acts of sexual violence in the eastern Congo; notes that the Congolese authorities have held 20 trials in recent months in respect of sexual violence in the eastern Congo, convicting 19 army officers, and that much more needs to be done; strongly encourages the Congolese authorities to continue their fight against impunity by investigating cases of sexual violence and prosecuting the perpetrators;

| 17. | Welcomes the decision of the Congolese authorities to review the adoption cases blocked since 25 September 2013; takes note of the work of the Congolese Interministerial Committee on the sporadic issuance of exit permits for adopted children; calls on the Interministerial Committee to continue its work diligently and coherently in a serene atmosphere; calls on the EU delegation and the Member States to monitor the situation closely; |
| --- | --- |

17.

Welcomes the decision of the Congolese authorities to review the adoption cases blocked since 25 September 2013; takes note of the work of the Congolese Interministerial Committee on the sporadic issuance of exit permits for adopted children; calls on the Interministerial Committee to continue its work diligently and coherently in a serene atmosphere; calls on the EU delegation and the Member States to monitor the situation closely;

| 18. | Calls on the African Union and the EU to ensure a permanent political dialogue among the countries of the Great Lakes region in order to prevent any further destabilisation; |
| --- | --- |

18.

Calls on the African Union and the EU to ensure a permanent political dialogue among the countries of the Great Lakes region in order to prevent any further destabilisation;

| 19. | Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the African Union, the President, Prime Minister and Parliament of the DRC, the Secretary-General of the United Nations, the UN Human Rights Council, and the ACP-EU Joint Parliamentary Assembly. |
| --- | --- |

19.

Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the African Union, the President, Prime Minister and Parliament of the DRC, the Secretary-General of the United Nations, the UN Human Rights Council, and the ACP-EU Joint Parliamentary Assembly.

---

(1)  Texts adopted, P8_TA(2015)0278.

(2)  Texts adopted, P8_TA(2015)0475.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/50 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/50

---

P8_TA(2016)0089

Towards a thriving data-driven economy

European Parliament resolution of 10 March 2016 on ‘Towards a thriving data-driven economy’ (2015/2612(RSP))

(2018/C 050/08)

The European Parliament,

| — | having regard to the Commission communication of 2 July 2014 entitled ‘Towards a thriving data-driven economy’ (COM(2014)0442), |
| --- | --- |

—

having regard to the Commission communication of 2 July 2014 entitled ‘Towards a thriving data-driven economy’ (COM(2014)0442),

| — | having regard to the question to the Commission on ‘Towards a thriving data-driven economy’ (O-000021/2016 — B8-0116/2016), |
| --- | --- |

—

having regard to the question to the Commission on ‘Towards a thriving data-driven economy’ (O-000021/2016 — B8-0116/2016),

| — | having regard to the motion for a resolution of the Committee on Industry, Research and Energy, |
| --- | --- |

—

having regard to the motion for a resolution of the Committee on Industry, Research and Energy,

| — | having regard to Article 8 of the EU Charter of Fundamental Rights and Article 16 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 8 of the EU Charter of Fundamental Rights and Article 16 of the Treaty on the Functioning of the European Union,

| — | having regard to its resolution of 10 December 2013 on unleashing the potential of cloud computing in Europe (1), |
| --- | --- |

—

having regard to its resolution of 10 December 2013 on unleashing the potential of cloud computing in Europe (1),

| — | having regard to the Commission communication of 6 May 2015 entitled ‘A Digital Single Market Strategy for Europe’ (COM(2015)0192), |
| --- | --- |

—

having regard to the Commission communication of 6 May 2015 entitled ‘A Digital Single Market Strategy for Europe’ (COM(2015)0192),

| — | having regard to Rules 128(5) and 123(2) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 128(5) and 123(2) of its Rules of Procedure,

| A. | whereas the growth rate in the Big Data market until 2017 will be six times faster than in the overall ICT market and will reach an overall total of EUR 50 billion, according to the International Data Corporation’s Worldwide Big Data Technology and Services Forecast for 2013-2017, which may result in 3,75 million new jobs by 2017 according to the Big Data Value Public-Private Partnership; |
| --- | --- |

A.

whereas the growth rate in the Big Data market until 2017 will be six times faster than in the overall ICT market and will reach an overall total of EUR 50 billion, according to the International Data Corporation’s Worldwide Big Data Technology and Services Forecast for 2013-2017, which may result in 3,75 million new jobs by 2017 according to the Big Data Value Public-Private Partnership;

| B. | whereas the volume of data is growing at an unprecedented pace, so that there will be 16 trillion gigabytes of data by 2020, which corresponds to an annual growth rate of 236 % in data generation; |
| --- | --- |

B.

whereas the volume of data is growing at an unprecedented pace, so that there will be 16 trillion gigabytes of data by 2020, which corresponds to an annual growth rate of 236 % in data generation;

| C. | whereas decisions based on knowledge generated by Big Data may bring about a sizeable increase in productivity and competitiveness, and whereas the benefits of a data-driven economy will bring 1,9 % in additional GDP growth by 2020; |
| --- | --- |

C.

whereas decisions based on knowledge generated by Big Data may bring about a sizeable increase in productivity and competitiveness, and whereas the benefits of a data-driven economy will bring 1,9 % in additional GDP growth by 2020;

| D. | whereas the development of Big Data is an integral part of a new digital market and should ensure the development of innovative and competitive business models while conforming to the EU framework on data protection, as Big Data can entail significant risks and challenges, particularly as regards fundamental rights (including privacy and data protection); |
| --- | --- |

D.

whereas the development of Big Data is an integral part of a new digital market and should ensure the development of innovative and competitive business models while conforming to the EU framework on data protection, as Big Data can entail significant risks and challenges, particularly as regards fundamental rights (including privacy and data protection);

| E. | whereas a future thriving data-driven economy can represent an opportunity for growth and employment, including by enabling new business models and services and improved productivity; whereas a good balance has to be achieved in order to create the right framework for economic growth, so as to maintain trust while safeguarding and upholding consumer rights through effective monitoring, assessment and appropriate responses, if necessary by legislative means; |
| --- | --- |

E.

whereas a future thriving data-driven economy can represent an opportunity for growth and employment, including by enabling new business models and services and improved productivity; whereas a good balance has to be achieved in order to create the right framework for economic growth, so as to maintain trust while safeguarding and upholding consumer rights through effective monitoring, assessment and appropriate responses, if necessary by legislative means;

| F. | whereas Big Data also brings opportunities for consumers (e.g. convenience, efficiency and savings), businesses (industry 4.0) and government (e-government), and in respect of housing (smart cities), science, medicine (Mhealth), disaster response and fighting crime; |
| --- | --- |

F.

whereas Big Data also brings opportunities for consumers (e.g. convenience, efficiency and savings), businesses (industry 4.0) and government (e-government), and in respect of housing (smart cities), science, medicine (Mhealth), disaster response and fighting crime;

The role of the data-driven economy within the Digital Union strategy

| 1. | Expects the benefits of a data-driven economy at national and European level to have an impact on society and on all types of enterprise in the value chain; sees the creation of a data-driven economy as being at the core of the Digital Single Market strategy, and appreciates its potential to help Europe regain competitiveness in advanced sectors and to accelerate Europe’s economic recovery, growth investment and innovation across all sectors, which can only be achieved if there is the right business environment and the means to activate the digital transformation, and if these technologies comply with the EU legal framework on data protection so that the associated risks and challenges — particularly with regard to fundamental rights, and especially privacy and data protection — are addressed; |
| --- | --- |

1.

Expects the benefits of a data-driven economy at national and European level to have an impact on society and on all types of enterprise in the value chain; sees the creation of a data-driven economy as being at the core of the Digital Single Market strategy, and appreciates its potential to help Europe regain competitiveness in advanced sectors and to accelerate Europe’s economic recovery, growth investment and innovation across all sectors, which can only be achieved if there is the right business environment and the means to activate the digital transformation, and if these technologies comply with the EU legal framework on data protection so that the associated risks and challenges — particularly with regard to fundamental rights, and especially privacy and data protection — are addressed;

| 2. | Stresses that the data-driven economy requires advanced skills and is expected to create a significant number of jobs in Europe in the coming years; |
| --- | --- |

2.

Stresses that the data-driven economy requires advanced skills and is expected to create a significant number of jobs in Europe in the coming years;

| 3. | Recognises the social and economic benefits associated with the integrated use of data in all sectors of the European economy and all fields of European research, and underlines the importance of transparency with regard to the value and use of collected data, management rules and the ways in which the data are collected and processed; emphasises that individuals should have up-to-date, meaningful rights of access to information about data processing; stresses the need, in this context, to collect accurate statistics on the level of awareness among citizens, businesses and public administrations; stresses that the digitisation of the economy is an important driver of development in the area of Big Data, and therefore requires a horizontal approach in order for the data economy to grow; |
| --- | --- |

3.

Recognises the social and economic benefits associated with the integrated use of data in all sectors of the European economy and all fields of European research, and underlines the importance of transparency with regard to the value and use of collected data, management rules and the ways in which the data are collected and processed; emphasises that individuals should have up-to-date, meaningful rights of access to information about data processing; stresses the need, in this context, to collect accurate statistics on the level of awareness among citizens, businesses and public administrations; stresses that the digitisation of the economy is an important driver of development in the area of Big Data, and therefore requires a horizontal approach in order for the data economy to grow;

| 4. | Believes that data represent a valuable asset for companies, the value of which could be significantly increased through the development of innovative and smart ways of allowing the integration of company-owned data with open data; asks that initiatives be launched to raise SMEs’ awareness of the value of their data and how they can be used to develop new business models in order to foster growth and to establish SMEs as a main player in Big Data; |
| --- | --- |

4.

Believes that data represent a valuable asset for companies, the value of which could be significantly increased through the development of innovative and smart ways of allowing the integration of company-owned data with open data; asks that initiatives be launched to raise SMEs’ awareness of the value of their data and how they can be used to develop new business models in order to foster growth and to establish SMEs as a main player in Big Data;

| 5. | Stresses that the processing of certain kinds of data, in particular personal data, falls under the scope of EU data protection law; urges, in this connection, the swift adoption of the Data Protection Package; |
| --- | --- |

5.

Stresses that the processing of certain kinds of data, in particular personal data, falls under the scope of EU data protection law; urges, in this connection, the swift adoption of the Data Protection Package;

| 6. | Points out that data protection and opportunities arising from the integrated use of data are not mutually exclusive, as the smart use of opportunities can ensure compatibility with data protection; considers that ensuring trust in these technologies should be at the heart of both public policy and business models, as a lack of trust can greatly damage growth and innovation in the digital sector; believes that there is an essential need for a future-proof and uniform legal framework for data protection in order to foster growth and innovation, and acknowledges the open and global character of the internet; recognises that data protection law is technologically neutral and already applies fully to Big Data activities operating in the EU, and must therefore be complied with fully; urges that public policy include privacy by design and privacy by default in the data generation and analysis cycle, while seizing any opportunity to foster the development of the potential of Big Data; |
| --- | --- |

6.

Points out that data protection and opportunities arising from the integrated use of data are not mutually exclusive, as the smart use of opportunities can ensure compatibility with data protection; considers that ensuring trust in these technologies should be at the heart of both public policy and business models, as a lack of trust can greatly damage growth and innovation in the digital sector; believes that there is an essential need for a future-proof and uniform legal framework for data protection in order to foster growth and innovation, and acknowledges the open and global character of the internet; recognises that data protection law is technologically neutral and already applies fully to Big Data activities operating in the EU, and must therefore be complied with fully; urges that public policy include privacy by design and privacy by default in the data generation and analysis cycle, while seizing any opportunity to foster the development of the potential of Big Data;

| 7. | Considers it essential to develop a regulatory framework to tackle the economic, technological, social and cultural challenges of a data-driven economy, such as access to, and control and ownership of, data, in particular public data; considers that security and data protection are a fundamental basis for data-driven industry growth; stresses that finding a synergy between Big Data, data protection, data security and open data is the basis for a new digital start in Europe; asks that the following challenges be addressed: data ownership, possession, management, access and security, interoperability, data limitation and storage, restrictions on the use and reuse of data across Europe, innovative interrupters in intellectual capital, accessibility and infrastructure, transparent transportation rules, cross-border mechanisms and, where applicable, the creation and dissemination of, and access to, open data, and its availability for public administrations and service providers; |
| --- | --- |

7.

Considers it essential to develop a regulatory framework to tackle the economic, technological, social and cultural challenges of a data-driven economy, such as access to, and control and ownership of, data, in particular public data; considers that security and data protection are a fundamental basis for data-driven industry growth; stresses that finding a synergy between Big Data, data protection, data security and open data is the basis for a new digital start in Europe; asks that the following challenges be addressed: data ownership, possession, management, access and security, interoperability, data limitation and storage, restrictions on the use and reuse of data across Europe, innovative interrupters in intellectual capital, accessibility and infrastructure, transparent transportation rules, cross-border mechanisms and, where applicable, the creation and dissemination of, and access to, open data, and its availability for public administrations and service providers;

Investing in a data-driven economy (infrastructure and R&D)

| 8. | Notes that a data-driven economy depends on a wider ICT ecosystem to succeed, including the Internet of Things (IoT) for sourcing data, high-speed broadband networks for transporting them and cloud computing for processing them, as well as skilled employees, access to data, and interoperability; points out that this sector requires enormous investments in cloud development, super-computing and high-speed broadband, which are prerequisites for a successful digital economy; calls for a better regulatory framework and environment that target both the private and public sectors; recalls that private-sector investment in network infrastructure should remain essential; encourages, in this connection, the Commission and the Member States to stimulate investments in network infrastructure through a positive regulatory framework and to continue to support broadband infrastructure through existing programmes such as the Connecting Europe Facility, the European Fund for Strategic Investments (EFSI) and the Cohesion Fund, but only in areas with identified market failures; |
| --- | --- |

8.

Notes that a data-driven economy depends on a wider ICT ecosystem to succeed, including the Internet of Things (IoT) for sourcing data, high-speed broadband networks for transporting them and cloud computing for processing them, as well as skilled employees, access to data, and interoperability; points out that this sector requires enormous investments in cloud development, super-computing and high-speed broadband, which are prerequisites for a successful digital economy; calls for a better regulatory framework and environment that target both the private and public sectors; recalls that private-sector investment in network infrastructure should remain essential; encourages, in this connection, the Commission and the Member States to stimulate investments in network infrastructure through a positive regulatory framework and to continue to support broadband infrastructure through existing programmes such as the Connecting Europe Facility, the European Fund for Strategic Investments (EFSI) and the Cohesion Fund, but only in areas with identified market failures;

| 9. | Expresses concern that the digital divide, insufficient investments and a lack of technical standardisation and future-proof data protection legislation could cause Europe to trail behind technologically and economically in the development of a data-driven economy; |
| --- | --- |

9.

Expresses concern that the digital divide, insufficient investments and a lack of technical standardisation and future-proof data protection legislation could cause Europe to trail behind technologically and economically in the development of a data-driven economy;

| 10. | Acknowledges the importance of interoperability and standards in boosting competitiveness in the ICT sector, and of a proactive role for the Commission in mandating standardising bodies; asks the Commission to develop a Big Data Standard strategy for identifying gaps in standards in the European Big Data industry, including as regards SMEs and key European sectors; supports the development of market-driven, voluntary, technology-neutral, transparent, internationally compatible and market-relevant standards; |
| --- | --- |

10.

Acknowledges the importance of interoperability and standards in boosting competitiveness in the ICT sector, and of a proactive role for the Commission in mandating standardising bodies; asks the Commission to develop a Big Data Standard strategy for identifying gaps in standards in the European Big Data industry, including as regards SMEs and key European sectors; supports the development of market-driven, voluntary, technology-neutral, transparent, internationally compatible and market-relevant standards;

| 11. | Considers that the ‘ISA2’ programme offers an opportunity to develop interoperability standards for Big Data management within public administrations and in their dealings with businesses and citizens; |
| --- | --- |

11.

Considers that the ‘ISA2’ programme offers an opportunity to develop interoperability standards for Big Data management within public administrations and in their dealings with businesses and citizens;

| 12. | Welcomes the Commission proposal to develop an initiative on the free movement of data; welcomes the announcement of a European ‘Free Flow of Data’ initiative, which needs to remove existing barriers to the single market for data; calls on the Commission to carry out a broad and transparent review of the creation of a data-driven economy aimed at anticipating needs as regards the necessary technologies and removing barriers to innovation in Europe; asks that this initiative address the following challenges: data security, interoperability, data ownership, limitation and storage, restrictions on the use and reuse of data across Europe, transparent transportation rules, cross-border mechanisms, and open data exchange between administrations, businesses and civil society; |
| --- | --- |

12.

Welcomes the Commission proposal to develop an initiative on the free movement of data; welcomes the announcement of a European ‘Free Flow of Data’ initiative, which needs to remove existing barriers to the single market for data; calls on the Commission to carry out a broad and transparent review of the creation of a data-driven economy aimed at anticipating needs as regards the necessary technologies and removing barriers to innovation in Europe; asks that this initiative address the following challenges: data security, interoperability, data ownership, limitation and storage, restrictions on the use and reuse of data across Europe, transparent transportation rules, cross-border mechanisms, and open data exchange between administrations, businesses and civil society;

| 13. | Notes that Big Data depends on a wider ICT ecosystem to succeed, including the IoT for sourcing data, broadband networks for transporting them and cloud computing for processing them; |
| --- | --- |

13.

Notes that Big Data depends on a wider ICT ecosystem to succeed, including the IoT for sourcing data, broadband networks for transporting them and cloud computing for processing them;

| 14. | Believes that the EU must facilitate procedures for allocating grants and increase funding for research and innovation relating to the integrated use of data, digital innovation and market development in areas identified as bringing added value for citizens, society and the economy and effectively fostering the entry into the market of innovative products and services; considers, in this connection, that a joint European road map for the Member States and the EU for the medium to long term needs to be drawn up and combined with a stable funding framework making it possible to progress towards e-research; believes that free software can play an important role in achieving these aims; |
| --- | --- |

14.

Believes that the EU must facilitate procedures for allocating grants and increase funding for research and innovation relating to the integrated use of data, digital innovation and market development in areas identified as bringing added value for citizens, society and the economy and effectively fostering the entry into the market of innovative products and services; considers, in this connection, that a joint European road map for the Member States and the EU for the medium to long term needs to be drawn up and combined with a stable funding framework making it possible to progress towards e-research; believes that free software can play an important role in achieving these aims;

| 15. | Recognises the Commission’s initiatives to create public-private partnerships (PPPs) based on the development of the data-driven economy, as cooperation between the public and private sectors is crucial for identifying barriers to the development of the necessary technologies; recognises that the Commission and the European data industry have committed to investing EUR 2,5 billion in a PPP to strengthen the data sector and put Europe at the forefront of the global data race by maximising the potential of the digital economy; points out that access to open data portals and research-related e-infrastructure is a possible way to reduce the disadvantages that researchers and SMEs based in remote regions may face; |
| --- | --- |

15.

Recognises the Commission’s initiatives to create public-private partnerships (PPPs) based on the development of the data-driven economy, as cooperation between the public and private sectors is crucial for identifying barriers to the development of the necessary technologies; recognises that the Commission and the European data industry have committed to investing EUR 2,5 billion in a PPP to strengthen the data sector and put Europe at the forefront of the global data race by maximising the potential of the digital economy; points out that access to open data portals and research-related e-infrastructure is a possible way to reduce the disadvantages that researchers and SMEs based in remote regions may face;

| 16. | Welcomes the creation of innovation spaces — areas where a pre-existing concentration of businesses and skills is present and can be increased, allowing experimentation with data-related technologies within innovative clusters which produce ecosystems and cross-sector industrial platform projects for achieving the networking of the real and digital economy; emphasises that these spaces should serve as business incubators, educating businesses on how to translate the use of data into business opportunities and supporting the growth and internationalisation of SMEs and innovative start-ups; calls for closer partnerships to be established between businesses and universities and research centres in order to foster Big Data innovation; points out, in this connection, the investment made in initiatives such as the Grand Coalition for Digital Jobs and the European e-Skills Week; |
| --- | --- |

16.

Welcomes the creation of innovation spaces — areas where a pre-existing concentration of businesses and skills is present and can be increased, allowing experimentation with data-related technologies within innovative clusters which produce ecosystems and cross-sector industrial platform projects for achieving the networking of the real and digital economy; emphasises that these spaces should serve as business incubators, educating businesses on how to translate the use of data into business opportunities and supporting the growth and internationalisation of SMEs and innovative start-ups; calls for closer partnerships to be established between businesses and universities and research centres in order to foster Big Data innovation; points out, in this connection, the investment made in initiatives such as the Grand Coalition for Digital Jobs and the European e-Skills Week;

| 17. | Encourages the Commission and the Member States to put in place a modern and future-proof regulatory framework that stimulates and furthers investments in the network infrastructure necessary for the future requirements of the digital connected economy, to adopt policies that enable the IoT to flourish, and to secure adequate data capacities and speeds, expanding mobile technology and encouraging IPv6 deployment; |
| --- | --- |

17.

Encourages the Commission and the Member States to put in place a modern and future-proof regulatory framework that stimulates and furthers investments in the network infrastructure necessary for the future requirements of the digital connected economy, to adopt policies that enable the IoT to flourish, and to secure adequate data capacities and speeds, expanding mobile technology and encouraging IPv6 deployment;

| 18. | Stresses that greater coordination is needed in order to apply openness to standards and interoperability in systems and collaboration platforms; |
| --- | --- |

18.

Stresses that greater coordination is needed in order to apply openness to standards and interoperability in systems and collaboration platforms;

| 19. | Asks the Commission to adopt policies that remove excessive barriers in innovative sectors, to incentivise investments in research and development and European standardisation and to address the current problem of infringements of standard-essential patents; considers it necessary to strike an appropriate balance between those who invest in research and innovation aimed at developing such essential patents and those who benefit from the existence of those patents; stresses that standard-essential patents are an important element of standardisation and, for a significant number of European ICT undertakings, a component of their business model; calls for measures to preserve a high-quality standardisation system that can attract the best technology contributions, deliver interoperable and innovative digital services and applications and enable patent licensing agreements on fair, reasonable and non-discriminatory (FRAND) terms; considers it necessary, however, to make further efforts to facilitate access and remove digital barriers for people with disabilities; |
| --- | --- |

19.

Asks the Commission to adopt policies that remove excessive barriers in innovative sectors, to incentivise investments in research and development and European standardisation and to address the current problem of infringements of standard-essential patents; considers it necessary to strike an appropriate balance between those who invest in research and innovation aimed at developing such essential patents and those who benefit from the existence of those patents; stresses that standard-essential patents are an important element of standardisation and, for a significant number of European ICT undertakings, a component of their business model; calls for measures to preserve a high-quality standardisation system that can attract the best technology contributions, deliver interoperable and innovative digital services and applications and enable patent licensing agreements on fair, reasonable and non-discriminatory (FRAND) terms; considers it necessary, however, to make further efforts to facilitate access and remove digital barriers for people with disabilities;

| 20. | Believes that, in order to reap the greatest benefits from innovation in the field of Big Data, Horizon 2020’s principle of ‘responsible innovation’ should guide the identification of opportunities to accelerate market entrance, especially for SMEs; |
| --- | --- |

20.

Believes that, in order to reap the greatest benefits from innovation in the field of Big Data, Horizon 2020’s principle of ‘responsible innovation’ should guide the identification of opportunities to accelerate market entrance, especially for SMEs;

| 21. | Asks the Commission to ensure investment in infrastructure and the future-proof development of cloud services in Europe by improving legal certainty about the obligations and responsibilities of each party, guaranteeing the fulfilment of common security and data protection measures, allowing data to cross borders and fostering the right business environment for an efficient, open and global market to develop; |
| --- | --- |

21.

Asks the Commission to ensure investment in infrastructure and the future-proof development of cloud services in Europe by improving legal certainty about the obligations and responsibilities of each party, guaranteeing the fulfilment of common security and data protection measures, allowing data to cross borders and fostering the right business environment for an efficient, open and global market to develop;

Creating a data-driven economy for the EU market

| 22. | Is of the opinion that Big Data has the potential to boost economic productivity and improve consumer and government services; recognises that Big Data may bring more business opportunities and increased availability of knowledge and capital, as long as governments and stakeholders work together in a constructive manner; stresses, however, that the current fragmented single market is undermining the development of a data-driven economy, Big Data, cloud computing, the IoT and other data-driven technologies; |
| --- | --- |

22.

Is of the opinion that Big Data has the potential to boost economic productivity and improve consumer and government services; recognises that Big Data may bring more business opportunities and increased availability of knowledge and capital, as long as governments and stakeholders work together in a constructive manner; stresses, however, that the current fragmented single market is undermining the development of a data-driven economy, Big Data, cloud computing, the IoT and other data-driven technologies;

| 23. | Believes that the major technological impediments to the development of a data-driven economy include the lack of interoperability and of a common interface framework to facilitate sensor and machine data communication and communication between the virtual and physical world, the insufficient availability of open data and the lack of market conditions enabling entrepreneurs to innovate and grow; asks the Commission to spur shared research to address these issues; |
| --- | --- |

23.

Believes that the major technological impediments to the development of a data-driven economy include the lack of interoperability and of a common interface framework to facilitate sensor and machine data communication and communication between the virtual and physical world, the insufficient availability of open data and the lack of market conditions enabling entrepreneurs to innovate and grow; asks the Commission to spur shared research to address these issues;

| 24. | Asks the Commission to spur and promote shared research on the creation of a common interface framework in order to reduce duplicate standards and ensure technical and semantic interoperability with a view to following a standard-setting process driven by consumer and business needs; |
| --- | --- |

24.

Asks the Commission to spur and promote shared research on the creation of a common interface framework in order to reduce duplicate standards and ensure technical and semantic interoperability with a view to following a standard-setting process driven by consumer and business needs;

| 25. | Welcomes the announcement of a European ‘Free Flow of Data’ initiative, which needs to remove existing barriers to the single market for data; |
| --- | --- |

25.

Welcomes the announcement of a European ‘Free Flow of Data’ initiative, which needs to remove existing barriers to the single market for data;

| 26. | Calls for a future-proof regulatory environment that adapts to the changing nature of the sector, is technology-neutral, encourages the creation of start-ups and the entry into the market of new operators, creates a level playing field and fair competition while avoiding excessive regulatory burden, and ensures full compliance with data protection and privacy standards; welcomes, in this context, the Commission’s plans to review the ePrivacy Directive; notes that regulatory action should be market-driven; believes that a level playing field should be a place which enables all operators, small and large, to invest, innovate and compete for the benefit of European end-users in terms of choice and affordability; |
| --- | --- |

26.

Calls for a future-proof regulatory environment that adapts to the changing nature of the sector, is technology-neutral, encourages the creation of start-ups and the entry into the market of new operators, creates a level playing field and fair competition while avoiding excessive regulatory burden, and ensures full compliance with data protection and privacy standards; welcomes, in this context, the Commission’s plans to review the ePrivacy Directive; notes that regulatory action should be market-driven; believes that a level playing field should be a place which enables all operators, small and large, to invest, innovate and compete for the benefit of European end-users in terms of choice and affordability;

| 27. | Notes the importance of open data as high-quality raw material for the development of value-added information services and products; stresses that the data generated by public institutions and European research programmes using public funds under programmes such as Copernicus and Galileo should be available to European citizens under an open-access model and be accessible to public administrations and private businesses so that they can improve the quality of their services while respecting the intellectual property rights in force; |
| --- | --- |

27.

Notes the importance of open data as high-quality raw material for the development of value-added information services and products; stresses that the data generated by public institutions and European research programmes using public funds under programmes such as Copernicus and Galileo should be available to European citizens under an open-access model and be accessible to public administrations and private businesses so that they can improve the quality of their services while respecting the intellectual property rights in force;

| 28. | Notes that more data should be available, with a view to a more competitive and innovative data-driven economy, and that internet platforms should therefore be encouraged to release their datasets as open data in an anonymised and aggregated form, in compliance with data protection rules; |
| --- | --- |

28.

Notes that more data should be available, with a view to a more competitive and innovative data-driven economy, and that internet platforms should therefore be encouraged to release their datasets as open data in an anonymised and aggregated form, in compliance with data protection rules;

| 29. | Believes that more effort is needed with regard to the anonymisation and pseudonymisation of data as a precondition for creative data innovation and a major step in lowering market entry barriers for start-ups and SMEs; believes that uptake technologies, including text and data mining, will be an important factor in deriving added value from open datasets; points out, however, that a clear distinction must be made between the processing of personal data and other kinds of data, and that technological solutions that are privacy-enhancing by design must be devised; |
| --- | --- |

29.

Believes that more effort is needed with regard to the anonymisation and pseudonymisation of data as a precondition for creative data innovation and a major step in lowering market entry barriers for start-ups and SMEs; believes that uptake technologies, including text and data mining, will be an important factor in deriving added value from open datasets; points out, however, that a clear distinction must be made between the processing of personal data and other kinds of data, and that technological solutions that are privacy-enhancing by design must be devised;

| 30. | Stresses that all the principles laid down in EU data protection law, such as fairness and lawfulness, purpose limitation, the legal basis for processing, consent, proportionality, accuracy and limited data retention periods, must be respected by Big Data providers when processing personal data; recalls, in this context, the opinion of the European Data Protection Supervisor on privacy and competitiveness in the age of Big Data; |
| --- | --- |

30.

Stresses that all the principles laid down in EU data protection law, such as fairness and lawfulness, purpose limitation, the legal basis for processing, consent, proportionality, accuracy and limited data retention periods, must be respected by Big Data providers when processing personal data; recalls, in this context, the opinion of the European Data Protection Supervisor on privacy and competitiveness in the age of Big Data;

Fostering start-ups and SMEs in the data-driven economy

| 31. | Recognises the need to develop a strong base of service providers, to promote the benefits and assets for the economy and society of the integrated use of data, and to foster trust in big-data-related technologies among SMEs; recognises the need to support the widespread application of Big Data services with a view to improving efficiency in various economic sectors, and to support new service providers; asks that one-stop shops be set up to help SMEs to make better use of their own and public data while adhering to EU laws on data protection; |
| --- | --- |

31.

Recognises the need to develop a strong base of service providers, to promote the benefits and assets for the economy and society of the integrated use of data, and to foster trust in big-data-related technologies among SMEs; recognises the need to support the widespread application of Big Data services with a view to improving efficiency in various economic sectors, and to support new service providers; asks that one-stop shops be set up to help SMEs to make better use of their own and public data while adhering to EU laws on data protection;

| 32. | Regrets the fact that many ideas and opportunities are being lost or realised outside of Europe owing to scalability issues driven by barriers such as administrative burdens and access to finance, all of which negatively affect Europe’s competitiveness; asks that the acquisition of private capital be facilitated through the provision of the right incentives, including efforts to tackle the challenges presented by different national, administrative, regulatory and tax rules; calls for stimulation of the development of ecosystems which bring together public and private institutions providing technology and infrastructure with start-ups providing application ideas; |
| --- | --- |

32.

Regrets the fact that many ideas and opportunities are being lost or realised outside of Europe owing to scalability issues driven by barriers such as administrative burdens and access to finance, all of which negatively affect Europe’s competitiveness; asks that the acquisition of private capital be facilitated through the provision of the right incentives, including efforts to tackle the challenges presented by different national, administrative, regulatory and tax rules; calls for stimulation of the development of ecosystems which bring together public and private institutions providing technology and infrastructure with start-ups providing application ideas;

| 33. | Recalls that only 1,7 % of companies make full use of advanced digital technologies despite the benefits that digital tools can bring in all economic sectors; urges the Commission and the Member States, therefore, to launch a digital entrepreneurship strategy; |
| --- | --- |

33.

Recalls that only 1,7 % of companies make full use of advanced digital technologies despite the benefits that digital tools can bring in all economic sectors; urges the Commission and the Member States, therefore, to launch a digital entrepreneurship strategy;

| 34. | Urges the Commission and the Member States to create European digital economy hubs that include the use of Big Data and other data technologies by entrepreneurs, SMEs and innovative companies and encompass researchers and the broader economy; calls on the Commission and the Member States to promote the establishment of innovation spaces and clusters in order to help develop skills, to create a competitive advantage in the area of intellectual capital and to better understand the perspectives and limitations of Big Data technology; |
| --- | --- |

34.

Urges the Commission and the Member States to create European digital economy hubs that include the use of Big Data and other data technologies by entrepreneurs, SMEs and innovative companies and encompass researchers and the broader economy; calls on the Commission and the Member States to promote the establishment of innovation spaces and clusters in order to help develop skills, to create a competitive advantage in the area of intellectual capital and to better understand the perspectives and limitations of Big Data technology;

| 35. | Asks that the EU and its Member States improve their coordinated efforts within schools and educational facilities to make ICT an attractive vocational field, in particular for women and girls, and believes that such efforts should include measures to foster a more entrepreneurial mind-set and facilitate entry into Big Data entrepreneurship through the founding of new start-ups in this field, thus creating more employment opportunities; points to the importance of adopting a multidisciplinary approach to the training of professionals and team-building; |
| --- | --- |

35.

Asks that the EU and its Member States improve their coordinated efforts within schools and educational facilities to make ICT an attractive vocational field, in particular for women and girls, and believes that such efforts should include measures to foster a more entrepreneurial mind-set and facilitate entry into Big Data entrepreneurship through the founding of new start-ups in this field, thus creating more employment opportunities; points to the importance of adopting a multidisciplinary approach to the training of professionals and team-building;

| 36. | Asks that initiatives be launched, and funding models recommended, which foster lifelong learning and tailored measures for all, including elderly people, and which facilitate access to education to enable professionals to widen their ICT and data processing skills, so as to increase the number of digitally skilled professionals; calls for the digital transformation of business to be given greater prominence in continuing education, and for e-leadership programmes to be drawn up; stresses the need to facilitate the movement of skilled workers across the EU and measures to address skills shortages, including specific measures to attract talent; |
| --- | --- |

36.

Asks that initiatives be launched, and funding models recommended, which foster lifelong learning and tailored measures for all, including elderly people, and which facilitate access to education to enable professionals to widen their ICT and data processing skills, so as to increase the number of digitally skilled professionals; calls for the digital transformation of business to be given greater prominence in continuing education, and for e-leadership programmes to be drawn up; stresses the need to facilitate the movement of skilled workers across the EU and measures to address skills shortages, including specific measures to attract talent;

| 37. | Supports initiatives to include coding and subjects relating to data handling in national curricula; stresses the multiple advantages of free software in education, and calls for a particular focus on ensuring that these new curricula motivate children to discover their talents and participate in data science and coding; |
| --- | --- |

37.

Supports initiatives to include coding and subjects relating to data handling in national curricula; stresses the multiple advantages of free software in education, and calls for a particular focus on ensuring that these new curricula motivate children to discover their talents and participate in data science and coding;

| 38. | Considers that the EU and its Member States should step up their efforts to prevent a brain drain of highly educated and skilled experts to other regions outside Europe; |
| --- | --- |

38.

Considers that the EU and its Member States should step up their efforts to prevent a brain drain of highly educated and skilled experts to other regions outside Europe;

| 39. | Calls for support for the development of front-end tools to allow casual end-users in SMEs to develop new data-driven business models; |
| --- | --- |

39.

Calls for support for the development of front-end tools to allow casual end-users in SMEs to develop new data-driven business models;

Involving society

| 40. | Calls for the stimulation of initiatives to increase awareness of, and encourage public debate in Member States and at European and international level on, the benefits and value of digital technologies, particularly in relation to those groups that do not yet have access to digital technologies or are not very familiar with them; calls for initiatives to empower citizens vis-à-vis the use and value of their data, in particular as regards the development of innovative new services, and to increase awareness of the benefits and value of Big Data for society; |
| --- | --- |

40.

Calls for the stimulation of initiatives to increase awareness of, and encourage public debate in Member States and at European and international level on, the benefits and value of digital technologies, particularly in relation to those groups that do not yet have access to digital technologies or are not very familiar with them; calls for initiatives to empower citizens vis-à-vis the use and value of their data, in particular as regards the development of innovative new services, and to increase awareness of the benefits and value of Big Data for society;

| 41. | Points out that Big Data analytics has the potential to accelerate significantly the development of innovative public services based on the use of open government data and the reuse of public-sector information; welcomes, therefore, the opportunities that digital infrastructure and the integrated use of data bring to increase popular participation and involvement by means of various forms of e-governance and e-democracy; |
| --- | --- |

41.

Points out that Big Data analytics has the potential to accelerate significantly the development of innovative public services based on the use of open government data and the reuse of public-sector information; welcomes, therefore, the opportunities that digital infrastructure and the integrated use of data bring to increase popular participation and involvement by means of various forms of e-governance and e-democracy;

| 42. | Urges the Commission and the Member States to speed up actions to develop e-governance; recognises, in particular, the value of the IoT, and calls on the Commission to coordinate the Digital Single Market framework with existing Europe 2020 targets; stresses the need also to exploit fully the advantages of the shared economy and the inclusive involvement of civil society and citizens; |
| --- | --- |

42.

Urges the Commission and the Member States to speed up actions to develop e-governance; recognises, in particular, the value of the IoT, and calls on the Commission to coordinate the Digital Single Market framework with existing Europe 2020 targets; stresses the need also to exploit fully the advantages of the shared economy and the inclusive involvement of civil society and citizens;

o

o o

| 43. | Instructs its President to forward this resolution to the Council and the Commission. |
| --- | --- |

43.

Instructs its President to forward this resolution to the Council and the Commission.

---

(1)  Texts adopted, P7_TA(2013)0535.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/57 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/57

---

P8_TA(2016)0090

Situation in Eritrea

European Parliament resolution of 10 March 2016 on the situation in Eritrea (2016/2568(RSP))

(2018/C 050/09)

The European Parliament,

| — | having regard to its previous resolutions on Eritrea, in particular those of 7 February 2002 (1), 18 November 2004 (2) and 15 September 2011 (3) on the human rights situation in the country, including the case of Dawit Isaak, |
| --- | --- |

—

having regard to its previous resolutions on Eritrea, in particular those of 7 February 2002 (1), 18 November 2004 (2) and 15 September 2011 (3) on the human rights situation in the country, including the case of Dawit Isaak,

| — | having regard to United Nations Security Council resolutions 751 (1992), 1882 (2009), 1907 (2009), 2023 (2011) and 2244 (2015), which extended the arms embargo on Eritrea until 15 November 2016, and to the report of 19 October 2015 of the Monitoring Group on Somalia and Eritrea, |
| --- | --- |

—

having regard to United Nations Security Council resolutions 751 (1992), 1882 (2009), 1907 (2009), 2023 (2011) and 2244 (2015), which extended the arms embargo on Eritrea until 15 November 2016, and to the report of 19 October 2015 of the Monitoring Group on Somalia and Eritrea,

| — | having regard to the report submitted to the Human Rights Council on 19 June 2015 by the Special Rapporteur on the situation of human rights in Eritrea, Sheila B. Keetharuth, |
| --- | --- |

—

having regard to the report submitted to the Human Rights Council on 19 June 2015 by the Special Rapporteur on the situation of human rights in Eritrea, Sheila B. Keetharuth,

| — | having regard to the ACP-EU Partnership Agreement (the Cotonou Agreement), as revised in 2005 and 2010, to which Eritrea is a signatory, |
| --- | --- |

—

having regard to the ACP-EU Partnership Agreement (the Cotonou Agreement), as revised in 2005 and 2010, to which Eritrea is a signatory,

| — | having regard to Council Decision 2010/127/CFSP of 1 March 2010 concerning restrictive measures against Eritrea (4), amended by Council Decision 2010/414/CFSP of 26 July 2010 (5) and further amended by Council Decision 2012/632/CFSP of 15 October 2012 (6), |
| --- | --- |

—

having regard to Council Decision 2010/127/CFSP of 1 March 2010 concerning restrictive measures against Eritrea (4), amended by Council Decision 2010/414/CFSP of 26 July 2010 (5) and further amended by Council Decision 2012/632/CFSP of 15 October 2012 (6),

| — | having regard to the conclusions of Scrutiny Working Group A of the Committee on Development of the European Parliament of 11 November 2015, |
| --- | --- |

—

having regard to the conclusions of Scrutiny Working Group A of the Committee on Development of the European Parliament of 11 November 2015,

| — | having regard to the statement by the spokesperson of the European External Action Service (EEAS) on political prisoners in Eritrea of 18 September 2014, |
| --- | --- |

—

having regard to the statement by the spokesperson of the European External Action Service (EEAS) on political prisoners in Eritrea of 18 September 2014,

| — | having regard to the EEAS report on the Eritrea-European Union Partnership of 2015, |
| --- | --- |

—

having regard to the EEAS report on the Eritrea-European Union Partnership of 2015,

| — | having regard to the UN Women Country Report on the Government of the State of Eritrea of June 2014, |
| --- | --- |

—

having regard to the UN Women Country Report on the Government of the State of Eritrea of June 2014,

| — | having regard to the National Indicative Programme for Eritrea under the 11th European Development Fund of 3 February 2016, |
| --- | --- |

—

having regard to the National Indicative Programme for Eritrea under the 11th European Development Fund of 3 February 2016,

| — | having regard to the statement to the media made by the UN Commission of Inquiry on Human Rights in Eritrea on 8 June 2015, |
| --- | --- |

—

having regard to the statement to the media made by the UN Commission of Inquiry on Human Rights in Eritrea on 8 June 2015,

| — | having regard to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, |
| --- | --- |

—

having regard to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment,

| — | having regard to the declarations of 23 November 2011 and 25 June 2013 by the Co-Presidents of the ACP-EU Joint Parliamentary Assembly on the situation of human rights in Eritrea, |
| --- | --- |

—

having regard to the declarations of 23 November 2011 and 25 June 2013 by the Co-Presidents of the ACP-EU Joint Parliamentary Assembly on the situation of human rights in Eritrea,

| — | having regard to its debate of 27 May 2015 on EU development aid to Eritrea in the light of documented human rights abuses, |
| --- | --- |

—

having regard to its debate of 27 May 2015 on EU development aid to Eritrea in the light of documented human rights abuses,

| — | having regard to the Constitution of Eritrea adopted in 1997, which guarantees civil liberties, including freedom of religion, |
| --- | --- |

—

having regard to the Constitution of Eritrea adopted in 1997, which guarantees civil liberties, including freedom of religion,

| — | having regard to International Labour Organisation Conventions No 29 concerning forced labour, No 105 concerning abolition of forced labour and No 87 concerning freedom of association and protection of the right to organise, |
| --- | --- |

—

having regard to International Labour Organisation Conventions No 29 concerning forced labour, No 105 concerning abolition of forced labour and No 87 concerning freedom of association and protection of the right to organise,

| — | having regard to the African Charter on Human and Peoples’ Rights of 1981, |
| --- | --- |

—

having regard to the African Charter on Human and Peoples’ Rights of 1981,

| — | having regard to the International Covenant on Civil and Political Rights of 1966, |
| --- | --- |

—

having regard to the International Covenant on Civil and Political Rights of 1966,

| — | having regard to the Universal Declaration of Human Rights of 1948, |
| --- | --- |

—

having regard to the Universal Declaration of Human Rights of 1948,

| — | having regard to Rule 123(2) and (4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 123(2) and (4) of its Rules of Procedure,

| A. | whereas the EU has been supporting Eritrea since its independence from Ethiopia in 1993; whereas the initial promise of democracy and the rule of law following the country’s independence has been inhibited by the Government of Eritrea on the pretext of national defence and national service; whereas presidential elections planned for 1997 never took place, and whereas the constitution ratified in the same year has never been implemented; whereas the regional elections of 2009 have yet to be held; whereas even before the National Assembly was disbanded in 2002, laws were passed by government decree; |
| --- | --- |

A.

whereas the EU has been supporting Eritrea since its independence from Ethiopia in 1993; whereas the initial promise of democracy and the rule of law following the country’s independence has been inhibited by the Government of Eritrea on the pretext of national defence and national service; whereas presidential elections planned for 1997 never took place, and whereas the constitution ratified in the same year has never been implemented; whereas the regional elections of 2009 have yet to be held; whereas even before the National Assembly was disbanded in 2002, laws were passed by government decree;

| B. | whereas Eritrea’s independence from Ethiopia in 1993 created expectations within the international community and among the people of Eritrea that this would help the latter to build a country that respects human rights and is free of repression; whereas this has not happened, but instead there has been even greater repression and even more violations of human rights; |
| --- | --- |

B.

whereas Eritrea’s independence from Ethiopia in 1993 created expectations within the international community and among the people of Eritrea that this would help the latter to build a country that respects human rights and is free of repression; whereas this has not happened, but instead there has been even greater repression and even more violations of human rights;

| C. | whereas the report by the UN Special Rapporteur noted that Eritrea has one of the worst human rights records in the world, with routine human rights violations taking place every day and no improvement recorded in recent years; whereas many young people have fled the country to escape the repressive government and mandatory military conscription, which often starts at a very young age, whereas the statute of an 18-month period of service is often flouted, with most Eritreans serving indefinitely, and whereas such an extended mandatory military conscription inhibits the country’s potential economic growth; whereas any increase in the national service salary is meaningless as the recent devaluation of the nakfa and bank restrictions have led to a current deficiency in the country; whereas many conscripts are used as forced labour and given civilian duties; whereas the majority of those in national service remain in a situation of slavery, in which any work, job applications and the possibility of having a family life are controlled; whereas freedom of worship and conscience, freedom of the media and freedom of expression are not guaranteed; |
| --- | --- |

C.

whereas the report by the UN Special Rapporteur noted that Eritrea has one of the worst human rights records in the world, with routine human rights violations taking place every day and no improvement recorded in recent years; whereas many young people have fled the country to escape the repressive government and mandatory military conscription, which often starts at a very young age, whereas the statute of an 18-month period of service is often flouted, with most Eritreans serving indefinitely, and whereas such an extended mandatory military conscription inhibits the country’s potential economic growth; whereas any increase in the national service salary is meaningless as the recent devaluation of the nakfa and bank restrictions have led to a current deficiency in the country; whereas many conscripts are used as forced labour and given civilian duties; whereas the majority of those in national service remain in a situation of slavery, in which any work, job applications and the possibility of having a family life are controlled; whereas freedom of worship and conscience, freedom of the media and freedom of expression are not guaranteed;

| D. | whereas the UN Commission of Inquiry on Human Rights in Eritrea has found that the violations in the areas of extrajudicial executions, torture (including sexual torture and sexual slavery), national service as a form of slavery, forced labour and the shoot-to-kill policy at the border may constitute crimes against humanity; |
| --- | --- |

D.

whereas the UN Commission of Inquiry on Human Rights in Eritrea has found that the violations in the areas of extrajudicial executions, torture (including sexual torture and sexual slavery), national service as a form of slavery, forced labour and the shoot-to-kill policy at the border may constitute crimes against humanity;

| E. | whereas Human Rights Watch stresses that there is no freedom of religion in Eritrea; whereas the government severely harasses citizens who practise religions other than the four it recognises; whereas even in the case of recognised religions the government interferes with people’s religious practice; |
| --- | --- |

E.

whereas Human Rights Watch stresses that there is no freedom of religion in Eritrea; whereas the government severely harasses citizens who practise religions other than the four it recognises; whereas even in the case of recognised religions the government interferes with people’s religious practice;

| F. | whereas homosexual activities are illegal in Eritrea, and the government refuses to implement anti-discrimination legislation to protect lesbian, gay, bisexual, transgender and intersex (LGBTI) persons; |
| --- | --- |

F.

whereas homosexual activities are illegal in Eritrea, and the government refuses to implement anti-discrimination legislation to protect lesbian, gay, bisexual, transgender and intersex (LGBTI) persons;

| G. | whereas discrimination and violence against women are present in all areas of Eritrean society; whereas women are not only at extreme risk of sexual violence within the military and in military training camps, but also in society at large, where violence against women is perpetrated in an environment of impunity; whereas an estimated 89 % of girls in Eritrea have undergone Female Genital Mutilation (FGM); whereas in March 2007 the government issued a proclamation declaring FGM a crime, prohibiting its practice and sponsoring education programmes discouraging the practice over that year; whereas women can lose their entitlement to food coupons and access to land; |
| --- | --- |

G.

whereas discrimination and violence against women are present in all areas of Eritrean society; whereas women are not only at extreme risk of sexual violence within the military and in military training camps, but also in society at large, where violence against women is perpetrated in an environment of impunity; whereas an estimated 89 % of girls in Eritrea have undergone Female Genital Mutilation (FGM); whereas in March 2007 the government issued a proclamation declaring FGM a crime, prohibiting its practice and sponsoring education programmes discouraging the practice over that year; whereas women can lose their entitlement to food coupons and access to land;

| H. | whereas a huge number of Eritrean people are arrested for various unjustifiable reasons such as expressing independent views or without any explicit justification, and thus for unspecified time periods; whereas detainees, including children, are held in extremely harsh conditions which in some cases amount to torture and denial of medical care; whereas female detainees are often guarded by male officers, thus increasing the risk of sexual and gender-based violence; whereas, according to the Freedom House Index (report 2015), Eritrea continues to rank among the most repressive media environments and received the lowest score possible which ranked it as the ‘worst of the worst’ and has one of the lowest internet access rates — only 1 % — in the world; |
| --- | --- |

H.

whereas a huge number of Eritrean people are arrested for various unjustifiable reasons such as expressing independent views or without any explicit justification, and thus for unspecified time periods; whereas detainees, including children, are held in extremely harsh conditions which in some cases amount to torture and denial of medical care; whereas female detainees are often guarded by male officers, thus increasing the risk of sexual and gender-based violence; whereas, according to the Freedom House Index (report 2015), Eritrea continues to rank among the most repressive media environments and received the lowest score possible which ranked it as the ‘worst of the worst’ and has one of the lowest internet access rates — only 1 % — in the world;

| I. | whereas the statement issued in Brussels on 18 September 2014 by the spokesperson for the EEAS expressed concern about the detention of a group of 11 members of parliament and eminent members of the People’s Front for Democracy and Justice (PFDJ) since 18 September 2001 without charge, judgment or the possibility of seeing a lawyer, and about the unlawful detention since 23 September 2001 of 10 independent journalists, including Dawit Isaak, a citizen of Sweden and the only European prisoner of conscience; whereas Patriarch Abune Antonios remains incommunicado and under house arrest since January 2006; |
| --- | --- |

I.

whereas the statement issued in Brussels on 18 September 2014 by the spokesperson for the EEAS expressed concern about the detention of a group of 11 members of parliament and eminent members of the People’s Front for Democracy and Justice (PFDJ) since 18 September 2001 without charge, judgment or the possibility of seeing a lawyer, and about the unlawful detention since 23 September 2001 of 10 independent journalists, including Dawit Isaak, a citizen of Sweden and the only European prisoner of conscience; whereas Patriarch Abune Antonios remains incommunicado and under house arrest since January 2006;

| J. | whereas there is no freedom of press, as independent media is forbidden in Eritrea, with the Reporters Without Borders World Press Freedom Index ranking Eritrea last out of the 170-180 evaluated countries for eight years in succession; |
| --- | --- |

J.

whereas there is no freedom of press, as independent media is forbidden in Eritrea, with the Reporters Without Borders World Press Freedom Index ranking Eritrea last out of the 170-180 evaluated countries for eight years in succession;

| K. | whereas Eritrea is ranked 186th out of 188 countries in the Human Development Index for 2015, according to the UNDP Human Development Report of 2015; |
| --- | --- |

K.

whereas Eritrea is ranked 186th out of 188 countries in the Human Development Index for 2015, according to the UNDP Human Development Report of 2015;

| L. | whereas according to the UN Special Rapporteur on the situation of human rights in Eritrea there are three key areas of concern, namely: the enjoyment of economic, social and cultural rights, including the right to adequate housing; smuggling and trafficking; and the increasing number of unaccompanied minors who form part of the more than 5 000 people fleeing the country on a monthly basis; |
| --- | --- |

L.

whereas according to the UN Special Rapporteur on the situation of human rights in Eritrea there are three key areas of concern, namely: the enjoyment of economic, social and cultural rights, including the right to adequate housing; smuggling and trafficking; and the increasing number of unaccompanied minors who form part of the more than 5 000 people fleeing the country on a monthly basis;

| M. | whereas on 26 June 2015 hundreds of Eritrean refugees demonstrated in front of the African Union headquarters, demanding that the regional organisation push for democratic reforms in their home country; whereas protesters accused long-time Eritrean President Isaias Afewerki of being a dictator and urged the African Union to take action; |
| --- | --- |

M.

whereas on 26 June 2015 hundreds of Eritrean refugees demonstrated in front of the African Union headquarters, demanding that the regional organisation push for democratic reforms in their home country; whereas protesters accused long-time Eritrean President Isaias Afewerki of being a dictator and urged the African Union to take action;

| N. | whereas in November 2015 the UN warned of a severe drought in the Horn of Africa as a result of the current El Niño pattern; whereas the UN stated in December 2015 that this drought is the strongest ever recorded in the region, reducing crops by 50 % to 90 %; whereas, as a result, Eritrea is among the countries which will face the considerable challenge of ensuring food security for its population; |
| --- | --- |

N.

whereas in November 2015 the UN warned of a severe drought in the Horn of Africa as a result of the current El Niño pattern; whereas the UN stated in December 2015 that this drought is the strongest ever recorded in the region, reducing crops by 50 % to 90 %; whereas, as a result, Eritrea is among the countries which will face the considerable challenge of ensuring food security for its population;

| O. | whereas, in total contradiction with the reality of the drought, the Eritrean President has dismissed fears of a food crisis, saying that ‘the country will not face any crisis in spite of reduced agricultural output’; |
| --- | --- |

O.

whereas, in total contradiction with the reality of the drought, the Eritrean President has dismissed fears of a food crisis, saying that ‘the country will not face any crisis in spite of reduced agricultural output’;

| P. | whereas the EU is an important donor for Eritrea in terms of development aid and assistance; |
| --- | --- |

P.

whereas the EU is an important donor for Eritrea in terms of development aid and assistance;

| Q. | whereas the Eritrean Government unilaterally suspended aid in 2011 and does not recognise publicly its collaboration and partnership with the EU; whereas Eritrea does not facilitate the possibility of MEPs visiting Eritrea freely and without controls; |
| --- | --- |

Q.

whereas the Eritrean Government unilaterally suspended aid in 2011 and does not recognise publicly its collaboration and partnership with the EU; whereas Eritrea does not facilitate the possibility of MEPs visiting Eritrea freely and without controls;

| R. | whereas loss of their livelihoods encourages women and children to flee the country; whereas in 2015 Eritreans fleeing their country accounted for the fourth-largest number of people risking the perilous journey to Europe (after Syrians, Iraqis and Afghans), who run the gauntlet of pitiless people-smugglers to make the dangerous Mediterranean crossing; whereas, therefore, the situation in Eritrea directly affects Europe, since if human rights were respected and upheld in the country and people could live there without fear, Eritreans would be able to return to their homeland; |
| --- | --- |

R.

whereas loss of their livelihoods encourages women and children to flee the country; whereas in 2015 Eritreans fleeing their country accounted for the fourth-largest number of people risking the perilous journey to Europe (after Syrians, Iraqis and Afghans), who run the gauntlet of pitiless people-smugglers to make the dangerous Mediterranean crossing; whereas, therefore, the situation in Eritrea directly affects Europe, since if human rights were respected and upheld in the country and people could live there without fear, Eritreans would be able to return to their homeland;

| S. | whereas, according to the UN High Commissioner for Refugees, over 400 000 Eritreans, or 9 % of the total population, have fled; whereas UNHCR estimates that some 5 000 Eritreans leave the country every month, this being explained to a large degree by the persistence of severe human rights violations; whereas in 2015 in 69 % of Eritrean asylum cases refugee status was granted in the EU while an additional 27 % of applicants received subsidiary protection, illustrating the gravity of persecution in Eritrea; |
| --- | --- |

S.

whereas, according to the UN High Commissioner for Refugees, over 400 000 Eritreans, or 9 % of the total population, have fled; whereas UNHCR estimates that some 5 000 Eritreans leave the country every month, this being explained to a large degree by the persistence of severe human rights violations; whereas in 2015 in 69 % of Eritrean asylum cases refugee status was granted in the EU while an additional 27 % of applicants received subsidiary protection, illustrating the gravity of persecution in Eritrea;

| T. | whereas human trafficking for ransom with severe torture practices in the Sinai is the cause of numerous killings and disappearances of Eritrean refugees who had been abducted, whilst the severely traumatised survivors have received no care or support; whereas total impunity prevails whilst those responsible have not been brought to justice; whereas particular attention should be paid to unaccompanied child victims of trafficking in human beings, as they need specific assistance and support owing to their situation of particular vulnerability; |
| --- | --- |

T.

whereas human trafficking for ransom with severe torture practices in the Sinai is the cause of numerous killings and disappearances of Eritrean refugees who had been abducted, whilst the severely traumatised survivors have received no care or support; whereas total impunity prevails whilst those responsible have not been brought to justice; whereas particular attention should be paid to unaccompanied child victims of trafficking in human beings, as they need specific assistance and support owing to their situation of particular vulnerability;

| U. | whereas on 22 February 2016 the Intergovernmental Authority on Development (IGAD) Security Sector Program (SSP) officially launched, in Addis Ababa (Ethiopia), a study report entitled ‘Human Smuggling and Trafficking on the Horn of Africa-Central Mediterranean Route’; |
| --- | --- |

U.

whereas on 22 February 2016 the Intergovernmental Authority on Development (IGAD) Security Sector Program (SSP) officially launched, in Addis Ababa (Ethiopia), a study report entitled ‘Human Smuggling and Trafficking on the Horn of Africa-Central Mediterranean Route’;

| V. | whereas Eritrea is supportive of the Khartoum Process (an EU and African Union initiative launched on 28 November 2014 with the aim of addressing the issue of migration and human trafficking), which encompasses the implementation of concrete projects, including capacity-building for the judiciary and awareness-raising; |
| --- | --- |

V.

whereas Eritrea is supportive of the Khartoum Process (an EU and African Union initiative launched on 28 November 2014 with the aim of addressing the issue of migration and human trafficking), which encompasses the implementation of concrete projects, including capacity-building for the judiciary and awareness-raising;

| W. | whereas the EU initially imposed sanctions on Eritrea in March 2010 in order to implement UN Security Council Resolution 1907 (2009), and whereas these included an arms embargo, travel restrictions and asset freezes relating to persons who constitute a threat to peace and national reconciliation; |
| --- | --- |

W.

whereas the EU initially imposed sanctions on Eritrea in March 2010 in order to implement UN Security Council Resolution 1907 (2009), and whereas these included an arms embargo, travel restrictions and asset freezes relating to persons who constitute a threat to peace and national reconciliation;

| X. | whereas the EU has a vested interest in seeing Eritrea stabilised, as the current situation is forcing a sizeable part of the population to flee, and thousands of people are losing their lives as a result of criminal activities, including smuggling of migrants and trafficking in human beings; |
| --- | --- |

X.

whereas the EU has a vested interest in seeing Eritrea stabilised, as the current situation is forcing a sizeable part of the population to flee, and thousands of people are losing their lives as a result of criminal activities, including smuggling of migrants and trafficking in human beings;

| Y. | whereas the regime extends its totalitarian grip to the Eritrean diaspora, extorting funds from its members via a 2 % tax on expatriate incomes, spying on them and targeting family members who have remained in Eritrea on the grounds of perceived wrongdoing; whereas on 28 January 2016 the Eritrean Minister for National Development and the EU Head of Delegation signed the National Indicative Programme (NIP) under the 11th European Development Fund (EDF) in Asmara, worth EUR 200 million for the next five years; whereas actions should focus on renewable energy, governance and public finance management in the energy sector in particular; |
| --- | --- |

Y.

whereas the regime extends its totalitarian grip to the Eritrean diaspora, extorting funds from its members via a 2 % tax on expatriate incomes, spying on them and targeting family members who have remained in Eritrea on the grounds of perceived wrongdoing; whereas on 28 January 2016 the Eritrean Minister for National Development and the EU Head of Delegation signed the National Indicative Programme (NIP) under the 11th European Development Fund (EDF) in Asmara, worth EUR 200 million for the next five years; whereas actions should focus on renewable energy, governance and public finance management in the energy sector in particular;

| Z. | whereas on 13 November 2015 Parliament’s Committee on Development asked the Commission and the EEAS to take into consideration the conclusions sent to the EDF Committee on the draft National Indicative Programme for Eritrea, which referred to the scale and seriousness of the human rights violations committed by the Eritrean regime, the lack of reliability of this regime as a development cooperation partner, the pervasive corruption and the virtually total absence of transparency in public financial management in the country, and the risk of misusing EDF funds for migration management; whereas the Committee on Development called on the EDF Committee not to adopt the NIP pending further discussion; whereas Parliament’s position was ignored; |
| --- | --- |

Z.

whereas on 13 November 2015 Parliament’s Committee on Development asked the Commission and the EEAS to take into consideration the conclusions sent to the EDF Committee on the draft National Indicative Programme for Eritrea, which referred to the scale and seriousness of the human rights violations committed by the Eritrean regime, the lack of reliability of this regime as a development cooperation partner, the pervasive corruption and the virtually total absence of transparency in public financial management in the country, and the risk of misusing EDF funds for migration management; whereas the Committee on Development called on the EDF Committee not to adopt the NIP pending further discussion; whereas Parliament’s position was ignored;

| AA. | whereas the PFDJ has established control and surveillance over the refugee and diaspora communities through the embassies, which are involved in extortion over diaspora taxes and ‘voluntary’ contributions in exchange for services, such as ID papers, passports, birth certificates and essential documents on which refugees may depend; whereas these practices are in breach of the Vienna Convention on Diplomatic Relations; whereas leaders of the PFDJ’s youth organisation in the Netherlands have initiated legal campaigns against Dutch academics, media and government institutions, with the support of the political leadership in Asmara, presumably to silence critics of the regime; whereas the UN Special Rapporteur on the situation of human rights in Eritrea has also been subjected to threats; |
| --- | --- |

AA.

whereas the PFDJ has established control and surveillance over the refugee and diaspora communities through the embassies, which are involved in extortion over diaspora taxes and ‘voluntary’ contributions in exchange for services, such as ID papers, passports, birth certificates and essential documents on which refugees may depend; whereas these practices are in breach of the Vienna Convention on Diplomatic Relations; whereas leaders of the PFDJ’s youth organisation in the Netherlands have initiated legal campaigns against Dutch academics, media and government institutions, with the support of the political leadership in Asmara, presumably to silence critics of the regime; whereas the UN Special Rapporteur on the situation of human rights in Eritrea has also been subjected to threats;

| 1. | Notes with great concern the continuing deplorable human rights situation and the complete absence of rule of law and media freedom in Eritrea; |
| --- | --- |

1.

Notes with great concern the continuing deplorable human rights situation and the complete absence of rule of law and media freedom in Eritrea;

| 2. | Stresses that addressing the justice deficit, democratic governance and restoration of the rule of law must be prioritised by ending authoritarian rule by fear of arbitrary and incommunicado detention, of torture and of other human rights violations, some of which may amount to crimes against humanity; |
| --- | --- |

2.

Stresses that addressing the justice deficit, democratic governance and restoration of the rule of law must be prioritised by ending authoritarian rule by fear of arbitrary and incommunicado detention, of torture and of other human rights violations, some of which may amount to crimes against humanity;

| 3. | Urges the Government of Eritrea to put an end to the system of indefinite national service by demobilising the conscripts who have completed their mandatory 18 months’ service and effectively ending the practice of engaging conscripts in forced labour after that period, to provide for conscientious objection, and to end the compulsory practice of all school students spending their final year of schooling in a military training camp; calls on the Eritrean Government to ensure that no one undertakes military training before they reach 18 years of age and that no members of the population past the normal conscription age are conscripted; notes that the Eritrean authorities recalled in February 2016 that the EU agreement would not lead to any reform of Eritrea’s military service policy; |
| --- | --- |

3.

Urges the Government of Eritrea to put an end to the system of indefinite national service by demobilising the conscripts who have completed their mandatory 18 months’ service and effectively ending the practice of engaging conscripts in forced labour after that period, to provide for conscientious objection, and to end the compulsory practice of all school students spending their final year of schooling in a military training camp; calls on the Eritrean Government to ensure that no one undertakes military training before they reach 18 years of age and that no members of the population past the normal conscription age are conscripted; notes that the Eritrean authorities recalled in February 2016 that the EU agreement would not lead to any reform of Eritrea’s military service policy;

| 4. | Believes that the EDF Committee should have taken into consideration the Committee on Development’s recommendations not to adopt the NIP and to engage in further discussion; considers that the decision to adopt the NIP for Eritrea despite Parliament’s opposition demonstrates a democratic deficit and severely undermines Parliament’s role in ensuring the effective implementation of EU development objectives; calls, in this connection, for Parliament to be given powers of scrutiny over the EDF through a binding interinstitutional agreement under Article 295 of the Treaty on the Functioning of the European Union; stresses that the Committee on Development’s conclusions on draft programming documents should be automatically sent by the Commission to the Permanent Representations of the Member States; |
| --- | --- |

4.

Believes that the EDF Committee should have taken into consideration the Committee on Development’s recommendations not to adopt the NIP and to engage in further discussion; considers that the decision to adopt the NIP for Eritrea despite Parliament’s opposition demonstrates a democratic deficit and severely undermines Parliament’s role in ensuring the effective implementation of EU development objectives; calls, in this connection, for Parliament to be given powers of scrutiny over the EDF through a binding interinstitutional agreement under Article 295 of the Treaty on the Functioning of the European Union; stresses that the Committee on Development’s conclusions on draft programming documents should be automatically sent by the Commission to the Permanent Representations of the Member States;

| 5. | Takes note of the allocation of EUR 200 million over the next five years for the NIP under the 11th European Development Fund, in order to promote poverty reduction and socio-economic development, to tackle the root economic and political causes of migration, and to finance projects relating to renewable energy, energy efficiency and economic governance; recalls that this envelope is complementary to other areas of cooperation such as the European Instrument for Democracy and Human Rights (EIDHR); |
| --- | --- |

5.

Takes note of the allocation of EUR 200 million over the next five years for the NIP under the 11th European Development Fund, in order to promote poverty reduction and socio-economic development, to tackle the root economic and political causes of migration, and to finance projects relating to renewable energy, energy efficiency and economic governance; recalls that this envelope is complementary to other areas of cooperation such as the European Instrument for Democracy and Human Rights (EIDHR);

| 6. | Calls on the Commission to ensure that the funding allocated does not benefit the Eritrean Government but is strictly assigned to meeting the needs of the Eritrean people for development, democracy, human rights, good governance and security, and freedom of speech, press and assembly; urges the EU to ensure the conditionality of the recently agreed aid and also to ensure that the NIP supports Eritrea in operating an important shift in its energy policy in order to make energy accessible for all, especially in the rural areas which are currently still without electricity; believes, moreover, that the governance component of the NIP should strongly focus on implementing the recommendations of the UN-led Universal Periodic Review on human rights; |
| --- | --- |

6.

Calls on the Commission to ensure that the funding allocated does not benefit the Eritrean Government but is strictly assigned to meeting the needs of the Eritrean people for development, democracy, human rights, good governance and security, and freedom of speech, press and assembly; urges the EU to ensure the conditionality of the recently agreed aid and also to ensure that the NIP supports Eritrea in operating an important shift in its energy policy in order to make energy accessible for all, especially in the rural areas which are currently still without electricity; believes, moreover, that the governance component of the NIP should strongly focus on implementing the recommendations of the UN-led Universal Periodic Review on human rights;

| 7. | Recalls that an unaccompanied minor is above all a child who is potentially in danger, and that child protection, rather than immigration policies, must be the leading principle for Member States and the EU when dealing with unaccompanied minors, so as to respect the core principle of the child’s best interests; recalls that, without exception, anyone below the age of 18 years is to be regarded as a child and thus as a minor; points out that unaccompanied minors, particularly girls, are twice as susceptible to problems and difficulties as other minors; |
| --- | --- |

7.

Recalls that an unaccompanied minor is above all a child who is potentially in danger, and that child protection, rather than immigration policies, must be the leading principle for Member States and the EU when dealing with unaccompanied minors, so as to respect the core principle of the child’s best interests; recalls that, without exception, anyone below the age of 18 years is to be regarded as a child and thus as a minor; points out that unaccompanied minors, particularly girls, are twice as susceptible to problems and difficulties as other minors;

| 8. | Appeals to the international community and Eritrea’s development partners to intervene in the situation and to put pressure on the Eritrean Government to allow foreign aid to support vulnerable communities before the crisis worsens; urges the EU to take urgent and effective measures to help the Eritrean people enhance their resilience to El Niño in order to guarantee food security, access to water and sanitation; |
| --- | --- |

8.

Appeals to the international community and Eritrea’s development partners to intervene in the situation and to put pressure on the Eritrean Government to allow foreign aid to support vulnerable communities before the crisis worsens; urges the EU to take urgent and effective measures to help the Eritrean people enhance their resilience to El Niño in order to guarantee food security, access to water and sanitation;

| 9. | Remains very concerned about the human rights situation in the country; reiterates its call to the Eritrean authorities to release immediately and unconditionally parliamentarians, journalists (including Swedish citizen Dawit Isaak, who has not been heard from since 2005), political prisoners and prisoners of conscience; |
| --- | --- |

9.

Remains very concerned about the human rights situation in the country; reiterates its call to the Eritrean authorities to release immediately and unconditionally parliamentarians, journalists (including Swedish citizen Dawit Isaak, who has not been heard from since 2005), political prisoners and prisoners of conscience;

| 10. | Encourages the Commission to seek clear guarantees from the Eritrean Government that it will implement democratic reforms and ensure respect for human rights, including by implementing the recommendations made by the 18th session of the Universal Periodic Review (UPR) Working Group, which it accepted on 7 February 2014; calls on the government to allow access to the country to UN and African Union independent experts, including the UN Special Rapporteur, and to allow the Commission of Inquiry on the Situation of Human Rights in Eritrea to fully exercise its mandate and to cooperate with it, including as regards public finance issues; |
| --- | --- |

10.

Encourages the Commission to seek clear guarantees from the Eritrean Government that it will implement democratic reforms and ensure respect for human rights, including by implementing the recommendations made by the 18th session of the Universal Periodic Review (UPR) Working Group, which it accepted on 7 February 2014; calls on the government to allow access to the country to UN and African Union independent experts, including the UN Special Rapporteur, and to allow the Commission of Inquiry on the Situation of Human Rights in Eritrea to fully exercise its mandate and to cooperate with it, including as regards public finance issues;

| 11. | Recalls that freedom of religion is a fundamental right, and strongly condemns any violence or discrimination on grounds of religion; |
| --- | --- |

11.

Recalls that freedom of religion is a fundamental right, and strongly condemns any violence or discrimination on grounds of religion;

| 12. | Welcomes the measures taken by the Eritrean Government to fight FGM; calls on the government to enhance in general the promotion and protection of women’s rights, including by taking further measures to combat harmful practices, such as child, early and forced marriage, and to end impunity in cases of sexual violence; calls on the Eritrean Government to respect single female-headed households and ensure that they are supported and protected; |
| --- | --- |

12.

Welcomes the measures taken by the Eritrean Government to fight FGM; calls on the government to enhance in general the promotion and protection of women’s rights, including by taking further measures to combat harmful practices, such as child, early and forced marriage, and to end impunity in cases of sexual violence; calls on the Eritrean Government to respect single female-headed households and ensure that they are supported and protected;

| 13. | Condemns the use by the Eritrean Government of the ‘Diaspora tax’, which is collected by extortion and other illegal means from Eritreans outside of Eritrea and is used in violation of UN resolutions to fund armed groups in neighbouring countries and thus destabilise the region; urges the government to end the ‘guilt-by-association’ policies that target family members of those who evade national service, seek to flee Eritrea or fail to pay the 2 % income tax imposed by the government on Eritrean expatriates; |
| --- | --- |

13.

Condemns the use by the Eritrean Government of the ‘Diaspora tax’, which is collected by extortion and other illegal means from Eritreans outside of Eritrea and is used in violation of UN resolutions to fund armed groups in neighbouring countries and thus destabilise the region; urges the government to end the ‘guilt-by-association’ policies that target family members of those who evade national service, seek to flee Eritrea or fail to pay the 2 % income tax imposed by the government on Eritrean expatriates;

| 14. | Demands that Eritrea sign and immediately enact the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment and fully uphold its obligations under the International Covenant on Civil and Political Rights and the African Charter on Human and Peoples’ Rights, both of which prohibit torture; notes with concern that public and private actors, including companies, are severely restricted by government control; recognises that the lack of any public finance management, including the absence of a national budget, makes budgetary control impossible, and that the fungibility of financial resources owing to central bank controls by the government may encourage military purchases and thus contribute to terrorism and destabilisation in the region; |
| --- | --- |

14.

Demands that Eritrea sign and immediately enact the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment and fully uphold its obligations under the International Covenant on Civil and Political Rights and the African Charter on Human and Peoples’ Rights, both of which prohibit torture; notes with concern that public and private actors, including companies, are severely restricted by government control; recognises that the lack of any public finance management, including the absence of a national budget, makes budgetary control impossible, and that the fungibility of financial resources owing to central bank controls by the government may encourage military purchases and thus contribute to terrorism and destabilisation in the region;

| 15. | Urges all international companies investing in Eritrea to act in respect of the full realisation of human rights and to do no harm; |
| --- | --- |

15.

Urges all international companies investing in Eritrea to act in respect of the full realisation of human rights and to do no harm;

| 16. | Urges the EU Member States to investigate the role of the PFDJ and its various wings, including the youth wing, and to prohibit all forms of association and activity that directly support control and surveillance exercises in Europe, undermine democratic principles and the rule of law, and create patterns of intimidation and extortion; urges the Member States to act to end the diaspora tax and to investigate the financial transactions related to any other ‘contributions’ raised by Eritrean government-linked associations abroad, and to fully protect the asylum rights of all Eritrean refugees in Europe; |
| --- | --- |

16.

Urges the EU Member States to investigate the role of the PFDJ and its various wings, including the youth wing, and to prohibit all forms of association and activity that directly support control and surveillance exercises in Europe, undermine democratic principles and the rule of law, and create patterns of intimidation and extortion; urges the Member States to act to end the diaspora tax and to investigate the financial transactions related to any other ‘contributions’ raised by Eritrean government-linked associations abroad, and to fully protect the asylum rights of all Eritrean refugees in Europe;

| 17. | Instructs its President to forward this resolution to the Council, the Commission, the ACP-EU Joint Parliamentary Assembly, the Council of the African Union, the East African Community, the Secretary-General of the UN, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, and the Eritrean authorities. |
| --- | --- |

17.

Instructs its President to forward this resolution to the Council, the Commission, the ACP-EU Joint Parliamentary Assembly, the Council of the African Union, the East African Community, the Secretary-General of the UN, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, and the Eritrean authorities.

---

(1)  OJ C 284 E, 21.11.2002, p. 359.

(2)  OJ C 201 E, 18.8.2005, p. 123.

(3)  OJ C 51 E, 22.2.2013, p. 146.

(4)  OJ L 51, 2.3.2010, p. 19.

(5)  OJ L 195, 27.7.2010, p. 74.

(6)  OJ L 282, 16.10.2012, p. 46.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/64 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/64

---

P8_TA(2016)0091

2015 Report on the former Yugoslav Republic of Macedonia

European Parliament resolution of 10 March 2016 on the 2015 Report on the former Yugoslav Republic of Macedonia (2015/2895(RSP))

(2018/C 050/10)

The European Parliament,

| — | having regard to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the former Yugoslav Republic of Macedonia, of the other part (1), |
| --- | --- |

—

having regard to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the former Yugoslav Republic of Macedonia, of the other part (1),

| — | having regard to UN Security Council resolutions 817 (1993) and 845 (1993), |
| --- | --- |

—

having regard to UN Security Council resolutions 817 (1993) and 845 (1993),

| — | having regard to the judgment of the International Court of Justice on the Application of the Interim Accord of 13 September 1995, |
| --- | --- |

—

having regard to the judgment of the International Court of Justice on the Application of the Interim Accord of 13 September 1995,

| — | having regard to the Presidency Conclusions of the Thessaloniki European Council of 19-20 June 2003 concerning the prospect of the Western Balkan countries joining the Union, |
| --- | --- |

—

having regard to the Presidency Conclusions of the Thessaloniki European Council of 19-20 June 2003 concerning the prospect of the Western Balkan countries joining the Union,

| — | having regard to the European Council’s decision of 16 December 2005 to grant the country the status of candidate for EU membership, and to the European Council conclusions of June 2008 and the Council conclusions of 15 December 2015, |
| --- | --- |

—

having regard to the European Council’s decision of 16 December 2005 to grant the country the status of candidate for EU membership, and to the European Council conclusions of June 2008 and the Council conclusions of 15 December 2015,

| — | having regard to the 12th meeting of the Stabilisation and Association Council between the country and the EU, held on 20 July 2015, |
| --- | --- |

—

having regard to the 12th meeting of the Stabilisation and Association Council between the country and the EU, held on 20 July 2015,

| — | having regard to the Final Declaration by the Chair of the Vienna Western Balkans Summit of 27 August 2015 and the Recommendations of the Civil Society Organisations for the Vienna Summit 2015, |
| --- | --- |

—

having regard to the Final Declaration by the Chair of the Vienna Western Balkans Summit of 27 August 2015 and the Recommendations of the Civil Society Organisations for the Vienna Summit 2015,

| — | having regard to the Declaration of the High-Level Conference on the Eastern Mediterranean — Western Balkans Route, held in Luxembourg on 8 October 2015, and the Leaders’ Statement issued after the Leaders’ Meeting on refugee flows along the Western Balkan Route, held in Brussels on 25 October 2015, |
| --- | --- |

—

having regard to the Declaration of the High-Level Conference on the Eastern Mediterranean — Western Balkans Route, held in Luxembourg on 8 October 2015, and the Leaders’ Statement issued after the Leaders’ Meeting on refugee flows along the Western Balkan Route, held in Brussels on 25 October 2015,

| — | having regard to the OSCE/ODIHR Needs Assessment Mission Report of 27 November 2015, |
| --- | --- |

—

having regard to the OSCE/ODIHR Needs Assessment Mission Report of 27 November 2015,

| — | having regard to the Commission’s Urgent Reform Priorities for the former Yugoslav Republic of Macedonia of June 2015, |
| --- | --- |

—

having regard to the Commission’s Urgent Reform Priorities for the former Yugoslav Republic of Macedonia of June 2015,

| — | having regard to the Recommendations of the Senior Experts’ Group on systemic Rule of Law issues relating to the interception of communications revealed in Spring 2015, |
| --- | --- |

—

having regard to the Recommendations of the Senior Experts’ Group on systemic Rule of Law issues relating to the interception of communications revealed in Spring 2015,

| — | having regard to the fifth meeting of the High Level Accession Dialogue, held in Skopje on 18 September 2015, |
| --- | --- |

—

having regard to the fifth meeting of the High Level Accession Dialogue, held in Skopje on 18 September 2015,

| — | having regard to the Commission communication of 10 November 2015 entitled ‘EU Enlargement Strategy’ (COM(2015)0611), accompanied by the Commission staff working document entitled ‘The former Yugoslav Republic of Macedonia Report 2015’ (SWD(2015)0212), |
| --- | --- |

—

having regard to the Commission communication of 10 November 2015 entitled ‘EU Enlargement Strategy’ (COM(2015)0611), accompanied by the Commission staff working document entitled ‘The former Yugoslav Republic of Macedonia Report 2015’ (SWD(2015)0212),

| — | having regard to the political agreement (the so-called ‘Przhino Agreement’) reached between the four main political parties in Skopje on 2 June and 15 July 2015, |
| --- | --- |

—

having regard to the political agreement (the so-called ‘Przhino Agreement’) reached between the four main political parties in Skopje on 2 June and 15 July 2015,

| — | having regard to the 13th meeting of the EU-Former Yugoslav Republic of Macedonia Joint Parliamentary Committee (JPC) held in Skopje on 3-4 December 2015, |
| --- | --- |

—

having regard to the 13th meeting of the EU-Former Yugoslav Republic of Macedonia Joint Parliamentary Committee (JPC) held in Skopje on 3-4 December 2015,

| — | having regard to the conclusions of the European Council of 18 and 19 February 2016, |
| --- | --- |

—

having regard to the conclusions of the European Council of 18 and 19 February 2016,

| — | having regard to its previous resolutions on the country, |
| --- | --- |

—

having regard to its previous resolutions on the country,

| — | having regard to the work of Ivo Vajgl as the standing rapporteur on the country of the Committee on Foreign Affairs, |
| --- | --- |

—

having regard to the work of Ivo Vajgl as the standing rapporteur on the country of the Committee on Foreign Affairs,

| — | having regard to Rule 123(2) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 123(2) of its Rules of Procedure,

| A. | whereas the prospect of EU membership is a major incentive for further reforms, particularly with regard to the rule of law, the independence of the judiciary and the fight against corruption, and a source of hope for a prosperous future for young generations; whereas opinion polls show considerable public support for EU membership in the former Yugoslav Republic of Macedonia; |
| --- | --- |

A.

whereas the prospect of EU membership is a major incentive for further reforms, particularly with regard to the rule of law, the independence of the judiciary and the fight against corruption, and a source of hope for a prosperous future for young generations; whereas opinion polls show considerable public support for EU membership in the former Yugoslav Republic of Macedonia;

| B. | whereas the rule of law, media freedom, regional cooperation and good neighbourly relations are key elements in the EU enlargement process; |
| --- | --- |

B.

whereas the rule of law, media freedom, regional cooperation and good neighbourly relations are key elements in the EU enlargement process;

| C. | whereas the country has been a candidate for EU membership for ten years and is still considered among the most advanced candidates in terms of alignment with the acquis; |
| --- | --- |

C.

whereas the country has been a candidate for EU membership for ten years and is still considered among the most advanced candidates in terms of alignment with the acquis;

| D. | whereas (potential) candidate countries are judged on their own merits, and the speed and quality of the necessary reforms determine the timetable for accession; |
| --- | --- |

D.

whereas (potential) candidate countries are judged on their own merits, and the speed and quality of the necessary reforms determine the timetable for accession;

| E. | whereas the Commission, supported by Parliament, has repeatedly called for the opening of accession negotiations, stressing the importance of negotiations as a key driver of the process of necessary reforms; |
| --- | --- |

E.

whereas the Commission, supported by Parliament, has repeatedly called for the opening of accession negotiations, stressing the importance of negotiations as a key driver of the process of necessary reforms;

| F. | whereas the Council has been blocking progress in the country’s accession process partly owing to the unresolved name issue with Greece; whereas bilateral issues should not be used to obstruct the EU accession process but should be addressed in a constructive spirit as early as possible in the accession process, taking into account the principles and values of the UN and of the EU; |
| --- | --- |

F.

whereas the Council has been blocking progress in the country’s accession process partly owing to the unresolved name issue with Greece; whereas bilateral issues should not be used to obstruct the EU accession process but should be addressed in a constructive spirit as early as possible in the accession process, taking into account the principles and values of the UN and of the EU;

| G. | whereas there is consensus between the Commission, the Council and Parliament that the maintenance of the positive recommendation to open accession negotiations with the country shall be conditional on the full implementation of the June/July 2015 political agreement and substantial progress in the implementation of the Urgent Reform Priorities; whereas full implementation of the political agreement would create an environment in which there is a realistic prospect of a negotiated resolution of the name issue with Greece; |
| --- | --- |

G.

whereas there is consensus between the Commission, the Council and Parliament that the maintenance of the positive recommendation to open accession negotiations with the country shall be conditional on the full implementation of the June/July 2015 political agreement and substantial progress in the implementation of the Urgent Reform Priorities; whereas full implementation of the political agreement would create an environment in which there is a realistic prospect of a negotiated resolution of the name issue with Greece;

| H. | whereas the divisive political mentality, the lack of compromise and the collapse of dialogue took the form of a political crisis, which led to the boycott of the country’s parliament by the major opposition party and further undermined confidence in public institutions; whereas it is the shared responsibility of the government and the opposition to ensure sustainable political dialogue and cooperation, which are essential for the country’s democratic development, the pursuit of the European agenda and the common good of its citizens; |
| --- | --- |

H.

whereas the divisive political mentality, the lack of compromise and the collapse of dialogue took the form of a political crisis, which led to the boycott of the country’s parliament by the major opposition party and further undermined confidence in public institutions; whereas it is the shared responsibility of the government and the opposition to ensure sustainable political dialogue and cooperation, which are essential for the country’s democratic development, the pursuit of the European agenda and the common good of its citizens;

| I. | whereas the country is facing serious challenges relating to intercepted communications, which have underlined crucial shortcomings and concerns; whereas the recent political crisis has demonstrated the lack of an effective system of checks and balances within the Macedonian institutions and the need to increase transparency and public accountability, including adequate mechanisms for oversight of the main services and internal structures; |
| --- | --- |

I.

whereas the country is facing serious challenges relating to intercepted communications, which have underlined crucial shortcomings and concerns; whereas the recent political crisis has demonstrated the lack of an effective system of checks and balances within the Macedonian institutions and the need to increase transparency and public accountability, including adequate mechanisms for oversight of the main services and internal structures;

| J. | whereas full implementation of the political agreement by the leaders of the four main political parties is crucial for the stability of the country; whereas this agreement envisaged, inter alia, a way out of the political stalemate, the opposition’s return to parliament, the implementation of systemic rule of law reforms, the strengthening of good neighbourly relations, the resignation of the incumbent government and the Prime Minister at least 100 days before early parliamentary elections, the establishment of the Office of the Special Prosecutor and free and fair early parliamentary elections; |
| --- | --- |

J.

whereas full implementation of the political agreement by the leaders of the four main political parties is crucial for the stability of the country; whereas this agreement envisaged, inter alia, a way out of the political stalemate, the opposition’s return to parliament, the implementation of systemic rule of law reforms, the strengthening of good neighbourly relations, the resignation of the incumbent government and the Prime Minister at least 100 days before early parliamentary elections, the establishment of the Office of the Special Prosecutor and free and fair early parliamentary elections;

| K. | whereas some of the critical issues in the reform process are political influence in the media, the judiciary and public administration, corruption and the completion of the review of the Ohrid Agreement; |
| --- | --- |

K.

whereas some of the critical issues in the reform process are political influence in the media, the judiciary and public administration, corruption and the completion of the review of the Ohrid Agreement;

| L. | whereas the country has been coping with an unprecedented flow of refugees transiting through its territory; |
| --- | --- |

L.

whereas the country has been coping with an unprecedented flow of refugees transiting through its territory;

| M. | whereas after more than 10 years, the country and Greece have mutually re-established bilateral visits at Foreign Minister level; |
| --- | --- |

M.

whereas after more than 10 years, the country and Greece have mutually re-established bilateral visits at Foreign Minister level;

| 1. | Welcomes the four-party agreement of 2 June and 15 July 2015 and its facilitation by the Commissioner for Enlargement, three Members of the European Parliament and the EU mediator on the ground; urges the political parties to assume their respective responsibilities vis-à-vis the citizens and to ensure without delay the full, constructive and timely implementation of all their commitments in a sustainable and negotiated manner, including their commitment to strengthen good neighbourly relations, also in order to maintain the positive recommendation to open EU membership negotiations; urges them also to constructively engage in political dialogue and to pursue efforts to restore public trust in the institutions in order to maintain political stability and to accelerate the reform agenda to ensure the country’s Euro-Atlantic integration and a European perspective; |
| --- | --- |

1.

Welcomes the four-party agreement of 2 June and 15 July 2015 and its facilitation by the Commissioner for Enlargement, three Members of the European Parliament and the EU mediator on the ground; urges the political parties to assume their respective responsibilities vis-à-vis the citizens and to ensure without delay the full, constructive and timely implementation of all their commitments in a sustainable and negotiated manner, including their commitment to strengthen good neighbourly relations, also in order to maintain the positive recommendation to open EU membership negotiations; urges them also to constructively engage in political dialogue and to pursue efforts to restore public trust in the institutions in order to maintain political stability and to accelerate the reform agenda to ensure the country’s Euro-Atlantic integration and a European perspective;

| 2. | Takes note of the fact that a number of obligations envisaged in the June/July 2015 Agreement have been fulfilled according to the agreed deadlines and objectives, but regrets the tendency to delay some of the commitments and some retrograde steps in relation to Urgent Reform Priorities; emphasises the aspects of the Agreement which refer to structural reforms, and the need for all parties to constructively engage in the Working Group convened by the EU mediator on a continuous basis and on the issues of implementing the agreement, even during the election period; calls on all parties to put the interests of the country before party interests and insists that an all-party agreement remains essential in order to fulfil all the elements of the June/July 2015 Agreement, which would put the country back on track towards the Euro-Atlantic perspective; welcomes the return to parliament of the main opposition party SDSM on 1 September 2015; welcomes the appointment of a Special Prosecutor on 15 September 2015 to lead independent and thorough investigations; notes that the amendments to the new electoral code, the law establishing the Inquiry Committee, the law on government and the law on the composition of the new State Election Commission were adopted with delay; |
| --- | --- |

2.

Takes note of the fact that a number of obligations envisaged in the June/July 2015 Agreement have been fulfilled according to the agreed deadlines and objectives, but regrets the tendency to delay some of the commitments and some retrograde steps in relation to Urgent Reform Priorities; emphasises the aspects of the Agreement which refer to structural reforms, and the need for all parties to constructively engage in the Working Group convened by the EU mediator on a continuous basis and on the issues of implementing the agreement, even during the election period; calls on all parties to put the interests of the country before party interests and insists that an all-party agreement remains essential in order to fulfil all the elements of the June/July 2015 Agreement, which would put the country back on track towards the Euro-Atlantic perspective; welcomes the return to parliament of the main opposition party SDSM on 1 September 2015; welcomes the appointment of a Special Prosecutor on 15 September 2015 to lead independent and thorough investigations; notes that the amendments to the new electoral code, the law establishing the Inquiry Committee, the law on government and the law on the composition of the new State Election Commission were adopted with delay;

| 3. | Welcomes the commitment of the main political party leaders under the 2 June 2015 agreement to work towards strengthening good neighbourly relations as an essential element for bringing the country closer to the European Union; |
| --- | --- |

3.

Welcomes the commitment of the main political party leaders under the 2 June 2015 agreement to work towards strengthening good neighbourly relations as an essential element for bringing the country closer to the European Union;

| 4. | Notes that, according to the June/July 2015 Agreement, the new government was to be sworn in on 15 January 2016, 100 days before the agreed date for early parliamentary elections; takes note of the vote by the Macedonian Parliament on 23 February 2016 to set a new date for early parliamentary elections of 5 June 2016; regrets, however, that an opportunity was missed to find a consensus between all parties; recalls that these elections will in themselves be an important test for the democratic process of the country; insists that all the political parties make efforts to create the conditions for credible early elections and underlines the paramount importance of these elections being free, fair, in full compliance with international standards and in line with OSCE/ODIHR recommendations; |
| --- | --- |

4.

Notes that, according to the June/July 2015 Agreement, the new government was to be sworn in on 15 January 2016, 100 days before the agreed date for early parliamentary elections; takes note of the vote by the Macedonian Parliament on 23 February 2016 to set a new date for early parliamentary elections of 5 June 2016; regrets, however, that an opportunity was missed to find a consensus between all parties; recalls that these elections will in themselves be an important test for the democratic process of the country; insists that all the political parties make efforts to create the conditions for credible early elections and underlines the paramount importance of these elections being free, fair, in full compliance with international standards and in line with OSCE/ODIHR recommendations;

| 5. | Underlines the need to prepare the elections to the highest international standards, including ensuring free and fair election procedures and enhancing media freedom; expresses concern about the slow pace of the audit of the voters’ list and media reform; emphasises that the State Election Commission must have full capacity to conduct its work and that a methodology for the audit of the voters’ list should be agreed by all parties, with an agreed level of field checks to ensure legitimacy; underlines, moreover, the importance of all political actors respecting the results of the elections and actively taking part in parliamentary activities; notes the shared responsibility of the major political forces for the process of preparation of the elections; urges the international community to be present for election observation; |
| --- | --- |

5.

Underlines the need to prepare the elections to the highest international standards, including ensuring free and fair election procedures and enhancing media freedom; expresses concern about the slow pace of the audit of the voters’ list and media reform; emphasises that the State Election Commission must have full capacity to conduct its work and that a methodology for the audit of the voters’ list should be agreed by all parties, with an agreed level of field checks to ensure legitimacy; underlines, moreover, the importance of all political actors respecting the results of the elections and actively taking part in parliamentary activities; notes the shared responsibility of the major political forces for the process of preparation of the elections; urges the international community to be present for election observation;

| 6. | Considers it of strategic importance to ensure continuity of support to the Macedonian progress towards EU membership; notes that the recommendation to open accession negotiations should be conditional upon the full implementation of the June/July 2015 political agreement and substantial progress on the implementation of the Urgent Reform Priorities; calls on the Council to address this issue at its earliest convenience after the early parliamentary elections, as indicated by the Commission; stresses the need to create the pre-conditions for democratic and fair elections, inter alia by the preparation of a reliable voters register and media freedom; welcomes the high level of alignment with the legislative acquis and the fact that the country has achieved some progress in the last year in 25 out of the 33 acquis chapters; |
| --- | --- |

6.

Considers it of strategic importance to ensure continuity of support to the Macedonian progress towards EU membership; notes that the recommendation to open accession negotiations should be conditional upon the full implementation of the June/July 2015 political agreement and substantial progress on the implementation of the Urgent Reform Priorities; calls on the Council to address this issue at its earliest convenience after the early parliamentary elections, as indicated by the Commission; stresses the need to create the pre-conditions for democratic and fair elections, inter alia by the preparation of a reliable voters register and media freedom; welcomes the high level of alignment with the legislative acquis and the fact that the country has achieved some progress in the last year in 25 out of the 33 acquis chapters;

| 7. | Considers it essential for the democratic process that the Special Prosecutor be given full support to fulfil her agreed functions and maintain full autonomy, and all resources required to investigate any wrongdoings arising from the wiretaps; calls for an end to obstructions in the courts against referring evidence to the Special Prosecutor, and for support for amendments to the law in order to ensure her autonomous authority as regards witness protection with respect to the cases for which her office is responsible; |
| --- | --- |

7.

Considers it essential for the democratic process that the Special Prosecutor be given full support to fulfil her agreed functions and maintain full autonomy, and all resources required to investigate any wrongdoings arising from the wiretaps; calls for an end to obstructions in the courts against referring evidence to the Special Prosecutor, and for support for amendments to the law in order to ensure her autonomous authority as regards witness protection with respect to the cases for which her office is responsible;

| 8. | Considers it essential for the democratic process that the Urgent Reform Priorities on systemic reforms on the rule of law and fundamental rights be implemented without delay; invites the Commission to report back to Parliament and the Council on the implementation of the political agreement and the Urgent Reform Priorities after the early parliamentary elections, and to give an assessment of the conduct of the elections; |
| --- | --- |

8.

Considers it essential for the democratic process that the Urgent Reform Priorities on systemic reforms on the rule of law and fundamental rights be implemented without delay; invites the Commission to report back to Parliament and the Council on the implementation of the political agreement and the Urgent Reform Priorities after the early parliamentary elections, and to give an assessment of the conduct of the elections;

| 9. | Underlines the key role of the country’s parliament in the democratic development of the country and as the forum for political dialogue and representation; calls for its legislative and oversight functions to be improved and strengthened; calls for the regular convening and smooth operation of the relevant parliamentary committees on interception of communications and on security and counterintelligence; notes that the deadlines in the Political Agreement for reports to be produced by parliamentary committees have not been met; calls for the finalisation of the recommendation of the committee of inquiry into the events which occurred in parliament on 24 December 2012; stresses the need to ensure the committee’s unhindered access to the necessary data, testimonies and technical assistance, and to provide credible parliamentary control of the work of the intelligence services, including the necessary checks and balances on the executive’s power; |
| --- | --- |

9.

Underlines the key role of the country’s parliament in the democratic development of the country and as the forum for political dialogue and representation; calls for its legislative and oversight functions to be improved and strengthened; calls for the regular convening and smooth operation of the relevant parliamentary committees on interception of communications and on security and counterintelligence; notes that the deadlines in the Political Agreement for reports to be produced by parliamentary committees have not been met; calls for the finalisation of the recommendation of the committee of inquiry into the events which occurred in parliament on 24 December 2012; stresses the need to ensure the committee’s unhindered access to the necessary data, testimonies and technical assistance, and to provide credible parliamentary control of the work of the intelligence services, including the necessary checks and balances on the executive’s power;

| 10. | Is concerned about the very weak internal and external oversight and control of the intelligence services; calls urgently for the strengthening of the oversight role of the relevant institutions over these services and for full implementation of the recommendations of the Senior Experts’ Group on systemic rule of law issues relating to the communications interception revealed in Spring 2015; |
| --- | --- |

10.

Is concerned about the very weak internal and external oversight and control of the intelligence services; calls urgently for the strengthening of the oversight role of the relevant institutions over these services and for full implementation of the recommendations of the Senior Experts’ Group on systemic rule of law issues relating to the communications interception revealed in Spring 2015;

| 11. | Is concerned that the Macedonian public administration remains subject to political influence; urges the government to enhance professionalism, neutrality and independence at all levels and to ensure the full implementation of the principles of accountability, transparency and merit; calls on the competent authorities to implement in a sustainable manner the Law on Administrative Servants and the Law on Public Employees, in full compliance with the principles of transparency, meritocracy and equal representation, and to adopt a comprehensive public administration reform strategy for 2016-2020, including an action plan, and a public financial management reform programme; |
| --- | --- |

11.

Is concerned that the Macedonian public administration remains subject to political influence; urges the government to enhance professionalism, neutrality and independence at all levels and to ensure the full implementation of the principles of accountability, transparency and merit; calls on the competent authorities to implement in a sustainable manner the Law on Administrative Servants and the Law on Public Employees, in full compliance with the principles of transparency, meritocracy and equal representation, and to adopt a comprehensive public administration reform strategy for 2016-2020, including an action plan, and a public financial management reform programme;

| 12. | Underlines the need to enhance administrative capacity and inclusive and evidence-based policy-making in order to ensure effective implementation of policies and lines of accountability; calls for the development of a designated training programme for public administration staff; urges the Commission to provide assistance and exchange possibilities in this regard; |
| --- | --- |

12.

Underlines the need to enhance administrative capacity and inclusive and evidence-based policy-making in order to ensure effective implementation of policies and lines of accountability; calls for the development of a designated training programme for public administration staff; urges the Commission to provide assistance and exchange possibilities in this regard;

| 13. | Supports the government’s plans to increase accessibility to public services by prioritising the development of e-services; suggests that the government look for twinning opportunities and take stock of existing best practices; notes that e-services would reduce the bureaucratic burden for the state, for citizens and when doing business; considers, furthermore, that e-services would enhance the country’s economic performance and enable the transparency of the public administration and services to be increased; |
| --- | --- |

13.

Supports the government’s plans to increase accessibility to public services by prioritising the development of e-services; suggests that the government look for twinning opportunities and take stock of existing best practices; notes that e-services would reduce the bureaucratic burden for the state, for citizens and when doing business; considers, furthermore, that e-services would enhance the country’s economic performance and enable the transparency of the public administration and services to be increased;

| 14. | Notes the well-established legal framework and earlier measures as regards judicial reform, but deplores the cases of selective justice, particularly through the misuse of Article 353 of the Criminal Code; calls once again for political will to depoliticise the appointment and promotion of judges and prosecutors and to ensure the professionalism and independence of the Judicial Council; stresses the need for the efficient functioning, sufficient staffing and independence of administrative courts and for the capacities of the Academy for Judges and Prosecutors to be strengthened; calls for the preparation and proper consultation of stakeholders on a new 2015-2020 Judicial Reform Strategy and action plan; |
| --- | --- |

14.

Notes the well-established legal framework and earlier measures as regards judicial reform, but deplores the cases of selective justice, particularly through the misuse of Article 353 of the Criminal Code; calls once again for political will to depoliticise the appointment and promotion of judges and prosecutors and to ensure the professionalism and independence of the Judicial Council; stresses the need for the efficient functioning, sufficient staffing and independence of administrative courts and for the capacities of the Academy for Judges and Prosecutors to be strengthened; calls for the preparation and proper consultation of stakeholders on a new 2015-2020 Judicial Reform Strategy and action plan;

| 15. | Considers civil society to be well-organised but remains concerned about the difficult climate surrounding it and the public attacks by politicians and media on civil society organisations (CSOs); calls on the authorities not to discriminate against CSOs on any grounds such as political affiliation, religious views or ethnic composition; regrets the insufficient cooperation with CSOs, at both central and local levels, in policy and law-making; calls on the authorities to encourage CSOs to actively participate in the overview of the whole electoral process; urges the government to acknowledge the added value of the CSOs by consulting with them during the process of drawing up legislation and policy, to develop the relevant 2015-2017 action plan, to establish the Council for Cooperation with CSOs, to facilitate the necessary dialogue and to include CSOs in policymaking in a regular and structured manner; notes with concern the violent clashes between protesters and police during the May 2015 demonstrations and calls on the government to ensure full respect for freedom of assembly; |
| --- | --- |

15.

Considers civil society to be well-organised but remains concerned about the difficult climate surrounding it and the public attacks by politicians and media on civil society organisations (CSOs); calls on the authorities not to discriminate against CSOs on any grounds such as political affiliation, religious views or ethnic composition; regrets the insufficient cooperation with CSOs, at both central and local levels, in policy and law-making; calls on the authorities to encourage CSOs to actively participate in the overview of the whole electoral process; urges the government to acknowledge the added value of the CSOs by consulting with them during the process of drawing up legislation and policy, to develop the relevant 2015-2017 action plan, to establish the Council for Cooperation with CSOs, to facilitate the necessary dialogue and to include CSOs in policymaking in a regular and structured manner; notes with concern the violent clashes between protesters and police during the May 2015 demonstrations and calls on the government to ensure full respect for freedom of assembly;

| 16. | Reiterates that the authorities and civil society should take appropriate measures to achieve historical reconciliation in order to overcome the divide between and within different ethnic and national groups, including citizens of Bulgarian identity; |
| --- | --- |

16.

Reiterates that the authorities and civil society should take appropriate measures to achieve historical reconciliation in order to overcome the divide between and within different ethnic and national groups, including citizens of Bulgarian identity;

| 17. | Encourages the country to establish joint expert committees with its neighbours on history and education and to refrain from using educational materials which might contain offensive language towards other countries, with the aim of contributing to an objective, fact-based interpretation of history, strengthening academic cooperation and promoting positive attitudes in young people towards their neighbours; |
| --- | --- |

17.

Encourages the country to establish joint expert committees with its neighbours on history and education and to refrain from using educational materials which might contain offensive language towards other countries, with the aim of contributing to an objective, fact-based interpretation of history, strengthening academic cooperation and promoting positive attitudes in young people towards their neighbours;

| 18. | Welcomes the efforts made so far by the authorities to retrieve the relevant Yugoslav secret service archives from Serbia, and encourages them to finalise the process, which would mark an important step towards breaking with the Communist past and moving towards further democratisation, accountability and institutional strength; |
| --- | --- |

18.

Welcomes the efforts made so far by the authorities to retrieve the relevant Yugoslav secret service archives from Serbia, and encourages them to finalise the process, which would mark an important step towards breaking with the Communist past and moving towards further democratisation, accountability and institutional strength;

| 19. | Remains concerned about widespread corruption, particularly in state and local administration, public procurement and political party financing; urges the government to fight corruption in a non-selective manner, to develop a credible track record on both prevention and prosecution of high-level corruption, and to ensure that all law enforcement and supervisory bodies have sufficient autonomy to act independently; takes note of the adoption of the law on whistleblower protection in November 2015 and urges the authorities to ensure its implementation in line with European standards; encourages independent CSOs and the media to bring corruption issues to light and support independent and impartial investigations and trials; stresses the need to strengthen the independence of the police, the Public Prosecutor’s Office and the State Commission for the Prevention of Corruption, and to reinforce the Interior Ministry’s staffing and technical capacities for fighting corruption; calls for enhanced scrutiny of potential conflicts of interest and of assets belonging to elected and appointed officials by establishing a central register of such public servants; |
| --- | --- |

19.

Remains concerned about widespread corruption, particularly in state and local administration, public procurement and political party financing; urges the government to fight corruption in a non-selective manner, to develop a credible track record on both prevention and prosecution of high-level corruption, and to ensure that all law enforcement and supervisory bodies have sufficient autonomy to act independently; takes note of the adoption of the law on whistleblower protection in November 2015 and urges the authorities to ensure its implementation in line with European standards; encourages independent CSOs and the media to bring corruption issues to light and support independent and impartial investigations and trials; stresses the need to strengthen the independence of the police, the Public Prosecutor’s Office and the State Commission for the Prevention of Corruption, and to reinforce the Interior Ministry’s staffing and technical capacities for fighting corruption; calls for enhanced scrutiny of potential conflicts of interest and of assets belonging to elected and appointed officials by establishing a central register of such public servants;

| 20. | Welcomes the fact that the police and the Public Prosecutor’s Office were reinforced in the fight against organised crime and that steps, including regional/international operations, have been taken to prevent and combat trafficking in human beings; commends the cooperation with neighbouring countries, EU Member States and Eurojust in taking down several organised crime networks; encourages further improvement of cooperation between law enforcement agencies, including those in neighbouring countries, and strengthening of the powers and resources of the courts and the Agency for Management of Confiscated Property; calls for the National Coordination Centre for the Fight against Organised Crime to be made operational and for the establishment of a sound track record on combating money laundering; commends the participation of the country in regional initiatives to fight the illegal trafficking of firearms and explosives; urges that cooperation in this field between the Commission and the Macedonian authorities, as well as governments in the region, should be stepped up further; |
| --- | --- |

20.

Welcomes the fact that the police and the Public Prosecutor’s Office were reinforced in the fight against organised crime and that steps, including regional/international operations, have been taken to prevent and combat trafficking in human beings; commends the cooperation with neighbouring countries, EU Member States and Eurojust in taking down several organised crime networks; encourages further improvement of cooperation between law enforcement agencies, including those in neighbouring countries, and strengthening of the powers and resources of the courts and the Agency for Management of Confiscated Property; calls for the National Coordination Centre for the Fight against Organised Crime to be made operational and for the establishment of a sound track record on combating money laundering; commends the participation of the country in regional initiatives to fight the illegal trafficking of firearms and explosives; urges that cooperation in this field between the Commission and the Macedonian authorities, as well as governments in the region, should be stepped up further;

| 21. | Notes the important contribution to regional efforts to fight Islamic radicalism; encourages the development of a comprehensive strategy and action plan to prevent and counter radicalisation, in close cooperation with religious leaders and communities, and the pursuit of efforts to identify, prevent and disrupt foreign terrorist fighters; strongly reiterates the need for the government to define a common proactive strategy of foreign, security and defence policy, bearing in mind the current international terrorist threat; |
| --- | --- |

21.

Notes the important contribution to regional efforts to fight Islamic radicalism; encourages the development of a comprehensive strategy and action plan to prevent and counter radicalisation, in close cooperation with religious leaders and communities, and the pursuit of efforts to identify, prevent and disrupt foreign terrorist fighters; strongly reiterates the need for the government to define a common proactive strategy of foreign, security and defence policy, bearing in mind the current international terrorist threat;

| 22. | Urges that the investigations into the events at Kumanovo be fully completed; welcomes the declarations from political actors that the events at Kumanovo should not be linked with interethnic relations; |
| --- | --- |

22.

Urges that the investigations into the events at Kumanovo be fully completed; welcomes the declarations from political actors that the events at Kumanovo should not be linked with interethnic relations;

| 23. | Reminds the government and the political parties of their responsibility in shaping a culture of inclusion and tolerance; reiterates its call for the Anti-Discrimination Law to be aligned with the acquis as regards discrimination on grounds of sexual orientation and gender identity; notes that the new Anti-Discrimination Commission has only one female member and that its members were elected on the grounds of political affiliation to the ruling coalition, which raises the question of whether it can function in an impartial and effective manner; condemns the use of any kind of violence against the LGBTI community and reiterates its request that those responsible for such acts of violence be brought to justice; underlines the need to combat prejudices and discrimination on any grounds against the Roma, and to facilitate their integration and their access to the educational system and the labour market; welcomes the new Law on Combating Domestic Violence, but notes that it fails to recognise all forms of violence; urges the competent authorities to provide support services to victims of domestic violence and to allocate sufficient budget for the implementation of the gender equality strategy and action plan; |
| --- | --- |

23.

Reminds the government and the political parties of their responsibility in shaping a culture of inclusion and tolerance; reiterates its call for the Anti-Discrimination Law to be aligned with the acquis as regards discrimination on grounds of sexual orientation and gender identity; notes that the new Anti-Discrimination Commission has only one female member and that its members were elected on the grounds of political affiliation to the ruling coalition, which raises the question of whether it can function in an impartial and effective manner; condemns the use of any kind of violence against the LGBTI community and reiterates its request that those responsible for such acts of violence be brought to justice; underlines the need to combat prejudices and discrimination on any grounds against the Roma, and to facilitate their integration and their access to the educational system and the labour market; welcomes the new Law on Combating Domestic Violence, but notes that it fails to recognise all forms of violence; urges the competent authorities to provide support services to victims of domestic violence and to allocate sufficient budget for the implementation of the gender equality strategy and action plan;

| 24. | Reaffirms that the Anti-Discrimination Law should be amended to bring it into line with the acquis as regards all the categories of discrimination listed in Article 19 of the Treaty on the Functioning of the European Union; condemns hate speech against discriminated groups and calls for prompt, impartial and effective investigation and prosecution of all hate crimes and attacks targeting people for discriminatory reasons; |
| --- | --- |

24.

Reaffirms that the Anti-Discrimination Law should be amended to bring it into line with the acquis as regards all the categories of discrimination listed in Article 19 of the Treaty on the Functioning of the European Union; condemns hate speech against discriminated groups and calls for prompt, impartial and effective investigation and prosecution of all hate crimes and attacks targeting people for discriminatory reasons;

| 25. | Welcomes, in this context, the ‘Pristina Declaration’, which calls upon governments and international, intergovernmental and civil society organisations to fully apply the principles of non-discrimination and equality when working and acting on promotion and respect of Roma rights and fighting anti-Gypsyism in the Western Balkans; |
| --- | --- |

25.

Welcomes, in this context, the ‘Pristina Declaration’, which calls upon governments and international, intergovernmental and civil society organisations to fully apply the principles of non-discrimination and equality when working and acting on promotion and respect of Roma rights and fighting anti-Gypsyism in the Western Balkans;

| 26. | Takes note of the progress made in improving respect for children’s rights; underlines the need to increase and monitor enrolment in early childhood development facilities, especially for the most vulnerable children; highlights the importance of improving inclusion of children with disabilities through integrated services; stresses the need to collect disaggregated and reliable data on the situation of Roma children and for legislative changes to prevent child marriage; emphasises the need for increased coordination among professionals to prevent and respond to violence against children; |
| --- | --- |

26.

Takes note of the progress made in improving respect for children’s rights; underlines the need to increase and monitor enrolment in early childhood development facilities, especially for the most vulnerable children; highlights the importance of improving inclusion of children with disabilities through integrated services; stresses the need to collect disaggregated and reliable data on the situation of Roma children and for legislative changes to prevent child marriage; emphasises the need for increased coordination among professionals to prevent and respond to violence against children;

| 27. | Notes with concern that interethnic coexistence remains fragile; calls on all political parties and CSOs to actively promote an inclusive and tolerant multi-ethnic and multi-religious society; stresses the need for a more proactive approach to strengthen coexistence and dialogue, and to achieve cohesion among the various ethnic, national and religious communities; reminds the government, institutions and party leaders of their commitment to fully implement the Ohrid Framework Agreement (OFA) and to complete its review, including policy recommendations; invites the Commission to report back to Parliament and the Council on the state of interethnic relations in the country and the implementation of the OFA; calls for better coordination of the strategic decentralisation programme for 2015-2020 and its action plan; |
| --- | --- |

27.

Notes with concern that interethnic coexistence remains fragile; calls on all political parties and CSOs to actively promote an inclusive and tolerant multi-ethnic and multi-religious society; stresses the need for a more proactive approach to strengthen coexistence and dialogue, and to achieve cohesion among the various ethnic, national and religious communities; reminds the government, institutions and party leaders of their commitment to fully implement the Ohrid Framework Agreement (OFA) and to complete its review, including policy recommendations; invites the Commission to report back to Parliament and the Council on the state of interethnic relations in the country and the implementation of the OFA; calls for better coordination of the strategic decentralisation programme for 2015-2020 and its action plan;

| 28. | Recalls that education and cultural training can help to create tolerance and promote reconciliation among the various ethnic groups; reiterates the recommendation made in its previous resolution regarding integrated education, and calls on the government and the competent local authorities to ensure an open, transparent and inclusive process as regards the effective implementation of the Strategy for Integrated Education, by allocating sufficient funding and including CSOs in the process of its review and implementation; |
| --- | --- |

28.

Recalls that education and cultural training can help to create tolerance and promote reconciliation among the various ethnic groups; reiterates the recommendation made in its previous resolution regarding integrated education, and calls on the government and the competent local authorities to ensure an open, transparent and inclusive process as regards the effective implementation of the Strategy for Integrated Education, by allocating sufficient funding and including CSOs in the process of its review and implementation;

| 29. | Calls on the authorities to ensure that the recommendations of the Ombudsman’s office and other advisory bodies are followed up by all state bodies in full respect of the law and of the principle of accountability, to ensure effective legal sanctions for non-compliance with the requests and recommendations of independent bodies and to ensure that the Ombudsman Law is amended to comply fully with the UN-defined Paris principles on the status and functioning of national institutions for the protection and promotion of human rights; |
| --- | --- |

29.

Calls on the authorities to ensure that the recommendations of the Ombudsman’s office and other advisory bodies are followed up by all state bodies in full respect of the law and of the principle of accountability, to ensure effective legal sanctions for non-compliance with the requests and recommendations of independent bodies and to ensure that the Ombudsman Law is amended to comply fully with the UN-defined Paris principles on the status and functioning of national institutions for the protection and promotion of human rights;

| 30. | Reiterates the importance of media freedom and independence as one of the core EU values and a cornerstone of any democracy; deplores the further deterioration of freedom of expression and media freedom; regrets, in this context, that in the index compiled by Reporters Without Borders the country has fallen from 34th place in 2009 to 117th in 2015; is very concerned about political pressure, hate speech, the continued polarisation, lack of independence and pluralism in the media, the widespread illegal wiretapping of journalists, the cases of violence and threats against journalists and intimidation and self-censorship, systemic political interference in the editorial policies and the poor professional and ethical standards of some journalists, as well as the absence of investigative and balanced reporting; |
| --- | --- |

30.

Reiterates the importance of media freedom and independence as one of the core EU values and a cornerstone of any democracy; deplores the further deterioration of freedom of expression and media freedom; regrets, in this context, that in the index compiled by Reporters Without Borders the country has fallen from 34th place in 2009 to 117th in 2015; is very concerned about political pressure, hate speech, the continued polarisation, lack of independence and pluralism in the media, the widespread illegal wiretapping of journalists, the cases of violence and threats against journalists and intimidation and self-censorship, systemic political interference in the editorial policies and the poor professional and ethical standards of some journalists, as well as the absence of investigative and balanced reporting;

| 31. | Urges that steps be taken to enhance media freedom; calls on all parties to agree on an urgent media reform which will ensure an independent regulatory body and objective and professional reporting; urges the government to enforce transparent and objective criteria on public service announcements, and to ensure the transparent and non-arbitrary implementation of the new law on electronic communications and audiovisual media services, including the strengthening of the independence and capacity of the media regulator; calls for the members of the council of the audiovisual services regulator to be given full decision-making powers for appointments to that council and to the public service broadcaster on a non-partisan basis and in consultation with the associations of journalists; calls for the editorial and financial independence of the public service broadcaster to be ensured, along with full and equal access to the media for all political parties; calls, in the context of the upcoming elections, for a level playing field also as regards the media; |
| --- | --- |

31.

Urges that steps be taken to enhance media freedom; calls on all parties to agree on an urgent media reform which will ensure an independent regulatory body and objective and professional reporting; urges the government to enforce transparent and objective criteria on public service announcements, and to ensure the transparent and non-arbitrary implementation of the new law on electronic communications and audiovisual media services, including the strengthening of the independence and capacity of the media regulator; calls for the members of the council of the audiovisual services regulator to be given full decision-making powers for appointments to that council and to the public service broadcaster on a non-partisan basis and in consultation with the associations of journalists; calls for the editorial and financial independence of the public service broadcaster to be ensured, along with full and equal access to the media for all political parties; calls, in the context of the upcoming elections, for a level playing field also as regards the media;

| 32. | Welcomes the good level of preparation for the development of a functioning market economy, including the simplification of the regulatory framework which has further eased the overall business environment; notes, however, that the weak enforcement of the rule of law, the inefficient judicial system, the large shadow economy and corruption are serious impediments to doing business; stresses that further strengthening legal certainty for foreign investors as well as domestic companies, avoiding discriminatory practices, strengthening administrative capacities and regulatory and supervisory agencies, and improving the quality of regulation, the rule of law and contract enforcement remain important challenges; calls, furthermore, for Article 353 of the Criminal Code on the misuse of official position and authority to be revised in line with the EU acquis and the principles of a market economy; encourages the removal of non-tariff barriers to trade; underlines the great potential and strategic advantage of agriculture and tourism in the further development of the country; |
| --- | --- |

32.

Welcomes the good level of preparation for the development of a functioning market economy, including the simplification of the regulatory framework which has further eased the overall business environment; notes, however, that the weak enforcement of the rule of law, the inefficient judicial system, the large shadow economy and corruption are serious impediments to doing business; stresses that further strengthening legal certainty for foreign investors as well as domestic companies, avoiding discriminatory practices, strengthening administrative capacities and regulatory and supervisory agencies, and improving the quality of regulation, the rule of law and contract enforcement remain important challenges; calls, furthermore, for Article 353 of the Criminal Code on the misuse of official position and authority to be revised in line with the EU acquis and the principles of a market economy; encourages the removal of non-tariff barriers to trade; underlines the great potential and strategic advantage of agriculture and tourism in the further development of the country;

| 33. | Is concerned about the high level of public debt; calls for improved fiscal discipline and encourages the principle of balanced budget; calls for budgetary implementation and transparency to be improved; |
| --- | --- |

33.

Is concerned about the high level of public debt; calls for improved fiscal discipline and encourages the principle of balanced budget; calls for budgetary implementation and transparency to be improved;

| 34. | Welcomes the GDP increase of 3,9 % in real terms in the first quarter of 2015, but is concerned that unemployment remains high at 27,4 % and that labour market participation is very low, especially among young people and women; recalls that employment should not be influenced by political affiliation or used for pressure and intimidation of citizens during election campaigns, as pointed out by the OSCE/ODIHR; urges the government to set up functioning social dialogue, to pursue a policy to tackle long-term and structural unemployment, to promote economic policy cooperation, to better align education with labour market demands and to develop a targeted strategy on how to better integrate young people and women into the labour market; calls on the government to dedicate particular attention to improving the perspectives of young people; |
| --- | --- |

34.

Welcomes the GDP increase of 3,9 % in real terms in the first quarter of 2015, but is concerned that unemployment remains high at 27,4 % and that labour market participation is very low, especially among young people and women; recalls that employment should not be influenced by political affiliation or used for pressure and intimidation of citizens during election campaigns, as pointed out by the OSCE/ODIHR; urges the government to set up functioning social dialogue, to pursue a policy to tackle long-term and structural unemployment, to promote economic policy cooperation, to better align education with labour market demands and to develop a targeted strategy on how to better integrate young people and women into the labour market; calls on the government to dedicate particular attention to improving the perspectives of young people;

| 35. | Is concerned about the increasing brain drain, especially among young people; takes note of the challenges faced by the country’s education system and emphasises the need for a comprehensive analysis in this respect; recommends strategic planning for future reforms and legislative changes through the involvement of student movements and organisations, in order to reduce the outflow of highly educated and professional people; with regard to the data and analysis of Eurostat and other international organisations, which indicate serious migration trends, especially among young people, recommends evaluating the 2013-2020 national strategy for networking, cooperation and reduction of the outflow of highly educated and professional people, and making records and statistics of these trends publicly available; |
| --- | --- |

35.

Is concerned about the increasing brain drain, especially among young people; takes note of the challenges faced by the country’s education system and emphasises the need for a comprehensive analysis in this respect; recommends strategic planning for future reforms and legislative changes through the involvement of student movements and organisations, in order to reduce the outflow of highly educated and professional people; with regard to the data and analysis of Eurostat and other international organisations, which indicate serious migration trends, especially among young people, recommends evaluating the 2013-2020 national strategy for networking, cooperation and reduction of the outflow of highly educated and professional people, and making records and statistics of these trends publicly available;

| 36. | Notes with concern the challenges faced by the country’s education system and emphasises the need for a comprehensive analysis in this respect; recommends strategic planning for future reforms and legislative changes with the involvement of the relevant student movements and organisations, enabling them to fully exercise their rights within this process; |
| --- | --- |

36.

Notes with concern the challenges faced by the country’s education system and emphasises the need for a comprehensive analysis in this respect; recommends strategic planning for future reforms and legislative changes with the involvement of the relevant student movements and organisations, enabling them to fully exercise their rights within this process;

| 37. | Urges the country’s Agency for Youth and Sport to acknowledge the role and support of, and to establish a permanent mechanism for cooperation with, the country’s National Youth Council; welcomes the process of creating a National Youth Strategy for 2016-2025 and emphasises the need to allocate proper funding for its implementation; |
| --- | --- |

37.

Urges the country’s Agency for Youth and Sport to acknowledge the role and support of, and to establish a permanent mechanism for cooperation with, the country’s National Youth Council; welcomes the process of creating a National Youth Strategy for 2016-2025 and emphasises the need to allocate proper funding for its implementation;

| 38. | Welcomes the plan to upgrade and modernise parts of the railway network and encourages the Macedonian authorities to continue to develop and further improve public transport in cooperation with the neighbouring countries; |
| --- | --- |

38.

Welcomes the plan to upgrade and modernise parts of the railway network and encourages the Macedonian authorities to continue to develop and further improve public transport in cooperation with the neighbouring countries;

| 39. | Regrets that energy targets have not been met with regard, in particular, to energy efficiency and the use of renewables, and calls for the swift adoption of the relevant action plans; |
| --- | --- |

39.

Regrets that energy targets have not been met with regard, in particular, to energy efficiency and the use of renewables, and calls for the swift adoption of the relevant action plans;

| 40. | Stresses the need to make progress in opening up the internal electricity market, and to fully comply with the Energy Community Treaty; underlines the need to adopt national energy efficiency and renewable energy action plans; is worried about the alarming air pollution levels and urges the government to act immediately in reducing air pollution, especially in urban areas; |
| --- | --- |

40.

Stresses the need to make progress in opening up the internal electricity market, and to fully comply with the Energy Community Treaty; underlines the need to adopt national energy efficiency and renewable energy action plans; is worried about the alarming air pollution levels and urges the government to act immediately in reducing air pollution, especially in urban areas;

| 41. | Reiterates its concern about the high levels of air and water pollution in the country; points out that significant efforts are needed in the field of the environment and in particular in the area of air quality; |
| --- | --- |

41.

Reiterates its concern about the high levels of air and water pollution in the country; points out that significant efforts are needed in the field of the environment and in particular in the area of air quality;

| 42. | Welcomes the fact that the Food and Veterinary Agency has continued to update the systems for controlling imports of live animals and animal products, thus improving controls on the identification, registration and movement of animals; welcomes the enactment of additional legislation on the non-commercial movement of pets and zoo-technical issues, as well as new legislation on animal welfare; |
| --- | --- |

42.

Welcomes the fact that the Food and Veterinary Agency has continued to update the systems for controlling imports of live animals and animal products, thus improving controls on the identification, registration and movement of animals; welcomes the enactment of additional legislation on the non-commercial movement of pets and zoo-technical issues, as well as new legislation on animal welfare;

| 43. | Remains concerned about the insufficient capacity to programme and absorb Instrument for Pre-accession assistance (IPA) funds; urges the government to strengthen the administrative and financing capacities in order to procure and implement EU funds properly and in a timely manner; calls on the Commission to closely monitor projects financed by the EU in order to avoid misuse of European public money for political and other inappropriate purposes; |
| --- | --- |

43.

Remains concerned about the insufficient capacity to programme and absorb Instrument for Pre-accession assistance (IPA) funds; urges the government to strengthen the administrative and financing capacities in order to procure and implement EU funds properly and in a timely manner; calls on the Commission to closely monitor projects financed by the EU in order to avoid misuse of European public money for political and other inappropriate purposes;

| 44. | Notes that the country has been facing an unprecedented migratory flow, with over 500 000 persons transiting through in 2015; recognises that it has acted as a responsible partner in coping with the huge influx of migrants and refugees and in setting up effective border management measures; is aware of the increasingly tense situation at the border with Greece, and calls on the authorities to continue cooperation and coordination with the EU on migration issues; encourages the stepping-up of measures related to border management to combat illegal migration and human trafficking; notes the economic burden created by this influx; calls on the Commission to enhance support for border management capacity and allow access to the relevant EU instruments and programmes; calls upon the competent authorities to avoid and refrain from any kind of actions, including violence and the use of force, which might discriminate against, and put at risk the lives of, refugees and migrants; notes that all relevant kinds of actions should be in line with EU values and principles and should respect the dignity of human beings and human life; encourages the competent authorities to enhance, with the EU’s help, reception and accommodation facilities, regional coordination and information exchange and effective border management, to extend law enforcement capacities and to combat trafficking in human beings; urges the country to do everything possible to ensure facilities for refugees and migrants, uphold humane conditions, refrain from violent pushbacks and ensure strict respect for the country’s own law and for international law on refugees and asylum; notes that the overall number of unfounded asylum applications filed in Schengen member countries has declined; recalls that special attention must be devoted to the vulnerable situation of refugee and migrant children and unaccompanied minors travelling across the country by providing them with basic services and ensuring outreach of social workers to provide appropriate protection; |
| --- | --- |

44.

Notes that the country has been facing an unprecedented migratory flow, with over 500 000 persons transiting through in 2015; recognises that it has acted as a responsible partner in coping with the huge influx of migrants and refugees and in setting up effective border management measures; is aware of the increasingly tense situation at the border with Greece, and calls on the authorities to continue cooperation and coordination with the EU on migration issues; encourages the stepping-up of measures related to border management to combat illegal migration and human trafficking; notes the economic burden created by this influx; calls on the Commission to enhance support for border management capacity and allow access to the relevant EU instruments and programmes; calls upon the competent authorities to avoid and refrain from any kind of actions, including violence and the use of force, which might discriminate against, and put at risk the lives of, refugees and migrants; notes that all relevant kinds of actions should be in line with EU values and principles and should respect the dignity of human beings and human life; encourages the competent authorities to enhance, with the EU’s help, reception and accommodation facilities, regional coordination and information exchange and effective border management, to extend law enforcement capacities and to combat trafficking in human beings; urges the country to do everything possible to ensure facilities for refugees and migrants, uphold humane conditions, refrain from violent pushbacks and ensure strict respect for the country’s own law and for international law on refugees and asylum; notes that the overall number of unfounded asylum applications filed in Schengen member countries has declined; recalls that special attention must be devoted to the vulnerable situation of refugee and migrant children and unaccompanied minors travelling across the country by providing them with basic services and ensuring outreach of social workers to provide appropriate protection;

| 45. | Considers that EU negotiations can only positively influence efforts towards resolving bilateral disputes, while also generating momentum and leverage as regards much-needed reforms, particularly in respect of the rule of law, the independence of the judiciary and the fight against corruption, strengthening multiethnic cohesion, and safeguarding the credibility of the EU’s enlargement policy; |
| --- | --- |

45.

Considers that EU negotiations can only positively influence efforts towards resolving bilateral disputes, while also generating momentum and leverage as regards much-needed reforms, particularly in respect of the rule of law, the independence of the judiciary and the fight against corruption, strengthening multiethnic cohesion, and safeguarding the credibility of the EU’s enlargement policy;

| 46. | Commends the agreement with Greece on 11 confidence-building measures, mainly in the fields of education, culture, energy and internal affairs; notes that cooperation is the best confidence-building measure; welcomes as a positive sign the high-level consultations of the two Foreign Ministers in the respective capitals and the creation of a joint task force aimed at overseeing the implementation of the measures; invites both sides to build upon the outcome of these meetings and engage in further constructive discussion at a high political level, including on the implementation of the confidence-building measures, with a view to enriching bilateral cooperation and strengthening mutual trust; encourages both governments to use the momentum and take concrete steps towards further enhancing mutual trust, including with regard to the name issue; invites the Vice-President/High Representative (VP/HR) and the Commission to support the spirit of cooperation and develop new initiatives to overcome the remaining differences in line with the ruling of the International Court of Justice of 5 December 2011, in order to work, in cooperation with the two countries and the UN Special Representative, towards a mutually acceptable solution on the name issue and to report back to Parliament thereon; |
| --- | --- |

46.

Commends the agreement with Greece on 11 confidence-building measures, mainly in the fields of education, culture, energy and internal affairs; notes that cooperation is the best confidence-building measure; welcomes as a positive sign the high-level consultations of the two Foreign Ministers in the respective capitals and the creation of a joint task force aimed at overseeing the implementation of the measures; invites both sides to build upon the outcome of these meetings and engage in further constructive discussion at a high political level, including on the implementation of the confidence-building measures, with a view to enriching bilateral cooperation and strengthening mutual trust; encourages both governments to use the momentum and take concrete steps towards further enhancing mutual trust, including with regard to the name issue; invites the Vice-President/High Representative (VP/HR) and the Commission to support the spirit of cooperation and develop new initiatives to overcome the remaining differences in line with the ruling of the International Court of Justice of 5 December 2011, in order to work, in cooperation with the two countries and the UN Special Representative, towards a mutually acceptable solution on the name issue and to report back to Parliament thereon;

| 47. | Underlines the importance of regional cooperation and believes that it is an essential element in the EU accession process, bringing stability and prosperity to the region; welcomes the country’s constructive role in regional and international cooperation, and its willingness to participate in high-level visits with neighbouring countries as a means of fostering regional cooperation; notes that open issues in relations with Bulgaria have remained and reiterates the importance of finalising the negotiations on a treaty on friendship, good neighbourliness and cooperation; reiterates its concern over the use of historical arguments in the current debate with neighbours, and welcomes any efforts towards joint celebrations of common historical events with neighbouring EU Member States; considers that this could contribute to a better understanding of history and good neighbourly relations; |
| --- | --- |

47.

Underlines the importance of regional cooperation and believes that it is an essential element in the EU accession process, bringing stability and prosperity to the region; welcomes the country’s constructive role in regional and international cooperation, and its willingness to participate in high-level visits with neighbouring countries as a means of fostering regional cooperation; notes that open issues in relations with Bulgaria have remained and reiterates the importance of finalising the negotiations on a treaty on friendship, good neighbourliness and cooperation; reiterates its concern over the use of historical arguments in the current debate with neighbours, and welcomes any efforts towards joint celebrations of common historical events with neighbouring EU Member States; considers that this could contribute to a better understanding of history and good neighbourly relations;

| 48. | Welcomes the country’s active participation in the Western Balkans 6 connectivity agenda by endorsing the agreement on the regional core transport network and other commitments undertaken as part of the Berlin Process; invites the competent authorities to swiftly implement the ‘soft measures’ agreed during the Western Balkans Summit in Vienna in 2015 (e.g. simplifying/aligning border-crossing procedures, railway reforms, information systems) before the next Western Balkans Summit, which will take place in 2016 in France; |
| --- | --- |

48.

Welcomes the country’s active participation in the Western Balkans 6 connectivity agenda by endorsing the agreement on the regional core transport network and other commitments undertaken as part of the Berlin Process; invites the competent authorities to swiftly implement the ‘soft measures’ agreed during the Western Balkans Summit in Vienna in 2015 (e.g. simplifying/aligning border-crossing procedures, railway reforms, information systems) before the next Western Balkans Summit, which will take place in 2016 in France;

| 49. | Invites the government to improve the overall level of alignment with the EU foreign policy as the rate of alignment (68 %) has remained low; invites the government to comply with the EU Common Positions on the integrity of the Rome Statute; |
| --- | --- |

49.

Invites the government to improve the overall level of alignment with the EU foreign policy as the rate of alignment (68 %) has remained low; invites the government to comply with the EU Common Positions on the integrity of the Rome Statute;

| 50. | Calls on the Commission and the Council to include the country in the EU macro-regional strategies for cooperation in South-East Europe; offers its congratulations on the successful completion of the Macedonian Presidency of the Central European Initiative; |
| --- | --- |

50.

Calls on the Commission and the Council to include the country in the EU macro-regional strategies for cooperation in South-East Europe; offers its congratulations on the successful completion of the Macedonian Presidency of the Central European Initiative;

| 51. | Is of the opinion that Macedonian membership of NATO could contribute to achieving greater security and political stability in South-East Europe; hopes for accession negotiations to be opened soon; recalls, however, that the EU and NATO accession processes are independent of each other; |
| --- | --- |

51.

Is of the opinion that Macedonian membership of NATO could contribute to achieving greater security and political stability in South-East Europe; hopes for accession negotiations to be opened soon; recalls, however, that the EU and NATO accession processes are independent of each other;

| 52. | Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States and the government and parliament of the country. |
| --- | --- |

52.

Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States and the government and parliament of the country.

---

(1)  OJ L 84, 20.3.2004, p. 13.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/73 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/73

---

P8_TA(2016)0092

2015 Report on Montenegro

European Parliament resolution of 10 March 2016 on the 2015 report on Montenegro (2015/2894(RSP))

(2018/C 050/11)

The European Parliament,

| — | having regard to the European Council conclusions of 19-20 June 2003 and to the annex thereto entitled ‘The Thessaloniki Agenda for the Western Balkans: moving towards European integration’, |
| --- | --- |

—

having regard to the European Council conclusions of 19-20 June 2003 and to the annex thereto entitled ‘The Thessaloniki Agenda for the Western Balkans: moving towards European integration’,

| — | having regard to the Stabilisation and Association Agreement (SAA) between the European Communities and their Member States, of the one part, and the Republic of Montenegro, of the other part, of 29 March 2010 (1), |
| --- | --- |

—

having regard to the Stabilisation and Association Agreement (SAA) between the European Communities and their Member States, of the one part, and the Republic of Montenegro, of the other part, of 29 March 2010 (1),

| — | having regard to the outcome of the seventh meeting of the EU-Montenegro Accession Conference at ministerial level of 21 December 2015, |
| --- | --- |

—

having regard to the outcome of the seventh meeting of the EU-Montenegro Accession Conference at ministerial level of 21 December 2015,

| — | having regard to the Declaration and Recommendations of the 11th Meeting of the EU-Montenegro Stabilisation and Association Parliamentary Committee (SAPC) held in Strasbourg on 16-17 December 2015, |
| --- | --- |

—

having regard to the Declaration and Recommendations of the 11th Meeting of the EU-Montenegro Stabilisation and Association Parliamentary Committee (SAPC) held in Strasbourg on 16-17 December 2015,

| — | having regard to the report from the Commission to the European Parliament and the Council of 22 May 2012 on Montenegro’s progress in the implementation of reforms (COM(2012)0222), and to the Council conclusions of 26 June 2012 deciding to open accession negotiations with Montenegro on 29 June 2012, |
| --- | --- |

—

having regard to the report from the Commission to the European Parliament and the Council of 22 May 2012 on Montenegro’s progress in the implementation of reforms (COM(2012)0222), and to the Council conclusions of 26 June 2012 deciding to open accession negotiations with Montenegro on 29 June 2012,

| — | having regard to the Commission communication of 10 November 2015 entitled ‘EU Enlargement Strategy’ (COM(2015)0611), accompanied by the Commission Staff Working Document entitled ‘Montenegro 2015 Report’ (SWD(2015)0210), |
| --- | --- |

—

having regard to the Commission communication of 10 November 2015 entitled ‘EU Enlargement Strategy’ (COM(2015)0611), accompanied by the Commission Staff Working Document entitled ‘Montenegro 2015 Report’ (SWD(2015)0210),

| — | having regard to the Final Declaration by the Chair of the Vienna Western Balkans Summit of 27 August 2015, |
| --- | --- |

—

having regard to the Final Declaration by the Chair of the Vienna Western Balkans Summit of 27 August 2015,

| — | having regard to the conclusions of the General Affairs Council of 15 December 2015 on the enlargement and stabilisation and association process, |
| --- | --- |

—

having regard to the conclusions of the General Affairs Council of 15 December 2015 on the enlargement and stabilisation and association process,

| — | having regard to the decision taken at the NATO Foreign Ministers meeting of 2 December 2015, |
| --- | --- |

—

having regard to the decision taken at the NATO Foreign Ministers meeting of 2 December 2015,

| — | having regard to its previous resolutions on Montenegro, |
| --- | --- |

—

having regard to its previous resolutions on Montenegro,

| — | having regard to the work of Charles Tannock as the standing rapporteur on Montenegro of the Committee on Foreign Affairs, |
| --- | --- |

—

having regard to the work of Charles Tannock as the standing rapporteur on Montenegro of the Committee on Foreign Affairs,

| — | having regard to Rule 123(2) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 123(2) of its Rules of Procedure,

| A. | whereas further progress has been made in the accession negotiations with Montenegro, and at the Intergovernmental Conference in Brussels on 21 December 2015 another two negotiation chapters were opened, concerning transport and energy; whereas Montenegro is the most advanced enlargement country in the negotiation process; |
| --- | --- |

A.

whereas further progress has been made in the accession negotiations with Montenegro, and at the Intergovernmental Conference in Brussels on 21 December 2015 another two negotiation chapters were opened, concerning transport and energy; whereas Montenegro is the most advanced enlargement country in the negotiation process;

| B. | whereas sustainable dialogue and constructive cooperation between the ruling coalition and the opposition are crucial in order to maintain progress in the accession process; |
| --- | --- |

B.

whereas sustainable dialogue and constructive cooperation between the ruling coalition and the opposition are crucial in order to maintain progress in the accession process;

| C. | whereas free, fair and transparent parliamentary elections are crucial for the democratic future of Montenegro; |
| --- | --- |

C.

whereas free, fair and transparent parliamentary elections are crucial for the democratic future of Montenegro;

| D. | whereas Montenegro should further develop a solid track record on the rule of law, which is a fundamental prerequisite for EU accession; |
| --- | --- |

D.

whereas Montenegro should further develop a solid track record on the rule of law, which is a fundamental prerequisite for EU accession;

| E. | whereas a strong civil society enhances political accountability, strengthens solidarity within the country and promotes better understanding and ownership of EU-related reforms; |
| --- | --- |

E.

whereas a strong civil society enhances political accountability, strengthens solidarity within the country and promotes better understanding and ownership of EU-related reforms;

| F. | whereas corruption continues to be a serious problem, and whereas organised crime and threats to freedom of expression remain a concern; |
| --- | --- |

F.

whereas corruption continues to be a serious problem, and whereas organised crime and threats to freedom of expression remain a concern;

| G. | whereas further steps should be taken towards combating unemployment, social discrimination and poverty and strengthening labour and trade union rights in line with EU standards; |
| --- | --- |

G.

whereas further steps should be taken towards combating unemployment, social discrimination and poverty and strengthening labour and trade union rights in line with EU standards;

| 1. | Welcomes the steady progress in the accession negotiations with Montenegro, noting that 22 negotiation chapters, including chapters 23 and 24, have been opened so far, two of which have been provisionally closed; encourages tangible progress in meeting the benchmarks for the closing of chapters already under negotiation and for the opening of new chapters; stresses that progress in the negotiations must be accompanied by the strict implementation of relevant action plans and strategies; reiterates that overall progress in the negotiations depends on the progress in the implementation of the rule of law and the visible track record thereof; |
| --- | --- |

1.

Welcomes the steady progress in the accession negotiations with Montenegro, noting that 22 negotiation chapters, including chapters 23 and 24, have been opened so far, two of which have been provisionally closed; encourages tangible progress in meeting the benchmarks for the closing of chapters already under negotiation and for the opening of new chapters; stresses that progress in the negotiations must be accompanied by the strict implementation of relevant action plans and strategies; reiterates that overall progress in the negotiations depends on the progress in the implementation of the rule of law and the visible track record thereof;

| 2. | Urges more parliamentary scrutiny over the accession process; welcomes the adoption of the 2015 action plan for strengthening parliamentary oversight, but emphasises the need to reinforce the capacities of the Montenegrin parliament and to improve its access to accession-related information; welcomes the newly adopted Code of Ethics, and calls for further measures to improve public trust in the Montenegrin parliament; |
| --- | --- |

2.

Urges more parliamentary scrutiny over the accession process; welcomes the adoption of the 2015 action plan for strengthening parliamentary oversight, but emphasises the need to reinforce the capacities of the Montenegrin parliament and to improve its access to accession-related information; welcomes the newly adopted Code of Ethics, and calls for further measures to improve public trust in the Montenegrin parliament;

| 3. | Is deeply concerned about the polarised domestic climate and the boycott of parliamentary activities by part of the opposition; urges all political forces, in government and opposition alike, to re-engage in sustainable dialogue and constructive cooperation within the Montenegrin parliament; takes note of the failed vote of no-confidence in the Montenegrin parliament on 27 January 2016 and of the following parliamentary dialogue on creating conditions for free and fair elections; recalls that dialogue and compromise are cornerstones of any democratic decision-making process; welcomes in this respect the plan presented to overcome the political crisis; calls on all opposition parties to consider the invitation to enter the government until the elections in October 2016 in order to ensure, without any further delay, that the conditions for free and fair elections are guaranteed, including completing the modification of the electoral laws and ensuring that no public resources are used for party purposes; considers it essential for a well-functioning democracy that any form of protest be conducted peacefully and in line with the relevant laws; expects the competent authorities to investigate thoroughly and in a timely manner all incidents of violence that occurred during the protests, including any allegations on the excessive use of force by some members of the police force; takes note of the modifications adopted in December 2015 to the law on public gathering; |
| --- | --- |

3.

Is deeply concerned about the polarised domestic climate and the boycott of parliamentary activities by part of the opposition; urges all political forces, in government and opposition alike, to re-engage in sustainable dialogue and constructive cooperation within the Montenegrin parliament; takes note of the failed vote of no-confidence in the Montenegrin parliament on 27 January 2016 and of the following parliamentary dialogue on creating conditions for free and fair elections; recalls that dialogue and compromise are cornerstones of any democratic decision-making process; welcomes in this respect the plan presented to overcome the political crisis; calls on all opposition parties to consider the invitation to enter the government until the elections in October 2016 in order to ensure, without any further delay, that the conditions for free and fair elections are guaranteed, including completing the modification of the electoral laws and ensuring that no public resources are used for party purposes; considers it essential for a well-functioning democracy that any form of protest be conducted peacefully and in line with the relevant laws; expects the competent authorities to investigate thoroughly and in a timely manner all incidents of violence that occurred during the protests, including any allegations on the excessive use of force by some members of the police force; takes note of the modifications adopted in December 2015 to the law on public gathering;

| 4. | Calls on the government to fully implement the new electoral legislation prior to any new elections and to further strengthen the State Election Commission, which needs to effectively fulfil its mandate; insists once again on the need for a due political follow-up on the ‘audio-recording affair’, while acknowledging the progress made on the judicial follow-up; |
| --- | --- |

4.

Calls on the government to fully implement the new electoral legislation prior to any new elections and to further strengthen the State Election Commission, which needs to effectively fulfil its mandate; insists once again on the need for a due political follow-up on the ‘audio-recording affair’, while acknowledging the progress made on the judicial follow-up;

| 5. | Notes some progress in the government’s 2011-2016 public administration reform, and calls for the timely adoption of a strategy covering the period 2016-2020; encourages further depoliticisation of the public administration; considers it essential to adhere to the principles of merit, depoliticisation, accountability and transparency in public administration and to ensure the citizens’ right to good administration free of corruption; welcomes the amendments to the Law on the Ombudsman; is concerned that the capacity of the Ombudsman’s Office to effectively handle complaints remains limited; stresses the need for a greater number of specialised independent state agencies; |
| --- | --- |

5.

Notes some progress in the government’s 2011-2016 public administration reform, and calls for the timely adoption of a strategy covering the period 2016-2020; encourages further depoliticisation of the public administration; considers it essential to adhere to the principles of merit, depoliticisation, accountability and transparency in public administration and to ensure the citizens’ right to good administration free of corruption; welcomes the amendments to the Law on the Ombudsman; is concerned that the capacity of the Ombudsman’s Office to effectively handle complaints remains limited; stresses the need for a greater number of specialised independent state agencies;

| 6. | Welcomes the good progress on strengthening the legislative framework to enhance the independence, accountability and professionalism of the judiciary, and looks forward to the full implementation of the relevant rules in practice; notes with satisfaction that the backlog of certain types of cases has further decreased; calls for ensuring the independence of the judiciary and welcomes its increased efficiency; remains concerned about undue influence on judicial independence, especially with regard to the appointment of judges; stresses the need to reinforce the capacity of the Judicial and Prosecutorial Councils, to further improve the efficiency of the Constitutional Court, to strengthen the enforcement of civil and administrative decisions and to implement fully the new recruitment and professional appraisal and promotion systems; |
| --- | --- |

6.

Welcomes the good progress on strengthening the legislative framework to enhance the independence, accountability and professionalism of the judiciary, and looks forward to the full implementation of the relevant rules in practice; notes with satisfaction that the backlog of certain types of cases has further decreased; calls for ensuring the independence of the judiciary and welcomes its increased efficiency; remains concerned about undue influence on judicial independence, especially with regard to the appointment of judges; stresses the need to reinforce the capacity of the Judicial and Prosecutorial Councils, to further improve the efficiency of the Constitutional Court, to strengthen the enforcement of civil and administrative decisions and to implement fully the new recruitment and professional appraisal and promotion systems;

| 7. | Calls for the improvement of legislative and administrative capacity in the field of asylum and migration, and urges the Commission to provide support to this end; commends the government of Montenegro for the steps it has taken to help stateless people on its territory resolve their status; encourages Montenegro to continue its efforts in this field, especially with regard to children, including by further facilitating birth registration and subsequent or re-registration in civil registers; |
| --- | --- |

7.

Calls for the improvement of legislative and administrative capacity in the field of asylum and migration, and urges the Commission to provide support to this end; commends the government of Montenegro for the steps it has taken to help stateless people on its territory resolve their status; encourages Montenegro to continue its efforts in this field, especially with regard to children, including by further facilitating birth registration and subsequent or re-registration in civil registers;

| 8. | Invites the government and prosecution service to intensify their efforts to fight impunity in war crimes and to demonstrate a more proactive approach in following up on outstanding allegations of war crimes, particularly with regard to the responsible officials at the top of the command chain, in order to ensure, in line with international standards, that court rulings are enforced, with a guarantee of fair and just indemnification, and that victims have access to justice and obtain reparations for damage sustained; calls for the full protection of witnesses; reiterates the need to resolve any issues that are not in line with the EU common position on the integrity of the Rome Statute or with the related EU guiding principles on bilateral immunity agreements; |
| --- | --- |

8.

Invites the government and prosecution service to intensify their efforts to fight impunity in war crimes and to demonstrate a more proactive approach in following up on outstanding allegations of war crimes, particularly with regard to the responsible officials at the top of the command chain, in order to ensure, in line with international standards, that court rulings are enforced, with a guarantee of fair and just indemnification, and that victims have access to justice and obtain reparations for damage sustained; calls for the full protection of witnesses; reiterates the need to resolve any issues that are not in line with the EU common position on the integrity of the Rome Statute or with the related EU guiding principles on bilateral immunity agreements;

| 9. | Welcomes the recent EU peer review on child rights, and calls for full implementation and monitoring of child-related policies and laws at all levels; stresses the need to adequately resource child-related policies and services at national and local level and to enhance capacities to produce and use quality, disaggregated, child-focused data for evidence-based policy-making and programming; |
| --- | --- |

9.

Welcomes the recent EU peer review on child rights, and calls for full implementation and monitoring of child-related policies and laws at all levels; stresses the need to adequately resource child-related policies and services at national and local level and to enhance capacities to produce and use quality, disaggregated, child-focused data for evidence-based policy-making and programming;

| 10. | Commends the government’s commitment to expanding good quality early childhood education, and welcomes the increases in pre-school enrolments following a targeted campaign; welcomes the efforts to improve the quality of education in general and of early education in particular through standard-setting, enhancing the capacities of education providers and establishing oversight and quality-assurance mechanisms; welcomes the pioneering work to develop socio-emotional and other soft skills among pupils in primary schools; |
| --- | --- |

10.

Commends the government’s commitment to expanding good quality early childhood education, and welcomes the increases in pre-school enrolments following a targeted campaign; welcomes the efforts to improve the quality of education in general and of early education in particular through standard-setting, enhancing the capacities of education providers and establishing oversight and quality-assurance mechanisms; welcomes the pioneering work to develop socio-emotional and other soft skills among pupils in primary schools;

| 11. | Acknowledges the government’s commitment and results achieved in the social and child care system reform, and stresses the need for these reforms to be implemented effectively by centres for social welfare through individual case management and coordination of services; points out that the recent legal amendment that allows adults to use the services of day-care centres together with children with disabilities is not in line with international standards; welcomes the government’s commitment to ensuring that no children under three years of age are placed in residential state institutions by 2017; commends the proposed amendments to the Family Law of Montenegro to prohibit corporal punishment in a family setting; calls for further efforts to include the principle of best interests of the child in all civil and administrative proceedings while promoting broader access to justice; |
| --- | --- |

11.

Acknowledges the government’s commitment and results achieved in the social and child care system reform, and stresses the need for these reforms to be implemented effectively by centres for social welfare through individual case management and coordination of services; points out that the recent legal amendment that allows adults to use the services of day-care centres together with children with disabilities is not in line with international standards; welcomes the government’s commitment to ensuring that no children under three years of age are placed in residential state institutions by 2017; commends the proposed amendments to the Family Law of Montenegro to prohibit corporal punishment in a family setting; calls for further efforts to include the principle of best interests of the child in all civil and administrative proceedings while promoting broader access to justice;

| 12. | Notes that, despite positive legislative changes, corruption remains a serious concern, particularly in public procurement, health care, education, spatial planning, privatisation and construction; reiterates the need to eliminate corruption at all levels, since it undermines democratic principles and negatively affects social and economic development; calls on the government to make combating corruption one of its priorities by allocating sufficient human and budgetary resources to it; welcomes the establishment of the Special Prosecutor’s Office, whose tasks include combating corruption offences, and urges that it be made fully operational as soon as possible; welcomes the establishment of the Anti-Corruption Agency launched on 1 January 2016; calls for its independence and capacity to conduct administrative investigations to be ensured; recalls the importance of protecting whistle-blowers; calls on the authorities to facilitate and widen access to information about ownership of companies, real estate, and details about public expenditure, in particular in the case of public procurement and privatisation processes; |
| --- | --- |

12.

Notes that, despite positive legislative changes, corruption remains a serious concern, particularly in public procurement, health care, education, spatial planning, privatisation and construction; reiterates the need to eliminate corruption at all levels, since it undermines democratic principles and negatively affects social and economic development; calls on the government to make combating corruption one of its priorities by allocating sufficient human and budgetary resources to it; welcomes the establishment of the Special Prosecutor’s Office, whose tasks include combating corruption offences, and urges that it be made fully operational as soon as possible; welcomes the establishment of the Anti-Corruption Agency launched on 1 January 2016; calls for its independence and capacity to conduct administrative investigations to be ensured; recalls the importance of protecting whistle-blowers; calls on the authorities to facilitate and widen access to information about ownership of companies, real estate, and details about public expenditure, in particular in the case of public procurement and privatisation processes;

| 13. | Calls on the government to further strengthen the legislative and institutional framework in the fight against corruption and to ensure the effective protection of whistle-blowers; calls for more active participation and effective cooperation from the government, all sectors of public life and civil society in the prevention of corruption; reiterates the need to reinforce anti-corruption track records in investigations, prosecutions and convictions at all levels, to strengthen the institutional and operational capacity of prosecutors, judges and police, and to systematically use financial investigations and the power to seize and confiscate assets; calls for criminalising illicit enrichment; |
| --- | --- |

13.

Calls on the government to further strengthen the legislative and institutional framework in the fight against corruption and to ensure the effective protection of whistle-blowers; calls for more active participation and effective cooperation from the government, all sectors of public life and civil society in the prevention of corruption; reiterates the need to reinforce anti-corruption track records in investigations, prosecutions and convictions at all levels, to strengthen the institutional and operational capacity of prosecutors, judges and police, and to systematically use financial investigations and the power to seize and confiscate assets; calls for criminalising illicit enrichment;

| 14. | Notes the bringing of criminal charges by the Montenegrin State Prosecutor’s Office in certain Montenegrin municipalities against several officials in relation to high-level corruption; welcomes this as a positive sign in establishing a track record in rooting out high-level corruption, and encourages Montenegro to continue with this practice; reiterates the need to further increase the track record of investigating and bringing to justice high-level corruption cases; commends the good performance of the Podgorica High Court in delivering convictions for corruption-related offences; |
| --- | --- |

14.

Notes the bringing of criminal charges by the Montenegrin State Prosecutor’s Office in certain Montenegrin municipalities against several officials in relation to high-level corruption; welcomes this as a positive sign in establishing a track record in rooting out high-level corruption, and encourages Montenegro to continue with this practice; reiterates the need to further increase the track record of investigating and bringing to justice high-level corruption cases; commends the good performance of the Podgorica High Court in delivering convictions for corruption-related offences;

| 15. | Is concerned that the reported number of final convictions in organised crime cases and the number of seizures and confiscations of criminal assets have remained very low; encourages stronger and better cooperation between judicial and law enforcement authorities; welcomes the good cooperation between Montenegro and its neighbouring countries across a broad range of issues; welcomes the Agreement on Cooperation between Eurojust and Montenegro; while noting that the legal framework on money laundering is largely at place, calls for the relevant supervisory framework to be significantly enhanced and for a higher number of investigations, prosecutions and convictions in money laundering cases; |
| --- | --- |

15.

Is concerned that the reported number of final convictions in organised crime cases and the number of seizures and confiscations of criminal assets have remained very low; encourages stronger and better cooperation between judicial and law enforcement authorities; welcomes the good cooperation between Montenegro and its neighbouring countries across a broad range of issues; welcomes the Agreement on Cooperation between Eurojust and Montenegro; while noting that the legal framework on money laundering is largely at place, calls for the relevant supervisory framework to be significantly enhanced and for a higher number of investigations, prosecutions and convictions in money laundering cases;

| 16. | Encourages further measures against trafficking in human beings to complement the relevant legal and institutional aspects, including the setting up of a multi-disciplinary coordination team; calls on the competent authorities to increase the number of financial investigations and the seizure and confiscation of assets, and to more efficiently identify and protect victims and prosecute cases; |
| --- | --- |

16.

Encourages further measures against trafficking in human beings to complement the relevant legal and institutional aspects, including the setting up of a multi-disciplinary coordination team; calls on the competent authorities to increase the number of financial investigations and the seizure and confiscation of assets, and to more efficiently identify and protect victims and prosecute cases;

| 17. | Notes that the Montenegrin police have intensified checks throughout the country with a view to preventing possible terrorist attacks and recruitment of Montenegrin nationals to jihadist organisations; welcomes the adoption of the 2016-2018 anti-terrorism strategy and the setting up of an interministerial group to monitor the situation and to assess terrorist threats; calls on the competent authorities to properly implement relevant legal provisions in order to prevent and monitor any potential threat to the security of its citizens; encourages the competent authorities to strengthen regional and international cooperation, including by exchanging information and best practices in a move to prevent radicalisation and respond to terrorist activities; is of the opinion that all measures taken in this direction should ensure respect for human rights and fundamental freedoms in accordance with international standards and instruments; considers that political stability in the region, the promotion of interethnic and interreligious tolerance and dialogue, and further progress towards the EU are essential in order to strengthen cohesion and security in the Western Balkans; |
| --- | --- |

17.

Notes that the Montenegrin police have intensified checks throughout the country with a view to preventing possible terrorist attacks and recruitment of Montenegrin nationals to jihadist organisations; welcomes the adoption of the 2016-2018 anti-terrorism strategy and the setting up of an interministerial group to monitor the situation and to assess terrorist threats; calls on the competent authorities to properly implement relevant legal provisions in order to prevent and monitor any potential threat to the security of its citizens; encourages the competent authorities to strengthen regional and international cooperation, including by exchanging information and best practices in a move to prevent radicalisation and respond to terrorist activities; is of the opinion that all measures taken in this direction should ensure respect for human rights and fundamental freedoms in accordance with international standards and instruments; considers that political stability in the region, the promotion of interethnic and interreligious tolerance and dialogue, and further progress towards the EU are essential in order to strengthen cohesion and security in the Western Balkans;

| 18. | Welcomes recent efforts by the government of Montenegro to step up the fight against illegal trafficking in weapons and explosives; calls for close coordination and sharing of best practices to take place between initiatives in Montenegro, and the wider region, and the Commission on this matter; |
| --- | --- |

18.

Welcomes recent efforts by the government of Montenegro to step up the fight against illegal trafficking in weapons and explosives; calls for close coordination and sharing of best practices to take place between initiatives in Montenegro, and the wider region, and the Commission on this matter;

| 19. | Welcomes efforts to improve consultation mechanisms with civil society organisations (CSOs) and to achieve more transparency in policy- and law-making, including by involving them in the process of rule of law reforms and in monitoring the electoral process and the implementation of reforms; appreciates the motivation and efforts of the CSO sector, which has proved to be vocal and effective in many fields; stresses the need to further improve CSOs’ access to accession-related information and to further improve cooperation between local self-governments and CSOs; invites the competent authorities to further develop a sustainable system of public funding for CSOs and to create conditions that are conducive to voluntary work and social entrepreneurship; |
| --- | --- |

19.

Welcomes efforts to improve consultation mechanisms with civil society organisations (CSOs) and to achieve more transparency in policy- and law-making, including by involving them in the process of rule of law reforms and in monitoring the electoral process and the implementation of reforms; appreciates the motivation and efforts of the CSO sector, which has proved to be vocal and effective in many fields; stresses the need to further improve CSOs’ access to accession-related information and to further improve cooperation between local self-governments and CSOs; invites the competent authorities to further develop a sustainable system of public funding for CSOs and to create conditions that are conducive to voluntary work and social entrepreneurship;

| 20. | Reiterates the importance of media freedom and pluralism, as well as freedom of expression in the broader sense, as one of the core EU values and a cornerstone of any democracy; remains concerned about the freedom of the media in Montenegro, which is ranked 114th in terms of press freedom by the annual ranking of Reporters Without Borders; encourages progress to be made in freedom of expression and decisions to be aligned with European Court of Human Rights case law on freedom of expression; urges measures to ensure the independence of the public service broadcaster RTCG; calls for fair and equal access to media for all parties involved in elections; highlights the importance of self-regulation of media outlets; welcomes the efforts made in the information society and technology sector; |
| --- | --- |

20.

Reiterates the importance of media freedom and pluralism, as well as freedom of expression in the broader sense, as one of the core EU values and a cornerstone of any democracy; remains concerned about the freedom of the media in Montenegro, which is ranked 114th in terms of press freedom by the annual ranking of Reporters Without Borders; encourages progress to be made in freedom of expression and decisions to be aligned with European Court of Human Rights case law on freedom of expression; urges measures to ensure the independence of the public service broadcaster RTCG; calls for fair and equal access to media for all parties involved in elections; highlights the importance of self-regulation of media outlets; welcomes the efforts made in the information society and technology sector;

| 21. | Welcomes the fact that no new attacks against journalists took place in the reporting period; expresses concern, however, at the shortcomings in the investigation of previous cases of violence and intimidation against journalists; urges the competent authorities to resolve the pending cases of violence and threats against journalists, including the murder of Duško Jovanović in 2004, by improving investigations, by identifying and bringing to justice not only the perpetrators but also those behind the attacks and by implementing the recommendations issued by the ad hoc commission set up for monitoring the investigations into cases of violence against journalists; questions the current composition of the commission, of which members of the security services constitute more than 50 %, enabling them to block progress and the adoption of reports if they act together; calls on the government to prolong the mandate of this commission and to provide it with much more information and more competences; is concerned that incidences of intimidation of journalists and media outlets can considerably encourage self-censorship and limit the scope for investigative journalism; condemns the ongoing personal smear campaigns, mostly by one tabloid newspaper, targeting prominent civil society activists and some politicians on a personal basis; recalls that all media outlets must fully respect the established rules of professional reporting; points out that the media community is highly politicised and divided, that professional and ethical standards are weak and that journalists are poorly paid and their jobs insecure; considers it essential for journalists to have full independence, away from any interventions, including by media owners; welcomes the agreement among media practitioners to improve the existing Code of Ethics in order to enhance qualitative journalism; calls for continuing the dialogue facilitated by the Organisation for Security and Cooperation in Europe on improving ethical and professional standards in the media; |
| --- | --- |

21.

Welcomes the fact that no new attacks against journalists took place in the reporting period; expresses concern, however, at the shortcomings in the investigation of previous cases of violence and intimidation against journalists; urges the competent authorities to resolve the pending cases of violence and threats against journalists, including the murder of Duško Jovanović in 2004, by improving investigations, by identifying and bringing to justice not only the perpetrators but also those behind the attacks and by implementing the recommendations issued by the ad hoc commission set up for monitoring the investigations into cases of violence against journalists; questions the current composition of the commission, of which members of the security services constitute more than 50 %, enabling them to block progress and the adoption of reports if they act together; calls on the government to prolong the mandate of this commission and to provide it with much more information and more competences; is concerned that incidences of intimidation of journalists and media outlets can considerably encourage self-censorship and limit the scope for investigative journalism; condemns the ongoing personal smear campaigns, mostly by one tabloid newspaper, targeting prominent civil society activists and some politicians on a personal basis; recalls that all media outlets must fully respect the established rules of professional reporting; points out that the media community is highly politicised and divided, that professional and ethical standards are weak and that journalists are poorly paid and their jobs insecure; considers it essential for journalists to have full independence, away from any interventions, including by media owners; welcomes the agreement among media practitioners to improve the existing Code of Ethics in order to enhance qualitative journalism; calls for continuing the dialogue facilitated by the Organisation for Security and Cooperation in Europe on improving ethical and professional standards in the media;

| 22. | Welcomes improvements in the legal framework with regard to the rights of people with disabilities; expresses concern, however, that most public buildings are still not accessible to people with disabilities, including all 13 priority public buildings, such as the parliament, schools, hospitals, social welfare centres and courts, despite the government’s commitment to changing the situation by 31 August 2013; calls for the full utilisation of the Fund for Professional Rehabilitation and Employment of Persons with Disabilities; |
| --- | --- |

22.

Welcomes improvements in the legal framework with regard to the rights of people with disabilities; expresses concern, however, that most public buildings are still not accessible to people with disabilities, including all 13 priority public buildings, such as the parliament, schools, hospitals, social welfare centres and courts, despite the government’s commitment to changing the situation by 31 August 2013; calls for the full utilisation of the Fund for Professional Rehabilitation and Employment of Persons with Disabilities;

| 23. | Calls on the competent authorities to encourage better representation of ethnic minorities in public sector employment, including in the police and the judiciary; urges them also to adopt a new law on minorities and a law on the legal status of religious communities in line with European standards and after due consultations with all stakeholders, to make further efforts to protect the multi-ethnic identity of Boka Kotorska (Bay of Kotor) and to address the issue of lack of transparency in funds for minority issues; welcomes Montenegro’s policies aimed at creating a climate of tolerance and inclusion for all national minorities; |
| --- | --- |

23.

Calls on the competent authorities to encourage better representation of ethnic minorities in public sector employment, including in the police and the judiciary; urges them also to adopt a new law on minorities and a law on the legal status of religious communities in line with European standards and after due consultations with all stakeholders, to make further efforts to protect the multi-ethnic identity of Boka Kotorska (Bay of Kotor) and to address the issue of lack of transparency in funds for minority issues; welcomes Montenegro’s policies aimed at creating a climate of tolerance and inclusion for all national minorities;

| 24. | Notes the improving participation of Roma students in all levels of education, but calls once again for additional measures to facilitate the access of Roma, Egyptian minorities and Ashkali to health care, housing and employment; urges both political and civil society actors to fight hostility, discrimination and hate crime against the LGBTI community, in particular with efforts to educate and inform the public with a view to changing attitudes, and by providing training to the police, prosecutors and judges; calls for the perpetrators of such discrimination and violence to be brought to justice; encourages the authorities to continue and enhance efforts to safeguard the rights of LGBTI people and ensure freedom of assembly; welcomes the fact that the third Montenegro pride parade was well protected and held without any major incidents on 13 December 2015; regrets, however, the ban of the pride march in Nikšić; |
| --- | --- |

24.

Notes the improving participation of Roma students in all levels of education, but calls once again for additional measures to facilitate the access of Roma, Egyptian minorities and Ashkali to health care, housing and employment; urges both political and civil society actors to fight hostility, discrimination and hate crime against the LGBTI community, in particular with efforts to educate and inform the public with a view to changing attitudes, and by providing training to the police, prosecutors and judges; calls for the perpetrators of such discrimination and violence to be brought to justice; encourages the authorities to continue and enhance efforts to safeguard the rights of LGBTI people and ensure freedom of assembly; welcomes the fact that the third Montenegro pride parade was well protected and held without any major incidents on 13 December 2015; regrets, however, the ban of the pride march in Nikšić;

| 25. | Remains concerned about domestic and sexual violence against women and girls, its underreporting, the lack of prosecutions and inefficient support and protection to victims as well as the lenient sentences imposed on perpetrators or outright impunity; urges the competent authorities to take domestic violence seriously, by establishing protection services, enhancing coordination between state institutions and by effectively implementing the convention on preventing and combating violence against women and domestic violence; urges the competent authorities to educate employees in state institutions (social workers, police officers, etc.) for working with victims; stresses the importance of increasing women’s representation in politics during the next elections, as well as access to the labour market for women; |
| --- | --- |

25.

Remains concerned about domestic and sexual violence against women and girls, its underreporting, the lack of prosecutions and inefficient support and protection to victims as well as the lenient sentences imposed on perpetrators or outright impunity; urges the competent authorities to take domestic violence seriously, by establishing protection services, enhancing coordination between state institutions and by effectively implementing the convention on preventing and combating violence against women and domestic violence; urges the competent authorities to educate employees in state institutions (social workers, police officers, etc.) for working with victims; stresses the importance of increasing women’s representation in politics during the next elections, as well as access to the labour market for women;

| 26. | Calls on the government to further reinforce human rights institutions, such as the Ombudsman and the Ministry of Human Rights and Minorities, and to allocate the adequate resources for the enforcement of human rights; |
| --- | --- |

26.

Calls on the government to further reinforce human rights institutions, such as the Ombudsman and the Ministry of Human Rights and Minorities, and to allocate the adequate resources for the enforcement of human rights;

| 27. | Commends the macroeconomic stability and favourable developments in the economy; notes also that, according to the World Bank’s Doing Business report for 2016, which measures the ease of doing business in a country, Montenegro ranks 46th worldwide, putting it in second place in the Western Balkans; notes, however, that Montenegro ranks 136th among 188 countries in enforcing contracts, which leads to legal uncertainty; notes the efforts to improve the competitiveness of industrial and agricultural products; urges the government to launch further structural reforms, to ensure a business-friendly regulatory environment while protecting consumer and social rights, to pursue efforts to reduce corruption in the economy, to implement economic reforms that will create jobs and growth, to address the country’s large current-account and general budget deficits and the sustainability of public finances, and to implement policies that will help diversify the economy; |
| --- | --- |

27.

Commends the macroeconomic stability and favourable developments in the economy; notes also that, according to the World Bank’s Doing Business report for 2016, which measures the ease of doing business in a country, Montenegro ranks 46th worldwide, putting it in second place in the Western Balkans; notes, however, that Montenegro ranks 136th among 188 countries in enforcing contracts, which leads to legal uncertainty; notes the efforts to improve the competitiveness of industrial and agricultural products; urges the government to launch further structural reforms, to ensure a business-friendly regulatory environment while protecting consumer and social rights, to pursue efforts to reduce corruption in the economy, to implement economic reforms that will create jobs and growth, to address the country’s large current-account and general budget deficits and the sustainability of public finances, and to implement policies that will help diversify the economy;

| 28. | Stresses the importance of strengthening the SME sector and of providing support through better legislation, financing, implementation of industrial policy and reducing the informal economy, as well as speeding up electronic registration of companies nation-wide; |
| --- | --- |

28.

Stresses the importance of strengthening the SME sector and of providing support through better legislation, financing, implementation of industrial policy and reducing the informal economy, as well as speeding up electronic registration of companies nation-wide;

| 29. | Notes with concern that Montenegro is not in alignment with the Third Energy Package and that there has been no progress in the development of the gas market; points out the need to dedicate sufficient resources in the interest of achieving the targets and the need to establish a specialised energy-efficiency agency; |
| --- | --- |

29.

Notes with concern that Montenegro is not in alignment with the Third Energy Package and that there has been no progress in the development of the gas market; points out the need to dedicate sufficient resources in the interest of achieving the targets and the need to establish a specialised energy-efficiency agency;

| 30. | Notes that state aid remains an issue of concern, particularly as regards the independence of the State Aid Control Commission and the State Aid Control Unit, the notification and compatibility of new legislation, and state aid to large investment projects and the KAP aluminium plant; remains concerned about the delay in the resolution of the KAP bankruptcy proceedings as it is in breach of the country’s obligations under the SAA; reiterates its call on the government and involved parties to reach a sustainable and negotiated solution for the KAP bankruptcy proceedings in compliance with state aid rules and the SAA, based on transparency and the rule of law; encourages the commissioning of a full and independent audit of KAP’s finances, from its acquisition by CEAC in 2005 to the present day; calls for special attention to be paid to the plans to build a new highway, which will become the largest ever public project and expenditure in Montenegrin history; calls on the authorities to ensure the appropriate use of public funds and compliance with the relevant law; |
| --- | --- |

30.

Notes that state aid remains an issue of concern, particularly as regards the independence of the State Aid Control Commission and the State Aid Control Unit, the notification and compatibility of new legislation, and state aid to large investment projects and the KAP aluminium plant; remains concerned about the delay in the resolution of the KAP bankruptcy proceedings as it is in breach of the country’s obligations under the SAA; reiterates its call on the government and involved parties to reach a sustainable and negotiated solution for the KAP bankruptcy proceedings in compliance with state aid rules and the SAA, based on transparency and the rule of law; encourages the commissioning of a full and independent audit of KAP’s finances, from its acquisition by CEAC in 2005 to the present day; calls for special attention to be paid to the plans to build a new highway, which will become the largest ever public project and expenditure in Montenegrin history; calls on the authorities to ensure the appropriate use of public funds and compliance with the relevant law;

| 31. | Reiterates its concern that in some parts of the country many people are living in relative poverty and that youth and long-term unemployment are at persistently high levels; stresses the importance of including the CSOs and the Social Council in the formulation of labour policies; calls for improvements in social dialogue; notes the skills mismatch between the educational system and the labour market and the widening socio-economic gap between the north and south of the country; calls for more active labour market measures to increase employment, in particular for young people; notes the need to fight tax evasion more effectively and for the establishment of more socially just taxation; encourages the government to accelerate its work in addressing Montenegro’s key challenges regarding social inclusion, poverty reduction and the grey economy; welcomes the adoption of the 2016 action plan on social inclusion; welcomes the memorandum of understanding with the International Labour Organisation; |
| --- | --- |

31.

Reiterates its concern that in some parts of the country many people are living in relative poverty and that youth and long-term unemployment are at persistently high levels; stresses the importance of including the CSOs and the Social Council in the formulation of labour policies; calls for improvements in social dialogue; notes the skills mismatch between the educational system and the labour market and the widening socio-economic gap between the north and south of the country; calls for more active labour market measures to increase employment, in particular for young people; notes the need to fight tax evasion more effectively and for the establishment of more socially just taxation; encourages the government to accelerate its work in addressing Montenegro’s key challenges regarding social inclusion, poverty reduction and the grey economy; welcomes the adoption of the 2016 action plan on social inclusion; welcomes the memorandum of understanding with the International Labour Organisation;

| 32. | Calls for further efforts to preserve the biodiversity of the Saline in Ulcinj, in particular, as the most important breeding and wintering site for birds on the eastern Adriatic coast; calls on the government to continue and enhance efforts for the sustainable national and international protection of this unique ecosystem, recognising the functioning of the salt flats as one of the best examples of economic development and environmental protection synergy, since only if they are functional can these salt flats provide a natural service to millions of birds every year; encourages the sustainable development of the coastline, and the protection of the natural environment and biodiversity in line with European standards; reiterates that further efforts should be made towards the adoption of a new law on the environment in conjunction with the need to assess environmental impact and to strengthen relevant administrative and coordination capacities; welcomes the adoption of the Climate Strategy in September 2015; notes the intention of the Montenegrin government to build new hydropower plants; recalls the need for a sound environmental impact assessment in line with the EU acquis and international standards; |
| --- | --- |

32.

Calls for further efforts to preserve the biodiversity of the Saline in Ulcinj, in particular, as the most important breeding and wintering site for birds on the eastern Adriatic coast; calls on the government to continue and enhance efforts for the sustainable national and international protection of this unique ecosystem, recognising the functioning of the salt flats as one of the best examples of economic development and environmental protection synergy, since only if they are functional can these salt flats provide a natural service to millions of birds every year; encourages the sustainable development of the coastline, and the protection of the natural environment and biodiversity in line with European standards; reiterates that further efforts should be made towards the adoption of a new law on the environment in conjunction with the need to assess environmental impact and to strengthen relevant administrative and coordination capacities; welcomes the adoption of the Climate Strategy in September 2015; notes the intention of the Montenegrin government to build new hydropower plants; recalls the need for a sound environmental impact assessment in line with the EU acquis and international standards;

| 33. | Commends Montenegro’s proactive participation and constructive role in regional and international cooperation, including in regional reconciliation and in contributing to crisis management operations under the Common Security and Defence Policy (CSDP); highlights Montenegro’s constructive role in the framework of the ‘Berlin Process’ and the Western Balkan Six initiative; congratulates Montenegro on fully aligning itself with the EU’s Common Foreign and Security Policy (CFSP), and encourages the government to continue the current 100 % alignment; welcomes the adoption of the law on the implementation of international restrictive measures, including in the context of Russia’s illegal annexation of Crimea and events in Eastern Ukraine; encourages other countries in the region to work together with the EU on foreign policy alignment and to follow Montenegro’s example; calls on the Montenegrin authorities to swiftly implement the ‘soft measures’ agreed at the 2015 Western Balkans Summit in Vienna (e.g. simplifying/aligning border-crossing procedures, railway reforms, information systems) before the next Western Balkans Summit in 2016 in France; |
| --- | --- |

33.

Commends Montenegro’s proactive participation and constructive role in regional and international cooperation, including in regional reconciliation and in contributing to crisis management operations under the Common Security and Defence Policy (CSDP); highlights Montenegro’s constructive role in the framework of the ‘Berlin Process’ and the Western Balkan Six initiative; congratulates Montenegro on fully aligning itself with the EU’s Common Foreign and Security Policy (CFSP), and encourages the government to continue the current 100 % alignment; welcomes the adoption of the law on the implementation of international restrictive measures, including in the context of Russia’s illegal annexation of Crimea and events in Eastern Ukraine; encourages other countries in the region to work together with the EU on foreign policy alignment and to follow Montenegro’s example; calls on the Montenegrin authorities to swiftly implement the ‘soft measures’ agreed at the 2015 Western Balkans Summit in Vienna (e.g. simplifying/aligning border-crossing procedures, railway reforms, information systems) before the next Western Balkans Summit in 2016 in France;

| 34. | Welcomes NATO’s decision to invite Montenegro to join the alliance, and encourages a quick and efficient process of accession negotiations; encourages, in this context, continuing the reform of the security sector; welcomes Montenegro’s participation in EU-led CSDP missions; recalls that the EU accession negotiations are independent from the NATO accession process; |
| --- | --- |

34.

Welcomes NATO’s decision to invite Montenegro to join the alliance, and encourages a quick and efficient process of accession negotiations; encourages, in this context, continuing the reform of the security sector; welcomes Montenegro’s participation in EU-led CSDP missions; recalls that the EU accession negotiations are independent from the NATO accession process;

| 35. | Welcomes the border agreements with Bosnia and Herzegovina and Kosovo, and urges Montenegro to build on this and speed up work to deal with unresolved border issues with Croatia and Serbia, and, should it prove impossible to reach a solution by mutual agreement, calls for disputes to be settled in the Hague International Court of Justice, in accordance with the rules and principles of international law; renews its call on the authorities to help resolve the succession issues related to the legacy of the former Socialist Federal Republic of Yugoslavia (SFRY), including the military and naval legacy; encourages Montenegro to continue to address, in a constructive and neighbourly spirit, outstanding bilateral issues with its neighbours as early as possible in the accession process; calls also on the Montenegrin authorities to broaden cooperation with neighbouring countries by sharing information about the experience of pre-accession negotiations; calls on the Montenegrin authorities to comply fully with the provisions on succession of the former SFRY, especially as regards military assets; |
| --- | --- |

35.

Welcomes the border agreements with Bosnia and Herzegovina and Kosovo, and urges Montenegro to build on this and speed up work to deal with unresolved border issues with Croatia and Serbia, and, should it prove impossible to reach a solution by mutual agreement, calls for disputes to be settled in the Hague International Court of Justice, in accordance with the rules and principles of international law; renews its call on the authorities to help resolve the succession issues related to the legacy of the former Socialist Federal Republic of Yugoslavia (SFRY), including the military and naval legacy; encourages Montenegro to continue to address, in a constructive and neighbourly spirit, outstanding bilateral issues with its neighbours as early as possible in the accession process; calls also on the Montenegrin authorities to broaden cooperation with neighbouring countries by sharing information about the experience of pre-accession negotiations; calls on the Montenegrin authorities to comply fully with the provisions on succession of the former SFRY, especially as regards military assets;

| 36. | Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States and the government and parliament of Montenegro. |
| --- | --- |

36.

Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States and the government and parliament of Montenegro.

---

(1)  OJ L 108, 29.4.2010, p. 1.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/80 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/80

---

P8_TA(2016)0093

Banking Union — Annual report 2015

European Parliament resolution of 10 March 2016 on the Banking Union — Annual Report 2015 (2015/2221(INI))

(2018/C 050/12)

The European Parliament,

| — | having regard to Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (1) (SSM Regulation), |
| --- | --- |

—

having regard to Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (1) (SSM Regulation),

| — | having regard to the Interinstitutional Agreement between the European Parliament and the European Central Bank on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the ECB within the framework of the Single Supervisory Mechanism (2), |
| --- | --- |

—

having regard to the Interinstitutional Agreement between the European Parliament and the European Central Bank on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the ECB within the framework of the Single Supervisory Mechanism (2),

| — | having regard to the ECB Annual Report on supervisory activities 2014 of March 2015 (3), |
| --- | --- |

—

having regard to the ECB Annual Report on supervisory activities 2014 of March 2015 (3),

| — | having regard to Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation) (4), |
| --- | --- |

—

having regard to Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation) (4),

| — | having regard to the Decision of the European Central Bank of 17 September 2014 on the implementation of separation between the monetary policy and supervision functions of the European Central Bank (ECB/2014/39) (5), |
| --- | --- |

—

having regard to the Decision of the European Central Bank of 17 September 2014 on the implementation of separation between the monetary policy and supervision functions of the European Central Bank (ECB/2014/39) (5),

| — | having regard to the Decision of the European Central Bank of 4 February 2014 identifying the credit institutions that are subject to the comprehensive assessment (ECB/2014/3) (6), |
| --- | --- |

—

having regard to the Decision of the European Central Bank of 4 February 2014 identifying the credit institutions that are subject to the comprehensive assessment (ECB/2014/3) (6),

| — | having regard to the recent work of the Basel Committee, especially to the Revisions to the Standardised Approach for credit risk and the Revision to the measurement of operational risk, |
| --- | --- |

—

having regard to the recent work of the Basel Committee, especially to the Revisions to the Standardised Approach for credit risk and the Revision to the measurement of operational risk,

| — | having regard to the comprehensive assessment carried out by the European Central Bank between November 2013 and October 2014 (7), |
| --- | --- |

—

having regard to the comprehensive assessment carried out by the European Central Bank between November 2013 and October 2014 (7),

| — | having regard to Regulation (EU) 2015/534 of the European Central Bank of 17 March 2015 on reporting of supervisory financial information (8), |
| --- | --- |

—

having regard to Regulation (EU) 2015/534 of the European Central Bank of 17 March 2015 on reporting of supervisory financial information (8),

| — | having regard to Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (9) (SRM Regulation), |
| --- | --- |

—

having regard to Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (9) (SRM Regulation),

| — | having regard to the Agreement between the European Parliament and the Single Resolution Board on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the Single Resolution Board within the framework of the Single Resolution Mechanism (10), |
| --- | --- |

—

having regard to the Agreement between the European Parliament and the Single Resolution Board on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the Single Resolution Board within the framework of the Single Resolution Mechanism (10),

| — | having regard to Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes (11), |
| --- | --- |

—

having regard to Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes (11),

| — | having regard to the Report on Completing Europe’s Economic and Monetary Union (‘Five Presidents’ Report’), |
| --- | --- |

—

having regard to the Report on Completing Europe’s Economic and Monetary Union (‘Five Presidents’ Report’),

| — | having regard to the decision of the Commission to refer the Czech Republic, Luxembourg, the Netherlands, Poland, Romania and Sweden to the Court of Justice of the European Union for failing to implement the Bank Recovery and Resolution Directive (2014/59/EU), |
| --- | --- |

—

having regard to the decision of the Commission to refer the Czech Republic, Luxembourg, the Netherlands, Poland, Romania and Sweden to the Court of Justice of the European Union for failing to implement the Bank Recovery and Resolution Directive (2014/59/EU),

| — | having regard to the Council statement of 8 December 2015 on Banking Union and bridge financing arrangements for the Single Resolution Fund, |
| --- | --- |

—

having regard to the Council statement of 8 December 2015 on Banking Union and bridge financing arrangements for the Single Resolution Fund,

| — | having regard to its resolution of 19 January 2016 on ‘Stocktaking and challenges of the EU Financial Services Regulation: impact and the way forward towards a more efficient and effective EU framework for financial regulation and a capital markets union’ (12), |
| --- | --- |

—

having regard to its resolution of 19 January 2016 on ‘Stocktaking and challenges of the EU Financial Services Regulation: impact and the way forward towards a more efficient and effective EU framework for financial regulation and a capital markets union’ (12),

| — | having regard to its resolution of 24 June 2015 on the review of the economic governance framework: stocktaking and challenges (13), |
| --- | --- |

—

having regard to its resolution of 24 June 2015 on the review of the economic governance framework: stocktaking and challenges (13),

| — | having regard to the report of the European Systemic Risk Board of March 2015 on the regulatory treatment of sovereign exposures, |
| --- | --- |

—

having regard to the report of the European Systemic Risk Board of March 2015 on the regulatory treatment of sovereign exposures,

| — | having regard to the Commission communication of 24 November 2015 entitled ‘Towards the completion of the Banking Union’ (COM(2015)0587), |
| --- | --- |

—

having regard to the Commission communication of 24 November 2015 entitled ‘Towards the completion of the Banking Union’ (COM(2015)0587),

| — | having regard to the Commission proposal of 24 November 2015 for a regulation of the European Parliament and of the Council amending Regulation (EU) No 806/2014 in order to establish a European Deposit Insurance Scheme (COM(2015)0586), |
| --- | --- |

—

having regard to the Commission proposal of 24 November 2015 for a regulation of the European Parliament and of the Council amending Regulation (EU) No 806/2014 in order to establish a European Deposit Insurance Scheme (COM(2015)0586),

| — | having regard to Rule 52 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 52 of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0033/2016), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0033/2016),

| A. | whereas the Banking Union (BU) is an indispensable component of a monetary union and a fundamental building block of a genuine economic and monetary union (EMU), and whereas participation in this is open to Member States whose currency is not the euro; |
| --- | --- |

A.

whereas the Banking Union (BU) is an indispensable component of a monetary union and a fundamental building block of a genuine economic and monetary union (EMU), and whereas participation in this is open to Member States whose currency is not the euro;

| B. | whereas the BU is instrumental to ensuring stability and restoring confidence in euro area banks, enhancing financial integration, reducing risk in the European banking system and moral hazard, contributing to breaking the link between sovereigns and banks and fostering risk sharing within the monetary union; |
| --- | --- |

B.

whereas the BU is instrumental to ensuring stability and restoring confidence in euro area banks, enhancing financial integration, reducing risk in the European banking system and moral hazard, contributing to breaking the link between sovereigns and banks and fostering risk sharing within the monetary union;

| C. | whereas the BU plays a key role in funding investment and therefore in fostering growth and job creation throughout the EU; |
| --- | --- |

C.

whereas the BU plays a key role in funding investment and therefore in fostering growth and job creation throughout the EU;

| D. | whereas in a BU a Single Rulebook should be complemented by a Single Supervisory Mechanism (SSM), a Single Resolution Mechanism (SRM), and a high and uniform level of protection of deposits and an efficient fiscal backstop at EU level; |
| --- | --- |

D.

whereas in a BU a Single Rulebook should be complemented by a Single Supervisory Mechanism (SSM), a Single Resolution Mechanism (SRM), and a high and uniform level of protection of deposits and an efficient fiscal backstop at EU level;

| E. | whereas the SSM is the first pillar of the BU and aims to ensure a uniform and homogeneous supervision of participating Member States’ banks, create a level playing field in the banking market, and contribute to the safety and soundness of credit institutions and the stability of the financial system while respecting the diversity of banks and their business models; |
| --- | --- |

E.

whereas the SSM is the first pillar of the BU and aims to ensure a uniform and homogeneous supervision of participating Member States’ banks, create a level playing field in the banking market, and contribute to the safety and soundness of credit institutions and the stability of the financial system while respecting the diversity of banks and their business models;

| F. | whereas the European Central Bank (ECB) has to date failed to take sufficient account of the proportionality principle in connection with its supervisory activities; |
| --- | --- |

F.

whereas the European Central Bank (ECB) has to date failed to take sufficient account of the proportionality principle in connection with its supervisory activities;

| G. | whereas the SRM is the second pillar of the BU and aims to ensure uniform rules and procedures and a common decision-making process for orderly resolution of failing banks with minimum impact on the rest of the financial system, the real economy, ordinary citizens or public finance throughout Europe; |
| --- | --- |

G.

whereas the SRM is the second pillar of the BU and aims to ensure uniform rules and procedures and a common decision-making process for orderly resolution of failing banks with minimum impact on the rest of the financial system, the real economy, ordinary citizens or public finance throughout Europe;

| H. | whereas the third pillar of the BU so far consists in an approximation of national DGSs, and a proposal for a European Deposit Insurance Scheme aimed at gradually ensuring a unified level of protection of deposits has only recently been presented by the Commission and will be subject to the co-legislators’ decision through the ordinary legislative procedure; |
| --- | --- |

H.

whereas the third pillar of the BU so far consists in an approximation of national DGSs, and a proposal for a European Deposit Insurance Scheme aimed at gradually ensuring a unified level of protection of deposits has only recently been presented by the Commission and will be subject to the co-legislators’ decision through the ordinary legislative procedure;

| I. | whereas the SSM Regulation and the SRM Regulation require that the new bodies created under the SSM — in particular the Supervisory Board of the ECB — and under the SRM — in particular the Single Resolution Board — comply with the principles of transparency and accountability in relation to the fulfilment of their tasks; whereas those bodies should be leading examples in this regard as well as in terms of technical competence and integrity; |
| --- | --- |

I.

whereas the SSM Regulation and the SRM Regulation require that the new bodies created under the SSM — in particular the Supervisory Board of the ECB — and under the SRM — in particular the Single Resolution Board — comply with the principles of transparency and accountability in relation to the fulfilment of their tasks; whereas those bodies should be leading examples in this regard as well as in terms of technical competence and integrity;

The Single Supervisory Mechanism (SSM)

| 1. | Welcomes the establishment of the SSM, which has been successful since its creation both from an operational point of view and in terms of supervisory quality, and considers it a remarkable achievement, taking into account the complexity of the project and the very short timeframe available; |
| --- | --- |

1.

Welcomes the establishment of the SSM, which has been successful since its creation both from an operational point of view and in terms of supervisory quality, and considers it a remarkable achievement, taking into account the complexity of the project and the very short timeframe available;

| 2. | Encourages broad representation in the BU through the future involvement and participation of NCAs of non-participating Member States in accordance with established legal rules and procedures, as well as through enhanced cooperation with third countries outside the EU; reaffirms that closer coordination between NCAs across the EU and internationally is essential for ensuring effective regulation and supervision of systemically important banks; |
| --- | --- |

2.

Encourages broad representation in the BU through the future involvement and participation of NCAs of non-participating Member States in accordance with established legal rules and procedures, as well as through enhanced cooperation with third countries outside the EU; reaffirms that closer coordination between NCAs across the EU and internationally is essential for ensuring effective regulation and supervision of systemically important banks;

| 3. | Welcomes in particular, in relation to the operational set-up:






  (a) | the recruitment process, which resulted in a good blend of competences, cultures and gender, thus contributing to the supranational nature of the SSM, and the thorough training activity programme for national competent authorities (NCAs) and ECB staff; points out, however, that ECB contracting practices leave room for improvement, especially in regard to the number of short-term contracts, checks on staff working hours, transparency of the recruitment process and willingness to negotiate with unions; notes the ECB’s announcement that it has appointed its first Chief Services Officer to manage all administrative services, IT services and human resources; |
| --- | --- | --- |

3.

Welcomes in particular, in relation to the operational set-up:

(a)

the recruitment process, which resulted in a good blend of competences, cultures and gender, thus contributing to the supranational nature of the SSM, and the thorough training activity programme for national competent authorities (NCAs) and ECB staff; points out, however, that ECB contracting practices leave room for improvement, especially in regard to the number of short-term contracts, checks on staff working hours, transparency of the recruitment process and willingness to negotiate with unions; notes the ECB’s announcement that it has appointed its first Chief Services Officer to manage all administrative services, IT services and human resources;

| (b) | the drafting, building on national best practices, of the Supervisory Manual laying down common processes, procedures and methods for conducting a euro-wide supervisory review process; |
| --- | --- |

(b)

the drafting, building on national best practices, of the Supervisory Manual laying down common processes, procedures and methods for conducting a euro-wide supervisory review process;

| (c) | the set-up of the IT infrastructure and of the supporting analytical tools; stresses the importance of strong and well-functioning IT systems corresponding to the needs of the supervisory functions of the SSM; encourages coordination between the SSM and national supervisory authorities in order to meet the needs of data through a single application; |
| --- | --- |

(c)

the set-up of the IT infrastructure and of the supporting analytical tools; stresses the importance of strong and well-functioning IT systems corresponding to the needs of the supervisory functions of the SSM; encourages coordination between the SSM and national supervisory authorities in order to meet the needs of data through a single application;

| (d) | the setting up of Joint Supervisory Teams (JSTs) and the dialogue they have established with the supervised credit institutions; |
| --- | --- |

(d)

the setting up of Joint Supervisory Teams (JSTs) and the dialogue they have established with the supervised credit institutions;

| (e) | the processes devised to work off the common procedures (authorisation of qualifying holdings, licensing, passporting, fit and proper assessments); |
| --- | --- |

(e)

the processes devised to work off the common procedures (authorisation of qualifying holdings, licensing, passporting, fit and proper assessments);

| 4. | Notes that a very significant share of work is routinely devoted to administrative procedures, required by the SSM Regulation, which may not always be proportionate, and stands ready to consider proposals aimed at reducing the operational burden on structures at all levels and improving the effectiveness of the SSM supervision, namely by exploiting the potential of streamlining administrative procedures, or by delegating certain decisions on specific administrative issues within clear limits and guidelines; |
| --- | --- |

4.

Notes that a very significant share of work is routinely devoted to administrative procedures, required by the SSM Regulation, which may not always be proportionate, and stands ready to consider proposals aimed at reducing the operational burden on structures at all levels and improving the effectiveness of the SSM supervision, namely by exploiting the potential of streamlining administrative procedures, or by delegating certain decisions on specific administrative issues within clear limits and guidelines;

| 5. | Notes with satisfaction that the ethics rules of the ECB have been reviewed, and stresses the importance of effective rules on conflict of interests and safeguards against undue influence of the financial industry, on staff as well as on members of the governing bodies; |
| --- | --- |

5.

Notes with satisfaction that the ethics rules of the ECB have been reviewed, and stresses the importance of effective rules on conflict of interests and safeguards against undue influence of the financial industry, on staff as well as on members of the governing bodies;

| 6. | Believes that while the degree of effectiveness achieved by JSTs in less than a year is remarkable, further improvements can be pursued, including by involving NCAs in a more effective way in the decision-making process; |
| --- | --- |

6.

Believes that while the degree of effectiveness achieved by JSTs in less than a year is remarkable, further improvements can be pursued, including by involving NCAs in a more effective way in the decision-making process;

| 7. | Takes note of the remarks made by supervised entities about the need for early planning of supervisory actions, in order to enhance their quality and avoid the unintended consequence of affecting banks’ business activities, and considers that there is a great deal of room for improvement in this respect; |
| --- | --- |

7.

Takes note of the remarks made by supervised entities about the need for early planning of supervisory actions, in order to enhance their quality and avoid the unintended consequence of affecting banks’ business activities, and considers that there is a great deal of room for improvement in this respect;

| 8. | Emphasises the need to avoid double reporting requirements and multiple reporting channels, and more generally an unnecessary administrative burden on credit institutions, in particular smaller banks, as well as to ensure that the proportionality principle is upheld; calls for increased effectiveness of data collection, which should abide by the ‘once only’ principle and should be examined for its usefulness, applicability and proportionality; |
| --- | --- |

8.

Emphasises the need to avoid double reporting requirements and multiple reporting channels, and more generally an unnecessary administrative burden on credit institutions, in particular smaller banks, as well as to ensure that the proportionality principle is upheld; calls for increased effectiveness of data collection, which should abide by the ‘once only’ principle and should be examined for its usefulness, applicability and proportionality;

| 9. | Calls on the ECB to ensure that the creation of a comprehensive credit risk database (Analytical Credit Dataset, AnaCredit) pays particular attention to the proportionality principle and to the need to avoid disproportionately high administrative costs, especially for smaller institutions; calls, in this context, for the relevant reporting thresholds to be set at an adequate level; |
| --- | --- |

9.

Calls on the ECB to ensure that the creation of a comprehensive credit risk database (Analytical Credit Dataset, AnaCredit) pays particular attention to the proportionality principle and to the need to avoid disproportionately high administrative costs, especially for smaller institutions; calls, in this context, for the relevant reporting thresholds to be set at an adequate level;

| 10. | Stresses the importance of close interaction between the ECB’s Directorates-General (DGs) in charge of direct and indirect micro-prudential supervision and the DG in charge of horizontal supervision and expertise services, and emphasises the role of the latter in improving the comprehension, among supervised entities, of a common supervisory approach underlying the concrete individual micro-prudential measures; stresses the importance of a full organisational separation between SSM staff and the staff providing services needed for independent monetary policy purposes; |
| --- | --- |

10.

Stresses the importance of close interaction between the ECB’s Directorates-General (DGs) in charge of direct and indirect micro-prudential supervision and the DG in charge of horizontal supervision and expertise services, and emphasises the role of the latter in improving the comprehension, among supervised entities, of a common supervisory approach underlying the concrete individual micro-prudential measures; stresses the importance of a full organisational separation between SSM staff and the staff providing services needed for independent monetary policy purposes;

| 11. | Calls for a systematic review of comprehensive assessments of ECB-supervised institutions, as well as for appropriate improvements of the methodology in the light of lessons learned, in all cases where an institution is deemed sound under the assessment and subsequently runs into trouble, as well as where an institution is deemed undercapitalised on the basis of a stress test scenario which turns out to be significantly unrealistic; emphasises the limitations of the current stress test methodology which evaluates third-country exposure on the basis of banks’ internal assessment; |
| --- | --- |

11.

Calls for a systematic review of comprehensive assessments of ECB-supervised institutions, as well as for appropriate improvements of the methodology in the light of lessons learned, in all cases where an institution is deemed sound under the assessment and subsequently runs into trouble, as well as where an institution is deemed undercapitalised on the basis of a stress test scenario which turns out to be significantly unrealistic; emphasises the limitations of the current stress test methodology which evaluates third-country exposure on the basis of banks’ internal assessment;

| 12. | Welcomes the fact that the ECB is working on enhancements in the macro stress testing framework in order to integrate more realistic dynamic features in the stress testing model framework, add a proper liquidity stress test component, and integrate contagion effects within the banking system, as well as the two-way interaction with the real economy and the shadow banking sector in the broader framework; |
| --- | --- |

12.

Welcomes the fact that the ECB is working on enhancements in the macro stress testing framework in order to integrate more realistic dynamic features in the stress testing model framework, add a proper liquidity stress test component, and integrate contagion effects within the banking system, as well as the two-way interaction with the real economy and the shadow banking sector in the broader framework;

| 13. | Considers the comprehensive assessment performed ahead of the launch of the SSM to be an important step towards restoring the confidence lost in the crisis years and enhancing the resilience of the euro area banking system by improving its capitalisation and increasing transparency; considers the Supervisory Review and Evaluation Process (SREP) and future comprehensive assessments of bank balance sheets to constitute a necessary tool in identifying banks, which should strengthen their capitalisation and reduce leverage; |
| --- | --- |

13.

Considers the comprehensive assessment performed ahead of the launch of the SSM to be an important step towards restoring the confidence lost in the crisis years and enhancing the resilience of the euro area banking system by improving its capitalisation and increasing transparency; considers the Supervisory Review and Evaluation Process (SREP) and future comprehensive assessments of bank balance sheets to constitute a necessary tool in identifying banks, which should strengthen their capitalisation and reduce leverage;

| 14. | Stresses the fact that economic recovery is under way but — in particular due to an insufficient level of structural reforms, convergence and investment and excessive dependence on external factors — is still fragile and modest, while inflation remains below target; against this backdrop, notes that while tangible improvements could be observed in the recent past, credit dynamics are still subdued in many jurisdictions and a large stock of non-performing loans weighs on many European banks’ balance sheets, limiting their capacity to finance the economy; |
| --- | --- |

14.

Stresses the fact that economic recovery is under way but — in particular due to an insufficient level of structural reforms, convergence and investment and excessive dependence on external factors — is still fragile and modest, while inflation remains below target; against this backdrop, notes that while tangible improvements could be observed in the recent past, credit dynamics are still subdued in many jurisdictions and a large stock of non-performing loans weighs on many European banks’ balance sheets, limiting their capacity to finance the economy;

| 15. | Recalls that the ability to write off or sell-on non-performing loans is vital, as it frees up capital to fund new loans, in particular to SMEs; stresses the need to address the issue of non-performing loans at European level, notably by facilitating the setting-up of asset management companies in those countries where this is deemed to be necessary, as was the case in Spain and Ireland; |
| --- | --- |

15.

Recalls that the ability to write off or sell-on non-performing loans is vital, as it frees up capital to fund new loans, in particular to SMEs; stresses the need to address the issue of non-performing loans at European level, notably by facilitating the setting-up of asset management companies in those countries where this is deemed to be necessary, as was the case in Spain and Ireland;

| 16. | Highlights that effective coordination between macro-prudential and micro-prudential policies is crucial, and underlines the fact that the SSM is fully part of the EU macro-prudential framework and has been given relevant macro-prudential responsibilities, together with the NCAs and the ECB Governing Council; stresses the need to enhance the role of the European Systemic Risk Board (ESRB) in order to complement the powers of NCAs and the SSM by an EU-wide cross-sectoral macro-prudential authority to ensure that macro risks are tackled in the overall European interest; considers that macro-prudential policy must place greater emphasis on preventing large fluctuations in the financial cycle; recalls that the ESRB should address the interconnectedness of financial markets and any other systemic risk affecting the stability of financial markets; |
| --- | --- |

16.

Highlights that effective coordination between macro-prudential and micro-prudential policies is crucial, and underlines the fact that the SSM is fully part of the EU macro-prudential framework and has been given relevant macro-prudential responsibilities, together with the NCAs and the ECB Governing Council; stresses the need to enhance the role of the European Systemic Risk Board (ESRB) in order to complement the powers of NCAs and the SSM by an EU-wide cross-sectoral macro-prudential authority to ensure that macro risks are tackled in the overall European interest; considers that macro-prudential policy must place greater emphasis on preventing large fluctuations in the financial cycle; recalls that the ESRB should address the interconnectedness of financial markets and any other systemic risk affecting the stability of financial markets;

| 17. | Agrees with the views expressed by senior ECB figures to the effect that macro-prudential policy must place greater emphasis on preventing large fluctuations in the financial cycle, rather than simply increasing resilience to shocks when they occur; welcomes the research by the ECB into the definition of financial stability, and urges the development of tools such as the systemic risk index discussed in the Financial Stability Review November 2015 for monitoring systemic risk as part of an effective toolkit for managing it; |
| --- | --- |

17.

Agrees with the views expressed by senior ECB figures to the effect that macro-prudential policy must place greater emphasis on preventing large fluctuations in the financial cycle, rather than simply increasing resilience to shocks when they occur; welcomes the research by the ECB into the definition of financial stability, and urges the development of tools such as the systemic risk index discussed in the Financial Stability Review November 2015 for monitoring systemic risk as part of an effective toolkit for managing it;

| 18. | Notes that Banking Structural Reform, which was conceived to reduce systemic risk and address the issue of ‘too big to fail’ institutions, has yet to be implemented; urges a swift legislative agreement; |
| --- | --- |

18.

Notes that Banking Structural Reform, which was conceived to reduce systemic risk and address the issue of ‘too big to fail’ institutions, has yet to be implemented; urges a swift legislative agreement;

| 19. | Notes that the insurance sector is becoming increasingly involved in financial services, and underlines the importance of a level playing field in order to avoid regulatory arbitrage of prudential and consumer protection rules; |
| --- | --- |

19.

Notes that the insurance sector is becoming increasingly involved in financial services, and underlines the importance of a level playing field in order to avoid regulatory arbitrage of prudential and consumer protection rules;

| 20. | Believes that the worldwide drive towards more and better quality bank capital and less leveraged banks is a necessary condition for a sound banking system capable of supporting the economy and for avoiding any repeat of the enormous bailouts witnessed during the crisis; underlines, however, that the development of regulatory, supervisory and other financial sector policies at global level (the Financial Stability Board (FSB), the Basel Committee on Banking Supervision (BCBS), etc.) must not target a particular funding model used in one part of the world; |
| --- | --- |

20.

Believes that the worldwide drive towards more and better quality bank capital and less leveraged banks is a necessary condition for a sound banking system capable of supporting the economy and for avoiding any repeat of the enormous bailouts witnessed during the crisis; underlines, however, that the development of regulatory, supervisory and other financial sector policies at global level (the Financial Stability Board (FSB), the Basel Committee on Banking Supervision (BCBS), etc.) must not target a particular funding model used in one part of the world;

| 21. | Notes that an increase in capital requirements beyond a certain threshold may in the short term create unintended consequences, limiting banks’ lending capacity, and that this risk should therefore be considered when determining the level of capital; underlines that the interdependence between capital requirements and credit supply is not linear; |
| --- | --- |

21.

Notes that an increase in capital requirements beyond a certain threshold may in the short term create unintended consequences, limiting banks’ lending capacity, and that this risk should therefore be considered when determining the level of capital; underlines that the interdependence between capital requirements and credit supply is not linear;

| 22. | Calls on the Commission, together with the European Supervisory Authorities (ESAs), to conduct a comprehensive assessment of capital requirements embedded in current and future legislation, in particular with a view to analysing their consequences as regards the financing conditions of SMEs and more generally of the real economy, while taking into account the balance between short-term and long-term impact of capital requirements and the need to safeguard financial stability; |
| --- | --- |

22.

Calls on the Commission, together with the European Supervisory Authorities (ESAs), to conduct a comprehensive assessment of capital requirements embedded in current and future legislation, in particular with a view to analysing their consequences as regards the financing conditions of SMEs and more generally of the real economy, while taking into account the balance between short-term and long-term impact of capital requirements and the need to safeguard financial stability;

| 23. | Recalls the importance of tools such as the ‘SME Supporting Factor’; suggests that the initiatives for improved SME funding should be expanded to start-ups, micro- enterprises and mid-cap companies; |
| --- | --- |

23.

Recalls the importance of tools such as the ‘SME Supporting Factor’; suggests that the initiatives for improved SME funding should be expanded to start-ups, micro- enterprises and mid-cap companies;

| 24. | Considers the stabilisation of the supervisory and regulatory framework to be an important element for restoring investors’ confidence, avoiding uncertainty over regulatory and supervisory action, and supporting growth and financial stability; calls for reducing the complexity of existing regulation in the short term and for establishing in the medium term an integrated European rulebook on financial regulation and consumer rights, replacing the current complex and burdensome silo-like legislation; |
| --- | --- |

24.

Considers the stabilisation of the supervisory and regulatory framework to be an important element for restoring investors’ confidence, avoiding uncertainty over regulatory and supervisory action, and supporting growth and financial stability; calls for reducing the complexity of existing regulation in the short term and for establishing in the medium term an integrated European rulebook on financial regulation and consumer rights, replacing the current complex and burdensome silo-like legislation;

| 25. | Welcomes the development of a common methodology for the 2015 round of the SREP; notes that, partly as a consequence of the swift start of the SSM, many aspects of this methodology were finalised only when the SREP cycle was already under way, and considers that in order to improve the robustness of results and consistency between banks’ risk profiles and capital levels, the process leading to the approval of the common supervisory standards for risk assessment can benefit from further refinement; welcomes the SSM’s willingness to work on bank governance, and in particular on risk management, risk appetite and cyber-risk; |
| --- | --- |

25.

Welcomes the development of a common methodology for the 2015 round of the SREP; notes that, partly as a consequence of the swift start of the SSM, many aspects of this methodology were finalised only when the SREP cycle was already under way, and considers that in order to improve the robustness of results and consistency between banks’ risk profiles and capital levels, the process leading to the approval of the common supervisory standards for risk assessment can benefit from further refinement; welcomes the SSM’s willingness to work on bank governance, and in particular on risk management, risk appetite and cyber-risk;

| 26. | Considers the calculation of Maximum Distributable Amount (MDA) for each individual bank in line with Article 141(6) of the Capital Requirements Directive (CRD) to be an important tool for achieving capital restoration, as an alternative to shrinking balance sheets; underlines that the legislation’s lack of clarity on the hierarchy between pillar two and capital buffers in relation to the MDA threshold and to other sanctioning measures does not prevent the SSM from using a margin of flexibility in order to avoid solutions which are too rigid and might negatively affect the AT1 bond market and the level playing field with other jurisdictions; calls for a legal clarification of the MDA mechanism and of the function of pillar two, which is to address ‘bank-specific risk’, in order to guarantee a level playing field in the EU and to provide more clarity on the aim of the mechanism; considers that the review of those provisions should aim to incorporate them into the regulation; |
| --- | --- |

26.

Considers the calculation of Maximum Distributable Amount (MDA) for each individual bank in line with Article 141(6) of the Capital Requirements Directive (CRD) to be an important tool for achieving capital restoration, as an alternative to shrinking balance sheets; underlines that the legislation’s lack of clarity on the hierarchy between pillar two and capital buffers in relation to the MDA threshold and to other sanctioning measures does not prevent the SSM from using a margin of flexibility in order to avoid solutions which are too rigid and might negatively affect the AT1 bond market and the level playing field with other jurisdictions; calls for a legal clarification of the MDA mechanism and of the function of pillar two, which is to address ‘bank-specific risk’, in order to guarantee a level playing field in the EU and to provide more clarity on the aim of the mechanism; considers that the review of those provisions should aim to incorporate them into the regulation;

| 27. | Stresses that national options and discretion attributed to Member States prevent the SSM from developing a single coherent supervisory approach within the euro area in order to ensure a true level playing field, and believes that the homogenisation of practices and standards should go hand in hand with the completion of the other two pillars of the Banking Union; in this respect, welcomes the publication by the ECB of a draft regulation aiming to close around 35 national options and discretions under the EU banking regulatory framework, as well as of a draft guide to help JSTs make decisions in a more consistent manner in the areas covered by the other options and discretions identified; considers that such a single implementation requires a gradual approach and should aim to address all existing barriers and segmentations; stands ready to cooperate at the legislative level in order to further improve regulatory and supervisory harmonisation; emphasises the need for the review of national options and discretions to guarantee a level playing field across the Banking Union, including between conglomerates and non-conglomerated institutions which have holdings in insurance undertakings; |
| --- | --- |

27.

Stresses that national options and discretion attributed to Member States prevent the SSM from developing a single coherent supervisory approach within the euro area in order to ensure a true level playing field, and believes that the homogenisation of practices and standards should go hand in hand with the completion of the other two pillars of the Banking Union; in this respect, welcomes the publication by the ECB of a draft regulation aiming to close around 35 national options and discretions under the EU banking regulatory framework, as well as of a draft guide to help JSTs make decisions in a more consistent manner in the areas covered by the other options and discretions identified; considers that such a single implementation requires a gradual approach and should aim to address all existing barriers and segmentations; stands ready to cooperate at the legislative level in order to further improve regulatory and supervisory harmonisation; emphasises the need for the review of national options and discretions to guarantee a level playing field across the Banking Union, including between conglomerates and non-conglomerated institutions which have holdings in insurance undertakings;

| 28. | Recalls that the application of fair value measurement for unrealised gains and losses on exposures to central governments classified under ‘Available for Sale’ not only strengthens the link between banks and sovereigns, but may also lead to own funds volatility; calls on the ECB to maintain the non-application of this measurement until such time as IFRS 9 is applied; |
| --- | --- |

28.

Recalls that the application of fair value measurement for unrealised gains and losses on exposures to central governments classified under ‘Available for Sale’ not only strengthens the link between banks and sovereigns, but may also lead to own funds volatility; calls on the ECB to maintain the non-application of this measurement until such time as IFRS 9 is applied;

| 29. | Stresses the fact that both Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and the Capital Requirements Directive (Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms), collectively referred to as ‘CRR/CRDIV’, were adopted by the co-legislators before the establishment of the Single Supervisory Mechanism; encourages the Commission to put forward a proposal for a technical adaptation of CRR/CRDIV in order to align it with the Banking Union framework; urges the Commission to use regulations (which are applicable directly and to all throughout the EU), rather than directives, as the legislative tool to ensure harmonised implementation across the EU and the Banking Union; |
| --- | --- |

29.

Stresses the fact that both Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and the Capital Requirements Directive (Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms), collectively referred to as ‘CRR/CRDIV’, were adopted by the co-legislators before the establishment of the Single Supervisory Mechanism; encourages the Commission to put forward a proposal for a technical adaptation of CRR/CRDIV in order to align it with the Banking Union framework; urges the Commission to use regulations (which are applicable directly and to all throughout the EU), rather than directives, as the legislative tool to ensure harmonised implementation across the EU and the Banking Union;

| 30. | Stresses the importance of the work that has been undertaken on the homogenisation of the calculation of risk-weighted assets, which is pivotal for comparability purposes, and on the review of internal models for the calculation of banks’ capital requirements; considers progress in this area, for all portfolios, to be crucial for preserving the effectiveness and credibility of banking supervision in the euro area in order to promote best practice in market and credit risk models; |
| --- | --- |

30.

Stresses the importance of the work that has been undertaken on the homogenisation of the calculation of risk-weighted assets, which is pivotal for comparability purposes, and on the review of internal models for the calculation of banks’ capital requirements; considers progress in this area, for all portfolios, to be crucial for preserving the effectiveness and credibility of banking supervision in the euro area in order to promote best practice in market and credit risk models;

| 31. | Welcomes the adoption by the SSM of five high-level priorities to guide its supervision throughout 2016; underlines that the SSM should look beyond credit risk to all forms of bank risk, including non-financial risk; underlines that further steps are necessary to reinforce the supervisory scrutiny of banks’ financial portfolios, especially level 3 financial assets, including derivatives; stresses the need for a reduction of the interlinkages between the regulated and the shadow banking sector, not least via limiting the respective credit risk exposure; |
| --- | --- |

31.

Welcomes the adoption by the SSM of five high-level priorities to guide its supervision throughout 2016; underlines that the SSM should look beyond credit risk to all forms of bank risk, including non-financial risk; underlines that further steps are necessary to reinforce the supervisory scrutiny of banks’ financial portfolios, especially level 3 financial assets, including derivatives; stresses the need for a reduction of the interlinkages between the regulated and the shadow banking sector, not least via limiting the respective credit risk exposure;

| 32. | Considers that more appropriate attention should be paid to increased exposure in the form of off-balance sheet items, in particular for global systematically important banks (G-SIBs); underlines in this respect the need to be vigilant over the development of the shadow banking sector; |
| --- | --- |

32.

Considers that more appropriate attention should be paid to increased exposure in the form of off-balance sheet items, in particular for global systematically important banks (G-SIBs); underlines in this respect the need to be vigilant over the development of the shadow banking sector;

| 33. | Takes note of the work of the BCBS and the ESRB on sovereign exposures of banks and other financial intermediaries; calls on the EU institutions to carefully and thoroughly assess possible changes in the medium term to the current regulatory framework, without reducing available funding for Member States, without creating unintended market or competition distortions and without affecting financial stability, and as part of a coordinated effort at the global level; underlines that in order to have a comprehensive risk reduction, parallel measures should be taken among others to reduce level 2 and level 3 assets exposure and to ensure the full convergence of internal ratings-based (IRB) systems for the measurement of credit risk; |
| --- | --- |

33.

Takes note of the work of the BCBS and the ESRB on sovereign exposures of banks and other financial intermediaries; calls on the EU institutions to carefully and thoroughly assess possible changes in the medium term to the current regulatory framework, without reducing available funding for Member States, without creating unintended market or competition distortions and without affecting financial stability, and as part of a coordinated effort at the global level; underlines that in order to have a comprehensive risk reduction, parallel measures should be taken among others to reduce level 2 and level 3 assets exposure and to ensure the full convergence of internal ratings-based (IRB) systems for the measurement of credit risk;

| 34. | Underlines that the SSM and SRM represent a step in the direction of a common market for banking services, making cross-border consolidation more appealing; believes that the introduction of a financial stability and resolvability assessment in the Qualifying Holdings Directive is necessary to avoid new too-big-to-fail problems that may be produced due to a higher number of mergers and acquisitions; |
| --- | --- |

34.

Underlines that the SSM and SRM represent a step in the direction of a common market for banking services, making cross-border consolidation more appealing; believes that the introduction of a financial stability and resolvability assessment in the Qualifying Holdings Directive is necessary to avoid new too-big-to-fail problems that may be produced due to a higher number of mergers and acquisitions;

| 35. | Underlines the important role played by the SSM during the Greek crisis in monitoring the condition of the country’s banking sector, in conducting a comprehensive assessment of the significant Greek institutions and in contributing to the determination of the recapitalisation needs; notes that the recapitalisation needs of Greek banks as assessed by the SSM range from EUR 4,4 billion in a baseline scenario to EUR 14,4 billion in the most risky scenario, while the buffer envisaged under the Programme was as high as EUR 25 billion; asks for clarification with regard to the role of financial consultancies, which were often hired without a public tender and played a role in all the euro area bailouts by providing expertise to the troika of international lenders; calls for more transparency and accountability in the hiring process in order to avoid potential conflicts of interest arising from links to investment funds and other financial service providers; asks the ECB to redefine its role with regard to assistance programmes as one of ‘silent observer’; stresses that emergency liquidity assistance (ELA) is an essential instrument for safeguarding the stability of the financial system by preventing liquidity crises from turning into solvency crises; notes that the responsibility for its provision has not yet been fully transferred to the euro area level; welcomes the remarks made by President Draghi to Parliament’s Committee on Economic and Monetary Affairs hinting at a diligent revision of the ELA regime in the light of the ‘Europeanisation’ of bank supervision; |
| --- | --- |

35.

Underlines the important role played by the SSM during the Greek crisis in monitoring the condition of the country’s banking sector, in conducting a comprehensive assessment of the significant Greek institutions and in contributing to the determination of the recapitalisation needs; notes that the recapitalisation needs of Greek banks as assessed by the SSM range from EUR 4,4 billion in a baseline scenario to EUR 14,4 billion in the most risky scenario, while the buffer envisaged under the Programme was as high as EUR 25 billion; asks for clarification with regard to the role of financial consultancies, which were often hired without a public tender and played a role in all the euro area bailouts by providing expertise to the troika of international lenders; calls for more transparency and accountability in the hiring process in order to avoid potential conflicts of interest arising from links to investment funds and other financial service providers; asks the ECB to redefine its role with regard to assistance programmes as one of ‘silent observer’; stresses that emergency liquidity assistance (ELA) is an essential instrument for safeguarding the stability of the financial system by preventing liquidity crises from turning into solvency crises; notes that the responsibility for its provision has not yet been fully transferred to the euro area level; welcomes the remarks made by President Draghi to Parliament’s Committee on Economic and Monetary Affairs hinting at a diligent revision of the ELA regime in the light of the ‘Europeanisation’ of bank supervision;

| 36. | Believes that the ECB’s supervisory strategy, while avoiding any differentiation along national lines, should reflect and safeguard pluralism and diversity of banking models across the EU, including authentic and healthy mutual, savings and cooperative banks, and should comply with the principle of proportionality; |
| --- | --- |

36.

Believes that the ECB’s supervisory strategy, while avoiding any differentiation along national lines, should reflect and safeguard pluralism and diversity of banking models across the EU, including authentic and healthy mutual, savings and cooperative banks, and should comply with the principle of proportionality;

| 37. | Considers transparency vis-à-vis market players and the public, including on sensitive topics such as capital targets as a result of the SREP cycle, supervisory practices and other requirements, to be essential for a level playing field between supervised entities, for fair competition in the banking market and for avoiding situations where regulatory uncertainty negatively influences banks’ business strategy; underlines that transparency of both supervisors and supervised entities is also a prerequisite for accountability, as it allows Parliament and the public to be informed about key policy issues and to assess consistency with rules and supervisory practices; calls for more transparency with regard to pillar 2 decisions and justifications; |
| --- | --- |

37.

Considers transparency vis-à-vis market players and the public, including on sensitive topics such as capital targets as a result of the SREP cycle, supervisory practices and other requirements, to be essential for a level playing field between supervised entities, for fair competition in the banking market and for avoiding situations where regulatory uncertainty negatively influences banks’ business strategy; underlines that transparency of both supervisors and supervised entities is also a prerequisite for accountability, as it allows Parliament and the public to be informed about key policy issues and to assess consistency with rules and supervisory practices; calls for more transparency with regard to pillar 2 decisions and justifications;

| 38. | Highlights that in this regard the publication of a list of Frequently Asked Questions on the SREP could be a useful tool; |
| --- | --- |

38.

Highlights that in this regard the publication of a list of Frequently Asked Questions on the SREP could be a useful tool;

| 39. | Welcomes the efficient and open way in which the ECB has so far fulfilled its accountability obligations towards Parliament, and calls on the ECB to continue to fully engage in this regard and to further contribute to improving Parliament’s capacity to assess SSM policies and activities; views favourably the willingness of the ECB President to further cooperate with Parliament regarding the ECB’s role in banking matters, in particular in the framework of global standards-setting bodies such as the FSB; |
| --- | --- |

39.

Welcomes the efficient and open way in which the ECB has so far fulfilled its accountability obligations towards Parliament, and calls on the ECB to continue to fully engage in this regard and to further contribute to improving Parliament’s capacity to assess SSM policies and activities; views favourably the willingness of the ECB President to further cooperate with Parliament regarding the ECB’s role in banking matters, in particular in the framework of global standards-setting bodies such as the FSB;

| 40. | Recalls that public audit is an integral part of the mechanisms for ensuring the accountability of institutions to citizens; notes, therefore, with some concern the statement published in June 2015 by the Contact Committee of the Heads of the Supreme Audit Institutions of the European Union and the European Court of Auditors (ECA), which warns against the emergence of audit gaps due to the transfer of supervisory tasks from national authorities to the SSM in a context where the audit mandate of the ECA over the ECB acting as a supervisor is less comprehensive than those of national audit institutions over national supervisors; recommends accordingly that consideration be given to strengthening the audit mandate of the ECA; |
| --- | --- |

40.

Recalls that public audit is an integral part of the mechanisms for ensuring the accountability of institutions to citizens; notes, therefore, with some concern the statement published in June 2015 by the Contact Committee of the Heads of the Supreme Audit Institutions of the European Union and the European Court of Auditors (ECA), which warns against the emergence of audit gaps due to the transfer of supervisory tasks from national authorities to the SSM in a context where the audit mandate of the ECA over the ECB acting as a supervisor is less comprehensive than those of national audit institutions over national supervisors; recommends accordingly that consideration be given to strengthening the audit mandate of the ECA;

| 41. | Underlines the importance of cooperating with the Single Resolution Board (SRB), the European Banking Authority (EBA) and other authorities within the European System of Financial Supervision, while fully respecting the division of roles and competences and the separation between regulation and supervision in order to help ensure compliance with the EU checks-and-balances structure; stresses in particular that the EBA, with its explicit consumer protection mandate, must enforce and enhance the consumer protection framework for banking services, complementing the SSM’s prudential supervision, and in the Union as a whole; |
| --- | --- |

41.

Underlines the importance of cooperating with the Single Resolution Board (SRB), the European Banking Authority (EBA) and other authorities within the European System of Financial Supervision, while fully respecting the division of roles and competences and the separation between regulation and supervision in order to help ensure compliance with the EU checks-and-balances structure; stresses in particular that the EBA, with its explicit consumer protection mandate, must enforce and enhance the consumer protection framework for banking services, complementing the SSM’s prudential supervision, and in the Union as a whole;

| 42. | Welcomes the credibility of the SSM on the international stage; considers it fundamental that the SSM is properly involved in the design of global regulatory standards, in particular the orientations negotiated within the FSB and the BCBS; |
| --- | --- |

42.

Welcomes the credibility of the SSM on the international stage; considers it fundamental that the SSM is properly involved in the design of global regulatory standards, in particular the orientations negotiated within the FSB and the BCBS;

Single Resolution Mechanism (SRM)

| 43. | Welcomes the efficient setting-up of the SRB and the establishment of national resolution authorities (NRAs) in the Member States; |
| --- | --- |

43.

Welcomes the efficient setting-up of the SRB and the establishment of national resolution authorities (NRAs) in the Member States;

| 44. | Highlights the importance of establishing efficient cooperation between the SRB and the NRAs for the smooth functioning of the SRM; considers Internal Resolution Teams (IRTs), as an equivalent to the SSM’s JSTs, to be a good basis for organising cooperation within the SRM; |
| --- | --- |

44.

Highlights the importance of establishing efficient cooperation between the SRB and the NRAs for the smooth functioning of the SRM; considers Internal Resolution Teams (IRTs), as an equivalent to the SSM’s JSTs, to be a good basis for organising cooperation within the SRM;

| 45. | Encourages the conclusion of a memorandum of understanding (MoU) on mutual cooperation and data sharing between the SRB and the ECB as a single supervisor, in order to increase efficiency and avoid double reporting for banks, while allowing the SRB to have access to the SSM data needed for it to fulfil its institutional mandate; underlines the importance of smooth cooperation between the SRM and the national competent authorities (NCAs); |
| --- | --- |

45.

Encourages the conclusion of a memorandum of understanding (MoU) on mutual cooperation and data sharing between the SRB and the ECB as a single supervisor, in order to increase efficiency and avoid double reporting for banks, while allowing the SRB to have access to the SSM data needed for it to fulfil its institutional mandate; underlines the importance of smooth cooperation between the SRM and the national competent authorities (NCAs);

| 46. | Underlines the discrepancy between banks directly supervised by the SSM and banks under the direct responsibility of the SRB (including other cross-border groups) and its potential consequences in terms of the SRB’s access to information; |
| --- | --- |

46.

Underlines the discrepancy between banks directly supervised by the SSM and banks under the direct responsibility of the SRB (including other cross-border groups) and its potential consequences in terms of the SRB’s access to information;

| 47. | Calls for specific arrangements to be created within the Commission and between the SRB and the Commission in order to define efficient procedures for decision-making in the event of resolution; |
| --- | --- |

47.

Calls for specific arrangements to be created within the Commission and between the SRB and the Commission in order to define efficient procedures for decision-making in the event of resolution;

| 48. | Encourages the conclusion of cooperation agreements between the SRB and the NRAs of non-participating Member States and third countries for effective mutual cooperation and information exchange; |
| --- | --- |

48.

Encourages the conclusion of cooperation agreements between the SRB and the NRAs of non-participating Member States and third countries for effective mutual cooperation and information exchange;

| 49. | Welcomes the preparation by the SRB of manuals on resolution activities, in line with the relevant EBA standards, which aim to promote a consistent, effective and proportionate approach to resolution tasks within the SRM; |
| --- | --- |

49.

Welcomes the preparation by the SRB of manuals on resolution activities, in line with the relevant EBA standards, which aim to promote a consistent, effective and proportionate approach to resolution tasks within the SRM;

| 50. | Calls for timely progress to be made in drawing up resolution plans and setting a minimum requirement for own funds and eligible liabilities (MREL) for institutions falling within the scope of the SRM, in order to be able to ensure an orderly resolution of failing banks with a minimum impact on the real economy and public finances; calls on the Commission to swiftly adopt the regulatory technical standard on MREL, with a high binding standard of at least 8 % MREL for all SRB banks, in line with the Bank Recovery and Resolution Directive (BRRD) (Directive 2014/59/EU of the European Parliament and the Council of 15 May 2014) (14) and minimising the chances of loss of SMEs’ uncovered deposits; takes note of the ongoing work on the implementation of Total Loss Absorbing Capacity (TLAC) and calls on the Commission to ensure consistency with MREL; |
| --- | --- |

50.

Calls for timely progress to be made in drawing up resolution plans and setting a minimum requirement for own funds and eligible liabilities (MREL) for institutions falling within the scope of the SRM, in order to be able to ensure an orderly resolution of failing banks with a minimum impact on the real economy and public finances; calls on the Commission to swiftly adopt the regulatory technical standard on MREL, with a high binding standard of at least 8 % MREL for all SRB banks, in line with the Bank Recovery and Resolution Directive (BRRD) (Directive 2014/59/EU of the European Parliament and the Council of 15 May 2014) (14) and minimising the chances of loss of SMEs’ uncovered deposits; takes note of the ongoing work on the implementation of Total Loss Absorbing Capacity (TLAC) and calls on the Commission to ensure consistency with MREL;

| 51. | Invites the Commission to assess, in the light of experience and in the framework of the review of Regulation (EU) No 806/2014, whether the SRB and the NRAs are equipped with sufficient early intervention powers and sufficient early intervention instruments to prevent the haemorrhaging of banks; |
| --- | --- |

51.

Invites the Commission to assess, in the light of experience and in the framework of the review of Regulation (EU) No 806/2014, whether the SRB and the NRAs are equipped with sufficient early intervention powers and sufficient early intervention instruments to prevent the haemorrhaging of banks;

| 52. | Underlines that according to the SRM regulation the Board should take due care, as a matter of priority, to establish the resolution plans of systemically important institutions, assess their resolvability and take all action necessary to address or remove all of the impediments to their resolvability; further emphasises that the Board has the power to require changes to the structure and organisation of institutions or groups with a view to taking measures which are necessary and proportionate to reduce or remove material impediments to the application of resolution tools and ensure the resolvability of the entities concerned; |
| --- | --- |

52.

Underlines that according to the SRM regulation the Board should take due care, as a matter of priority, to establish the resolution plans of systemically important institutions, assess their resolvability and take all action necessary to address or remove all of the impediments to their resolvability; further emphasises that the Board has the power to require changes to the structure and organisation of institutions or groups with a view to taking measures which are necessary and proportionate to reduce or remove material impediments to the application of resolution tools and ensure the resolvability of the entities concerned;

| 53. | Takes note of the double role of the Board members, who are at the same time members of an executive body with decision-making roles and senior managers accountable in that capacity to the Chair, and considers that an evaluation of this structure should be undertaken before the end of the current mandate; |
| --- | --- |

53.

Takes note of the double role of the Board members, who are at the same time members of an executive body with decision-making roles and senior managers accountable in that capacity to the Chair, and considers that an evaluation of this structure should be undertaken before the end of the current mandate;

| 54. | Calls on those Member States which have not yet done so to complete the transposition of the BRRD, and highlights the importance of full implementation and enforcement of its provisions; |
| --- | --- |

54.

Calls on those Member States which have not yet done so to complete the transposition of the BRRD, and highlights the importance of full implementation and enforcement of its provisions;

| 55. | Welcomes the ratification by Member States of the Intergovernmental Agreement on the transfer and mutualisation of contributions to a single resolution fund (SRF), which allows the SRM to become fully operational, including the use of the bail-in instrument, as of 1 January 2016 according to the planned schedule; welcomes the establishment of calculation and collection procedures for ex ante contributions to the SRF through the SRB; regrets the decision to set up the SRF through an intergovernmental agreement (IGA) rather than through Union law; calls on the Commission swiftly to take the necessary steps for a quick integration of the IGA into the framework of EU law, as provided for in Article 16 of the Agreement and in the Five Presidents’ Report; |
| --- | --- |

55.

Welcomes the ratification by Member States of the Intergovernmental Agreement on the transfer and mutualisation of contributions to a single resolution fund (SRF), which allows the SRM to become fully operational, including the use of the bail-in instrument, as of 1 January 2016 according to the planned schedule; welcomes the establishment of calculation and collection procedures for ex ante contributions to the SRF through the SRB; regrets the decision to set up the SRF through an intergovernmental agreement (IGA) rather than through Union law; calls on the Commission swiftly to take the necessary steps for a quick integration of the IGA into the framework of EU law, as provided for in Article 16 of the Agreement and in the Five Presidents’ Report;

| 56. | Calls on the Commission to present proposals to further reduce the legal risks of claims under the no-creditor-worse-off-principle; |
| --- | --- |

56.

Calls on the Commission to present proposals to further reduce the legal risks of claims under the no-creditor-worse-off-principle;

| 57. | Calls on the Member States to collect the BRRD and SRM-related contributions fully, effectively and in a timely manner at the national level in order to transfer them to the SRF in accordance with the IGA; |
| --- | --- |

57.

Calls on the Member States to collect the BRRD and SRM-related contributions fully, effectively and in a timely manner at the national level in order to transfer them to the SRF in accordance with the IGA;

| 58. | Calls on the Commission to undertake an extremely careful review of the calculation of contributions to the SRF provided for in recital 27 of Delegated Regulation (EU) 2015/63, and when so doing to review in particular the appropriateness of the risk factor in order to ensure that the risk profile of less complex institutions is reflected appropriately; |
| --- | --- |

58.

Calls on the Commission to undertake an extremely careful review of the calculation of contributions to the SRF provided for in recital 27 of Delegated Regulation (EU) 2015/63, and when so doing to review in particular the appropriateness of the risk factor in order to ensure that the risk profile of less complex institutions is reflected appropriately;

| 59. | Recommends, for the successful management of banking crises in the future, careful assessment of the various choices at the disposal of the Board on the basis of the EU legislation (different resolution tools as an alternative to the liquidation of the bank), keeping in mind the importance of safeguarding financial stability and maintaining confidence in the banking system; |
| --- | --- |

59.

Recommends, for the successful management of banking crises in the future, careful assessment of the various choices at the disposal of the Board on the basis of the EU legislation (different resolution tools as an alternative to the liquidation of the bank), keeping in mind the importance of safeguarding financial stability and maintaining confidence in the banking system;

| 60. | Draws attention to the difference in timing between the rules on burden-sharing and those on the full bail-in, which have retroactively affected the effective riskiness of the debt instruments issued before the latter legal provisions, and the definition and implementation of appropriate investment protection rules; invites the SRB to conduct a careful assessment of the transition period and to ensure that, in line with the requirements of the legislation, the new rules are implemented with the necessary proportionality and fairness; asks the Commission and the European Securities and Markets Authority (ESMA) to guarantee appropriate investor protection; |
| --- | --- |

60.

Draws attention to the difference in timing between the rules on burden-sharing and those on the full bail-in, which have retroactively affected the effective riskiness of the debt instruments issued before the latter legal provisions, and the definition and implementation of appropriate investment protection rules; invites the SRB to conduct a careful assessment of the transition period and to ensure that, in line with the requirements of the legislation, the new rules are implemented with the necessary proportionality and fairness; asks the Commission and the European Securities and Markets Authority (ESMA) to guarantee appropriate investor protection;

| 61. | Stresses the need, as a consequence of the existence of the national compartments in the SRF, to rapidly put in place an adequate bridge financing mechanism in order to provide the fund, if necessary, with sufficient resources in the period before its completion and guarantee the effective separation between banks and sovereigns; recalls that the Eurogroup and the ECOFIN ministers identified, in their statement of 18 December 2013, the possibility of having recourse either to national sources, backed by bank levies, or to the European Stability Mechanism (ESM); |
| --- | --- |

61.

Stresses the need, as a consequence of the existence of the national compartments in the SRF, to rapidly put in place an adequate bridge financing mechanism in order to provide the fund, if necessary, with sufficient resources in the period before its completion and guarantee the effective separation between banks and sovereigns; recalls that the Eurogroup and the ECOFIN ministers identified, in their statement of 18 December 2013, the possibility of having recourse either to national sources, backed by bank levies, or to the European Stability Mechanism (ESM);

| 62. | Welcomes, nonetheless, the agreement reached to secure public bridge financing to help ensure the availability of funds for concrete resolution action through national resources; |
| --- | --- |

62.

Welcomes, nonetheless, the agreement reached to secure public bridge financing to help ensure the availability of funds for concrete resolution action through national resources;

| 63. | Recalls the ECOFIN statement of 8 December 2015 and the commitment made in it to consider, after completion of the ratification of the IGA, the full transposition of the BRRD and the establishment of the bridge financing arrangements as well as the way forward and timing in order to develop a common backstop to facilitate borrowings by the SRF, to be fully operational at the latest by the end of the transition period; stresses, however, that a common fiscal backstop will be used only as a last resort should the other prudential measures to strengthen supervision and crisis management not be able to eliminate the risk; recalls that the backstop should be fiscally neutral in the medium term, and underlines the importance of avoiding moral hazard; underlines that the banking sector should remain liable for repayment by bank levies in all participating Member States, including ex post; |
| --- | --- |

63.

Recalls the ECOFIN statement of 8 December 2015 and the commitment made in it to consider, after completion of the ratification of the IGA, the full transposition of the BRRD and the establishment of the bridge financing arrangements as well as the way forward and timing in order to develop a common backstop to facilitate borrowings by the SRF, to be fully operational at the latest by the end of the transition period; stresses, however, that a common fiscal backstop will be used only as a last resort should the other prudential measures to strengthen supervision and crisis management not be able to eliminate the risk; recalls that the backstop should be fiscally neutral in the medium term, and underlines the importance of avoiding moral hazard; underlines that the banking sector should remain liable for repayment by bank levies in all participating Member States, including ex post;

Third pillar

| 64. | Recalls that, together with the SSM and the SRM, the capacity to afford a uniform and high level of protection of deposits, irrespective of their location, should be ensured in an effective BU, thus contributing to genuinely breaking the sovereign-bank loop, restoring depositors’ confidence, creating a level playing field and enhancing financial stability; considers that any system of protection of deposits must always avoid the introduction of any moral hazard, while ensuring that risk takers remain liable for their risk taking; |
| --- | --- |

64.

Recalls that, together with the SSM and the SRM, the capacity to afford a uniform and high level of protection of deposits, irrespective of their location, should be ensured in an effective BU, thus contributing to genuinely breaking the sovereign-bank loop, restoring depositors’ confidence, creating a level playing field and enhancing financial stability; considers that any system of protection of deposits must always avoid the introduction of any moral hazard, while ensuring that risk takers remain liable for their risk taking;

| 65. | Welcomes the Commission’s package proposed on 24 November 2015 on risk sharing and risk reduction in the BU; takes note of the gradual approach from a reinsurance of national Deposit Guarantee Schemes (DGSs) to a co-insurance scheme and, finally, full insurance for participating national DGSs in the steady state and the risk-based approach to the calculation of contributions; looks forward to engaging in the legislative negotiations on the basis of the position that is adopted; |
| --- | --- |

65.

Welcomes the Commission’s package proposed on 24 November 2015 on risk sharing and risk reduction in the BU; takes note of the gradual approach from a reinsurance of national Deposit Guarantee Schemes (DGSs) to a co-insurance scheme and, finally, full insurance for participating national DGSs in the steady state and the risk-based approach to the calculation of contributions; looks forward to engaging in the legislative negotiations on the basis of the position that is adopted;

| 66. | Notes that the creation of a European Deposit Insurance Scheme (EDIS) requires the implementation of the single rulebook as well as of the first and second pillars of the BU, as well as the transposition of the BRRD and the Deposit Guarantee Schemes Directive (DGSD) by all the participating Member States and further measures to achieve a substantial reduction of risks in the European banking system; stresses that the application of the bail-in tool will introduce a systemic mechanism of risk avoidance, thus reducing the fears of moral hazard which could be induced by the progressive mutualisation of guarantee schemes; underlines the commitment of the Commission to further reduce risks and ensure a level playing field in the BU; |
| --- | --- |

66.

Notes that the creation of a European Deposit Insurance Scheme (EDIS) requires the implementation of the single rulebook as well as of the first and second pillars of the BU, as well as the transposition of the BRRD and the Deposit Guarantee Schemes Directive (DGSD) by all the participating Member States and further measures to achieve a substantial reduction of risks in the European banking system; stresses that the application of the bail-in tool will introduce a systemic mechanism of risk avoidance, thus reducing the fears of moral hazard which could be induced by the progressive mutualisation of guarantee schemes; underlines the commitment of the Commission to further reduce risks and ensure a level playing field in the BU;

| 67. | Notes that a well-functioning deposit guarantee scheme funded through contributions from the financial sector is one of the proven ways to prevent bail-outs of banks with taxpayers’ money; |
| --- | --- |

67.

Notes that a well-functioning deposit guarantee scheme funded through contributions from the financial sector is one of the proven ways to prevent bail-outs of banks with taxpayers’ money;

| 68. | Recalls that the role of the Commission is to guarantee a level playing field across the EU and that it should avoid any fragmentation within the internal market; |
| --- | --- |

68.

Recalls that the role of the Commission is to guarantee a level playing field across the EU and that it should avoid any fragmentation within the internal market;

o

o o

| 69. | Instructs its President to forward this resolution to the Council, the Commission, the European Central Bank and the Single Resolution Board. |
| --- | --- |

69.

Instructs its President to forward this resolution to the Council, the Commission, the European Central Bank and the Single Resolution Board.

---

(1)  OJ L 287, 29.10.2013, p. 63.

(2)  OJ L 320, 30.11.2013, p. 1.

(3)  https://www.bankingsupervision.europa.eu/ecb/pub/pdf/ssmar2014.en.pdf.

(4)  OJ L 141, 14.5.2014, p. 1.

(5)  OJ L 300, 18.10.2014, p. 57.

(6)  OJ L 69, 8.3.2014, p. 107.

(7)  https://www.bankingsupervision.europa.eu/banking/comprehensive/2014/html/index.en.html.

(8)  OJ L 86, 31.3.2015, p. 13.

(9)  OJ L 225, 30.7.2014, p. 1.

(10)  OJ L 339, 24.12.2015, p. 58.

(11)  OJ L 173, 12.6.2014, p. 149.

(12)  Texts adopted, P8_TA(2016)0006.

(13)  Texts adopted, P8_TA(2015)0238.

(14)  OJ L 173, 12.6.2014, p. 190.

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Parliament

Wednesday 9 March 2016

| 9.2.2018 | EN | Official Journal of the European Union | C 50/91 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/91

---

P8_TA(2016)0081

Interinstitutional agreement on Better Law-making

European Parliament decision of 9 March 2016 on the conclusion of an Interinstitutional Agreement on Better Law-Making between the European Parliament, the Council of the European Union and the European Commission (2016/2005(ACI))

(2018/C 050/13)

The European Parliament,

| — | having regard to the decision of the Conference of Presidents of 16 December 2015, |
| --- | --- |

—

having regard to the decision of the Conference of Presidents of 16 December 2015,

| — | having regard to the draft Interinstitutional Agreement on Better Law-Making between the European Parliament, the Council of the European Union and the European Commission, |
| --- | --- |

—

having regard to the draft Interinstitutional Agreement on Better Law-Making between the European Parliament, the Council of the European Union and the European Commission,

| — | having regard to Article 17(1) of the Treaty on European Union, |
| --- | --- |

—

having regard to Article 17(1) of the Treaty on European Union,

| — | having regard to Article 295 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 295 of the Treaty on the Functioning of the European Union,

| — | having regard to the Commission proposal for an Interinstitutional Agreement on Better Regulation (COM(2015)0216 and the annexes thereto), |
| --- | --- |

—

having regard to the Commission proposal for an Interinstitutional Agreement on Better Regulation (COM(2015)0216 and the annexes thereto),

| — | having regard to the Framework Agreement of 20 October 2010 on relations between the European Parliament and the European Commission (1) (‘the 2010 Framework Agreement’), |
| --- | --- |

—

having regard to the Framework Agreement of 20 October 2010 on relations between the European Parliament and the European Commission (1) (‘the 2010 Framework Agreement’),

| — | having regard to the Interinstitutional Agreement of 16 December 2003 on Better Law-making between the European Parliament, the Council of the European Union and the Commission of the European Communities (2) (‘the 2003 Interinstitutional Agreement’), |
| --- | --- |

—

having regard to the Interinstitutional Agreement of 16 December 2003 on Better Law-making between the European Parliament, the Council of the European Union and the Commission of the European Communities (2) (‘the 2003 Interinstitutional Agreement’),

| — | having regard to its resolution of 4 February 2014 on EU Regulatory Fitness and Subsidiarity and Proportionality — 19th report on Better Lawmaking covering the year 2011 (3), |
| --- | --- |

—

having regard to its resolution of 4 February 2014 on EU Regulatory Fitness and Subsidiarity and Proportionality — 19th report on Better Lawmaking covering the year 2011 (3),

| — | having regard to its resolution of 16 September 2015 on the Commission Work Programme 2016 (4), |
| --- | --- |

—

having regard to its resolution of 16 September 2015 on the Commission Work Programme 2016 (4),

| — | having regard to the conclusions of the European Council of 18 and 19 February 2016, |
| --- | --- |

—

having regard to the conclusions of the European Council of 18 and 19 February 2016,

| — | having regard to Rule 140(1) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 140(1) of its Rules of Procedure,

| — | having regard to the report of the Committee on Constitutional Affairs (A8-0039/2016), |
| --- | --- |

—

having regard to the report of the Committee on Constitutional Affairs (A8-0039/2016),

| A. | whereas Parliament has repeatedly called for the 2003 Interinstitutional Agreement to be renegotiated in order to take into account the new legislative environment created by the Treaty of Lisbon, consolidate current best practices, and bring that agreement up to date in line with the ‘better law-making’ agenda; |
| --- | --- |

A.

whereas Parliament has repeatedly called for the 2003 Interinstitutional Agreement to be renegotiated in order to take into account the new legislative environment created by the Treaty of Lisbon, consolidate current best practices, and bring that agreement up to date in line with the ‘better law-making’ agenda;

| B. | whereas the Committee of the Regions, the European Economic and Social Committee and various national parliaments have expressed their views on the Commission's Communication of 19 May 2015 on Better regulation for better results — An EU agenda (COM(2015)0215), the above-mentioned Commission proposal for an Interinstitutional Agreement on Better Regulation or the consensus reached between the institutions on a new Interinstitutional Agreement on Better Law-Making; |
| --- | --- |

B.

whereas the Committee of the Regions, the European Economic and Social Committee and various national parliaments have expressed their views on the Commission's Communication of 19 May 2015 on Better regulation for better results — An EU agenda (COM(2015)0215), the above-mentioned Commission proposal for an Interinstitutional Agreement on Better Regulation or the consensus reached between the institutions on a new Interinstitutional Agreement on Better Law-Making;

| C. | whereas, in its above-mentioned resolution of 16 September 2015, Parliament welcomed the opening of negotiations for a new interinstitutional agreement on better law-making and set out a number of priorities, notably as regards the quality of the Commission’s legislative drafting, multiannual and annual programming, the strengthening of impact assessment of draft laws, equal treatment of the two branches of the legislative authority throughout the legislative process in terms of access to information, proper interinstitutional consultations, the Commission's follow-up to Parliament’s proposals and recommendations and the provision of detailed justifications for each envisaged withdrawal; |
| --- | --- |

C.

whereas, in its above-mentioned resolution of 16 September 2015, Parliament welcomed the opening of negotiations for a new interinstitutional agreement on better law-making and set out a number of priorities, notably as regards the quality of the Commission’s legislative drafting, multiannual and annual programming, the strengthening of impact assessment of draft laws, equal treatment of the two branches of the legislative authority throughout the legislative process in terms of access to information, proper interinstitutional consultations, the Commission's follow-up to Parliament’s proposals and recommendations and the provision of detailed justifications for each envisaged withdrawal;

| D. | whereas interinstitutional negotiations were formally opened on 25 June 2015; |
| --- | --- |

D.

whereas interinstitutional negotiations were formally opened on 25 June 2015;

| E. | whereas, on 16 December 2015, the Conference of President endorsed, by a majority vote, the provisional agreement that had been reached between negotiators of the three institutions on 8 December 2015 on the wording of a new Interinstitutional Agreement on Better Law-Making (‘the new IIA’); |
| --- | --- |

E.

whereas, on 16 December 2015, the Conference of President endorsed, by a majority vote, the provisional agreement that had been reached between negotiators of the three institutions on 8 December 2015 on the wording of a new Interinstitutional Agreement on Better Law-Making (‘the new IIA’);

| F. | whereas the new IIA aims to replace the 2003 Interinstitutional Agreement and the Interinstitutional Common Approach to Impact Assessment of November 2005, and whereas the Annex to the new IIA is intended to replace the 2011 Common Understanding on Delegated Acts; |
| --- | --- |

F.

whereas the new IIA aims to replace the 2003 Interinstitutional Agreement and the Interinstitutional Common Approach to Impact Assessment of November 2005, and whereas the Annex to the new IIA is intended to replace the 2011 Common Understanding on Delegated Acts;

| G. | whereas, in accordance with the declaration of the European Parliament and the Commission set out in Annex II to this decision, the new IIA is without prejudice to the 2010 Framework Agreement; |
| --- | --- |

G.

whereas, in accordance with the declaration of the European Parliament and the Commission set out in Annex II to this decision, the new IIA is without prejudice to the 2010 Framework Agreement;

| H. | whereas, nevertheless, certain provisions of the 2010 Framework Agreement may become obsolete or may need to be brought up to date as a result of the new IIA; |
| --- | --- |

H.

whereas, nevertheless, certain provisions of the 2010 Framework Agreement may become obsolete or may need to be brought up to date as a result of the new IIA;

| I. | whereas the new IIA envisages further interinstitutional negotiations, notably on practical arrangements for cooperation and information-sharing in the context of the conclusion of international agreements and on criteria for the application of Articles 290 and 291 of the TFEU on delegated and implementing acts respectively; |
| --- | --- |

I.

whereas the new IIA envisages further interinstitutional negotiations, notably on practical arrangements for cooperation and information-sharing in the context of the conclusion of international agreements and on criteria for the application of Articles 290 and 291 of the TFEU on delegated and implementing acts respectively;

| J. | whereas certain provisions of Parliament's Rules of Procedure will need to be adapted as a consequence of the new IIA, such as those relating to the Commission Work Programme and verification of the legal basis of acts; |
| --- | --- |

J.

whereas certain provisions of Parliament's Rules of Procedure will need to be adapted as a consequence of the new IIA, such as those relating to the Commission Work Programme and verification of the legal basis of acts;

| K. | whereas the new IIA addresses, in one way or another, the main concerns expressed by Parliament's Committee on Constitutional Affairs in its ‘Contribution of AFCO to the position of the European Parliament for the negotiations on the revision of the Interinstitutional Agreement on Better Law-Making’ of 22 April 2015; |
| --- | --- |

K.

whereas the new IIA addresses, in one way or another, the main concerns expressed by Parliament's Committee on Constitutional Affairs in its ‘Contribution of AFCO to the position of the European Parliament for the negotiations on the revision of the Interinstitutional Agreement on Better Law-Making’ of 22 April 2015;

| 1. | Welcomes the agreement reached between the institutions and considers this a good basis for establishing and developing a new, more open and transparent relationship between them with a view to delivering better law-making in the interest of the Union's citizens; |
| --- | --- |

1.

Welcomes the agreement reached between the institutions and considers this a good basis for establishing and developing a new, more open and transparent relationship between them with a view to delivering better law-making in the interest of the Union's citizens;

| 2. | Deeply regrets, in the context of better law-making, that negotiations on the IIA failed to follow established practice in terms of a committee procedure in the European Parliament; |
| --- | --- |

2.

Deeply regrets, in the context of better law-making, that negotiations on the IIA failed to follow established practice in terms of a committee procedure in the European Parliament;

| 3. | Welcomes, in particular, the results of the negotiations as regards multiannual and annual interinstitutional programming, the Commission's follow-up to Parliament's legislative initiatives, and the provision of justifications for and consultations on envisaged withdrawals of legislative proposals; stresses that the agreed strong focus on the Commission's work programme cannot be understood as justifying any restriction of Parliament's own legislative powers or right of initiative; welcomes the agreed interinstitutional exchange of views in the event that a modification of the legal basis of an act is envisaged, and expresses its strong determination to resist any attempt to undermine the legislative powers of the European Parliament by means of a modification of the legal basis; |
| --- | --- |

3.

Welcomes, in particular, the results of the negotiations as regards multiannual and annual interinstitutional programming, the Commission's follow-up to Parliament's legislative initiatives, and the provision of justifications for and consultations on envisaged withdrawals of legislative proposals; stresses that the agreed strong focus on the Commission's work programme cannot be understood as justifying any restriction of Parliament's own legislative powers or right of initiative; welcomes the agreed interinstitutional exchange of views in the event that a modification of the legal basis of an act is envisaged, and expresses its strong determination to resist any attempt to undermine the legislative powers of the European Parliament by means of a modification of the legal basis;

| 4. | Underlines the importance of the new IIA’s provisions on better law-making tools (impact assessments, public and stakeholder consultations, evaluations, etc.) for a well-informed, inclusive and transparent decision-making process and for the correct application of legislation, whilst noting that those provisions safeguard the prerogatives of the legislators; believes that impact assessments must be comprehensive and balanced and should assess, inter alia, the cost to producers, consumers, workers, administrators and to the environment of not adopting the necessary legislation; is concerned that the wording in relation to impact assessments does not sufficiently commit the three institutions to include small and medium-sized enterprises (SMEs) and competitiveness tests in their impact assessments; stresses the importance of taking into account, and paying attention to, the needs of SMEs at all stages of the legislative cycle; underlines that, in accordance with the Commission Staff Working Document of 19 May 2015 on Better Regulation guidelines (SWD(2015)0111), the assessment of the impact on SME shall be included in impact assessment reports and calls on the Commission to provide supplementary information on this practice; welcomes the aim of improving the implementation and application of Union legislation, inter alia through better identification of national measures that are not required by the Union legislation that is to be transposed (‘gold-plating’), and, whilst bearing in mind that Member States are free to apply higher standards if only minimum standards are defined by Union law, expects Member States to clearly indicate and document such measures; |
| --- | --- |

4.

Underlines the importance of the new IIA’s provisions on better law-making tools (impact assessments, public and stakeholder consultations, evaluations, etc.) for a well-informed, inclusive and transparent decision-making process and for the correct application of legislation, whilst noting that those provisions safeguard the prerogatives of the legislators; believes that impact assessments must be comprehensive and balanced and should assess, inter alia, the cost to producers, consumers, workers, administrators and to the environment of not adopting the necessary legislation; is concerned that the wording in relation to impact assessments does not sufficiently commit the three institutions to include small and medium-sized enterprises (SMEs) and competitiveness tests in their impact assessments; stresses the importance of taking into account, and paying attention to, the needs of SMEs at all stages of the legislative cycle; underlines that, in accordance with the Commission Staff Working Document of 19 May 2015 on Better Regulation guidelines (SWD(2015)0111), the assessment of the impact on SME shall be included in impact assessment reports and calls on the Commission to provide supplementary information on this practice; welcomes the aim of improving the implementation and application of Union legislation, inter alia through better identification of national measures that are not required by the Union legislation that is to be transposed (‘gold-plating’), and, whilst bearing in mind that Member States are free to apply higher standards if only minimum standards are defined by Union law, expects Member States to clearly indicate and document such measures;

| 5. | Notes that the cumulative cost of legislation can result in significant difficulties for businesses and individuals affected by Union rules; |
| --- | --- |

5.

Notes that the cumulative cost of legislation can result in significant difficulties for businesses and individuals affected by Union rules;

| 6. | Takes note of the letter of 15 December 2015 from the First Vice President of the Commission on the functioning of the new Regulatory Scrutiny Board, which is to oversee the quality of the Commission's impact assessments (but without giving it a power of veto over legislative proposals, which is a matter for the elected authorities); recalls that, in its resolution of 27 November 2014 on the revision of the Commission’s impact assessment guidelines and the role of the SME test (5), it requested that the independence of the Regulatory Scrutiny Board (formerly ‘Impact Assessment Board’) be strengthened including, in particular, that members of the Board should not be subject to political control; believes, in this respect, that the establishment of the Regulatory Scrutiny Board is a welcome first step in achieving independence thereof; points out that the legislators may also carry out their own impact assessments where they consider this necessary; notes that impact assessments do not replace the political decision-making process; underlines, furthermore, that the new IIA provides for exchanges of information between the institutions on best practice and methodologies relating to impact assessments, thereby providing an opportunity to review in due time the functioning of the Regulatory Scrutiny Board with a view to achieving a common methodology; |
| --- | --- |

6.

Takes note of the letter of 15 December 2015 from the First Vice President of the Commission on the functioning of the new Regulatory Scrutiny Board, which is to oversee the quality of the Commission's impact assessments (but without giving it a power of veto over legislative proposals, which is a matter for the elected authorities); recalls that, in its resolution of 27 November 2014 on the revision of the Commission’s impact assessment guidelines and the role of the SME test (5), it requested that the independence of the Regulatory Scrutiny Board (formerly ‘Impact Assessment Board’) be strengthened including, in particular, that members of the Board should not be subject to political control; believes, in this respect, that the establishment of the Regulatory Scrutiny Board is a welcome first step in achieving independence thereof; points out that the legislators may also carry out their own impact assessments where they consider this necessary; notes that impact assessments do not replace the political decision-making process; underlines, furthermore, that the new IIA provides for exchanges of information between the institutions on best practice and methodologies relating to impact assessments, thereby providing an opportunity to review in due time the functioning of the Regulatory Scrutiny Board with a view to achieving a common methodology;

| 7. | Welcomes the agreement between the institutions to cooperate in order to update and simplify legislation and to exchange views thereon, prior to the finalisation of the Commission Work Programme; underlines the importance of the agreed ‘Annual Burden Survey’ as a tool to identify and monitor, in a clear and transparent manner, the results of the Union's efforts, in order to avoid and reduce any overregulation and administrative burdens, which should include a list relating specifically to SME's and should distinguish between burdens that individual Commission proposals seek to impose and acts by individual Member States; points out that the feasibility and desirability of establishing objectives for the reduction of burdens in specific sectors must be carefully evaluated on a case-by-case basis in close cooperation between the institutions, while focusing on the quality of legislation, and without undermining relevant Union standards; expects the Commission to propose, on a regular basis, the repeal of legal acts where such repeal is deemed to be necessary; welcomes in this respect the fact that the three institutions have agreed that impact assessments should also address the impact of proposals on administrative burdens, particularly as regards SMEs; recognises that appropriate Union legislation can cut administrative burdens for SME's by replacing 28 divergent sets of rules with a single set of rules for the internal market; |
| --- | --- |

7.

Welcomes the agreement between the institutions to cooperate in order to update and simplify legislation and to exchange views thereon, prior to the finalisation of the Commission Work Programme; underlines the importance of the agreed ‘Annual Burden Survey’ as a tool to identify and monitor, in a clear and transparent manner, the results of the Union's efforts, in order to avoid and reduce any overregulation and administrative burdens, which should include a list relating specifically to SME's and should distinguish between burdens that individual Commission proposals seek to impose and acts by individual Member States; points out that the feasibility and desirability of establishing objectives for the reduction of burdens in specific sectors must be carefully evaluated on a case-by-case basis in close cooperation between the institutions, while focusing on the quality of legislation, and without undermining relevant Union standards; expects the Commission to propose, on a regular basis, the repeal of legal acts where such repeal is deemed to be necessary; welcomes in this respect the fact that the three institutions have agreed that impact assessments should also address the impact of proposals on administrative burdens, particularly as regards SMEs; recognises that appropriate Union legislation can cut administrative burdens for SME's by replacing 28 divergent sets of rules with a single set of rules for the internal market;

| 8. | Believes that, in principle, a balanced solution has been found with regard to delegated and implementing acts, ensuring transparency and parity between legislators, but points to the need for a swift agreement on appropriate criteria for delineating delegated and implementing acts and a prompt alignment of all basic acts to the legal framework introduced by the Treaty of Lisbon; |
| --- | --- |

8.

Believes that, in principle, a balanced solution has been found with regard to delegated and implementing acts, ensuring transparency and parity between legislators, but points to the need for a swift agreement on appropriate criteria for delineating delegated and implementing acts and a prompt alignment of all basic acts to the legal framework introduced by the Treaty of Lisbon;

| 9. | Acknowledges that the agreed measures to improve the mutual exchange of views and information between Parliament and the Council in their capacity as legislators constitute a step forward; considers, however, that those measures should be developed further, particularly in terms of mutual access to information and meetings, so as to ensure a truly equal balance and equal treatment between the legislators throughout the legislative procedure, and to guarantee that the principle of mutual sincere cooperation among institutions is complied with; warns that the agreed informal exchanges of views should not develop into a new arena of non-transparent interinstitutional negotiations; |
| --- | --- |

9.

Acknowledges that the agreed measures to improve the mutual exchange of views and information between Parliament and the Council in their capacity as legislators constitute a step forward; considers, however, that those measures should be developed further, particularly in terms of mutual access to information and meetings, so as to ensure a truly equal balance and equal treatment between the legislators throughout the legislative procedure, and to guarantee that the principle of mutual sincere cooperation among institutions is complied with; warns that the agreed informal exchanges of views should not develop into a new arena of non-transparent interinstitutional negotiations;

| 10. | Recalls that the TFEU establishes an ordinary legislative procedure with three readings; points out that, where Parliament and the Council fully exercise their prerogatives in the legislative procedure, second-reading agreements should be the standard procedure whereas first reading agreements should be used only where a considered and explicit decision has been taken to do so; |
| --- | --- |

10.

Recalls that the TFEU establishes an ordinary legislative procedure with three readings; points out that, where Parliament and the Council fully exercise their prerogatives in the legislative procedure, second-reading agreements should be the standard procedure whereas first reading agreements should be used only where a considered and explicit decision has been taken to do so;

| 11. | Welcomes the commitment to ensure transparency of legislative procedures, but underlines the need for more concrete provisions and tools to achieve this, in particular as regards the use of first-reading agreements; |
| --- | --- |

11.

Welcomes the commitment to ensure transparency of legislative procedures, but underlines the need for more concrete provisions and tools to achieve this, in particular as regards the use of first-reading agreements;

| 12. | Believes, also, that better use should be made of the arrangements for political dialogue with national parliaments; highlights, in this connection, the important role given to national parliaments by the Lisbon Treaty and stresses that, alongside the role which they play in monitoring respect for the principles of subsidiarity and proportionality, they can and do make positive contributions in the framework of the political dialogue; encourages better use of the existing subsidiarity and proportionality mechanisms as laid down in the Treaties; emphasises the need for greater flexibility in the enforcement of the eight week deadline for national parliaments to issue a reasoned opinion on non-compliance with the principle of subsidiarity; |
| --- | --- |

12.

Believes, also, that better use should be made of the arrangements for political dialogue with national parliaments; highlights, in this connection, the important role given to national parliaments by the Lisbon Treaty and stresses that, alongside the role which they play in monitoring respect for the principles of subsidiarity and proportionality, they can and do make positive contributions in the framework of the political dialogue; encourages better use of the existing subsidiarity and proportionality mechanisms as laid down in the Treaties; emphasises the need for greater flexibility in the enforcement of the eight week deadline for national parliaments to issue a reasoned opinion on non-compliance with the principle of subsidiarity;

| 13. | Calls for a comprehensive evaluation of the impact that the new IIA will have on the 2010 Framework Agreement and other related existing interinstitutional agreements, bearing in mind the need to safeguard the European Parliament's position and prerogatives and to simplify the architecture of the numerous arrangements regulating interinstitutional relations; |
| --- | --- |

13.

Calls for a comprehensive evaluation of the impact that the new IIA will have on the 2010 Framework Agreement and other related existing interinstitutional agreements, bearing in mind the need to safeguard the European Parliament's position and prerogatives and to simplify the architecture of the numerous arrangements regulating interinstitutional relations;

| 14. | Considers that such simplification should be carried through once all practical arrangements to implement the new IIA in its entirety are in place, at which point the institutions could also evaluate whether adjustments to the new IIA may be necessary in light of experience gained up until that point in time with the implementation of the new IIA; |
| --- | --- |

14.

Considers that such simplification should be carried through once all practical arrangements to implement the new IIA in its entirety are in place, at which point the institutions could also evaluate whether adjustments to the new IIA may be necessary in light of experience gained up until that point in time with the implementation of the new IIA;

| 15. | Underlines the importance of proper implementation and of ensuring that the commitments given and the deadlines set out in the new IIA are honoured; |
| --- | --- |

15.

Underlines the importance of proper implementation and of ensuring that the commitments given and the deadlines set out in the new IIA are honoured;

| 16. | Points out that the following issues in particular need further follow-up at technical and/or political level, with the active involvement, and drawing on the expertise, of all parliamentary committees having the relevant experience:






  — | programming (technical review of the 2010 Framework Agreement and Parliament's Rules of Procedure); |
| --- | --- | --- |

16.

Points out that the following issues in particular need further follow-up at technical and/or political level, with the active involvement, and drawing on the expertise, of all parliamentary committees having the relevant experience:

—

programming (technical review of the 2010 Framework Agreement and Parliament's Rules of Procedure);

| — | verification of the legal basis of acts (review of the Rules of Procedure to incorporate arrangements for a trilateral exchange of views); |
| --- | --- |

—

verification of the legal basis of acts (review of the Rules of Procedure to incorporate arrangements for a trilateral exchange of views);

| — | evaluation of the application by the Commission of its abovementioned Better Regulation Guidelines and of the effective functioning of the newly created Regulatory Scrutiny Board, in particular in order to verify, in accordance with paragraph 6, that it operates in an independent manner and that its members are not subject to any political control; |
| --- | --- |

—

evaluation of the application by the Commission of its abovementioned Better Regulation Guidelines and of the effective functioning of the newly created Regulatory Scrutiny Board, in particular in order to verify, in accordance with paragraph 6, that it operates in an independent manner and that its members are not subject to any political control;

| — | the transparency and coordination of the legislative process (including the appropriate use of first and second-reading procedures, practical arrangements for exchanges of views, information-sharing and comparison of time-tables, transparency in the context of trilateral negotiations, development of platforms and tools for the establishment of a joint database on the state of play of legislative files, the provision of information to national parliaments and practical arrangements for cooperation and information-sharing regarding negotiations on, and the conclusion of, international agreements); |
| --- | --- |

—

the transparency and coordination of the legislative process (including the appropriate use of first and second-reading procedures, practical arrangements for exchanges of views, information-sharing and comparison of time-tables, transparency in the context of trilateral negotiations, development of platforms and tools for the establishment of a joint database on the state of play of legislative files, the provision of information to national parliaments and practical arrangements for cooperation and information-sharing regarding negotiations on, and the conclusion of, international agreements);

| — | an evaluation and possible follow up of the independence of the Regulatory Scrutiny Board in fulfilling its role in supervising and providing objective advice on respective impact assessments; |
| --- | --- |

—

an evaluation and possible follow up of the independence of the Regulatory Scrutiny Board in fulfilling its role in supervising and providing objective advice on respective impact assessments;

| — | the expectation by Parliament, pursuant to the relevant provisions of the new IIA, that the Commission comes forward with proposals establishing targets, where feasible, for the reduction of burdens in key sectors as soon as possible while ensuring that the objectives of the legislation are met; |
| --- | --- |

—

the expectation by Parliament, pursuant to the relevant provisions of the new IIA, that the Commission comes forward with proposals establishing targets, where feasible, for the reduction of burdens in key sectors as soon as possible while ensuring that the objectives of the legislation are met;

| — | ensuring operational and legal coherence between the new IIA and cooperation agreements regarding the Union advisory bodies; |
| --- | --- |

—

ensuring operational and legal coherence between the new IIA and cooperation agreements regarding the Union advisory bodies;

| — | delegated and implementing acts, on the basis of its resolution of 25 February 2014 on follow-up on the delegation of legislative powers and control by Member States of the Commission's exercise of implementing powers (6) (negotiations on delineation criteria for delegated and implementing acts, the setting-up of a register of delegated acts and full alignment of pre-Lisbon acts); |
| --- | --- |

—

delegated and implementing acts, on the basis of its resolution of 25 February 2014 on follow-up on the delegation of legislative powers and control by Member States of the Commission's exercise of implementing powers (6) (negotiations on delineation criteria for delegated and implementing acts, the setting-up of a register of delegated acts and full alignment of pre-Lisbon acts);

| — | implementation and application of Union legislation (scrutiny of the communication, by Member States, of the transposition of directives, as well as of each national measure that goes beyond the provisions of Union legislation (‘gold-plating’)); |
| --- | --- |

—

implementation and application of Union legislation (scrutiny of the communication, by Member States, of the transposition of directives, as well as of each national measure that goes beyond the provisions of Union legislation (‘gold-plating’));

| 17. | Approves the draft agreement contained in Annex I to this decision; |
| --- | --- |

17.

Approves the draft agreement contained in Annex I to this decision;

| 18. | Approves the statement by Parliament and the Commission contained in Annex II to this decision; |
| --- | --- |

18.

Approves the statement by Parliament and the Commission contained in Annex II to this decision;

| 19. | Asks its competent committee to examine the extent to which amendments or interpretation of the Rules of Procedure or changes to Parliament's practices, administration and channels of contact with other institutions are necessary for the implementation of the new IIA; |
| --- | --- |

19.

Asks its competent committee to examine the extent to which amendments or interpretation of the Rules of Procedure or changes to Parliament's practices, administration and channels of contact with other institutions are necessary for the implementation of the new IIA;

| 20. | Instructs its President to sign the new IIA with the President of the Council and the President of the Commission and to arrange for its publication in the Official Journal of the European Union; |
| --- | --- |

20.

Instructs its President to sign the new IIA with the President of the Council and the President of the Commission and to arrange for its publication in the Official Journal of the European Union;

| 21. | Instructs its President to forward this decision, including its annexes, to the Council and the Commission for information. |
| --- | --- |

21.

Instructs its President to forward this decision, including its annexes, to the Council and the Commission for information.

---

(1)  OJ L 304, 20.11.2010, p. 47.

(2)  OJ C 321, 31.12.2003, p. 1.

(3)  Texts adopted, P7_TA(2014)0061.

(4)  Texts adopted, P8_TA(2015)0323.

(5)  Texts adopted, P8_TA(2014)0069.

(6)  Texts adopted, P7_TA(2014)0127.

---

ANNEX I

Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making

(The text of this annex is not reproduced here since it corresponds to the interinstitutional agreement as published in OJ L 123, 12.5.2016, p. 1.)

---

ANNEX II

STATEMENT OF THE EUROPEAN PARLIAMENT AND OF THE COMMISSION ON THE OCCASION OF THE ADOPTION OF THE INTERINSTITUTIONAL AGREEMENT ON BETTER LAW-MAKING

The European Parliament and the Commission consider that this Agreement reflects the balance between, and respective competences of, the European Parliament, the Council and the Commission as set out in the Treaties.

It is without prejudice to the Framework Agreement of 20 October 2010 on relations between the European Parliament and the European Commission (1).

---

(1)  OJ L 304, 20.11.2010, p. 47.

---

III Preparatory acts

EUROPEAN PARLIAMENT

Tuesday 8 March 2016

| 9.2.2018 | EN | Official Journal of the European Union | C 50/98 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/98

---

P8_TA(2016)0067

Animal health ***II

European Parliament legislative resolution of 8 March 2016 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (11779/1/2015 — C8-0008/2016 — 2013/0136(COD))

(Ordinary legislative procedure: second reading)

(2018/C 050/14)

The European Parliament,

| — | having regard to the Council position at first reading (11779/1/2015 — C8-0008/2016), |
| --- | --- |

—

having regard to the Council position at first reading (11779/1/2015 — C8-0008/2016),

| — | having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Austrian Federal Council, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
| --- | --- |

—

having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Austrian Federal Council, asserting that the draft legislative act does not comply with the principle of subsidiarity,

| — | having regard to the opinion of the European Economic and Social Committee of 10 December 2013 (1), |
| --- | --- |

—

having regard to the opinion of the European Economic and Social Committee of 10 December 2013 (1),

| — | after consulting the Committee of the Regions, |
| --- | --- |

—

after consulting the Committee of the Regions,

| — | having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2013)0260), |
| --- | --- |

—

having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2013)0260),

| — | having regard to Article 294(7) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(7) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 76 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 76 of its Rules of Procedure,

| — | having regard to the recommendation for second reading of the Committee on Agriculture and Rural Development (A8-0041/2016), |
| --- | --- |

—

having regard to the recommendation for second reading of the Committee on Agriculture and Rural Development (A8-0041/2016),

| 1. | Approves the Council position at first reading; |
| --- | --- |

1.

Approves the Council position at first reading;

| 2. | Approves the joint statement by Parliament, the Council and the Commission annexed to this resolution; |
| --- | --- |

2.

Approves the joint statement by Parliament, the Council and the Commission annexed to this resolution;

| 3. | Takes note of the Commission statements annexed to this resolution; |
| --- | --- |

3.

Takes note of the Commission statements annexed to this resolution;

| 4. | Notes that the act is adopted in accordance with the Council position; |
| --- | --- |

4.

Notes that the act is adopted in accordance with the Council position;

| 5. | Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union; |
| --- | --- |

5.

Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union;

| 6. | Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union; |
| --- | --- |

6.

Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union;

| 7. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

7.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

---

(1)  OJ C 170, 5.6.2014, p. 104.

(2)  Texts adopted, P7_TA(2014)0381.

---

ANNEX TO THE LEGISLATIVE RESOLUTION

Joint Statement by the European Parliament, the Council and the Commission on antimicrobial resistance and the use of veterinary medicinal products

The Communication from the Commission to the European Parliament and the Council entitled ‘Action plan against the rising threats from Antimicrobial Resistance’ (COM(2011)0748) emphasises the preventive role of the Regulation on transmissible animal diseases (‘Animal Health Law’) and the consequent expected reduction of the use of antibiotics in animals. In addition to the requirements of this Regulation, Member States are called upon to commit themselves to collect relevant, comparable and sufficiently detailed data on the actual use of antimicrobial medicinal products in animals and to send such data to the Commission in order to ensure a more prudent use of antimicrobial medicinal products in animals, hence contributing to the reduction of the risk of antimicrobial resistance.

Commission Statement on the regular reporting on the use of antimicrobial medicinal products in animals in the Union

The Commission undertakes to publish a regular report as regards the use of antimicrobial medicinal products in animals in the EU on the basis of data made available by the Member States.

Commission Statement on animal welfare

This Regulation lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans and does not contain provisions which regulate specifically animal welfare, albeit animal health and welfare are linked. The Union has a well-developed acquis regarding animal welfare covering different species (broilers, laying hens, pigs, calves) or activities (farming, transport, slaughter, research, etc.). This animal welfare legislation will necessarily continue to apply. The Commission is fully committed to paying full regard to animal welfare in accordance with Article 13 of the Treaty and within the limits set out therein, including ensuring full implementation and appropriate development of this legislation.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/101 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/101

---

P8_TA(2016)0068

Aid scheme for the supply of fruit and vegetables, bananas and milk in the educational establishments ***I

European Parliament legislative resolution of 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 1308/2013 and Regulation (EU) No 1306/2013 as regards the aid scheme for the supply of fruit and vegetables, bananas and milk in the educational establishments (COM(2014)0032 — C7-0025/2014 — 2014/0014(COD))

(Ordinary legislative procedure: first reading)

(2018/C 050/15)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2014)0032), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2014)0032),

| — | having regard to Article 294(2) and Article 42 and Article 43(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0025/2014), |
| --- | --- |

—

having regard to Article 294(2) and Article 42 and Article 43(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0025/2014),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the opinion of the European Economic and Social Committee of 9 July 2014 (1), |
| --- | --- |

—

having regard to the opinion of the European Economic and Social Committee of 9 July 2014 (1),

| — | having regard to the opinion of the Committee of the Regions of 7 October 2014 (2), |
| --- | --- |

—

having regard to the opinion of the Committee of the Regions of 7 October 2014 (2),

| — | having regard to its decision of 27 May 2015 on the opening of, and the mandate for, interinstitutional negotiations on the proposal (3), |
| --- | --- |

—

having regard to its decision of 27 May 2015 on the opening of, and the mandate for, interinstitutional negotiations on the proposal (3),

| — | having regard to the undertaking given by the Council representative by letter of 16 December 2015 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the undertaking given by the Council representative by letter of 16 December 2015 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Agriculture and Rural Development (A8-0006/2016), |
| --- | --- |

—

having regard to the report of the Committee on Agriculture and Rural Development (A8-0006/2016),

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

Adopts its position at first reading hereinafter set out;

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
| --- | --- |

2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

---

(1)  OJ C 451, 16.12.2014, p. 142.

(2)  OJ C 415, 20.11.2014, p. 30.

(3)  Texts adopted of that date, P8_TA(2015)0216.

---

P8_TC1-COD(2014)0014

Position of the European Parliament adopted at first reading on 8 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council amending Regulations (EU) No 1308/2013 and (EU) No 1306/2013 as regards the aid scheme for the supply of fruit and vegetables, bananas and milk in educational establishments

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2016/791.)

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/102 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/102

---

P8_TA(2016)0069

Market access to port services and financial transparency of ports ***I

Amendments adopted by the European Parliament on 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council establishing a framework on market access to port services and financial transparency of ports (COM(2013)0296 — C7-0144/2013 — 2013/0157(COD)) (1)

(Ordinary legislative procedure: first reading)

(2018/C 050/16)

Amendment 1

Proposal for a regulation

Title

| Text proposed by the Commission | Amendment |
| --- | --- |
| Proposal for a | Proposal for a |
| REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL | REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL |
| establishing a framework
  on market access to
  port services and financial transparency of ports | establishing a framework
  for the organisation of
  port services and
  for
  financial transparency of ports |

Text proposed by the Commission

Amendment

Proposal for a

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a framework
  on market access to
  port services and financial transparency of ports

establishing a framework
  for the organisation of
  port services and
  for
  financial transparency of ports

Amendment 2

Proposal for a regulation

Recital 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (1a) | Ports are able to contribute to the long-term competitiveness of European industries in world markets while adding value and jobs in all Union coastal regions. In order to address the challenges facing the maritime transport sector, such as inefficiencies in the sustainable transport and logistics chain, it is essential that the actions set out in the Commission's communication entitled ‘Ports: an engine for growth’ on administrative simplification be implemented in tandem with this Regulation. The complexity of administrative procedures for customs clearance, resulting in delays at ports, represents a major obstacle to the competitiveness of short sea shipping and the efficiency of Union ports. |

Text proposed by the Commission

Amendment

(1a)

Ports are able to contribute to the long-term competitiveness of European industries in world markets while adding value and jobs in all Union coastal regions. In order to address the challenges facing the maritime transport sector, such as inefficiencies in the sustainable transport and logistics chain, it is essential that the actions set out in the Commission's communication entitled ‘Ports: an engine for growth’ on administrative simplification be implemented in tandem with this Regulation. The complexity of administrative procedures for customs clearance, resulting in delays at ports, represents a major obstacle to the competitiveness of short sea shipping and the efficiency of Union ports.

Amendment 3

Proposal for a regulation

Recital 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (3a) | A high level of simplification of customs procedures can represent a major economic advantage for a port in terms of competitiveness. In order to avoid unfair competition of ports and to reduce customs formalities which might seriously harm the Union's financial interests, port authorities should adopt a proper and effective risk-based policy approach in order to avoid the distortion of competition. Member States and the Commission should effectively monitor these procedures on a regular basis, and the Commission should evaluate whether it is necessary to take appropriate measures to tackle unfair competition. |

Text proposed by the Commission

Amendment

(3a)

A high level of simplification of customs procedures can represent a major economic advantage for a port in terms of competitiveness. In order to avoid unfair competition of ports and to reduce customs formalities which might seriously harm the Union's financial interests, port authorities should adopt a proper and effective risk-based policy approach in order to avoid the distortion of competition. Member States and the Commission should effectively monitor these procedures on a regular basis, and the Commission should evaluate whether it is necessary to take appropriate measures to tackle unfair competition.

Amendment 4

Proposal for a regulation

Recital 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| (4) | The overwhelming majority of Union maritime traffic transits through the
  seaports
  of the trans-European transport network. In order to achieve the aim of this Regulation in a proportionate way without imposing any unnecessary burden on other ports, this Regulation should apply to the
  ports
  of the trans-European transport network, each of which playing a significant role for the European transport system either because it handles more than 0,1  % of the total EU freight or the total number of passengers or because it improves the regional accessibility of island or peripheral areas
  , without prejudice, however, to the possibility of Member States deciding to apply this Regulation to other ports as well
  . Pilotage services performed in the deep sea do not have a direct impact on the efficiency of the ports as they are not used for the direct entry and exit of the ports and therefore do not need to be included in this Regulation. |

Text proposed by the Commission

Amendment

(4)

The overwhelming majority of Union maritime traffic transits through the
  seaports
  of the trans-European transport network. In order to achieve the aim of this Regulation in a proportionate way without imposing any unnecessary burden on other ports, this Regulation should apply to the
  ports
  of the trans-European transport network, each of which playing a significant role for the European transport system either because it handles more than 0,1  % of the total EU freight or the total number of passengers or because it improves the regional accessibility of island or peripheral areas
  , without prejudice, however, to the possibility of Member States deciding to apply this Regulation to other ports as well
  . Pilotage services performed in the deep sea do not have a direct impact on the efficiency of the ports as they are not used for the direct entry and exit of the ports and therefore do not need to be included in this Regulation.

| (4) | The overwhelming majority of Union maritime traffic transits through the
  maritime ports
  of the trans-European transport network. In order to achieve the aim of this Regulation in a proportionate way without imposing any unnecessary burden on other ports, this Regulation should
  only
  apply to the
  maritime ports
  of the trans-European transport network, each of which playing a significant role for the European transport system either because it handles more than 0,1  % of the total EU freight or the total number of passengers or because it improves the regional accessibility of island or peripheral areas.
  However
  ,
  this Regulation should give Member States the possibility to decide whether or not to apply this Regulation to maritime ports of the comprehensive trans-European transport network located in the outermost regions. Member States should also have the possibility of introducing derogations in order to avoid disproportionate administrative burdens for those maritime ports of the comprehensive trans-European transport network the annual traffic of which does not justify the full application of this Regulation
  . Pilotage services performed in the deep sea do not have a direct impact on the efficiency of the ports as they are not used for the direct entry and exit of the ports and therefore do not need to be included in this Regulation. |
| --- | --- |

(4)

The overwhelming majority of Union maritime traffic transits through the
  maritime ports
  of the trans-European transport network. In order to achieve the aim of this Regulation in a proportionate way without imposing any unnecessary burden on other ports, this Regulation should
  only
  apply to the
  maritime ports
  of the trans-European transport network, each of which playing a significant role for the European transport system either because it handles more than 0,1  % of the total EU freight or the total number of passengers or because it improves the regional accessibility of island or peripheral areas.
  However
  ,
  this Regulation should give Member States the possibility to decide whether or not to apply this Regulation to maritime ports of the comprehensive trans-European transport network located in the outermost regions. Member States should also have the possibility of introducing derogations in order to avoid disproportionate administrative burdens for those maritime ports of the comprehensive trans-European transport network the annual traffic of which does not justify the full application of this Regulation
  . Pilotage services performed in the deep sea do not have a direct impact on the efficiency of the ports as they are not used for the direct entry and exit of the ports and therefore do not need to be included in this Regulation.

Amendment 5

Proposal for a regulation

Recital 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (4a) | This Regulation does not impose a specific port management model to the managing bodies of ports. Provided that rules relating to market access and financial transparency are respected, existing port management models established at national level in the Member States can be maintained in accordance with Protocol No. 26 to the Treaty on the Functioning of the European Union. |

Text proposed by the Commission

Amendment

(4a)

This Regulation does not impose a specific port management model to the managing bodies of ports. Provided that rules relating to market access and financial transparency are respected, existing port management models established at national level in the Member States can be maintained in accordance with Protocol No. 26 to the Treaty on the Functioning of the European Union.

Amendment 6

Proposal for a regulation

Recital 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| (5) | The objective of Article 56 of the Treaty on the Functioning of the European Union is to eliminate restrictions on freedom to provide services in the Union. In accordance with Article 58 of the Treaty on the Functioning of the European Union should be achieved within the framework of the provisions of the Title relating to transport, more specifically Article 100 (2). |

Text proposed by the Commission

Amendment

(5)

The objective of Article 56 of the Treaty on the Functioning of the European Union is to eliminate restrictions on freedom to provide services in the Union. In accordance with Article 58 of the Treaty on the Functioning of the European Union should be achieved within the framework of the provisions of the Title relating to transport, more specifically Article 100 (2).

deleted

Amendment 7

Proposal for a regulation

Recital 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| (6) | The self-provision of service which entails shipping companies or providers of port services to employ staff of their own choice and to provide themselves port services is regulated in a number of Member States for safety or social reasons. The stakeholders consulted by the Commission when preparing its proposal highlighted that imposing a generalised allowance of the self-provision of service at Union level would require additional rules on safety and social issues in order to avoid possible negative impacts in these areas. It appears therefore appropriate at this stage not to regulate this issue at Union level and to leave it to the Member States to regulate the self-provision of port services or not. Therefore, this Regulation should only cover the provision of port services for remuneration. |

Text proposed by the Commission

Amendment

(6)

The self-provision of service which entails shipping companies or providers of port services to employ staff of their own choice and to provide themselves port services is regulated in a number of Member States for safety or social reasons. The stakeholders consulted by the Commission when preparing its proposal highlighted that imposing a generalised allowance of the self-provision of service at Union level would require additional rules on safety and social issues in order to avoid possible negative impacts in these areas. It appears therefore appropriate at this stage not to regulate this issue at Union level and to leave it to the Member States to regulate the self-provision of port services or not. Therefore, this Regulation should only cover the provision of port services for remuneration.

deleted

Amendment 8

Proposal for a regulation

Recital 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| (7) | In the interest of efficient, safe and environmentally sound port management, the managing body of the port should be able to require that port service providers can demonstrate that they meet minimum requirements to perform the service in an appropriate way. These minimum requirements should be limited to a clearly defined set of conditions concerning the professional qualifications of the operators,
  including in terms of training, and the equipment required insofar as these
  requirements
  are transparent, non-discriminatory, objective and relevant for the provision
  of the port service. |

Text proposed by the Commission

Amendment

(7)

In the interest of efficient, safe and environmentally sound port management, the managing body of the port should be able to require that port service providers can demonstrate that they meet minimum requirements to perform the service in an appropriate way. These minimum requirements should be limited to a clearly defined set of conditions concerning the professional qualifications of the operators,
  including in terms of training, and the equipment required insofar as these
  requirements
  are transparent, non-discriminatory, objective and relevant for the provision
  of the port service.

| (7) | In the interest of efficient, safe and environmentally sound port management, the managing body of the port should be able to require that port service providers can demonstrate that they meet minimum requirements to perform the service in an appropriate way. These minimum requirements should be limited to a clearly defined set of conditions concerning the professional qualifications of the operators,
  the equipment needed in order to provide the relevant port service, the availability of the service and the compliance with maritime safety requirements. These minimum
  requirements
  should also take into account environmental requirements as well as national social standards and the good repute
  of the port service
  provider
  . |
| --- | --- |

(7)

In the interest of efficient, safe and environmentally sound port management, the managing body of the port should be able to require that port service providers can demonstrate that they meet minimum requirements to perform the service in an appropriate way. These minimum requirements should be limited to a clearly defined set of conditions concerning the professional qualifications of the operators,
  the equipment needed in order to provide the relevant port service, the availability of the service and the compliance with maritime safety requirements. These minimum
  requirements
  should also take into account environmental requirements as well as national social standards and the good repute
  of the port service
  provider
  .

Amendment 9

Proposal for a regulation

Recital 7 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (7a) | All service providers, and especially those that are new market entrants, should demonstrate their ability to serve a minimum number of vessels with their own staff and equipment. Service providers should apply the relevant provisions and rules including applicable labour laws, applicable collective agreements, and quality requirements of the port concerned. |

Text proposed by the Commission

Amendment

(7a)

All service providers, and especially those that are new market entrants, should demonstrate their ability to serve a minimum number of vessels with their own staff and equipment. Service providers should apply the relevant provisions and rules including applicable labour laws, applicable collective agreements, and quality requirements of the port concerned.

Amendment 10

Proposal for a regulation

Recital 7 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (7b) | In determining whether a service provider has satisfied the requirement of good repute, the Member State should consider whether there are compelling grounds to doubt the good repute of the provider of port services, its manager, and any other relevant persons as may be determined by Member State, such as convictions or penalties in any Member States for serious offences or infringement of the applicable Union and national law, including in the following fields: social law, labour law, occupational safety law, health law and environmental law. |

Text proposed by the Commission

Amendment

(7b)

In determining whether a service provider has satisfied the requirement of good repute, the Member State should consider whether there are compelling grounds to doubt the good repute of the provider of port services, its manager, and any other relevant persons as may be determined by Member State, such as convictions or penalties in any Member States for serious offences or infringement of the applicable Union and national law, including in the following fields: social law, labour law, occupational safety law, health law and environmental law.

Amendment 11

Proposal for a regulation

Recital 7 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (7c) | In accordance with Council Regulation (EEC) No 3577/92

   (1a)

  and the judgment of the Court of Justice of 11 January 2007 in Case C-251/04, Commission v Hellenic Republic

   (1b)

  , according to which it cannot be inferred that towage can be assimilated to maritime transport service, it is possible for reasons of maritime safety and the protection of the environment for minimum requirements to stipulate that the vessels used for towage or mooring operations be registered in, and fly the flag of the Member State of the port concerned. |

Text proposed by the Commission

Amendment

(7c)

In accordance with Council Regulation (EEC) No 3577/92

   (1a)

  and the judgment of the Court of Justice of 11 January 2007 in Case C-251/04, Commission v Hellenic Republic

   (1b)

  , according to which it cannot be inferred that towage can be assimilated to maritime transport service, it is possible for reasons of maritime safety and the protection of the environment for minimum requirements to stipulate that the vessels used for towage or mooring operations be registered in, and fly the flag of the Member State of the port concerned.

Amendment 12

Proposal for a regulation

Recital 10

| Text proposed by the Commission | Amendment |
| --- | --- |
| (10) | Since ports are constituted of limited geographical areas, access to the market could, in certain cases, be subject to limitations relating to the scarcity of land or in case the land is reserved for certain type of activities in accordance with a formal development plan which plans in a transparent way the land use and with relevant national legislation such as those related to town and country planning objectives. |

Text proposed by the Commission

Amendment

(10)

Since ports are constituted of limited geographical areas, access to the market could, in certain cases, be subject to limitations relating to the scarcity of land or in case the land is reserved for certain type of activities in accordance with a formal development plan which plans in a transparent way the land use and with relevant national legislation such as those related to town and country planning objectives.

deleted

Amendment 13

Proposal for a regulation

Recital 10 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (10a) | The Union's port system is highly diverse and includes many different models for the organisation of port services. Accordingly, a single system would not be appropriate. The managing body of the port or the competent authority should be able to limit the number of providers of a port service, if circumstances so require. |

Text proposed by the Commission

Amendment

(10a)

The Union's port system is highly diverse and includes many different models for the organisation of port services. Accordingly, a single system would not be appropriate. The managing body of the port or the competent authority should be able to limit the number of providers of a port service, if circumstances so require.

Amendment 14

Proposal for a regulation

Recital 11

| Text proposed by the Commission | Amendment |
| --- | --- |
| (11) | Any intention to limit the number of port service providers should be published in advance by the
  competent authority and should be fully justified, in order to give the interested parties the opportunity to comment
  . The criteria for any limitation should be objective, transparent and non-discriminatory. |

Text proposed by the Commission

Amendment

(11)

Any intention to limit the number of port service providers should be published in advance by the
  competent authority and should be fully justified, in order to give the interested parties the opportunity to comment
  . The criteria for any limitation should be objective, transparent and non-discriminatory.

| (11) | Any intention to limit the number of port service providers should be published in advance by the
  managing body of the port or the competent authority
  . The criteria for any limitation should be objective, transparent and non-discriminatory. |
| --- | --- |

(11)

Any intention to limit the number of port service providers should be published in advance by the
  managing body of the port or the competent authority
  . The criteria for any limitation should be objective, transparent and non-discriminatory.

Amendment 15

Proposal for a regulation

Recital 12

| Text proposed by the Commission | Amendment |
| --- | --- |
| (12) | In order to be open and transparent, the
  procedure to
  select the
  providers of port services and its result should be made public and
  full documentation should be communicated to
  interested parties. |

Text proposed by the Commission

Amendment

(12)

In order to be open and transparent, the
  procedure to
  select the
  providers of port services and its result should be made public and
  full documentation should be communicated to
  interested parties.

| (12) | The
  procedure to
  choose
  providers of port services and its result should be made public and
  should be non-discriminatory, transparent, and open to all
  interested parties. |
| --- | --- |

(12)

The
  procedure to
  choose
  providers of port services and its result should be made public and
  should be non-discriminatory, transparent, and open to all
  interested parties.

Amendment 16

Proposal for a regulation

Recital 13

| Text proposed by the Commission | Amendment |
| --- | --- |
| (13) | The selection procedure for providers of port service in the case the number of those providers is limited should follow the principles and approach determined in Directive ../../... [concession]

   (7)

  , including the threshold and method for determining the value of the contracts as well as the definition of substantial modifications and the elements related to the duration of the contract. |

Text proposed by the Commission

Amendment

(13)

The selection procedure for providers of port service in the case the number of those providers is limited should follow the principles and approach determined in Directive ../../... [concession]

   (7)

  , including the threshold and method for determining the value of the contracts as well as the definition of substantial modifications and the elements related to the duration of the contract.

deleted

Amendment 17

Proposal for a regulation

Recital 13 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (13a) | In its interpretative communication of 1 August 2006 on the Community law applicable to contract awards not or not fully subject to the provisions of the Public Procurement Directives

   (2)

  , the Commission has provided a clear framework for the selection procedures which fall outside the scope of the Public Procurement Directives and are not awarded in the form of concessions. |

Text proposed by the Commission

Amendment

(13a)

In its interpretative communication of 1 August 2006 on the Community law applicable to contract awards not or not fully subject to the provisions of the Public Procurement Directives

   (2)

  , the Commission has provided a clear framework for the selection procedures which fall outside the scope of the Public Procurement Directives and are not awarded in the form of concessions.

Amendment 18

Proposal for a regulation

Recital 14

| Text proposed by the Commission | Amendment |
| --- | --- |
| (14) | The recourse to public service obligations leading to a limitation in the number of providers of a port service should only be justified for reasons of public interest in order to ensure the accessibility of the port service to all users, the availability of the port service all year long
  or
  the affordability of the port service to certain category of users. |

Text proposed by the Commission

Amendment

(14)

The recourse to public service obligations leading to a limitation in the number of providers of a port service should only be justified for reasons of public interest in order to ensure the accessibility of the port service to all users, the availability of the port service all year long
  or
  the affordability of the port service to certain category of users.

| (14) | The recourse to public service obligations leading to a limitation in the number of providers of a port service should only be justified for reasons of public interest in order to ensure the accessibility of the port service to all users, the availability of the port service all year long, the affordability of the port service to
  a
  certain category of users
  , or safe, secure or environmentally sustainable port operations
  . |
| --- | --- |

(14)

The recourse to public service obligations leading to a limitation in the number of providers of a port service should only be justified for reasons of public interest in order to ensure the accessibility of the port service to all users, the availability of the port service all year long, the affordability of the port service to
  a
  certain category of users
  , or safe, secure or environmentally sustainable port operations
  .

Amendment 19

Proposal for a regulation

Recital 18

| Text proposed by the Commission | Amendment |
| --- | --- |
| (18) | The
  competent authorities designated in a Member State should have the choice to decide to provide port services
  with public service obligations
  themselves or to entrust directly the provision of such services directly to an internal operator. In the case that a competent authority decides to provide the service itself, this may cover the provision of services through agents employed by the competent authority or commissioned by the competent authority. When such limitation is applied in all the TEN-T
  ports
  in the territory of a Member State, the Commission should be informed. In the cases where the competent authorities in a Member State
  prevail on such a choice
  , the provision of port services by the internal operators should be confined only to the port or ports for which those internal operators were designated. Moreover, in such cases, the port service charges applied by such an operator should be subject to
  supervision by the
  independent
  supervisory body
  . |

Text proposed by the Commission

Amendment

(18)

The
  competent authorities designated in a Member State should have the choice to decide to provide port services
  with public service obligations
  themselves or to entrust directly the provision of such services directly to an internal operator. In the case that a competent authority decides to provide the service itself, this may cover the provision of services through agents employed by the competent authority or commissioned by the competent authority. When such limitation is applied in all the TEN-T
  ports
  in the territory of a Member State, the Commission should be informed. In the cases where the competent authorities in a Member State
  prevail on such a choice
  , the provision of port services by the internal operators should be confined only to the port or ports for which those internal operators were designated. Moreover, in such cases, the port service charges applied by such an operator should be subject to
  supervision by the
  independent
  supervisory body
  .

| (18) | The managing body of the port or the
  competent authorities designated in a Member State should have the choice to decide to provide port services themselves or to entrust directly the provision of such services directly to an internal operator. In the case that a competent authority decides to provide the service itself, this may cover the provision of services through agents employed by the competent authority or commissioned by the competent authority. When such limitation is applied in all the TEN-T
  maritime ports
  in the territory of a Member State, the Commission should be informed. In the cases where the competent authorities in a Member State
  provide a port service under public service obligations
  , the provision of port services by the internal operators should be confined only to the port or ports for which those internal operators were designated. Moreover, in such cases, the port service charges applied by such an operator should be subject to independent
  supervision
  . |
| --- | --- |

(18)

The managing body of the port or the
  competent authorities designated in a Member State should have the choice to decide to provide port services themselves or to entrust directly the provision of such services directly to an internal operator. In the case that a competent authority decides to provide the service itself, this may cover the provision of services through agents employed by the competent authority or commissioned by the competent authority. When such limitation is applied in all the TEN-T
  maritime ports
  in the territory of a Member State, the Commission should be informed. In the cases where the competent authorities in a Member State
  provide a port service under public service obligations
  , the provision of port services by the internal operators should be confined only to the port or ports for which those internal operators were designated. Moreover, in such cases, the port service charges applied by such an operator should be subject to independent
  supervision
  .

Amendment 20

Proposal for a regulation

Recital 19

| Text proposed by the Commission | Amendment |
| --- | --- |
| (19) | Member States should retain the power to ensure an adequate level of social protection for the staff of undertaking providing port services. This Regulation
  shall
  not affect the application of the social and labour rules of the Member States
  . In cases of limitation of the number of port service providers,
  where the conclusion of a port service contract may entail a change of port service operator,
  it should be possible for the competent authorities to ask
  the chosen service operator to apply the provisions of Council Directive 2001/23/EC on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses (11). |

Text proposed by the Commission

Amendment

(19)

Member States should retain the power to ensure an adequate level of social protection for the staff of undertaking providing port services. This Regulation
  shall
  not affect the application of the social and labour rules of the Member States
  . In cases of limitation of the number of port service providers,
  where the conclusion of a port service contract may entail a change of port service operator,
  it should be possible for the competent authorities to ask
  the chosen service operator to apply the provisions of Council Directive 2001/23/EC on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses (11).

| (19) | Member States should retain the power to ensure an adequate level of social protection for the staff of undertaking providing port services. This Regulation
  should
  not affect the application of the social and labour rules of the Member States
  and should take into account Article 28 of the Charter of Fundamental Rights of the European Union.
  Where the conclusion of a port service contract may entail a change of port service operator,
  the competent authority should, in case of transfer of staff, require
  the chosen service operator to apply the provisions of Council Directive 2001/23/EC
  of 12 March 2001
  on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses (11). |
| --- | --- |

(19)

Member States should retain the power to ensure an adequate level of social protection for the staff of undertaking providing port services. This Regulation
  should
  not affect the application of the social and labour rules of the Member States
  and should take into account Article 28 of the Charter of Fundamental Rights of the European Union.
  Where the conclusion of a port service contract may entail a change of port service operator,
  the competent authority should, in case of transfer of staff, require
  the chosen service operator to apply the provisions of Council Directive 2001/23/EC
  of 12 March 2001
  on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses (11).

Amendment 21

Proposal for a regulation

Recital 19 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (19a) | In a highly complex and competitive sector, such as port services, training of new recruits and the lifelong training of staff are essential for ensuring port workers' health and safety, the quality of services and the competitiveness of Union ports. Member States should take the necessary measures to ensure relevant training is provided for every worker in the port sector. The EU-level Sectoral Social Dialogue Committee for Ports should be in a position to develop guidelines for the establishment of training requirements to ensure a high quality of education and training of port workers, to minimise the risk of accidents and to take account of the future needs of the sector in light of technological and logistical changes imposed by customers' demands. |

Text proposed by the Commission

Amendment

(19a)

In a highly complex and competitive sector, such as port services, training of new recruits and the lifelong training of staff are essential for ensuring port workers' health and safety, the quality of services and the competitiveness of Union ports. Member States should take the necessary measures to ensure relevant training is provided for every worker in the port sector. The EU-level Sectoral Social Dialogue Committee for Ports should be in a position to develop guidelines for the establishment of training requirements to ensure a high quality of education and training of port workers, to minimise the risk of accidents and to take account of the future needs of the sector in light of technological and logistical changes imposed by customers' demands.

Amendment 22

Proposal for a regulation

Recital 19 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (19b) | The European port sector is facing a number of challenges that are capable of having an impact both on its competitiveness and on its social dimension. Those challenges include the following: the increasing size of vessels, the competition from non-Union ports, increasing market power as a result of alliances between shipping lines, the need to negotiate, in a timely fashion, new working patterns and to provide adequate training for technological innovation, as well as to minimise its social impact, the growing volumes which are more and more clustered, the lack of adequate investments on hinterland infrastructures, the removal of administrative barriers to the internal market, the changing energy landscape and growing societal and environmental pressure. Member States, together with the social partners, should address these challenges and take measures with the aim of safeguarding both the competitiveness of the sector and of preventing precarious working conditions in ports, despite the fluctuations in demand for port labour. |

Text proposed by the Commission

Amendment

(19b)

The European port sector is facing a number of challenges that are capable of having an impact both on its competitiveness and on its social dimension. Those challenges include the following: the increasing size of vessels, the competition from non-Union ports, increasing market power as a result of alliances between shipping lines, the need to negotiate, in a timely fashion, new working patterns and to provide adequate training for technological innovation, as well as to minimise its social impact, the growing volumes which are more and more clustered, the lack of adequate investments on hinterland infrastructures, the removal of administrative barriers to the internal market, the changing energy landscape and growing societal and environmental pressure. Member States, together with the social partners, should address these challenges and take measures with the aim of safeguarding both the competitiveness of the sector and of preventing precarious working conditions in ports, despite the fluctuations in demand for port labour.

Amendment 23

Proposal for a regulation

Recital 19 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (19c) | All models for the organisation of port labour that secure quality jobs and safe working conditions should be supported by the Commission and the Member States. Any necessary adjustments should only be promoted through negotiations between the social partners, and the Commission should duly take into account the results of such negotiations. |

Text proposed by the Commission

Amendment

(19c)

All models for the organisation of port labour that secure quality jobs and safe working conditions should be supported by the Commission and the Member States. Any necessary adjustments should only be promoted through negotiations between the social partners, and the Commission should duly take into account the results of such negotiations.

Amendment 24

Proposal for a regulation

Recital 19 d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (19d) | Automation and technological innovation offer the opportunity to improve efficiency and safety of ports. Before introducing significant changes, employers and port workers’ unions should cooperate in order to guarantee the necessary training and re-training and to find shared solutions to reduce the negative effects of such progress on occupational health and safety and on employability. |

Text proposed by the Commission

Amendment

(19d)

Automation and technological innovation offer the opportunity to improve efficiency and safety of ports. Before introducing significant changes, employers and port workers’ unions should cooperate in order to guarantee the necessary training and re-training and to find shared solutions to reduce the negative effects of such progress on occupational health and safety and on employability.

Amendment 25

Proposal for a regulation

Recital 20

| Text proposed by the Commission | Amendment |
| --- | --- |
| (20) | In many ports, the market access for providers of cargo-handling and terminal passenger services is granted by means of public concession contracts. This type of contracts will be covered by the Directive .../...[concessions]. Consequently,
  Chapter II of this Regulation should not apply to the provision of cargo-handling and passenger services
  , but Member States should remain free to decide to apply nevertheless the rules of this Chapter to these two services.
  For
  other
  types of contracts used by public authorities for granting market access to cargo handling and terminal passenger services, the Court of Justice of the European Union has confirmed that the competent authorities are bound by the principles of transparency and non-discrimination when concluding these contracts. These principles are fully applicable as regards the provision of any port service. |

Text proposed by the Commission

Amendment

(20)

In many ports, the market access for providers of cargo-handling and terminal passenger services is granted by means of public concession contracts. This type of contracts will be covered by the Directive .../...[concessions]. Consequently,
  Chapter II of this Regulation should not apply to the provision of cargo-handling and passenger services
  , but Member States should remain free to decide to apply nevertheless the rules of this Chapter to these two services.
  For
  other
  types of contracts used by public authorities for granting market access to cargo handling and terminal passenger services, the Court of Justice of the European Union has confirmed that the competent authorities are bound by the principles of transparency and non-discrimination when concluding these contracts. These principles are fully applicable as regards the provision of any port service.

| (20) | Chapter II of this Regulation should not apply to the provision of cargo-handling and passenger services. For types of contracts,
  other than public concession contracts
  , used by public authorities for granting market access to cargo handling and terminal passenger services, the Court of Justice of the European Union has confirmed that the competent authorities are bound by the principles of transparency and non-discrimination when concluding these contracts. These principles are fully applicable as regards the provision of any port service. |
| --- | --- |

(20)

Chapter II of this Regulation should not apply to the provision of cargo-handling and passenger services. For types of contracts,
  other than public concession contracts
  , used by public authorities for granting market access to cargo handling and terminal passenger services, the Court of Justice of the European Union has confirmed that the competent authorities are bound by the principles of transparency and non-discrimination when concluding these contracts. These principles are fully applicable as regards the provision of any port service.

Amendment 26

Proposal for a regulation

Recital 20 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (20a) | According to Resolution A.960 of the International Maritime Organization (IMO), each pilotage area needs highly specialised experience and local knowledge on the part of the pilot. Given that the IMO recognises the appropriateness of regional or local administration of pilotage, pilotage should not be subject to Chapter II of this Regulation. |

Text proposed by the Commission

Amendment

(20a)

According to Resolution A.960 of the International Maritime Organization (IMO), each pilotage area needs highly specialised experience and local knowledge on the part of the pilot. Given that the IMO recognises the appropriateness of regional or local administration of pilotage, pilotage should not be subject to Chapter II of this Regulation.

Amendment 27

Proposal for a regulation

Recital 21 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (21a) | The Connecting Europe Facility provides that ports in the Trans-European Transport Network are able to benefit from Union subsidies during the ongoing 2014-2020 period. Furthermore, the Commission intends to set up a revised framework on state aid to ports and, given that Directive 2014/23/EU of the European Parliament and of the Council

   (1a)

  also establishes a new legislative framework for concession contracts which will also affect port services provided under a concession agreement, strict rules on the transparency of financial flows need to be introduced in this Regulation to prevent unfair competition between ports in the Union or dumping. |

Text proposed by the Commission

Amendment

(21a)

The Connecting Europe Facility provides that ports in the Trans-European Transport Network are able to benefit from Union subsidies during the ongoing 2014-2020 period. Furthermore, the Commission intends to set up a revised framework on state aid to ports and, given that Directive 2014/23/EU of the European Parliament and of the Council

   (1a)

  also establishes a new legislative framework for concession contracts which will also affect port services provided under a concession agreement, strict rules on the transparency of financial flows need to be introduced in this Regulation to prevent unfair competition between ports in the Union or dumping.

Amendment 28

Proposal for a regulation

Recital 22

| Text proposed by the Commission | Amendment |
| --- | --- |
| (22) | It is necessary to impose on the managing body of the port which receives public funds, when it is also acting as a service provider, an obligation to keep separate accounts for activities carried out in their capacity as managing body of the port from those carried out on a competitive basis in order to ensure a level playing field, transparency in the allocation and use of public funds and to avoid market distortions. In any case compliance with the State aid rules should be ensured. |

Text proposed by the Commission

Amendment

(22)

It is necessary to impose on the managing body of the port which receives public funds, when it is also acting as a service provider, an obligation to keep separate accounts for activities carried out in their capacity as managing body of the port from those carried out on a competitive basis in order to ensure a level playing field, transparency in the allocation and use of public funds and to avoid market distortions. In any case compliance with the State aid rules should be ensured.

| (22) | It is necessary to impose on the managing body of the port which receives public funds, when it is also acting as a service provider, an obligation to keep separate accounts for
  publicly funded
  activities carried out in their capacity as managing body of the port from those carried out on a competitive basis in order to ensure a level playing field, transparency in the allocation and use of public funds and to avoid market distortions. In any case compliance with the State aid rules should be ensured. |
| --- | --- |

(22)

It is necessary to impose on the managing body of the port which receives public funds, when it is also acting as a service provider, an obligation to keep separate accounts for
  publicly funded
  activities carried out in their capacity as managing body of the port from those carried out on a competitive basis in order to ensure a level playing field, transparency in the allocation and use of public funds and to avoid market distortions. In any case compliance with the State aid rules should be ensured.

Amendment 29

Proposal for a regulation

Recital 22 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (22a) | Maritime ports with a turnover below the threshold provided for in Commission Directive 2006/111/EC should meet the transparency obligations contained in Article 12 of this Regulation in a proportionate way, without being subjected to a disproportionate administrative burden. |

Text proposed by the Commission

Amendment

(22a)

Maritime ports with a turnover below the threshold provided for in Commission Directive 2006/111/EC should meet the transparency obligations contained in Article 12 of this Regulation in a proportionate way, without being subjected to a disproportionate administrative burden.

Amendment 30

Proposal for a regulation

Recital 22 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (22b) | With a view to ensuring fair competition and to reducing administrative burdens, the Commission should, in writing, clarify the notion of State aid with regard to the financing of port infrastructures, taking into consideration the fact that public access and defence infrastructure, whether maritime or on land, which is accessible to all potential users on equal and non-discriminatory terms, and infrastructure that is linked to the operation of Services of General non-economic Interest, have a non-economic nature since their goals are predominantly public in nature; such infrastructures fall within the State's responsibility to meet the general needs of the population. |

Text proposed by the Commission

Amendment

(22b)

With a view to ensuring fair competition and to reducing administrative burdens, the Commission should, in writing, clarify the notion of State aid with regard to the financing of port infrastructures, taking into consideration the fact that public access and defence infrastructure, whether maritime or on land, which is accessible to all potential users on equal and non-discriminatory terms, and infrastructure that is linked to the operation of Services of General non-economic Interest, have a non-economic nature since their goals are predominantly public in nature; such infrastructures fall within the State's responsibility to meet the general needs of the population.

Amendment 31

Proposal for a regulation

Recital 22 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (22c) | Moreover, the Commission should, in a timely manner and in consultation with the sector, identify which public investments in port infrastructure fall within the scope of Commission Regulation (EU) No 651/2014 (General Block Exemption Regulation)

   (1a)

  . |

Text proposed by the Commission

Amendment

(22c)

Moreover, the Commission should, in a timely manner and in consultation with the sector, identify which public investments in port infrastructure fall within the scope of Commission Regulation (EU) No 651/2014 (General Block Exemption Regulation)

   (1a)

  .

Amendment 32

Proposal for a regulation

Recital 23

| Text proposed by the Commission | Amendment |
| --- | --- |
| (23) | Port service charges applied by providers of port services which are not designated in accordance with an open, transparent and non-discriminatory procedure
  entail a higher risk of price abuse given their monopolistic or oligopolistic situation
  and the
  fact that their market cannot be contested. The same is true for charges levied by internal operators in the meaning of this Regulation
  . For those services, in the absence of fair market mechanisms, arrangements should be established to ensure that the charges
  they levy reflect the normal conditions
  of the
  relevant market
  and are set in a transparent and non-discriminatory way. |

Text proposed by the Commission

Amendment

(23)

Port service charges applied by providers of port services which are not designated in accordance with an open, transparent and non-discriminatory procedure
  entail a higher risk of price abuse given their monopolistic or oligopolistic situation
  and the
  fact that their market cannot be contested. The same is true for charges levied by internal operators in the meaning of this Regulation
  . For those services, in the absence of fair market mechanisms, arrangements should be established to ensure that the charges
  they levy reflect the normal conditions
  of the
  relevant market
  and are set in a transparent and non-discriminatory way.

| (23) | Port service charges applied by providers of port services which are not designated in accordance with an open, transparent and non-discriminatory procedure and the
  charges applied by providers of pilotage services, which are not exposed to effective competition, entail a higher risk of price abuse
  . For those services, in the absence of fair market mechanisms, arrangements should be established to ensure that the charges
  levied are not disproportionate to the economic value
  of the
  services provided
  and are set in a transparent and non-discriminatory way. |
| --- | --- |

(23)

Port service charges applied by providers of port services which are not designated in accordance with an open, transparent and non-discriminatory procedure and the
  charges applied by providers of pilotage services, which are not exposed to effective competition, entail a higher risk of price abuse
  . For those services, in the absence of fair market mechanisms, arrangements should be established to ensure that the charges
  levied are not disproportionate to the economic value
  of the
  services provided
  and are set in a transparent and non-discriminatory way.

Amendment 33

Proposal for a regulation

Recital 24

| Text proposed by the Commission | Amendment |
| --- | --- |
| (24) | In order to be efficient
  , the port infrastructure charges of each individual port should be set in a transparent and autonomous way in accordance with that port's own commercial and investment strategy. |

Text proposed by the Commission

Amendment

(24)

In order to be efficient
  , the port infrastructure charges of each individual port should be set in a transparent and autonomous way in accordance with that port's own commercial and investment strategy.

| (24) | The role of the managing body of the port is, inter alia, to facilitate trade and to act as an intermediary between regional industry and transport operators. Therefore, in the interest of efficiency
  , the port infrastructure charges of each individual port should be set in a transparent and autonomous way in accordance with that port's own commercial and investment strategy. |
| --- | --- |

(24)

The role of the managing body of the port is, inter alia, to facilitate trade and to act as an intermediary between regional industry and transport operators. Therefore, in the interest of efficiency
  , the port infrastructure charges of each individual port should be set in a transparent and autonomous way in accordance with that port's own commercial and investment strategy.

Amendment 34

Proposal for a regulation

Recital 25

| Text proposed by the Commission | Amendment |
| --- | --- |
| (25) | The variation of port infrastructure charges should be allowed in order to promote short sea shipping and to attract waterborne vessels having an environmental performance or energy and carbon efficiency of the transport operations, notably the off-shore or on-shore maritime transport operations, that is better than average. This should help to contribute to the environmental and climate change policies and the sustainable development of the port and its surroundings notably by contributing to reducing the environmental footprint of the waterborne vessels calling and staying in the port. |

Text proposed by the Commission

Amendment

(25)

The variation of port infrastructure charges should be allowed in order to promote short sea shipping and to attract waterborne vessels having an environmental performance or energy and carbon efficiency of the transport operations, notably the off-shore or on-shore maritime transport operations, that is better than average. This should help to contribute to the environmental and climate change policies and the sustainable development of the port and its surroundings notably by contributing to reducing the environmental footprint of the waterborne vessels calling and staying in the port.

| (25) | The variation of port infrastructure charges
  is an important tool for the managing body of the port and
  should be allowed
  . Port infrastructure charges may vary, for example,
  in order to promote short sea shipping and to attract waterborne vessels having an environmental performance or energy and carbon efficiency of the transport operations, notably the off-shore or on-shore maritime transport operations, that is better than average. This should help to contribute to the environmental and climate change policies and the sustainable development of the port and its surroundings notably by contributing to reducing the environmental footprint of the waterborne vessels calling and staying in the port. |
| --- | --- |

(25)

The variation of port infrastructure charges
  is an important tool for the managing body of the port and
  should be allowed
  . Port infrastructure charges may vary, for example,
  in order to promote short sea shipping and to attract waterborne vessels having an environmental performance or energy and carbon efficiency of the transport operations, notably the off-shore or on-shore maritime transport operations, that is better than average. This should help to contribute to the environmental and climate change policies and the sustainable development of the port and its surroundings notably by contributing to reducing the environmental footprint of the waterborne vessels calling and staying in the port.

Amendment 35

Proposal for a regulation

Recital 26

| Text proposed by the Commission | Amendment |
| --- | --- |
| (26) | Adequate facilities should be in place to ensure
  that the users of the ports which are requested to pay a port infrastructure charge and/or a port service charge are regularly consulted when the port infrastructure charge and the port service charge are defined and changed. The managing bodies of the ports should also regularly consult other stakeholders on key issues related to the sound development of the port, its performance and its capacity to attract and generate economic activities such as the coordination of port services within the port area and the efficiency of the connections with the hinterland and of the administrative procedures in ports. |

Text proposed by the Commission

Amendment

(26)

Adequate facilities should be in place to ensure
  that the users of the ports which are requested to pay a port infrastructure charge and/or a port service charge are regularly consulted when the port infrastructure charge and the port service charge are defined and changed. The managing bodies of the ports should also regularly consult other stakeholders on key issues related to the sound development of the port, its performance and its capacity to attract and generate economic activities such as the coordination of port services within the port area and the efficiency of the connections with the hinterland and of the administrative procedures in ports.

| (26) | It
  should
  be ensured
  that the users of the ports which are requested to pay a port infrastructure charge and/or a port service charge are regularly consulted when the port infrastructure charge and the port service charge are defined and changed. The managing bodies of the ports should also regularly consult other stakeholders on key issues related to the sound development of the port, its performance and its capacity to attract and generate economic activities such as the coordination of port services within the port area and the efficiency of the connections with the hinterland and of the administrative procedures in ports.
  The managing body of the port should engage private investors, who make large significant investments in ports, in sustainable consultation regarding port development plans. |
| --- | --- |

(26)

It
  should
  be ensured
  that the users of the ports which are requested to pay a port infrastructure charge and/or a port service charge are regularly consulted when the port infrastructure charge and the port service charge are defined and changed. The managing bodies of the ports should also regularly consult other stakeholders on key issues related to the sound development of the port, its performance and its capacity to attract and generate economic activities such as the coordination of port services within the port area and the efficiency of the connections with the hinterland and of the administrative procedures in ports.
  The managing body of the port should engage private investors, who make large significant investments in ports, in sustainable consultation regarding port development plans.

Amendment 36

Proposal for a regulation

Recital 27

| Text proposed by the Commission | Amendment |
| --- | --- |
| (27) | In order to ensure
  the proper and effective application of this Regulation, an
  independent
  supervisory body, which could be an
  already existing
  body, should
  be designated
  in every Member State
  . |

Text proposed by the Commission

Amendment

(27)

In order to ensure
  the proper and effective application of this Regulation, an
  independent
  supervisory body, which could be an
  already existing
  body, should
  be designated
  in every Member State
  .

| (27) | In order to ensure
  that an independent complaints mechanism is in place, one or more bodies providing
  independent
  supervision should be designated by each Member State. It should be possible for
  already existing
  bodies, such as competition authorities, courts, ministries or departments within ministries not linked to the managing body of the port, to
  be designated
  for this purpose
  . |
| --- | --- |

(27)

In order to ensure
  that an independent complaints mechanism is in place, one or more bodies providing
  independent
  supervision should be designated by each Member State. It should be possible for
  already existing
  bodies, such as competition authorities, courts, ministries or departments within ministries not linked to the managing body of the port, to
  be designated
  for this purpose
  .

Amendment 37

Proposal for a regulation

Recital 28

| Text proposed by the Commission | Amendment |
| --- | --- |
| (28) | The
  different
  independent supervisory bodies
  should exchange information on their work
  and cooperate in order to ensure a uniform application of this Regulation
  . |

Text proposed by the Commission

Amendment

(28)

The
  different
  independent supervisory bodies
  should exchange information on their work
  and cooperate in order to ensure a uniform application of this Regulation
  .

| (28) | In cases concerning cross-border disputes and complaints, the
  different
  bodies providing independent supervision
  should
  cooperate with each other and
  exchange information on their work |
| --- | --- |

(28)

In cases concerning cross-border disputes and complaints, the
  different
  bodies providing independent supervision
  should
  cooperate with each other and
  exchange information on their work

Amendment 38

Proposal for a regulation

Recital 28 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (28a) | Port labour relations have a large influence on the functioning of the ports. The EU-level Sectoral Social Dialogue Committee for Ports therefore gives the social partners a framework to establish results regarding work organisation and working conditions, such as health and safety, training and qualifications, Union policy on low sulphur fuels, and the attractiveness of the sector to young workers and female workers. |

Text proposed by the Commission

Amendment

(28a)

Port labour relations have a large influence on the functioning of the ports. The EU-level Sectoral Social Dialogue Committee for Ports therefore gives the social partners a framework to establish results regarding work organisation and working conditions, such as health and safety, training and qualifications, Union policy on low sulphur fuels, and the attractiveness of the sector to young workers and female workers.

Amendment 39

Proposal for a regulation

Recital 29

| Text proposed by the Commission | Amendment |
| --- | --- |
| (29) | In order to supplement and amend certain non-essential elements of this Regulation and in particular to promote the uniform application of environmental charging, reinforce the Union-wide coherence of environmental charging and to ensure common charging principles in relation to the promotion of short sea shipping, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of common classifications of vessels, fuels and types of operations according to which to vary the infrastructure charges and common charging principles for port infrastructure charges. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council. |

Text proposed by the Commission

Amendment

(29)

In order to supplement and amend certain non-essential elements of this Regulation and in particular to promote the uniform application of environmental charging, reinforce the Union-wide coherence of environmental charging and to ensure common charging principles in relation to the promotion of short sea shipping, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of common classifications of vessels, fuels and types of operations according to which to vary the infrastructure charges and common charging principles for port infrastructure charges. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

deleted

Amendment 40

Proposal for a regulation

Recital 30

| Text proposed by the Commission | Amendment |
| --- | --- |
| (30) | In order to ensure uniform conditions for the implementation of this Regulation implementing powers relating to appropriate arrangements for the exchange of information between independent supervisory bodies should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers

   (13)

  . |

Text proposed by the Commission

Amendment

(30)

In order to ensure uniform conditions for the implementation of this Regulation implementing powers relating to appropriate arrangements for the exchange of information between independent supervisory bodies should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers

   (13)

  .

deleted

Amendment 41

Proposal for a regulation

Recital 30 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (30a) | The Commission is invited to submit a legislative proposal concerning Pilotage Exemption Certificates (PECs) in order to encourage their use in all Member States so as to improve efficiency in ports, and in particular to stimulate short sea shipping, where safety conditions allow it. The specific requirements on the basis of which PECs are to be issued should be defined by the Member States after a risk assessment and should take into account local conditions. The requirements should be transparent, non-discriminatory and proportionate. |

Text proposed by the Commission

Amendment

(30a)

The Commission is invited to submit a legislative proposal concerning Pilotage Exemption Certificates (PECs) in order to encourage their use in all Member States so as to improve efficiency in ports, and in particular to stimulate short sea shipping, where safety conditions allow it. The specific requirements on the basis of which PECs are to be issued should be defined by the Member States after a risk assessment and should take into account local conditions. The requirements should be transparent, non-discriminatory and proportionate.

Amendment 42

Proposal for a regulation

Recital 31

| Text proposed by the Commission | Amendment |
| --- | --- |
| (31) | Since the objectives of this Regulation, namely ensuring
  the modernisation
  of port services and the appropriate framework to attract necessary investments in all the
  ports
  of the trans-European transport network, cannot be sufficiently achieved by the Member States because of the European dimension, international and cross-border nature of port and related maritime business and can therefore, by reason of the need for a European level playing field, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. |

Text proposed by the Commission

Amendment

(31)

Since the objectives of this Regulation, namely ensuring
  the modernisation
  of port services and the appropriate framework to attract necessary investments in all the
  ports
  of the trans-European transport network, cannot be sufficiently achieved by the Member States because of the European dimension, international and cross-border nature of port and related maritime business and can therefore, by reason of the need for a European level playing field, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

| (31) | Since the objectives of this Regulation, namely ensuring
  a framework for the organisation
  of port services and the appropriate framework to attract necessary investments in all the
  maritime ports
  of the trans-European transport network, cannot be sufficiently achieved by the Member States because of the European dimension, international and cross-border nature of port and related maritime business and can therefore, by reason of the need for a European level playing field, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
  Union ports should be protected against third countries ports which are not subject to the same organisation and operation criteria of this Regulation. |
| --- | --- |

(31)

Since the objectives of this Regulation, namely ensuring
  a framework for the organisation
  of port services and the appropriate framework to attract necessary investments in all the
  maritime ports
  of the trans-European transport network, cannot be sufficiently achieved by the Member States because of the European dimension, international and cross-border nature of port and related maritime business and can therefore, by reason of the need for a European level playing field, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
  Union ports should be protected against third countries ports which are not subject to the same organisation and operation criteria of this Regulation.

Amendment 43

Proposal for a regulation

Recital 31 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (31a) | Port labour relations have a significant influence on the activities and functioning of the ports. Therefore the EU-level Sectoral Social Dialogue Committee for Ports should be able to provide the Union social partners with a framework for the possible adoption of common results regarding social issues related to port labour relations. The Commission should, where necessary, facilitate and support the negotiations, as well as provide technical assistance to them, while respecting the autonomy of the social partners. The Union social partners should have the possibility to report on any progress made, if they so wish, to enable that the Commission to take into account their outcomes when reporting on the effects of this Regulation. |

Text proposed by the Commission

Amendment

(31a)

Port labour relations have a significant influence on the activities and functioning of the ports. Therefore the EU-level Sectoral Social Dialogue Committee for Ports should be able to provide the Union social partners with a framework for the possible adoption of common results regarding social issues related to port labour relations. The Commission should, where necessary, facilitate and support the negotiations, as well as provide technical assistance to them, while respecting the autonomy of the social partners. The Union social partners should have the possibility to report on any progress made, if they so wish, to enable that the Commission to take into account their outcomes when reporting on the effects of this Regulation.

Amendment 44

Proposal for a regulation

Article 1 — paragraph 1 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | a clear framework for
  access to the market
  of port services; |

Text proposed by the Commission

Amendment

(a)

a clear framework for
  access to the market
  of port services;

| (a) | a clear framework for
  the organisation
  of port services; |
| --- | --- |

(a)

a clear framework for
  the organisation
  of port services;

Amendment 45

Proposal for a regulation

Article 1 — paragraph 1 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | common rules on the financial transparency and charges to be applied by managing bodies or providers of port services. |

Text proposed by the Commission

Amendment

(b)

common rules on the financial transparency and charges to be applied by managing bodies or providers of port services.

| (b) | common rules on the financial transparency and charges to be applied by managing bodies or providers of port services
  covered by this Regulation
  . |
| --- | --- |

(b)

common rules on the financial transparency and charges to be applied by managing bodies or providers of port services
  covered by this Regulation
  .

Amendment 46

Proposal for a regulation

Article 1 — paragraph 2 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | dredging; |

Text proposed by the Commission

Amendment

(c)

dredging;

deleted

Amendment 47

Proposal for a regulation

Article 1 — paragraph 2 — subparagraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | In addition, Article 12(2) of this Regulation shall also apply to dredging. |

Text proposed by the Commission

Amendment

In addition, Article 12(2) of this Regulation shall also apply to dredging.

Amendment 48

Proposal for a regulation

Article 1 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   This Regulation shall apply to all
  seaports
  of the trans-European transport network,
  as defined
  in Annex
  I
  of Regulation
  XXX [regulation on the TEN-T Guidelines]
  . | 3.   This Regulation shall apply to all
  maritime ports
  of the trans-European transport network,
  listed
  in Annex
  II
  of Regulation (EU) No 1315/2013 of the European Parliament and the Council

   (1a). |

Text proposed by the Commission

Amendment

3.   This Regulation shall apply to all
  seaports
  of the trans-European transport network,
  as defined
  in Annex
  I
  of Regulation
  XXX [regulation on the TEN-T Guidelines]
  .

3.   This Regulation shall apply to all
  maritime ports
  of the trans-European transport network,
  listed
  in Annex
  II
  of Regulation (EU) No 1315/2013 of the European Parliament and the Council

   (1a).

Amendment 49

Proposal for a regulation

Article 1 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  This Regulation is without prejudice to any port structure which respects the principles referred to in paragraphs 1(a) and 1(b). |

Text proposed by the Commission

Amendment

3a.
     
  This Regulation is without prejudice to any port structure which respects the principles referred to in paragraphs 1(a) and 1(b).

Amendment 50

Proposal for a regulation

Article 1 — paragraph 3 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3b.
     
  Member States may decide not to apply this Regulation to maritime ports of the comprehensive trans-European transport network located in the outermost regions as referred to in Article 349 TFEU. When Member States decide not to apply this Regulation to such maritime ports, they shall notify that decision to the Commission. |

Text proposed by the Commission

Amendment

3b.
     
  Member States may decide not to apply this Regulation to maritime ports of the comprehensive trans-European transport network located in the outermost regions as referred to in Article 349 TFEU. When Member States decide not to apply this Regulation to such maritime ports, they shall notify that decision to the Commission.

Amendment 51

Proposal for a regulation

Article 2 — paragraph 1 — point 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2. | ‘cargo handling services’ means the organisation and handling of cargo between the carrying waterborne vessel and the shore be it for import, export or transit of the cargo, including the processing, transporting and temporary storage of the cargo on the relevant cargo handling terminal and directly related to the transporting of the cargo, but excluding warehousing, stripping, repackaging or any other value added services related to the handled cargo; |

Text proposed by the Commission

Amendment

2.

‘cargo handling services’ means the organisation and handling of cargo between the carrying waterborne vessel and the shore be it for import, export or transit of the cargo, including the processing, transporting and temporary storage of the cargo on the relevant cargo handling terminal and directly related to the transporting of the cargo, but excluding warehousing, stripping, repackaging or any other value added services related to the handled cargo;

| 2. | ‘cargo handling services’ means the organisation and handling of cargo between the carrying waterborne vessel and the shore, be it for import, export or transit of the cargo, including the processing,
  lashing, unlashing, stowing,
  transporting and temporary storage of the cargo on the relevant cargo handling terminal and directly related to the transporting of the cargo, but excluding
  unless the Member State determines otherwise,
  warehousing, stripping, repackaging or any other value added services related to the handled cargo; |
| --- | --- |

2.

‘cargo handling services’ means the organisation and handling of cargo between the carrying waterborne vessel and the shore, be it for import, export or transit of the cargo, including the processing,
  lashing, unlashing, stowing,
  transporting and temporary storage of the cargo on the relevant cargo handling terminal and directly related to the transporting of the cargo, but excluding
  unless the Member State determines otherwise,
  warehousing, stripping, repackaging or any other value added services related to the handled cargo;

Amendment 52

Proposal for a regulation

Article 2 — paragraph 1 — point 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2 a. | ‘competent authority’ means any public or private body which, on behalf of a local, regional or national level, is entitled to carry out under national law or instruments activities related to the organisation and management of port activities, in conjunction with or alternatively to the managing body of the port; |

Text proposed by the Commission

Amendment

2 a.

Amendment 53

Proposal for a regulation

Article 2 — paragraph 1 — point 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3. | ‘dredging’ means the removal of sand, sediment or other substances from the bottom of the waterway access to a port in order to allow waterborne vessel to have access to the port and comprises both the initial removal (capital dredging) and the maintenance dredging in order to keep the waterway accessible; |

Text proposed by the Commission

Amendment

3.

‘dredging’ means the removal of sand, sediment or other substances from the bottom of the waterway access to a port in order to allow waterborne vessel to have access to the port and comprises both the initial removal (capital dredging) and the maintenance dredging in order to keep the waterway accessible;

| 3. | ‘dredging’ means the removal of sand, sediment or other substances from the bottom of the waterway access to a port in order to allow waterborne vessel to have access to the port and comprises both the initial removal (capital dredging) and the maintenance dredging in order to keep the waterway accessible
  and is not a port service offered to the user
  ; |
| --- | --- |

3.

‘dredging’ means the removal of sand, sediment or other substances from the bottom of the waterway access to a port in order to allow waterborne vessel to have access to the port and comprises both the initial removal (capital dredging) and the maintenance dredging in order to keep the waterway accessible
  and is not a port service offered to the user
  ;

Amendment 54

Proposal for a regulation

Article 2 — paragraph 1 — point 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5. | ‘managing body of the port’ means any public or private body which, whether or not in conjunction with other activities, has as its objective
  under
  national law or instruments the administration and management of the port infrastructures,
  port traffic,
  the coordination and, where appropriate,
  the
  control of the activities of the operators present in the port concerned; |

Text proposed by the Commission

Amendment

5.

‘managing body of the port’ means any public or private body which, whether or not in conjunction with other activities, has as its objective
  under
  national law or instruments the administration and management of the port infrastructures,
  port traffic,
  the coordination and, where appropriate,
  the
  control of the activities of the operators present in the port concerned;

| 5. | ‘managing body of the port’ means any public or private body which, whether or not in conjunction with other activities, has as its objective
  authorised by
  national law or instruments the administration and management of the port infrastructures
  and
  ,
  where appropriate,
  the coordination
  carrying-out, organisation or
  control of the activities of the operators present in the port concerned
  , the administration of and management of port traffic and the development of the port area
  ; |
| --- | --- |

5.

‘managing body of the port’ means any public or private body which, whether or not in conjunction with other activities, has as its objective
  authorised by
  national law or instruments the administration and management of the port infrastructures
  and
  ,
  where appropriate,
  the coordination
  carrying-out, organisation or
  control of the activities of the operators present in the port concerned
  , the administration of and management of port traffic and the development of the port area
  ;

Amendment 55

Proposal for a regulation

Article 2 — paragraph 1 — point 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6. | ‘mooring’ means the berthing
  and
  un-berthing services required for a waterborne vessel
  being anchored or otherwise fastened to the shore in the port or in the waterways access to the port
  ; |

Text proposed by the Commission

Amendment

6.

‘mooring’ means the berthing
  and
  un-berthing services required for a waterborne vessel
  being anchored or otherwise fastened to the shore in the port or in the waterways access to the port
  ;

| 6. | ‘mooring’ means the
  safe
  berthing, un-berthing
  and shifting
  services required for a waterborne vessel; |
| --- | --- |

6.

‘mooring’ means the
  safe
  berthing, un-berthing
  and shifting
  services required for a waterborne vessel;

Amendment 56

Proposal for a regulation

Article 2 — paragraph 1 — point 8

| Text proposed by the Commission | Amendment |
| --- | --- |
| 8. | ‘pilotage’ means the guidance service of a waterborne vessel by a pilot or a pilotage station in order to allow for a safe entry or exit of the vessel in the waterways access to the port; |

Text proposed by the Commission

Amendment

8.

‘pilotage’ means the guidance service of a waterborne vessel by a pilot or a pilotage station in order to allow for a safe entry or exit of the vessel in the waterways access to the port;

| 8. | ‘pilotage’ means the guidance service of a waterborne vessel by a pilot or a pilotage station in order to allow for a safe entry or exit of the vessel in the waterways access to the
  port or safe navigation within
  the port; |
| --- | --- |

8.

‘pilotage’ means the guidance service of a waterborne vessel by a pilot or a pilotage station in order to allow for a safe entry or exit of the vessel in the waterways access to the
  port or safe navigation within
  the port;

Amendment 57

Proposal for a regulation

Article 2 — paragraph 1 — point 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| 9. | ‘port infrastructure charge’ means a fee collected for the direct or indirect benefit of the managing body of the port and paid by the operators of waterborne vessels or cargo owners for the use of facilities and services that allow vessels entry and exit in and out of the port, including the waterways giving access to
  those ports
  , as well as access to the processing of passengers and cargo; |

Text proposed by the Commission

Amendment

9.

‘port infrastructure charge’ means a fee collected for the direct or indirect benefit of the managing body of the port and paid by the operators of waterborne vessels or cargo owners for the use of facilities and services that allow vessels entry and exit in and out of the port, including the waterways giving access to
  those ports
  , as well as access to the processing of passengers and cargo;

| 9. | ‘port infrastructure charge’ means a fee collected for the direct or indirect benefit of the managing body of the port and paid by the operators of waterborne vessels or cargo owners for the use of
  infrastructures,
  facilities and services that allow vessels entry and exit in and out of the port, including the waterways giving access to
  the port, if such waterways fall within the legal competence of the managing body of the port
  , as well as access to the processing of passengers and cargo
  , but excluding land lease rates and charges having equivalent effect
  ; |
| --- | --- |

9.

‘port infrastructure charge’ means a fee collected for the direct or indirect benefit of the managing body of the port and paid by the operators of waterborne vessels or cargo owners for the use of
  infrastructures,
  facilities and services that allow vessels entry and exit in and out of the port, including the waterways giving access to
  the port, if such waterways fall within the legal competence of the managing body of the port
  , as well as access to the processing of passengers and cargo
  , but excluding land lease rates and charges having equivalent effect
  ;

Amendment 58

Proposal for a regulation

Article 2 — paragraph 1 — point 12

| Text proposed by the Commission | Amendment |
| --- | --- |
| 12. | ‘port service contract’ means a formal and legally binding agreement between a provider of port service and a competent authority whereby
  this
  body designates a provider of port service to provide port services following a procedure to limit the number of providers of port services; |

Text proposed by the Commission

Amendment

12.

‘port service contract’ means a formal and legally binding agreement between a provider of port service and a competent authority whereby
  this
  body designates a provider of port service to provide port services following a procedure to limit the number of providers of port services;

| 12. | ‘port service contract’ means a formal and legally binding agreement between a provider of port service and
  the managing body of the port or
  a competent authority whereby
  that
  body
  or authority
  designates a provider of port service to provide port services following a procedure to limit the number of providers of port services; |
| --- | --- |

12.

‘port service contract’ means a formal and legally binding agreement between a provider of port service and
  the managing body of the port or
  a competent authority whereby
  that
  body
  or authority
  designates a provider of port service to provide port services following a procedure to limit the number of providers of port services;

Amendment 59

Proposal for a regulation

Article 2 — paragraph 1 — point 16

| Text proposed by the Commission | Amendment |
| --- | --- |
| 16. | ‘seaport’
  means an area of land and water made up of
  such works and equipment
  so as to permit, principally, the reception of ships, their loading and unloading, the storage of goods, the receipt and delivery of these goods and the embarkation and disembarkation of passengers
  ; and any other infrastructure necessary for transport operators within the port area
  ; |

Text proposed by the Commission

Amendment

16.

‘seaport’
  means an area of land and water made up of
  such works and equipment
  so as to permit, principally, the reception of ships, their loading and unloading, the storage of goods, the receipt and delivery of these goods and the embarkation and disembarkation of passengers
  ; and any other infrastructure necessary for transport operators within the port area
  ;

| 16. | ‘
  maritime port
  ’ means
  a delimited
  area of land and water
  , managed by the managing body of the port and
  made up of
  infrastructures and facilities
  so as to permit, principally, the reception of ships, their loading and unloading, the storage of goods, the receipt and delivery of these goods and the embarkation and disembarkation of passengers and
  staff
  ; |
| --- | --- |

16.

‘
  maritime port
  ’ means
  a delimited
  area of land and water
  , managed by the managing body of the port and
  made up of
  infrastructures and facilities
  so as to permit, principally, the reception of ships, their loading and unloading, the storage of goods, the receipt and delivery of these goods and the embarkation and disembarkation of passengers and
  staff
  ;

Amendment 60

Proposal for a regulation

Article 2 — point 17

| Text proposed by the Commission | Amendment |
| --- | --- |
| 17. | ‘towage’ means the assistance to a waterborne vessel by means of a tug in order to allow for a safe entry or exit of the port by providing assistance to the manoeuvring of the waterborne vessel; |

Text proposed by the Commission

Amendment

17.

‘towage’ means the assistance to a waterborne vessel by means of a tug in order to allow for a safe entry or exit of the port by providing assistance to the manoeuvring of the waterborne vessel;

| 17. | ‘towage’ means the assistance to a waterborne vessel by means of a tug in order to allow for a safe entry or exit of the port
  or safe navigation within the port
  by providing assistance to the manoeuvring of the waterborne vessel; |
| --- | --- |

17.

‘towage’ means the assistance to a waterborne vessel by means of a tug in order to allow for a safe entry or exit of the port
  or safe navigation within the port
  by providing assistance to the manoeuvring of the waterborne vessel;

Amendment 61

Proposal for a regulation

Article 2 — paragraph 1 — point 18

| Text proposed by the Commission | Amendment |
| --- | --- |
| 18. | ‘waterway access to a port’ means water access to the port from the open sea, such as port approaches, fairways, rivers, sea canals and fjords. |

Text proposed by the Commission

Amendment

18.

‘waterway access to a port’ means water access to the port from the open sea, such as port approaches, fairways, rivers, sea canals and fjords.

| 18. | ‘waterway access to a port’ means water access to the port from the open sea, such as port approaches, fairways, rivers, sea canals and fjords
  , if such a waterway falls within the legal competence of the managing body of the port
  . |
| --- | --- |

18.

‘waterway access to a port’ means water access to the port from the open sea, such as port approaches, fairways, rivers, sea canals and fjords
  , if such a waterway falls within the legal competence of the managing body of the port
  .

Amendment 62

Proposal for a regulation

Chapter II — title

| Text proposed by the Commission | Amendment |
| --- | --- |
| Market access | Organisation of port services |

Text proposed by the Commission

Amendment

Market access

Organisation of port services

Amendment 63

Proposal for a regulation

Article 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| Article 3 | deleted |
| Freedom to provide services | |
| 1.
     
  Freedom to provide services in seaports covered by this Regulation shall apply to the providers of port services established in the Union under the conditions set out in this Chapter. | |
| 2.
     
  Providers of port services shall have access to essential port facilities to the extent necessary for them to carry out their activities. The terms of the access shall be fair, reasonable and non-discriminatory. | |

Text proposed by the Commission

Amendment

Article 3

deleted

Freedom to provide services

1.
     
  Freedom to provide services in seaports covered by this Regulation shall apply to the providers of port services established in the Union under the conditions set out in this Chapter.

2.
     
  Providers of port services shall have access to essential port facilities to the extent necessary for them to carry out their activities. The terms of the access shall be fair, reasonable and non-discriminatory.

Amendment 64

Proposal for a regulation

Article 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 3 a |
| | Freedom to organise port services |
| | 1.
     
  With regard to this Regulation, the organisation of port services covered by this Chapter may be subject to: |
| | (a) | minimum requirements to port service providers; |

Text proposed by the Commission

Amendment

Article 3 a

Freedom to organise port services

1.
     
  With regard to this Regulation, the organisation of port services covered by this Chapter may be subject to:

(a)

minimum requirements to port service providers;

| (b) | limitations of the number of providers; |
| --- | --- |

(b)

limitations of the number of providers;

| (c) | public service obligations; |
| --- | --- |

(c)

public service obligations;

| (d) | internal operators; |
| --- | --- |

(d)

internal operators;

| (e) | free open access to the market of port services. |
| --- | --- |

(e)

free open access to the market of port services.

2.
     
  When organising port services as foreseen in paragraph 1 the conditions put forward in this Chapter shall be respected.

Amendment 65

Proposal for a regulation

Article 4 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   
  The
  managing body of the port may require that providers of port services comply with minimum requirements to perform the corresponding port service. | 1.   
  Without prejudice to the possibility of imposing public service obligations, provided for in Article 8, the
  managing body of the port
  or the competent authority
  may require that providers of port services
  , including subcontractors,
  comply with minimum requirements to perform the corresponding port service. |

Text proposed by the Commission

Amendment

1.   
  The
  managing body of the port may require that providers of port services comply with minimum requirements to perform the corresponding port service.

1.   
  Without prejudice to the possibility of imposing public service obligations, provided for in Article 8, the
  managing body of the port
  or the competent authority
  may require that providers of port services
  , including subcontractors,
  comply with minimum requirements to perform the corresponding port service.

Amendment 66

Proposal for a regulation

Article 4 — paragraph 2 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The minimum requirements provided for in paragraph 1
  may only
  relate
  , where applicable,
  to: | 2.   The minimum requirements provided for in paragraph 1 relate to: |

Text proposed by the Commission

Amendment

2.   The minimum requirements provided for in paragraph 1
  may only
  relate
  , where applicable,
  to:

2.   The minimum requirements provided for in paragraph 1 relate to:

Amendment 67

Proposal for a regulation

Article 4 — paragraph 2 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | the equipment needed to provide the relevant port service in normal and safe conditions and the capacity to maintain this equipment at the
  appropriate
  level; |

Text proposed by the Commission

Amendment

(b)

the equipment needed to provide the relevant port service in normal and safe conditions and the capacity to maintain this equipment at the
  appropriate
  level;

| (b) | the equipment needed to provide the relevant port service in normal and safe conditions
  in a continuous manner
  and the
  technical and financial
  capacity to maintain this equipment at the
  required
  level; |
| --- | --- |

(b)

the equipment needed to provide the relevant port service in normal and safe conditions
  in a continuous manner
  and the
  technical and financial
  capacity to maintain this equipment at the
  required
  level;

Amendment 68

Proposal for a regulation

Article 4 — paragraph 2 — point b a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ba) | the availability of the port service to all users, at all berths and without interruptions day and night, throughout the year; |

Text proposed by the Commission

Amendment

(ba)

the availability of the port service to all users, at all berths and without interruptions day and night, throughout the year;

Amendment 69

Proposal for a regulation

Article 4 — paragraph 2 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | the compliance with requirements on the maritime safety or the safety and security of the port or access to it, its installations, equipment and persons; |

Text proposed by the Commission

Amendment

(c)

the compliance with requirements on the maritime safety or the safety and security of the port or access to it, its installations, equipment and persons;

| (c) | the compliance with requirements on the maritime safety or the safety and security of the port or access to it, its installations, equipment
  , workers
  and
  other
  persons; |
| --- | --- |

(c)

the compliance with requirements on the maritime safety or the safety and security of the port or access to it, its installations, equipment
  , workers
  and
  other
  persons;

Amendment 70

Proposal for a regulation

Article 4 — paragraph 2 — point d a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (da) | the compliance with national social and labour legislation of the Member State of the port concerned, including the terms of collective bargaining agreements; |

Text proposed by the Commission

Amendment

(da)

the compliance with national social and labour legislation of the Member State of the port concerned, including the terms of collective bargaining agreements;

Amendment 71

Proposal for a regulation

Article 4 — paragraph 2 — point d b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (db) | the good repute of the port service provider, as determined by the Member State. |

Text proposed by the Commission

Amendment

(db)

the good repute of the port service provider, as determined by the Member State.

Amendment 72

Proposal for a regulation

Article 4 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  Under no circumstances shall the implementation of this Regulation constitute grounds for a reduction in the level of minimum requirements for the provision of port services that have already been imposed by Member States or competent authorities. |

Text proposed by the Commission

Amendment

3a.
     
  Under no circumstances shall the implementation of this Regulation constitute grounds for a reduction in the level of minimum requirements for the provision of port services that have already been imposed by Member States or competent authorities.

Amendment 73

Proposal for a regulation

Article 4 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   Where the minimum requirements include specific local knowledge or acquaints with local conditions, the managing body of the port shall ensure that adequate access to
  relevant training
  exists, under transparent and non-discriminatory conditions
  , unless adequate access to such training is ensured by the Member State
  . | 4.   Where the minimum requirements include specific local knowledge or acquaints with local conditions, the managing body of the port shall ensure that adequate access to
  information
  exists, under transparent and non-discriminatory conditions. |

Text proposed by the Commission

Amendment

4.   Where the minimum requirements include specific local knowledge or acquaints with local conditions, the managing body of the port shall ensure that adequate access to
  relevant training
  exists, under transparent and non-discriminatory conditions
  , unless adequate access to such training is ensured by the Member State
  .

4.   Where the minimum requirements include specific local knowledge or acquaints with local conditions, the managing body of the port shall ensure that adequate access to
  information
  exists, under transparent and non-discriminatory conditions.

Amendment 74

Proposal for a regulation

Article 4 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.   In the cases provided for in paragraph 1, the minimum requirements referred to in paragraph 2 and the procedure for the granting of the right to provide port services under those requirements shall have been published by the managing body of the port
  by 1 July 2015
  or for minimum requirements being applicable after that date at least three months before the date on which those requirements would become applicable. Providers of port services shall be informed in advance of any change in the criteria and of the procedure. | 5.   In the cases provided for in paragraph 1, the minimum requirements referred to in paragraph 2 and the procedure for the granting of the right to provide port services under those requirements shall have been published by the managing body of the port by ...
   (*1) or for minimum requirements being applicable after that date at least three months before the date on which those requirements would become applicable. Providers of port services shall be informed in advance of any change in the criteria and of the procedure. |

Text proposed by the Commission

Amendment

5.   In the cases provided for in paragraph 1, the minimum requirements referred to in paragraph 2 and the procedure for the granting of the right to provide port services under those requirements shall have been published by the managing body of the port
  by 1 July 2015
  or for minimum requirements being applicable after that date at least three months before the date on which those requirements would become applicable. Providers of port services shall be informed in advance of any change in the criteria and of the procedure.

5.   In the cases provided for in paragraph 1, the minimum requirements referred to in paragraph 2 and the procedure for the granting of the right to provide port services under those requirements shall have been published by the managing body of the port by ...
   (*1) or for minimum requirements being applicable after that date at least three months before the date on which those requirements would become applicable. Providers of port services shall be informed in advance of any change in the criteria and of the procedure.

Amendment 75

Proposal for a regulation

Article 4 — paragraph 5 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 5a.
     
  In order to ensure maritime safety and the protection of the environment, the Member State or the competent authority may require that the ships used for towage or mooring operations are registered in and fly the flag Member State of the port concerned. |

Text proposed by the Commission

Amendment

5a.
     
  In order to ensure maritime safety and the protection of the environment, the Member State or the competent authority may require that the ships used for towage or mooring operations are registered in and fly the flag Member State of the port concerned.

Amendment 76

Proposal for a regulation

Article 5 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   The managing body of the port shall treat providers of port services equally and shall act in a transparent manner. | 1.   The managing body of the port
  or the competent authority
  shall treat providers of port services equally and shall act in a transparent
  , objective, non-discriminatory and proportionate
  manner. |

Text proposed by the Commission

Amendment

1.   The managing body of the port shall treat providers of port services equally and shall act in a transparent manner.

1.   The managing body of the port
  or the competent authority
  shall treat providers of port services equally and shall act in a transparent
  , objective, non-discriminatory and proportionate
  manner.

Amendment 77

Proposal for a regulation

Article 5 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The managing body of the port shall grant or refuse the right to provide port services on the basis of the minimum requirements established in accordance with Article 4 within
  one month
  from receiving a request for the granting of such a right. Any refusal shall be duly justified on the basis of objective, transparent, non-discriminatory and proportionate criteria. | 2.   The managing body of the port
  or the competent authority
  shall grant or refuse the right to provide port services on the basis of the minimum requirements established in accordance with Article 4
  . It shall do so
  within
  a reasonable time, and in any event not exceeding four months,
  from receiving a request for the granting of such a right and the necessary documents. Any refusal shall be duly justified on the basis of objective, transparent, non-discriminatory and proportionate criteria. |

Text proposed by the Commission

Amendment

2.   The managing body of the port shall grant or refuse the right to provide port services on the basis of the minimum requirements established in accordance with Article 4 within
  one month
  from receiving a request for the granting of such a right. Any refusal shall be duly justified on the basis of objective, transparent, non-discriminatory and proportionate criteria.

2.   The managing body of the port
  or the competent authority
  shall grant or refuse the right to provide port services on the basis of the minimum requirements established in accordance with Article 4
  . It shall do so
  within
  a reasonable time, and in any event not exceeding four months,
  from receiving a request for the granting of such a right and the necessary documents. Any refusal shall be duly justified on the basis of objective, transparent, non-discriminatory and proportionate criteria.

Amendment 78

Proposal for a regulation

Article 6 — paragraph - 1 (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | -1.
     


  In the cases referred to in Article 9 of this Regulation, where the managing body of the port is not a contracting authority within the meaning of Directive 2014/24/EU of the European Parliament and of the Council

   (1a)

  , this Article shall not apply. |

Text proposed by the Commission

Amendment

-1.
     


  In the cases referred to in Article 9 of this Regulation, where the managing body of the port is not a contracting authority within the meaning of Directive 2014/24/EU of the European Parliament and of the Council

   (1a)

  , this Article shall not apply.

Amendment 79

Proposal for a regulation

Article 6 — paragraph 1 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   
  By way of derogation from Article 3
  , the managing body of the port may limit the number of providers of port service for a given port service for one or several of the following reasons: | 1.   
  Without prejudice to the existing different models for the organisation of port services
  , the managing body of the port
  or the competent authority
  may limit the number of providers of port service for a given port service for one or several of the following reasons: |

Text proposed by the Commission

Amendment

1.   
  By way of derogation from Article 3
  , the managing body of the port may limit the number of providers of port service for a given port service for one or several of the following reasons:

1.   
  Without prejudice to the existing different models for the organisation of port services
  , the managing body of the port
  or the competent authority
  may limit the number of providers of port service for a given port service for one or several of the following reasons:

Amendment 80

Proposal for a regulation

Article 6 — paragraph 1 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | the scarcity or reserved use of land provided that the managing body can demonstrate that the land constitutes
  an essential
  port facility
  to provide the port service
  and that the limitation is in accordance with the formal development plan of the port
  as
  agreed by the management body of the port and where appropriate any other public competent authorities
  according to the
  national legislation; |

Text proposed by the Commission

Amendment

(a)

the scarcity or reserved use of land provided that the managing body can demonstrate that the land constitutes
  an essential
  port facility
  to provide the port service
  and that the limitation is in accordance with the formal development plan of the port
  as
  agreed by the management body of the port and where appropriate any other public competent authorities
  according to the
  national legislation;

| (a) | the scarcity or reserved use of land provided that the managing body can demonstrate that the land constitutes
  a
  port facility
  which is essential for the provision of port services
  and that the limitation is
  , where applicable,
  in accordance with
  decisions or plans
  agreed by the management body of the port and where appropriate any other public competent authorities
  in conformity with
  national legislation; |
| --- | --- |

(a)

the scarcity or reserved use of land provided that the managing body can demonstrate that the land constitutes
  a
  port facility
  which is essential for the provision of port services
  and that the limitation is
  , where applicable,
  in accordance with
  decisions or plans
  agreed by the management body of the port and where appropriate any other public competent authorities
  in conformity with
  national legislation;

Amendment 81

Proposal for a regulation

Article 6 — paragraph 1 — point a a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (aa) | the scarcity of waterside space, where this constitutes an essential element of the ability to provide the port service concerned in a safe and efficient way; |

Text proposed by the Commission

Amendment

(aa)

the scarcity of waterside space, where this constitutes an essential element of the ability to provide the port service concerned in a safe and efficient way;

Amendment 82

Proposal for a regulation

Article 6 — paragraph 1 — point a b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ab) | the inability of the characteristics of the port traffic to enable multiple providers of port services to operate in economically satisfactory conditions in the port; |

Text proposed by the Commission

Amendment

(ab)

the inability of the characteristics of the port traffic to enable multiple providers of port services to operate in economically satisfactory conditions in the port;

Amendment 83

Proposal for a regulation

Article 6 — paragraph 1 — point a c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ac) | the need to ensure the provision of safe, secure or environmentally sustainable port operations; |

Text proposed by the Commission

Amendment

(ac)

the need to ensure the provision of safe, secure or environmentally sustainable port operations;

Amendment 84

Proposal for a regulation

Article 6 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  Any limitation of providers for a port service shall follow a selection procedure, which shall be open to all interested parties, non-discriminatory and transparent. The managing body of the port shall communicate to all interested parties all necessary information concerning the organisation of the selection procedure and the submission deadline, as well as all relevant award criteria and requirements. The submission deadline shall be long enough to allow interested parties to make a meaningful assessment and prepare their application, under normal circumstances the minimum limit shall be 30 days. |

Text proposed by the Commission

Amendment

3a.
     
  Any limitation of providers for a port service shall follow a selection procedure, which shall be open to all interested parties, non-discriminatory and transparent. The managing body of the port shall communicate to all interested parties all necessary information concerning the organisation of the selection procedure and the submission deadline, as well as all relevant award criteria and requirements. The submission deadline shall be long enough to allow interested parties to make a meaningful assessment and prepare their application, under normal circumstances the minimum limit shall be 30 days.

Amendment 85

Proposal for a regulation

Article 6 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   When a managing body of a port provides port services itself or through a legally distinct entity which it directly or indirectly controls, the Member State may entrust the adoption of the decision limiting the number of providers of port services to an authority which is independent from the managing body of the port. If the Member State does not entrust the adoption of the decision limiting the number of providers of port services to such an authority, the number of providers shall not be less than two. | 4.   When a managing body of a port provides port services itself or through a legally distinct entity which it directly or indirectly controls, the Member State
  shall take necessary measures to avoid conflicts of interest. In absence of such measures,
  the number of providers shall not be less than two
  , unless any of the reasons set out in paragraph 1 justifies a limitation to a single provider
  . |

Text proposed by the Commission

Amendment

4.   When a managing body of a port provides port services itself or through a legally distinct entity which it directly or indirectly controls, the Member State may entrust the adoption of the decision limiting the number of providers of port services to an authority which is independent from the managing body of the port. If the Member State does not entrust the adoption of the decision limiting the number of providers of port services to such an authority, the number of providers shall not be less than two.

4.   When a managing body of a port provides port services itself or through a legally distinct entity which it directly or indirectly controls, the Member State
  shall take necessary measures to avoid conflicts of interest. In absence of such measures,
  the number of providers shall not be less than two
  , unless any of the reasons set out in paragraph 1 justifies a limitation to a single provider
  .

Amendment 86

Proposal for a regulation

Article 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| Article 7 | deleted |
| Procedure for the limitation of the number of providers of port services | |
| 1.
     
  Any limitation of the number of providers for a port service in accordance with Article 6 shall follow a selection procedure which shall be open to all interested parties, non-discriminatory and transparent. | |
| 2.
     
  If the estimated value of the port service exceeds the threshold defined in paragraph 3, the rules on the award procedure, the procedural guarantees and the maximum duration of the concessions as set out in Directive ..../.... [concession] shall apply. | |
| 3.
     
  The threshold and the method to determine the value of the port service shall be those of the relevant and applicable provisions of Directive ..../.... [concession]. | |
| 4.
     
  The selected provider or providers and the managing body of the port shall conclude a port service contract. | |
| 5.
     
  For the purposes of this Regulation, a substantial modification within the meaning of Directive ..../... [concession] of the provisions of a port service contract during its term shall be considered as a new port service contract and shall require a new procedure as referred to in paragraph 2. | |
| 6.
     
  Paragraphs 1 to 5 of this Article shall not apply in the cases referred to in Article 9. | |
| 7.
     
  This Regulation is without prejudice to Directive .../... [concession]

   (15)

  , Directive ..../....[public utilities]

   (16)

  and Directive .../... [public procurement]

   (17) | |

Text proposed by the Commission

Amendment

Article 7

deleted

Procedure for the limitation of the number of providers of port services

1.
     
  Any limitation of the number of providers for a port service in accordance with Article 6 shall follow a selection procedure which shall be open to all interested parties, non-discriminatory and transparent.

2.
     
  If the estimated value of the port service exceeds the threshold defined in paragraph 3, the rules on the award procedure, the procedural guarantees and the maximum duration of the concessions as set out in Directive ..../.... [concession] shall apply.

3.
     
  The threshold and the method to determine the value of the port service shall be those of the relevant and applicable provisions of Directive ..../.... [concession].

4.
     
  The selected provider or providers and the managing body of the port shall conclude a port service contract.

5.
     
  For the purposes of this Regulation, a substantial modification within the meaning of Directive ..../... [concession] of the provisions of a port service contract during its term shall be considered as a new port service contract and shall require a new procedure as referred to in paragraph 2.

6.
     
  Paragraphs 1 to 5 of this Article shall not apply in the cases referred to in Article 9.

7.
     
  This Regulation is without prejudice to Directive .../... [concession]

   (15)

  , Directive ..../....[public utilities]

   (16)

  and Directive .../... [public procurement]

   (17)

Amendment 87

Proposal for a regulation

Article 8 — paragraph 1 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   
  Member States
  may decide to impose public service obligations related to port services on providers in order to ensure the following: | 1.   
  The Member States shall designate the competent authority within their territory, which may be the managing body of the port, entitled
  to
  implement
  public service obligations related to port services on providers in order to ensure
  at least one of
  the following: |

Text proposed by the Commission

Amendment

1.   
  Member States
  may decide to impose public service obligations related to port services on providers in order to ensure the following:

1.   
  The Member States shall designate the competent authority within their territory, which may be the managing body of the port, entitled
  to
  implement
  public service obligations related to port services on providers in order to ensure
  at least one of
  the following:

Amendment 88

Proposal for a regulation

Article 8 — paragraph 1 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | the availability of the service to all users; |

Text proposed by the Commission

Amendment

(b)

the availability of the service to all users;

| (b) | the availability of the service to all users
  , where appropriate on equal terms
  ; |
| --- | --- |

(b)

the availability of the service to all users
  , where appropriate on equal terms
  ;

Amendment 89

Proposal for a regulation

Article 8 — paragraph 1 — point c a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ca) | the safety, security or environmental sustainability of ports operations; |

Text proposed by the Commission

Amendment

(ca)

the safety, security or environmental sustainability of ports operations;

Amendment 90

Proposal for a regulation

Article 8 — paragraph 1 — point c b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (cb) | the provision of adequate transport services to the public and territorial cohesion. |

Text proposed by the Commission

Amendment

(cb)

the provision of adequate transport services to the public and territorial cohesion.

Amendment 91

Proposal for a regulation

Article 8 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.
     
  The Member States shall designate the competent authorities within their territory to impose such public service obligations. The managing body of the port may be the competent authority. | deleted |

Text proposed by the Commission

Amendment

3.
     
  The Member States shall designate the competent authorities within their territory to impose such public service obligations. The managing body of the port may be the competent authority.

deleted

Amendment 92

Proposal for a regulation

Article 8 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   When the competent authority designated in accordance with
  paragraph 3
  is different from the managing body of the port, that competent authority shall exercise the powers provided for in
  Articles 6 and 7
  concerning the limitation of the number of providers of port services based on public service obligations. | 4.   When the competent authority designated in accordance with
  paragraph 1 of this Article
  is different from the managing body of the port, that competent authority shall exercise the powers provided for in
  Article 6
  concerning the limitation of the number of providers of port services based on public service obligations. |

Text proposed by the Commission

Amendment

4.   When the competent authority designated in accordance with
  paragraph 3
  is different from the managing body of the port, that competent authority shall exercise the powers provided for in
  Articles 6 and 7
  concerning the limitation of the number of providers of port services based on public service obligations.

4.   When the competent authority designated in accordance with
  paragraph 1 of this Article
  is different from the managing body of the port, that competent authority shall exercise the powers provided for in
  Article 6
  concerning the limitation of the number of providers of port services based on public service obligations.

Amendment 93

Proposal for a regulation

Article 8 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.   If a 
  competent authority
  decides to impose public service obligations in all
  the seaports
  covered by this Regulation in a Member State, it shall notify these obligations to the Commission. | 5.   If a 
  Member State
  decides to impose public service obligations in all
  the maritime ports
  covered by this Regulation in a Member State, it shall notify these obligations to the Commission. |

Text proposed by the Commission

Amendment

5.   If a 
  competent authority
  decides to impose public service obligations in all
  the seaports
  covered by this Regulation in a Member State, it shall notify these obligations to the Commission.

5.   If a 
  Member State
  decides to impose public service obligations in all
  the maritime ports
  covered by this Regulation in a Member State, it shall notify these obligations to the Commission.

Amendment 94

Proposal for a regulation

Article 8 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6.   In the event of a disruption of port services for which public service obligations are imposed or when an immediate risk of such a situation occurs, the competent authority may take an emergency measure. The emergency measure may take the form of a direct award so as to attribute the service to a different provider for a period up to one year. During that time period, the competent authority shall either launch a new procedure to select a provider of port service
  in accordance with Article 7
  or shall apply Article 9. | 6.   In the event of a disruption of port services for which public service obligations are imposed or when an immediate risk of such a situation occurs, the competent authority may take an emergency measure. The emergency measure may take the form of a direct award so as to attribute the service to a different provider for a period up to one year. During that time period, the competent authority shall either launch a new procedure to select a provider of port service or shall apply Article 9.
  Collective industrial action taking place in accordance with national legislation of the respective Member State and/or applicable agreements between the social partners shall not be considered a disruption of port services for which emergency measures may be taken. |

Text proposed by the Commission

Amendment

6.   In the event of a disruption of port services for which public service obligations are imposed or when an immediate risk of such a situation occurs, the competent authority may take an emergency measure. The emergency measure may take the form of a direct award so as to attribute the service to a different provider for a period up to one year. During that time period, the competent authority shall either launch a new procedure to select a provider of port service
  in accordance with Article 7
  or shall apply Article 9.

6.   In the event of a disruption of port services for which public service obligations are imposed or when an immediate risk of such a situation occurs, the competent authority may take an emergency measure. The emergency measure may take the form of a direct award so as to attribute the service to a different provider for a period up to one year. During that time period, the competent authority shall either launch a new procedure to select a provider of port service or shall apply Article 9.
  Collective industrial action taking place in accordance with national legislation of the respective Member State and/or applicable agreements between the social partners shall not be considered a disruption of port services for which emergency measures may be taken.

Amendment 95

Proposal for a regulation

Article 9 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   
  In the cases provided for in Article 6 (1) (b),
  the competent authority may decide to provide a port service
  under public service obligations
  itself or
  to impose such obligations directly on
  a legally distinct entity over which it exercises a control similar to that exercised over its own departments. In such a case, the port service provider shall be considered as an internal operator for the purpose of this Regulation. | 1.   
  The managing body of the port or
  the competent authority may decide to provide a port service itself or
  through
  a legally distinct entity over which it exercises a control similar to that exercised over its own departments,
  provided that Article 4 applies equally to all operators providing the service concerned
  . In such a case, the port service provider shall be considered as an internal operator for the purpose of this Regulation. |

Text proposed by the Commission

Amendment

1.   
  In the cases provided for in Article 6 (1) (b),
  the competent authority may decide to provide a port service
  under public service obligations
  itself or
  to impose such obligations directly on
  a legally distinct entity over which it exercises a control similar to that exercised over its own departments. In such a case, the port service provider shall be considered as an internal operator for the purpose of this Regulation.

1.   
  The managing body of the port or
  the competent authority may decide to provide a port service itself or
  through
  a legally distinct entity over which it exercises a control similar to that exercised over its own departments,
  provided that Article 4 applies equally to all operators providing the service concerned
  . In such a case, the port service provider shall be considered as an internal operator for the purpose of this Regulation.

Amendment 96

Proposal for a regulation

Article 9 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The competent authority shall be considered as exercising a control of a legally distinct entity similar to that exercised to its own departments only if it exercises a decisive influence over both the strategic objectives and the significant decisions of the
  controlled
  legal entity. | 2.   
  The managing body of the port or
  the competent authority shall be considered as exercising a control of a legally distinct entity similar to that exercised to its own departments only if it exercises a decisive influence over both the strategic objectives and the significant decisions of the legal entity
  concerned
  . |

Text proposed by the Commission

Amendment

2.   The competent authority shall be considered as exercising a control of a legally distinct entity similar to that exercised to its own departments only if it exercises a decisive influence over both the strategic objectives and the significant decisions of the
  controlled
  legal entity.

2.   
  The managing body of the port or
  the competent authority shall be considered as exercising a control of a legally distinct entity similar to that exercised to its own departments only if it exercises a decisive influence over both the strategic objectives and the significant decisions of the legal entity
  concerned
  .

Amendment 97

Proposal for a regulation

Article 9 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   
  The
  internal operator shall be confined to perform the assigned port service only in the port(s) for which the assignment to provide the port service has been attributed to him. | 3.   
  In the cases provided for in Article 8, the
  internal operator shall be confined to perform the assigned port service only in the port(s) for which the assignment to provide the port service has been attributed to him. |

Text proposed by the Commission

Amendment

3.   
  The
  internal operator shall be confined to perform the assigned port service only in the port(s) for which the assignment to provide the port service has been attributed to him.

3.   
  In the cases provided for in Article 8, the
  internal operator shall be confined to perform the assigned port service only in the port(s) for which the assignment to provide the port service has been attributed to him.

Amendment 98

Proposal for a regulation

Article 10 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Without prejudice to national and Union law including collective agreements between social partners, the
  managing bodies of the port may
  require the designated provider of port services
  appointed in accordance with the procedure established by Article 7
  , in
  the
  case where this provider is different from the incumbent provider of port services, to grant staff previously taken on by the incumbent provider of port services the rights to which they would have been entitled if there had been a transfer within the meaning of Directive 2001/23/EC. | 2.   Without prejudice to national and Union law, including
  representative
  collective agreements between social partners, the
  competent authority shall
  require the designated provider of port services to grant staff
  working conditions on the basis of binding national, regional or local social standards. In
  case
  of a transfer of staff due to a change of service
  provider
  , the staff
  previously taken on by the incumbent provider of port services
  shall be granted
  the
  same
  rights to which they would have been entitled if there had been a transfer within the meaning of Directive 2001/23/EC. |

Text proposed by the Commission

Amendment

2.   Without prejudice to national and Union law including collective agreements between social partners, the
  managing bodies of the port may
  require the designated provider of port services
  appointed in accordance with the procedure established by Article 7
  , in
  the
  case where this provider is different from the incumbent provider of port services, to grant staff previously taken on by the incumbent provider of port services the rights to which they would have been entitled if there had been a transfer within the meaning of Directive 2001/23/EC.

2.   Without prejudice to national and Union law, including
  representative
  collective agreements between social partners, the
  competent authority shall
  require the designated provider of port services to grant staff
  working conditions on the basis of binding national, regional or local social standards. In
  case
  of a transfer of staff due to a change of service
  provider
  , the staff
  previously taken on by the incumbent provider of port services
  shall be granted
  the
  same
  rights to which they would have been entitled if there had been a transfer within the meaning of Directive 2001/23/EC.

Amendment 99

Proposal for a regulation

Article 10 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   
  Where
  managing bodies of the port require providers of port services to comply with
  certain
  social standards as
  regards the provision of relevant port services
  , tender documents and port service contracts shall list the staff concerned and give transparent details of their contractual rights and the conditions under which employees are deemed to be linked to the port services. | 3.   
  The
  managing bodies of the port
  or the competent authority shall
  require
  all
  providers of port services to comply with
  all
  social
  and labour
  standards as
  set out in Union and/or national law, as well as applicable collective agreements in accordance with national customs and traditions. When, in the context of the provision of relevant port services, a transfer of staff occurs,
  , tender documents and port service contracts shall list the staff concerned and give transparent details of their contractual rights and the conditions under which employees are deemed to be linked to the port services. |

Text proposed by the Commission

Amendment

3.   
  Where
  managing bodies of the port require providers of port services to comply with
  certain
  social standards as
  regards the provision of relevant port services
  , tender documents and port service contracts shall list the staff concerned and give transparent details of their contractual rights and the conditions under which employees are deemed to be linked to the port services.

3.   
  The
  managing bodies of the port
  or the competent authority shall
  require
  all
  providers of port services to comply with
  all
  social
  and labour
  standards as
  set out in Union and/or national law, as well as applicable collective agreements in accordance with national customs and traditions. When, in the context of the provision of relevant port services, a transfer of staff occurs,
  , tender documents and port service contracts shall list the staff concerned and give transparent details of their contractual rights and the conditions under which employees are deemed to be linked to the port services.

Amendment 100

Proposal for a regulation

Article 10 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 10 a |
| | Training and labour protection |
| | 1.
     
  The employer shall ensure that its employees receive the necessary training to acquire a sound knowledge of the conditions in which their work is conducted and that they are properly trained to tackle the hazards which the work may entail. |
| | 2.
     
  In full respect of the autonomy of social partners, the EU-level Sectoral Social Dialogue Committee for Ports is invited to develop guidelines for the establishment of training requirements to prevent accidents and ensure the highest level of safety and health for workers. Such training requirements shall be regularly updated in order to reduce on an ongoing basis the occurrence of accidents at the workplace. |
| | 3.
     
  The social partners are invited to develop models which ensure a balance between the fluctuation in the demand for port work and flexibility required by port operations, on the one hand, and continuity and protection of employment, on the other hand. |

Text proposed by the Commission

Amendment

Article 10 a

Training and labour protection

1.
     
  The employer shall ensure that its employees receive the necessary training to acquire a sound knowledge of the conditions in which their work is conducted and that they are properly trained to tackle the hazards which the work may entail.

2.
     
  In full respect of the autonomy of social partners, the EU-level Sectoral Social Dialogue Committee for Ports is invited to develop guidelines for the establishment of training requirements to prevent accidents and ensure the highest level of safety and health for workers. Such training requirements shall be regularly updated in order to reduce on an ongoing basis the occurrence of accidents at the workplace.

3.
     
  The social partners are invited to develop models which ensure a balance between the fluctuation in the demand for port work and flexibility required by port operations, on the one hand, and continuity and protection of employment, on the other hand.

Amendment 101

Proposal for a regulation

Article 11

| Text proposed by the Commission | Amendment |
| --- | --- |
| This Chapter and the transitional provisions of Article 24 shall not apply to cargo handling services
  and
  passenger services. | This Chapter
  , with the exception of Article 10a,
  and the transitional provisions of Article 24 shall not apply to cargo handling services, passenger services
  and pilotage
  . |

Text proposed by the Commission

Amendment

This Chapter and the transitional provisions of Article 24 shall not apply to cargo handling services
  and
  passenger services.

This Chapter
  , with the exception of Article 10a,
  and the transitional provisions of Article 24 shall not apply to cargo handling services, passenger services
  and pilotage
  .

Amendment 102

Proposal for a regulation

Article 12 — paragraph 2 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Where the managing body of the port that receives public funds provides port services itself, it shall keep the accounts of
  each port service
  activity separate from the accounts of its other activities, in such a way that: | 2.   Where the managing body of the port that receives public funds provides port services
  or dredging
  itself, it shall keep the accounts of
  that publicly funded
  activity
  or investment
  separate from the accounts of its other activities, in such a way that: |

Text proposed by the Commission

Amendment

2.   Where the managing body of the port that receives public funds provides port services itself, it shall keep the accounts of
  each port service
  activity separate from the accounts of its other activities, in such a way that:

2.   Where the managing body of the port that receives public funds provides port services
  or dredging
  itself, it shall keep the accounts of
  that publicly funded
  activity
  or investment
  separate from the accounts of its other activities, in such a way that:

Amendment 103

Proposal for a regulation

Article 12 — paragraph 2 — subparagraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | When a managing body of the port, or an association of ports, carries out dredging itself and receives public funds for this activity, it shall not carry out dredging in other Member States. |

Text proposed by the Commission

Amendment

When a managing body of the port, or an association of ports, carries out dredging itself and receives public funds for this activity, it shall not carry out dredging in other Member States.

Amendment 104

Proposal for a regulation

Article 12 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   The public funds referred to in paragraph 1 shall include share capital or quasi-capital funds, non-refundable grants, grants only refundable in certain circumstances, award of loans including overdrafts and advances on capital injections, guarantees given to the managing body of the port by public authorities
  , dividends paid out and profits retained
  or any other form of public financial support. | 3.   The public funds referred to in paragraph 1 shall include share capital or quasi-capital funds, non-refundable grants, grants only refundable in certain circumstances, award of loans including overdrafts and advances on capital injections, guarantees given to the managing body of the port by public authorities or any other form of public financial support. |

Text proposed by the Commission

Amendment

3.   The public funds referred to in paragraph 1 shall include share capital or quasi-capital funds, non-refundable grants, grants only refundable in certain circumstances, award of loans including overdrafts and advances on capital injections, guarantees given to the managing body of the port by public authorities
  , dividends paid out and profits retained
  or any other form of public financial support.

3.   The public funds referred to in paragraph 1 shall include share capital or quasi-capital funds, non-refundable grants, grants only refundable in certain circumstances, award of loans including overdrafts and advances on capital injections, guarantees given to the managing body of the port by public authorities or any other form of public financial support.

Amendment 105

Proposal for a regulation

Article 12 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   The managing body of the port shall keep the information concerning the financial relations as referred to in paragraphs 1 and 2 of this Article at the disposal of the Commission and of the
  competent independent supervisory body as referred to in
  Article 17 for five years from the end of the fiscal year to which the information refers. | 4.   The managing body of the port shall keep the information concerning the financial relations as referred to in paragraphs 1 and 2 of this Article at the disposal of the Commission and of the
  body designated pursuant to
  Article 17 for five years from the end of the fiscal year to which the information refers. |

Text proposed by the Commission

Amendment

4.   The managing body of the port shall keep the information concerning the financial relations as referred to in paragraphs 1 and 2 of this Article at the disposal of the Commission and of the
  competent independent supervisory body as referred to in
  Article 17 for five years from the end of the fiscal year to which the information refers.

4.   The managing body of the port shall keep the information concerning the financial relations as referred to in paragraphs 1 and 2 of this Article at the disposal of the Commission and of the
  body designated pursuant to
  Article 17 for five years from the end of the fiscal year to which the information refers.

Amendment 106

Proposal for a regulation

Article 12 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.   The managing body of the port shall make available to the Commission and
  the competent independent supervisory body, upon request
  , any additional information that they deem necessary in order to complete a thorough appraisal of the data submitted and to assess compliance with this Regulation. The information shall be transmitted within two months from the date of the request. | 5.   The managing body of the port shall
  , in the event of a formal complaint and upon request,
  make available to the Commission and
  to the body designated pursuant to Article 17
  any additional information that they deem necessary in order to complete a thorough appraisal of the data submitted and to assess compliance with this Regulation. The information shall be transmitted within two months from the date of the request. |

Text proposed by the Commission

Amendment

5.   The managing body of the port shall make available to the Commission and
  the competent independent supervisory body, upon request
  , any additional information that they deem necessary in order to complete a thorough appraisal of the data submitted and to assess compliance with this Regulation. The information shall be transmitted within two months from the date of the request.

5.   The managing body of the port shall
  , in the event of a formal complaint and upon request,
  make available to the Commission and
  to the body designated pursuant to Article 17
  any additional information that they deem necessary in order to complete a thorough appraisal of the data submitted and to assess compliance with this Regulation. The information shall be transmitted within two months from the date of the request.

Amendment 107

Proposal for a regulation

Article 12 — paragraph 7 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 7a.
     
  Member States may decide that paragraph 2 of this Article shall not apply to their ports of the comprehensive network which do not meet the criteria in point (a) or point (b) of Article 20(2) of Regulation (EU) No 1315/2013 in case of disproportionate administrative burdens, provided that any public funds received, and their use for providing port services, remain fully transparent in the accounting system. Where the Member States so decide, they shall inform the Commission thereof before their decision takes effect. |

Text proposed by the Commission

Amendment

7a.
     
  Member States may decide that paragraph 2 of this Article shall not apply to their ports of the comprehensive network which do not meet the criteria in point (a) or point (b) of Article 20(2) of Regulation (EU) No 1315/2013 in case of disproportionate administrative burdens, provided that any public funds received, and their use for providing port services, remain fully transparent in the accounting system. Where the Member States so decide, they shall inform the Commission thereof before their decision takes effect.

Amendment 108

Proposal for a regulation

Article 13 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   The charges for the services provided by an internal operator
  as referred to in Article 9 and
  the charges levied by providers of port service,
  in cases of limitation of the number of providers which have not been designated on the basis of procedures which are open, transparent and non-discriminatory
  , shall be set in a transparent and non-discriminatory way. These charges shall reflect the conditions on a competitive relevant market and shall not be disproportionate to the economic value of the service provided. | 1.   The charges for the services provided by an internal operator
  under a public service obligation,
  the charges
  for pilotage services that are not exposed to effective competition and the charges
  levied by providers of port services,
  referred to in point (b) of Article 6(1)
  , shall be set in a transparent and non-discriminatory way. These charges shall
  , as far as possible,
  reflect the conditions on a competitive relevant market and shall not be disproportionate to the economic value of the service provided. |

Text proposed by the Commission

Amendment

1.   The charges for the services provided by an internal operator
  as referred to in Article 9 and
  the charges levied by providers of port service,
  in cases of limitation of the number of providers which have not been designated on the basis of procedures which are open, transparent and non-discriminatory
  , shall be set in a transparent and non-discriminatory way. These charges shall reflect the conditions on a competitive relevant market and shall not be disproportionate to the economic value of the service provided.

1.   The charges for the services provided by an internal operator
  under a public service obligation,
  the charges
  for pilotage services that are not exposed to effective competition and the charges
  levied by providers of port services,
  referred to in point (b) of Article 6(1)
  , shall be set in a transparent and non-discriminatory way. These charges shall
  , as far as possible,
  reflect the conditions on a competitive relevant market and shall not be disproportionate to the economic value of the service provided.

Amendment 109

Proposal for a regulation

Article 13 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   The port service provider shall make available to the
  competent independent supervisory body as referred to in
  Article 17
  , upon request
  , information on the elements serving as a basis to determine the structure and the level of the port service charges that falls under the application of paragraph 1 of this Article. This information shall include the methodology used for setting the port charges with regard to the facilities and services to which these port service charges relate to. | 3.   The port service provider shall
  , in the event of a formal complaint and upon request,
  make available to the
  body designated pursuant to
  Article 17, information on the elements serving as a basis to determine the structure and the level of the port service charges that falls under the application of paragraph 1 of this Article. This information shall include the methodology used for setting the port charges with regard to the facilities and services to which these port service charges relate to. |

Text proposed by the Commission

Amendment

3.   The port service provider shall make available to the
  competent independent supervisory body as referred to in
  Article 17
  , upon request
  , information on the elements serving as a basis to determine the structure and the level of the port service charges that falls under the application of paragraph 1 of this Article. This information shall include the methodology used for setting the port charges with regard to the facilities and services to which these port service charges relate to.

3.   The port service provider shall
  , in the event of a formal complaint and upon request,
  make available to the
  body designated pursuant to
  Article 17, information on the elements serving as a basis to determine the structure and the level of the port service charges that falls under the application of paragraph 1 of this Article. This information shall include the methodology used for setting the port charges with regard to the facilities and services to which these port service charges relate to.

Amendment 110

Proposal for a regulation

Article 14 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   In order to contribute to an efficient infrastructure charging system, the structure and the level of port infrastructure charges shall be defined in an autonomous way by the managing body of the port according to its own commercial strategy and investment plan
  reflecting competitive conditions of the relevant market and
  in accordance with State aid rules. | 3.   In order to contribute to an efficient infrastructure charging system, the structure and the level of port infrastructure charges shall be defined in an autonomous way by the managing body of the port according to its own commercial strategy and investment plan in accordance with State aid
  and competition
  rules. |

Text proposed by the Commission

Amendment

3.   In order to contribute to an efficient infrastructure charging system, the structure and the level of port infrastructure charges shall be defined in an autonomous way by the managing body of the port according to its own commercial strategy and investment plan
  reflecting competitive conditions of the relevant market and
  in accordance with State aid rules.

3.   In order to contribute to an efficient infrastructure charging system, the structure and the level of port infrastructure charges shall be defined in an autonomous way by the managing body of the port according to its own commercial strategy and investment plan in accordance with State aid
  and competition
  rules.

Amendment 111

Proposal for a regulation

Article 14 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   Without prejudice to paragraph 3, port infrastructure charges may vary in accordance with commercial practices related to frequent users, or in order to promote a more efficient use of the port infrastructure, short sea shipping or a high environmental performance, energy efficiency or carbon efficiency of transport operations. The criteria used for such a variation shall be relevant, objective, transparent and non-discriminatory and
  in due respect of the
  competition rules.
  The resulting variation shall in particular be available to all relevant port service users on equal terms. | 4.   Without prejudice to paragraph 3, port infrastructure charges may vary in accordance with
  the port's economic strategy and the port's spatial planning policy
  related
  , inter alia,
  to
  certain categories of
  users, or in order to promote a more efficient use of the port infrastructure, short sea shipping or a high environmental performance, energy efficiency or carbon efficiency of transport operations. The criteria used for such a variation shall be
  fair,
  non-discriminatory
  as to nationality and shall comply with State aid and
  competition rules.
  The managing body of the port may take into account external costs when setting the charges. The managing body of the port may vary the infrastructure charges in accordance with commercial practices. |

Text proposed by the Commission

Amendment

4.   Without prejudice to paragraph 3, port infrastructure charges may vary in accordance with commercial practices related to frequent users, or in order to promote a more efficient use of the port infrastructure, short sea shipping or a high environmental performance, energy efficiency or carbon efficiency of transport operations. The criteria used for such a variation shall be relevant, objective, transparent and non-discriminatory and
  in due respect of the
  competition rules.
  The resulting variation shall in particular be available to all relevant port service users on equal terms.

4.   Without prejudice to paragraph 3, port infrastructure charges may vary in accordance with
  the port's economic strategy and the port's spatial planning policy
  related
  , inter alia,
  to
  certain categories of
  users, or in order to promote a more efficient use of the port infrastructure, short sea shipping or a high environmental performance, energy efficiency or carbon efficiency of transport operations. The criteria used for such a variation shall be
  fair,
  non-discriminatory
  as to nationality and shall comply with State aid and
  competition rules.
  The managing body of the port may take into account external costs when setting the charges. The managing body of the port may vary the infrastructure charges in accordance with commercial practices.

Amendment 112

Proposal for a regulation

Article 14 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.
     
  The Commission shall be empowered to adopt, where necessary, delegated acts in accordance with the procedure referred to in Article 21 concerning common classifications of vessels, fuels and types of operations according to which the infrastructure charges can vary and common charging principles for port infrastructure charges. | deleted |

Text proposed by the Commission

Amendment

5.
     
  The Commission shall be empowered to adopt, where necessary, delegated acts in accordance with the procedure referred to in Article 21 concerning common classifications of vessels, fuels and types of operations according to which the infrastructure charges can vary and common charging principles for port infrastructure charges.

deleted

Amendment 113

Proposal for a regulation

Article 14 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6.   The managing body of the port shall inform port users and the representatives or associations of port users about the structure and the criteria used to determine the amount of the port infrastructure charges
  , including the total costs and revenues serving as a basis to determine the structure and the level of the port infrastructure charges
  . It shall inform users of the port infrastructures of any changes in the amount of the port infrastructure charges or in the structure or criteria used in order to determine such charges at least three months in advance. | 6.   The managing body of the port shall inform port users and the representatives or associations of port users
  in a transparent manner
  about the structure and the criteria used to determine the amount of the port infrastructure charges. It shall inform users of the port infrastructures of any changes in the amount of the port infrastructure charges or in the structure or criteria used in order to determine such charges at least three months in advance.
  The managing body of the port shall not be required to disclose differentiations in the charges that are a result of individual negotiations. |

Text proposed by the Commission

Amendment

6.   The managing body of the port shall inform port users and the representatives or associations of port users about the structure and the criteria used to determine the amount of the port infrastructure charges
  , including the total costs and revenues serving as a basis to determine the structure and the level of the port infrastructure charges
  . It shall inform users of the port infrastructures of any changes in the amount of the port infrastructure charges or in the structure or criteria used in order to determine such charges at least three months in advance.

6.   The managing body of the port shall inform port users and the representatives or associations of port users
  in a transparent manner
  about the structure and the criteria used to determine the amount of the port infrastructure charges. It shall inform users of the port infrastructures of any changes in the amount of the port infrastructure charges or in the structure or criteria used in order to determine such charges at least three months in advance.
  The managing body of the port shall not be required to disclose differentiations in the charges that are a result of individual negotiations.

Amendment 114

Proposal for a regulation

Article 14 — paragraph 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| 7.   The managing body of the port shall
  make available to the competent independent supervisory body and to the Commission,
  upon request,
  the information referred to in paragraph 4 and the detailed costs and revenues, serving as a basis to determine the structure
  and the level of the port infrastructure charges and the methodology used for setting the port infrastructure charges with regard to the facilities and services to which these port charges relate to. | 7.   The managing body of the port shall
  , in the event of a formal complaint and
  upon request,
  make available to the body designated pursuant to Article 17 and to the Commission, the information referred to in paragraph 4 of this Article
  and the level of the port infrastructure charges and the methodology used for setting the port infrastructure charges with regard to the facilities and services to which these port charges relate to. |

Text proposed by the Commission

Amendment

7.   The managing body of the port shall
  make available to the competent independent supervisory body and to the Commission,
  upon request,
  the information referred to in paragraph 4 and the detailed costs and revenues, serving as a basis to determine the structure
  and the level of the port infrastructure charges and the methodology used for setting the port infrastructure charges with regard to the facilities and services to which these port charges relate to.

7.   The managing body of the port shall
  , in the event of a formal complaint and
  upon request,
  make available to the body designated pursuant to Article 17 and to the Commission, the information referred to in paragraph 4 of this Article
  and the level of the port infrastructure charges and the methodology used for setting the port infrastructure charges with regard to the facilities and services to which these port charges relate to.

Amendment 115

Proposal for a regulation

Article 15 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.
     
  The managing body of the port shall establish a committee of representatives of operators of waterborne vessels, cargo owners or other port users which are requested to pay an infrastructure charge or a port service charge or both. This committee shall be called the ‘port users' advisory committee’. | deleted |

Text proposed by the Commission

Amendment

1.
     
  The managing body of the port shall establish a committee of representatives of operators of waterborne vessels, cargo owners or other port users which are requested to pay an infrastructure charge or a port service charge or both. This committee shall be called the ‘port users' advisory committee’.

deleted

Amendment 116

Proposal for a regulation

Article 15 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The managing body of the port shall
  consult on an annual basis prior to the setting of port infrastructure charges the
  port users
  ' advisory committee on
  the structure
  and level of such
  charges. The providers of port services as referred to in Article 6
  and in Article 9
  shall consult on an annual basis prior to the setting of port service charges
  the port users' advisory committee
  on the structure and level of such charges. The managing body of the port shall provide adequate
  facilities
  for such consultation and shall be informed of the results of the consultation by the providers of port services. | 2.   The managing body of the port shall
  ensure that adequate mechanisms for the consultation of port users, including relevant interconnected transport operators, are in place. It shall consult port users in the event of substantial changes to
  port infrastructure charges
  . The providers of port services shall provide
  port users
  with adequate information about
  the structure
  of port service charges and the criteria used to determine them
  .
  Internal operators providing services under a public service obligation and
  the providers of port services as referred to in Article 6
  (1b)
  shall consult
  port users
  on an annual basis
  and
  prior to the setting of port service charges on the structure and level of such charges. The managing body of the port shall provide adequate
  mechanisms
  for such consultation and shall be informed of the results of the consultation by the providers of port services. |
| | It shall be possible to impose the obligations mentioned in this paragraph to bodies, including those with a distinct composition, that are already established within the port. |

Text proposed by the Commission

Amendment

2.   The managing body of the port shall
  consult on an annual basis prior to the setting of port infrastructure charges the
  port users
  ' advisory committee on
  the structure
  and level of such
  charges. The providers of port services as referred to in Article 6
  and in Article 9
  shall consult on an annual basis prior to the setting of port service charges
  the port users' advisory committee
  on the structure and level of such charges. The managing body of the port shall provide adequate
  facilities
  for such consultation and shall be informed of the results of the consultation by the providers of port services.

2.   The managing body of the port shall
  ensure that adequate mechanisms for the consultation of port users, including relevant interconnected transport operators, are in place. It shall consult port users in the event of substantial changes to
  port infrastructure charges
  . The providers of port services shall provide
  port users
  with adequate information about
  the structure
  of port service charges and the criteria used to determine them
  .
  Internal operators providing services under a public service obligation and
  the providers of port services as referred to in Article 6
  (1b)
  shall consult
  port users
  on an annual basis
  and
  prior to the setting of port service charges on the structure and level of such charges. The managing body of the port shall provide adequate
  mechanisms
  for such consultation and shall be informed of the results of the consultation by the providers of port services.

It shall be possible to impose the obligations mentioned in this paragraph to bodies, including those with a distinct composition, that are already established within the port.

Amendment 117

Proposal for a regulation

Article 16 — paragraph 1 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   The managing body of the port shall regularly consult stakeholders such as undertakings established in the port, providers of port services, operators of waterborne vessels, cargo owners, land transport operators
  and public administrations
  operating in the port area on the following: | 1.   The managing body of the port shall regularly consult
  the relevant
  stakeholders operating in the port area
  as well as public administrations responsible for transport infrastructure planning, where appropriate
  on the following: |

Text proposed by the Commission

Amendment

1.   The managing body of the port shall regularly consult stakeholders such as undertakings established in the port, providers of port services, operators of waterborne vessels, cargo owners, land transport operators
  and public administrations
  operating in the port area on the following:

1.   The managing body of the port shall regularly consult
  the relevant
  stakeholders operating in the port area
  as well as public administrations responsible for transport infrastructure planning, where appropriate
  on the following:

Amendment 118

Proposal for a regulation

Article 16 — paragraph 1 — point c a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ca) | the consequences of planning and of spatial planning decisions in terms of environmental performance; |

Text proposed by the Commission

Amendment

(ca)

the consequences of planning and of spatial planning decisions in terms of environmental performance;

Amendment 119

Proposal for a regulation

Article 16 — paragraph 1 — point c b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (cb) | measures to ensure and improve safety in the port area, including health and safety of port workers and information on access to training of port workers. |

Text proposed by the Commission

Amendment

(cb)

measures to ensure and improve safety in the port area, including health and safety of port workers and information on access to training of port workers.

Amendment 120

Proposal for a regulation

Article 17 — title

| Text proposed by the Commission | Amendment |
| --- | --- |
| Independent
  supervisory body | Independent
  supervision |

Text proposed by the Commission

Amendment

Independent
  supervisory body

Independent
  supervision

Amendment 121

Proposal for a regulation

Article 17 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Member States shall ensure that
  an independent supervisory body monitors and supervises the application of this Regulation
  in all the
  seaports
  covered by this Regulation on the territory of each Member State. | 1.   Member States shall ensure that
  effective mechanisms are in place to handle complaints for
  all the
  maritime ports
  covered by this Regulation on the territory of each Member State.
  To that end, the Member States shall designate one or more bodies. |

Text proposed by the Commission

Amendment

1.   Member States shall ensure that
  an independent supervisory body monitors and supervises the application of this Regulation
  in all the
  seaports
  covered by this Regulation on the territory of each Member State.

1.   Member States shall ensure that
  effective mechanisms are in place to handle complaints for
  all the
  maritime ports
  covered by this Regulation on the territory of each Member State.
  To that end, the Member States shall designate one or more bodies.

Amendment 122

Proposal for a regulation

Article 17 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The independent
  supervisory body
  shall be legally distinct from and functionally independent of any managing body of the port or providers of port services. Member States that retain ownership or control of ports or port managing bodies shall ensure
  an
  effective structural separation between the functions relating to the
  supervision and monitoring of this Regulation
  and the activities associated with that ownership or control. The independent
  supervisory body
  shall
  exercise its powers impartially and transparently and with due
  respect
  to
  the right to freely conduct business. | 2.   The independent
  supervision
  shall be
  carried out in a manner which excludes conflicts of interest and is
  legally distinct from and functionally independent of any managing body of the port or providers of port services. Member States that retain ownership or control of ports or port managing bodies shall ensure
  that there is
  effective structural separation between the functions relating to the
  handling of complaints
  and the activities associated with that ownership or control. The independent
  supervision
  shall
  be impartial and transparent and shall duly
  respect the right to freely conduct business. |

Text proposed by the Commission

Amendment

2.   The independent
  supervisory body
  shall be legally distinct from and functionally independent of any managing body of the port or providers of port services. Member States that retain ownership or control of ports or port managing bodies shall ensure
  an
  effective structural separation between the functions relating to the
  supervision and monitoring of this Regulation
  and the activities associated with that ownership or control. The independent
  supervisory body
  shall
  exercise its powers impartially and transparently and with due
  respect
  to
  the right to freely conduct business.

2.   The independent
  supervision
  shall be
  carried out in a manner which excludes conflicts of interest and is
  legally distinct from and functionally independent of any managing body of the port or providers of port services. Member States that retain ownership or control of ports or port managing bodies shall ensure
  that there is
  effective structural separation between the functions relating to the
  handling of complaints
  and the activities associated with that ownership or control. The independent
  supervision
  shall
  be impartial and transparent and shall duly
  respect the right to freely conduct business.

Amendment 123

Proposal for a regulation

Article 17 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   
  The independent supervisory body shall handle the complaints lodged by any party with a legitimate interest and the disputes brought before it arising in connection with the application of this Regulation. | 3.   
  Member States shall ensure that port users and other relevant stakeholders are informed of where and how to lodge a complaint, including an indication of the bodies authorised to handle complaints referred to in Articles 12(5), 13(3) and 14(7). |

Text proposed by the Commission

Amendment

3.   
  The independent supervisory body shall handle the complaints lodged by any party with a legitimate interest and the disputes brought before it arising in connection with the application of this Regulation.

3.   
  Member States shall ensure that port users and other relevant stakeholders are informed of where and how to lodge a complaint, including an indication of the bodies authorised to handle complaints referred to in Articles 12(5), 13(3) and 14(7).

Amendment 124

Proposal for a regulation

Article 17 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   In the event that the dispute arises between parties established in different Member States, the
  independent supervisory body of the
  Member State of the port where the dispute is presumed to have its origin shall have competence to solve the dispute. | 4.   In the event that the dispute arises between parties established in different Member States, the Member State of the port where the dispute is presumed to have its origin shall have competence to solve the dispute.
  The Member States concerned shall cooperate with each other and exchange information concerning their work. |

Text proposed by the Commission

Amendment

4.   In the event that the dispute arises between parties established in different Member States, the
  independent supervisory body of the
  Member State of the port where the dispute is presumed to have its origin shall have competence to solve the dispute.

4.   In the event that the dispute arises between parties established in different Member States, the Member State of the port where the dispute is presumed to have its origin shall have competence to solve the dispute.
  The Member States concerned shall cooperate with each other and exchange information concerning their work.

Amendment 125

Proposal for a regulation

Article 17 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.   
  The independent supervisory body
  shall have the right to require managing bodies of the ports, providers of port services and port users to submit
  information needed to ensure monitoring and supervision of the application of this Regulation
  . | 5.   
  In the event that a formal complaint is lodged by any party with a legitimate interest, the relevant body providing independent supervision
  shall have the right to require managing bodies of the ports, providers of port services and port users to submit
  the necessary information
  . |

Text proposed by the Commission

Amendment

5.   
  The independent supervisory body
  shall have the right to require managing bodies of the ports, providers of port services and port users to submit
  information needed to ensure monitoring and supervision of the application of this Regulation
  .

5.   
  In the event that a formal complaint is lodged by any party with a legitimate interest, the relevant body providing independent supervision
  shall have the right to require managing bodies of the ports, providers of port services and port users to submit
  the necessary information
  .

Amendment 126

Proposal for a regulation

Article 17 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6.
     
  The independent supervisory body may issue opinions at the request of a competent authority in the Member State on any issues in relation to the application of this Regulation. | deleted |

Text proposed by the Commission

Amendment

6.
     
  The independent supervisory body may issue opinions at the request of a competent authority in the Member State on any issues in relation to the application of this Regulation.

deleted

Amendment 127

Proposal for a regulation

Article 17 — paragraph 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| 7.
     
  The independent supervisory body may consult the port users' advisory committee of the port concerned when dealing with the complaints or disputes. | deleted |

Text proposed by the Commission

Amendment

7.
     
  The independent supervisory body may consult the port users' advisory committee of the port concerned when dealing with the complaints or disputes.

deleted

Amendment 128

Proposal for a regulation

Article 17 — paragraph 8

| Text proposed by the Commission | Amendment |
| --- | --- |
| 8.   The decisions of the
  independent supervisory body
  shall have binding effects, without prejudice to judicial review. | 8.   The decisions of the
  relevant body providing independent supervision
  shall have binding effects, without prejudice to judicial review. |

Text proposed by the Commission

Amendment

8.   The decisions of the
  independent supervisory body
  shall have binding effects, without prejudice to judicial review.

8.   The decisions of the
  relevant body providing independent supervision
  shall have binding effects, without prejudice to judicial review.

Amendment 129

Proposal for a regulation

Article 17 — paragraph 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| 9.   Member States shall notify to the Commission
  the identity of the independent supervisory bodies by 1 July 2015 at the latest and subsequently any
  modification thereof. The Commission shall publish and update the list of the
  independent supervisory
  bodies on its website. | 9.   Member States shall notify to the Commission
  mechanisms and procedures put in place to comply with paragraphs 1 and 2 of this Article by ...

   (*2)

  and shall notify it without delay of any subsequent
  modification thereof. The Commission shall publish and update the list of the
  relevant
  bodies on its website. |

Text proposed by the Commission

Amendment

9.   Member States shall notify to the Commission
  the identity of the independent supervisory bodies by 1 July 2015 at the latest and subsequently any
  modification thereof. The Commission shall publish and update the list of the
  independent supervisory
  bodies on its website.

9.   Member States shall notify to the Commission
  mechanisms and procedures put in place to comply with paragraphs 1 and 2 of this Article by ...

   (*2)

  and shall notify it without delay of any subsequent
  modification thereof. The Commission shall publish and update the list of the
  relevant
  bodies on its website.

Amendment 130

Proposal for a regulation

Article 18

| Text proposed by the Commission | Amendment |
| --- | --- |
| Article 18 | deleted |
| Cooperation between independent supervisory bodies | |
| 1.
     
  The independent supervisory bodies shall exchange information about their work and decision-making principles and practices in order to facilitate a uniform implementation of this Regulation. For this purpose, they shall participate and work together in a network that convenes at regular intervals and at least once a year. The Commission shall participate, coordinate and support the work of the network. | |
| 2.
     
  The independent supervisory bodies shall cooperate closely for the purposes of mutual assistance in their tasks, including in carrying out investigations required to handle complaints and disputes in cases involving ports in different Member States. For this purpose, an independent supervisory body shall make available to another such body, after a substantiated request, the information necessary to allow that body to fulfil its responsibilities under this Regulation. | |
| 3.
     
  The Member States shall ensure that the independent supervisory bodies shall provide the Commission, after a reasoned request, with the information necessary for it to carry its tasks. The information requested by the Commission shall be proportionate to the performance of those tasks. | |
| 4.
     
  Where information is considered confidential by the independent supervisory body in accordance with Union or national rules on business confidentiality, the other national supervisory body and the Commission shall ensure such confidentiality. This information may only be used for the purpose which it was requested. | |
| 5.
     
  Based on the experience of the independent supervisory bodies and on the activities of the network referred to in paragraph 1, and in order to ensure efficient cooperation, the Commission may adopt common principles on the appropriate arrangements for the exchange of information between independent supervisory bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). | |

Text proposed by the Commission

Amendment

Article 18

deleted

Cooperation between independent supervisory bodies

1.
     
  The independent supervisory bodies shall exchange information about their work and decision-making principles and practices in order to facilitate a uniform implementation of this Regulation. For this purpose, they shall participate and work together in a network that convenes at regular intervals and at least once a year. The Commission shall participate, coordinate and support the work of the network.

2.
     
  The independent supervisory bodies shall cooperate closely for the purposes of mutual assistance in their tasks, including in carrying out investigations required to handle complaints and disputes in cases involving ports in different Member States. For this purpose, an independent supervisory body shall make available to another such body, after a substantiated request, the information necessary to allow that body to fulfil its responsibilities under this Regulation.

3.
     
  The Member States shall ensure that the independent supervisory bodies shall provide the Commission, after a reasoned request, with the information necessary for it to carry its tasks. The information requested by the Commission shall be proportionate to the performance of those tasks.

4.
     
  Where information is considered confidential by the independent supervisory body in accordance with Union or national rules on business confidentiality, the other national supervisory body and the Commission shall ensure such confidentiality. This information may only be used for the purpose which it was requested.

5.
     
  Based on the experience of the independent supervisory bodies and on the activities of the network referred to in paragraph 1, and in order to ensure efficient cooperation, the Commission may adopt common principles on the appropriate arrangements for the exchange of information between independent supervisory bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2).

Amendment 131

Proposal for a regulation

Article 19 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Any party with a legitimate interest shall have the right to appeal against the decisions or individual measures taken under this Regulation by the competent authorities, by the managing body of the port or by the
  independent supervisory body
  to an appeal body which is independent of the parties involved. This appeal body may be a court. | 1.   Any party with a legitimate interest shall have the right to appeal against the decisions or individual measures taken under this Regulation by the competent authorities, by the managing body of the port or by the
  body designated pursuant to Article 17
  to an appeal body which is independent of the parties involved. This appeal body may be a court. |

Text proposed by the Commission

Amendment

1.   Any party with a legitimate interest shall have the right to appeal against the decisions or individual measures taken under this Regulation by the competent authorities, by the managing body of the port or by the
  independent supervisory body
  to an appeal body which is independent of the parties involved. This appeal body may be a court.

1.   Any party with a legitimate interest shall have the right to appeal against the decisions or individual measures taken under this Regulation by the competent authorities, by the managing body of the port or by the
  body designated pursuant to Article 17
  to an appeal body which is independent of the parties involved. This appeal body may be a court.

Amendment 132

Proposal for a regulation

Article 20 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission
  by 1 July 2015 at the latest
  and shall notify it without delay of any subsequent amendment affecting them. | Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by ...
   (*3) and shall notify it without delay of any subsequent amendment affecting them. |

Text proposed by the Commission

Amendment

Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission
  by 1 July 2015 at the latest
  and shall notify it without delay of any subsequent amendment affecting them.

Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by ...
   (*3) and shall notify it without delay of any subsequent amendment affecting them.

Amendment 133

Proposal for a regulation

Article 21

| Text proposed by the Commission | Amendment |
| --- | --- |
| Article 21 | deleted |
| Exercise of the delegation | |
| 1.
     
  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. | |
| 2.
     
  The power to adopt delegated acts referred to in Article 14 shall be conferred on the Commission for an indeterminate period of time. | |
| 3.
     
  The delegation of power referred to in Article 14 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. | |
| 4.
     
  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. | |
| 5.
     
  A delegated act adopted pursuant to Article 14 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council. | |

Text proposed by the Commission

Amendment

Article 21

deleted

Exercise of the delegation

1.
     
  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.
     
  The power to adopt delegated acts referred to in Article 14 shall be conferred on the Commission for an indeterminate period of time.

3.
     
  The delegation of power referred to in Article 14 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.
     
  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5.
     
  A delegated act adopted pursuant to Article 14 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.

Amendment 134

Proposal for a regulation

Article 22

| Text proposed by the Commission | Amendment |
| --- | --- |
| Article 22 | deleted |
| Committee procedure | |
| 1.
     
  The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. | |
| 2.
     
  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. | |

Text proposed by the Commission

Amendment

Article 22

deleted

Committee procedure

1.
     
  The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.
     
  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Amendment 135

Proposal for a regulation

Article 23

| Text proposed by the Commission | Amendment |
| --- | --- |
| No later than three years after the entry into force
  of this Regulation,
  the Commission
  shall
  present a report
  to the European Parliament and the Council
  on the functioning and effect
  of this Regulation, accompanied, if appropriate, by relevant proposals. | For the purpose of evaluating the functioning and effect
  of this Regulation,
  periodic reports
  shall
  be presented
  to the European Parliament and the Council
  . By ...

   (*4),
  the Commission shall present a first report and periodic reports every three years thereafter
  accompanied, if appropriate, by relevant proposals.
  The reports of the Commission shall take into account any progress achieved by the EU-level Sectoral Social Dialogue Committee for Ports. |

Text proposed by the Commission

Amendment

No later than three years after the entry into force
  of this Regulation,
  the Commission
  shall
  present a report
  to the European Parliament and the Council
  on the functioning and effect
  of this Regulation, accompanied, if appropriate, by relevant proposals.

For the purpose of evaluating the functioning and effect
  of this Regulation,
  periodic reports
  shall
  be presented
  to the European Parliament and the Council
  . By ...

   (*4),
  the Commission shall present a first report and periodic reports every three years thereafter
  accompanied, if appropriate, by relevant proposals.
  The reports of the Commission shall take into account any progress achieved by the EU-level Sectoral Social Dialogue Committee for Ports.

Amendment 136

Proposal for a regulation

Article 25

| Text proposed by the Commission | Amendment |
| --- | --- |
| This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. | This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. |
| It shall apply with effect
  from 1 July 2015
  . | It shall apply with effect from ...
   (*5). |

Text proposed by the Commission

Amendment

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply with effect
  from 1 July 2015
  .

It shall apply with effect from ...
   (*5).

---

(1)  The matter was referred back to the committee responsible for reconsideration pursuant to Rule 61(2), second subparagraph (A8-0023/2016).

(1a)  
  Council Regulation (EEC) No 3577/92 of 7 December 1992 applying the principle of freedom to provide services to maritime transport within Member States (maritime cabotage) (OJ L 364, 12.12.1992, p. 7).

(1b)  
  Judgment of the Court of Justice of 11 January 2007 in Case C-251/04, Commission v Hellenic Republic, C-251/04, ECLI:EU:C:2007:5.

(7)  
  Proposal for a Directive on the award of concession contracts (COM 2011) 897 final

(2)  

  OJ C 179, 1.8.2006, p. 2.

(11)  OJ L 82, 22.3.2001, p. 16.

(11)  OJ L 82, 22.3.2001, p. 16.

(1a)  
  Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014, p. 1).

(1a)  
  Commission Regulation (EU) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in application of Articles 107 and 108 of the Treaty (OJ L 187, 26.6.2014, p. 1).

(13)  

  OJ L 55, 28.2.2011, p. 13.

(1a)  
  Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1).

(*1)  
  24 months after the entry into force of this Regulation

(1a)  
  Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).

(15)  
  Proposal for a Directive on the award of concession contracts (COM 2011) 897 final

(16)  
  Proposal for a Directive on procurement by entities operating in the water, energy, transport and postal services sectors (COM/2011/0895 final)

(17)  
  Proposal for a Directive on public procurement (COM/2011/0896 final)

(*2)  
  24 months after the entry into force of this Regulation.

(*3)  
  24 months after the entry into force of this Regulation.

(*4)  
  Four years after the date of entry into force of this Regulation.

(*5)  
  24 months after the entry into force of this Regulation.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/149 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/149

---

P8_TA(2016)0070

Harmonised indices of consumer prices ***I

European Parliament legislative resolution of 8 March 2016 on the proposal for a regulation of the European Parliament and of the Council on harmonised indices of consumer prices and repealing Regulation (EC) No 2494/95 (COM(2014)0724 — C8-0283/2014 — 2014/0346(COD))

(Ordinary legislative procedure: first reading)

(2018/C 050/17)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2014)0724), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2014)0724),

| — | having regard to Article 294(2) and Article 338(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0283/2014), |
| --- | --- |

—

having regard to Article 294(2) and Article 338(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0283/2014),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the opinion of the European Central Bank of 13 March 2015 (1), |
| --- | --- |

—

having regard to the opinion of the European Central Bank of 13 March 2015 (1),

| — | having regard to the undertaking given by the Council representative by letter of 18 December 2015 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the undertaking given by the Council representative by letter of 18 December 2015 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0313/2015), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0313/2015),

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

Adopts its position at first reading hereinafter set out;

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
| --- | --- |

2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

---

(1)  OJ C 175, 29.5.2015, p. 2.

---

P8_TC1-COD(2014)0346

Position of the European Parliament adopted at first reading on 8 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council on harmonised indices of consumer prices and the house price index, and repealing Council Regulation (EC) No 2494/95

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2016/792.)

---

Wednesday 9 March 2016

| 9.2.2018 | EN | Official Journal of the European Union | C 50/150 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/150

---

P8_TA(2016)0074

Non-objection to an implementing measure: pilot training, testing and periodic checking for performance-based navigation

European Parliament decision to raise no objections to the draft Commission regulation amending Commission Regulation (EU) No 1178/2011 as regards pilot training, testing and periodic checking for performance-based navigation (D042244/03 — 2016/2545(RPS))

(2018/C 050/18)

The European Parliament,

| — | having regard to the draft Commission regulation (D042244/03, |
| --- | --- |

—

having regard to the draft Commission regulation (D042244/03,

| — | having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (1), and in particular Article 7(6) thereof, |
| --- | --- |

—

having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (1), and in particular Article 7(6) thereof,

| — | having regard to the opinion delivered on 18 December 2015 by the committee referred to in Article 65 of the above regulation, |
| --- | --- |

—

having regard to the opinion delivered on 18 December 2015 by the committee referred to in Article 65 of the above regulation,

| — | having regard to the Commission’s letter of 12 February 2016 asking Parliament to declare that it will raise no objections to the draft regulation, |
| --- | --- |

—

having regard to the Commission’s letter of 12 February 2016 asking Parliament to declare that it will raise no objections to the draft regulation,

| — | having regard to the letter from the Committee on Transport and Tourism to the Chair of the Conference of Committee Chairs of 23 February 2016, |
| --- | --- |

—

having regard to the letter from the Committee on Transport and Tourism to the Chair of the Conference of Committee Chairs of 23 February 2016,

| — | having regard to Article 5a(3) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (2), |
| --- | --- |

—

having regard to Article 5a(3) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (2),

| — | having regard to the recommendation for a decision of the Committee on Transport and Tourism, |
| --- | --- |

—

having regard to the recommendation for a decision of the Committee on Transport and Tourism,

| — | having regard to Rules 106(4)(d) and 105(6) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 106(4)(d) and 105(6) of its Rules of Procedure,

| — | having regard to the fact that no objections have been raised within the period laid down in the third and fourth indents of Rule 105(6) of its Rules of Procedure, which expired on 8 March 2016, |
| --- | --- |

—

having regard to the fact that no objections have been raised within the period laid down in the third and fourth indents of Rule 105(6) of its Rules of Procedure, which expired on 8 March 2016,

| A. | whereas the draft Commission regulation is aimed at, among other things, prolonging by one year an existing transition period for holders of a private pilot licence, from 8 April 2016 to April 2017; |
| --- | --- |

A.

whereas the draft Commission regulation is aimed at, among other things, prolonging by one year an existing transition period for holders of a private pilot licence, from 8 April 2016 to April 2017;

| B. | whereas the deadline for Parliament to object to the draft Commission regulation will expire on 23 April 2016; |
| --- | --- |

B.

whereas the deadline for Parliament to object to the draft Commission regulation will expire on 23 April 2016;

| C. | whereas the entry into force of the Commission regulation by 8 April 2016 would prevent a legal void regarding the situation of several thousand EU citizens who hold a private pilot licence (PPL) issued by the Federal Aviation Administration (FAA) of the United States; |
| --- | --- |

C.

whereas the entry into force of the Commission regulation by 8 April 2016 would prevent a legal void regarding the situation of several thousand EU citizens who hold a private pilot licence (PPL) issued by the Federal Aviation Administration (FAA) of the United States;

| D. | whereas if the date is not modified these pilots will be obliged to validate or convert their FAA licence into an EU licence, which will require significant resources and time both from national authorities and from pilots; |
| --- | --- |

D.

whereas if the date is not modified these pilots will be obliged to validate or convert their FAA licence into an EU licence, which will require significant resources and time both from national authorities and from pilots;

| E. | whereas the Commission and the European Aviation Safety Agency are willing to negotiate a simplified procedure to facilitate the reciprocal recognition and conversion of such pilot licences between the EU and the USA, and whereas this new procedure is likely to become available to pilots in the second half of 2016; |
| --- | --- |

E.

whereas the Commission and the European Aviation Safety Agency are willing to negotiate a simplified procedure to facilitate the reciprocal recognition and conversion of such pilot licences between the EU and the USA, and whereas this new procedure is likely to become available to pilots in the second half of 2016;

| 1. | Declares that it has no objections to the draft Commission regulation; |
| --- | --- |

1.

Declares that it has no objections to the draft Commission regulation;

| 2. | Instructs its President to forward this decision to the Commission and, for information, to the Council. |
| --- | --- |

2.

Instructs its President to forward this decision to the Commission and, for information, to the Council.

---

(1)  OJ L 79, 19.3.2008, p. 1.

(2)  OJ L 184, 17.7.1999, p. 23.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/152 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/152

---

P8_TA(2016)0075

Reduction in the sulphur content of certain liquid fuels ***I

European Parliament legislative resolution of 9 March 2016 on the proposal for a directive of the European Parliament and of the Council relating to a reduction in the sulphur content of certain liquid fuels (codified text) (COM(2014)0466 — C8-0107/2014 — 2014/0216(COD))

(Ordinary legislative procedure — codification)

(2018/C 050/19)

The European Parliament,

| — | having regard to the Commission proposal to the European Parliament and the Council (COM(2014)0466), |
| --- | --- |

—

having regard to the Commission proposal to the European Parliament and the Council (COM(2014)0466),

| — | having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0107/2014), |
| --- | --- |

—

having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0107/2014),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the opinion of the European Economic and Social Committee of 15 October 2014 (1), |
| --- | --- |

—

having regard to the opinion of the European Economic and Social Committee of 15 October 2014 (1),

| — | after consulting the Committee of the Regions, |
| --- | --- |

—

after consulting the Committee of the Regions,

| — | having regard to the Interinstitutional Agreement of 20 December 1994 — Accelerated working method for official codification of legislative texts (2), |
| --- | --- |

—

having regard to the Interinstitutional Agreement of 20 December 1994 — Accelerated working method for official codification of legislative texts (2),

| — | having regard to Rules 103 and 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 103 and 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Legal Affairs (A8-0037/2016), |
| --- | --- |

—

having regard to the report of the Committee on Legal Affairs (A8-0037/2016),

| A. | whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance; |
| --- | --- |

A.

whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance;

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

Adopts its position at first reading hereinafter set out;

| 2. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

2.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

---

(1)  OJ C 12, 15.1.2015, p. 117.

(2)  OJ C 102, 4.4.1996, p. 2.

---

P8_TC1-COD(2014)0216

Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Directive (EU) 2016/... of the European Parliament and of the Council relating to a reduction in the sulphur content of certain liquid fuels (codification)

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2016/802.)

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/153 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/153

---

P8_TA(2016)0076

Trade diversion into the European Union of certain key medicines ***I

European Parliament legislative resolution of 9 March 2016 on the proposal for a regulation of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codified text) (COM(2014)0319 — C8-0015/2014 — 2014/0165(COD))

(Ordinary legislative procedure — codification)

(2018/C 050/20)

The European Parliament,

| — | having regard to the Commission proposal to the European Parliament and the Council (COM(2014)0319), |
| --- | --- |

—

having regard to the Commission proposal to the European Parliament and the Council (COM(2014)0319),

| — | having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0015/2014), |
| --- | --- |

—

having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0015/2014),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the Interinstitutional Agreement of 20 December 1994 — Accelerated working method for official codification of legislative texts (1), |
| --- | --- |

—

having regard to the Interinstitutional Agreement of 20 December 1994 — Accelerated working method for official codification of legislative texts (1),

| — | having regard to Rules 103 and 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 103 and 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Legal Affairs (A8-0038/2016), |
| --- | --- |

—

having regard to the report of the Committee on Legal Affairs (A8-0038/2016),

| A. | whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance; |
| --- | --- |

A.

whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance;

| 1. | Adopts its position at first reading, hereinafter set out; |
| --- | --- |

1.

Adopts its position at first reading, hereinafter set out;

| 2. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

2.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

---

(1)  OJ C 102, 4.4.1996, p. 2.

---

P8_TC1-COD(2014)0165

Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codification)

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2016/793.)

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/154 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/154

---

P8_TA(2016)0077

EU-Andorra agreement on the automatic exchange of financial account information *

European Parliament legislative resolution of 9 March 2016 on the proposal for a Council decision on the conclusion, on behalf of the European Union, of the Amending Protocol to the Agreement between the European Community and the Principality of Andorra providing for measures equivalent to those laid down in Council Directive 2003/48/EC on taxation of savings income in the form of interest payments (COM(2015)0631 — C8-0028/2016 — 2015/0285(NLE))

(Consultation)

(2018/C 050/21)

The European Parliament,

| — | having regard to the proposal for a Council decision (COM(2015)0631), |
| --- | --- |

—

having regard to the proposal for a Council decision (COM(2015)0631),

| — | having regard to the draft Amending Protocol to the Agreement between the European Community and the Principality of Andorra providing for measures equivalent to those laid down in Council Directive 2003/48/EC on taxation of savings income in the form of interest payments (15510/2015), |
| --- | --- |

—

having regard to the draft Amending Protocol to the Agreement between the European Community and the Principality of Andorra providing for measures equivalent to those laid down in Council Directive 2003/48/EC on taxation of savings income in the form of interest payments (15510/2015),

| — | having regard to Article 115 and Article 218(6), second subparagraph, point (b), and paragraph (8), second subparagraph, of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0028/2016), |
| --- | --- |

—

having regard to Article 115 and Article 218(6), second subparagraph, point (b), and paragraph (8), second subparagraph, of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0028/2016),

| — | having regard to Rules 59, 108(7) and 50(1) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 59, 108(7) and 50(1) of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0047/2016), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0047/2016),

| 1. | Approves conclusion of the Amending Protocol to the Agreement; |
| --- | --- |

1.

Approves conclusion of the Amending Protocol to the Agreement;

| 2. | Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Member States and of the Principality of Andorra. |
| --- | --- |

2.

Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Member States and of the Principality of Andorra.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/155 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/155

---

P8_TA(2016)0078

Appointment of a new Executive Director of the European Insurance and Occupational Pensions Authority (EIOPA)

European Parliament decision of 9 March 2016 on the proposal for the appointment of the Executive Director of the European Insurance and Occupational Pensions Authority (EIOPA) (C8-0023/2016 — 2016/0902(NLE))

(Approval)

(2018/C 050/22)

The European Parliament,

| — | having regard to the proposal of the Board of Supervisors of the European Insurance and Occupational Pensions Authority (EIOPA) of 3 February 2016 for the appointment of the Executive Director of the EIOPA for a five-year term (C8-0023/2016), |
| --- | --- |

—

having regard to the proposal of the Board of Supervisors of the European Insurance and Occupational Pensions Authority (EIOPA) of 3 February 2016 for the appointment of the Executive Director of the EIOPA for a five-year term (C8-0023/2016),

| — | having regard to Article 51(2) of Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (1), |
| --- | --- |

—

having regard to Article 51(2) of Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (1),

| — | having regard to its Rules of Procedure, |
| --- | --- |

—

having regard to its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0045/2016), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0045/2016),

| A. | whereas the term of office of EIOPA’s current Executive Director ends on 31 March 2016; |
| --- | --- |

A.

whereas the term of office of EIOPA’s current Executive Director ends on 31 March 2016;

| B. | whereas, on 28 January 2016, the Board of Supervisors of the EIOPA, following an open selection procedure, proposed to appoint Fausto Parente as Executive Director for a term of office of five years, in accordance with Article 51(2) and (3) of Regulation (EU) No 1094/2010; |
| --- | --- |

B.

whereas, on 28 January 2016, the Board of Supervisors of the EIOPA, following an open selection procedure, proposed to appoint Fausto Parente as Executive Director for a term of office of five years, in accordance with Article 51(2) and (3) of Regulation (EU) No 1094/2010;

| C. | whereas, on 23 February 2016, the Committee on Economic and Monetary Affairs held a hearing with Fausto Parente, at which he made an opening statement and then responded to questions from the members of the Committee; |
| --- | --- |

C.

whereas, on 23 February 2016, the Committee on Economic and Monetary Affairs held a hearing with Fausto Parente, at which he made an opening statement and then responded to questions from the members of the Committee;

| 1. | Approves the appointment of Fausto Parente as Executive Director of the EIOPA; |
| --- | --- |

1.

Approves the appointment of Fausto Parente as Executive Director of the EIOPA;

| 2. | Instructs its President to forward this decision to the Council, the Commission, the EIOPA and the governments of the Member States. |
| --- | --- |

2.

Instructs its President to forward this decision to the Council, the Commission, the EIOPA and the governments of the Member States.

---

(1)  OJ L 331, 15.12.2010, p. 48.

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/156 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/156

---

P8_TA(2016)0079

Procedural safeguards for children suspected or accused in criminal proceedings ***I

European Parliament legislative resolution of 9 March 2016 on the proposal for a directive of the European Parliament and of the Council on procedural safeguards for children suspected or accused in criminal proceedings (COM(2013)0822 — C7-0428/2013 — 2013/0408(COD))

(Ordinary legislative procedure: first reading)

(2018/C 050/23)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2013)0822), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2013)0822),

| — | having regard to Article 294(2) and Article 82(2)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0428/2013), |
| --- | --- |

—

having regard to Article 294(2) and Article 82(2)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0428/2013),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Netherlands House of Representatives, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
| --- | --- |

—

having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Netherlands House of Representatives, asserting that the draft legislative act does not comply with the principle of subsidiarity,

| — | having regard to the opinion of the European Economic and Social Committee of 25 March 2014 (1), |
| --- | --- |

—

having regard to the opinion of the European Economic and Social Committee of 25 March 2014 (1),

| — | having regard to the undertaking given by the Council representative by letter of 16 December 2015 to approve Parliament's position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the undertaking given by the Council representative by letter of 16 December 2015 to approve Parliament's position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs (A8-0020/2015), |
| --- | --- |

—

having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs (A8-0020/2015),

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

Adopts its position at first reading hereinafter set out;

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
| --- | --- |

2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

---

(1)  OJ C 226, 16.7.2014, p. 63.

---

P8_TC1-COD(2013)0408

Position of the European Parliament adopted at first reading on 9 March 2016 with a view to the adoption of Directive (EU) 2016/... of the European Parliament and of the Council on procedural safeguards for children who are suspects or accused persons in criminal proceedings

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2016/800.)

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/157 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/157

---

P8_TA(2016)0080

Guidelines for the 2017 Budget — Section III

European Parliament resolution of 9 March 2016 on general guidelines for the preparation of the 2017 budget, Section III — Commission (2016/2004(BUD))

(2018/C 050/24)

The European Parliament,

| — | having regard to Article 314 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 314 of the Treaty on the Functioning of the European Union,

| — | having regard to Article 106a of the Treaty establishing the European Atomic Energy Community, |
| --- | --- |

—

having regard to Article 106a of the Treaty establishing the European Atomic Energy Community,

| — | having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (1), |
| --- | --- |

—

having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (1),

| — | having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (2), |
| --- | --- |

—

having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (2),

| — | having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3), |
| --- | --- |

—

having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (3),

| — | having regard to its legislative resolution of 25 November 2015 on the joint text on the draft general budget of the European Union for the financial year 2016 approved by the Conciliation Committee under the budgetary procedure (4), |
| --- | --- |

—

having regard to its legislative resolution of 25 November 2015 on the joint text on the draft general budget of the European Union for the financial year 2016 approved by the Conciliation Committee under the budgetary procedure (4),

| — | having regard to the general budget of the European Union for the financial year 2016 (5) and to the two related joint statements agreed between Parliament, the Council and the Commission (6), |
| --- | --- |

—

having regard to the general budget of the European Union for the financial year 2016 (5) and to the two related joint statements agreed between Parliament, the Council and the Commission (6),

| — | having regard to the joint statement for a payment plan 2015-2016 (7) agreed on 19 May 2015, |
| --- | --- |

—

having regard to the joint statement for a payment plan 2015-2016 (7) agreed on 19 May 2015,

| — | having regard to the Commission’s European Economic Forecast (Autumn 2015) (8), |
| --- | --- |

—

having regard to the Commission’s European Economic Forecast (Autumn 2015) (8),

| — | having regard to the Commission’s Annual Growth Survey for 2016 (9), |
| --- | --- |

—

having regard to the Commission’s Annual Growth Survey for 2016 (9),

| — | having regard to Title II, Chapter 8 of its Rules of Procedure, |
| --- | --- |

—

having regard to Title II, Chapter 8 of its Rules of Procedure,

| — | having regard to the report of the Committee on Budgets (A8-0036/2016), |
| --- | --- |

—

having regard to the report of the Committee on Budgets (A8-0036/2016),

| A. | whereas the 2017 budget should lay down the path towards economic growth and job creation, in the context of a fragile economic recovery jeopardised by the situation in emerging global markets and ongoing geopolitical tensions; |
| --- | --- |

A.

whereas the 2017 budget should lay down the path towards economic growth and job creation, in the context of a fragile economic recovery jeopardised by the situation in emerging global markets and ongoing geopolitical tensions;

| B. | whereas the 2017 budget will be affected by the evolving migration and refugee crisis; |
| --- | --- |

B.

whereas the 2017 budget will be affected by the evolving migration and refugee crisis;

| C. | whereas the 2017 budget will coincide with the mid-term revision of the multiannual financial framework (MFF); |
| --- | --- |

C.

whereas the 2017 budget will coincide with the mid-term revision of the multiannual financial framework (MFF);

| D. | whereas the balance between internal demand and external trade makes the EU to a certain extent economically dependent on global developments; |
| --- | --- |

D.

whereas the balance between internal demand and external trade makes the EU to a certain extent economically dependent on global developments;

General remarks

| 1. | Notes that the Union budget has proven to be a crucial resource in tackling recent crises and responding to needs that had not been necessarily anticipated during the negotiation of the MFF 2014-2020, such as the European Fund for Strategic Investments (EFSI), the migration and refugee crisis or geopolitical tensions in Europe’s neighbourhood causing a number of serious challenges and emergencies, while within the EU the pace of economic recovery and investment is below potential and an investment gap still persists; |
| --- | --- |

1.

Notes that the Union budget has proven to be a crucial resource in tackling recent crises and responding to needs that had not been necessarily anticipated during the negotiation of the MFF 2014-2020, such as the European Fund for Strategic Investments (EFSI), the migration and refugee crisis or geopolitical tensions in Europe’s neighbourhood causing a number of serious challenges and emergencies, while within the EU the pace of economic recovery and investment is below potential and an investment gap still persists;

| 2. | Underlines that the limited capacity of the Union budget to tackle these crises is at this stage primarily the result of the use of all means available agreed on in the MFF negotiations, and particularly of the use of special instruments such as the flexibility instrument; recalls Parliament’s decisive role in shaping those instruments during the MFF negotiations; highlights, however, that if the crises continue to worsen even the full activation of the existing flexibility provisions will be insufficient to address the problem; urges the Council, in this context, to reconsider its position on the question of budgeting the MFF special instruments so as to alleviate the constraints weighing on the Union budget; reiterates in this connection its longstanding position that the payment appropriations for the special instruments (the flexibility instrument, the EU Solidarity Fund, the European Globalisation Adjustment Fund and the Emergency Aid Reserve) should be calculated over and above the MFF ceilings, as is the case for commitments; expects this issue to be resolved in the context of the mid-term revision of the MFF; |
| --- | --- |

2.

Underlines that the limited capacity of the Union budget to tackle these crises is at this stage primarily the result of the use of all means available agreed on in the MFF negotiations, and particularly of the use of special instruments such as the flexibility instrument; recalls Parliament’s decisive role in shaping those instruments during the MFF negotiations; highlights, however, that if the crises continue to worsen even the full activation of the existing flexibility provisions will be insufficient to address the problem; urges the Council, in this context, to reconsider its position on the question of budgeting the MFF special instruments so as to alleviate the constraints weighing on the Union budget; reiterates in this connection its longstanding position that the payment appropriations for the special instruments (the flexibility instrument, the EU Solidarity Fund, the European Globalisation Adjustment Fund and the Emergency Aid Reserve) should be calculated over and above the MFF ceilings, as is the case for commitments; expects this issue to be resolved in the context of the mid-term revision of the MFF;

Budgeting taking into account economic forecasts and consistent with the European Semester for economic policy coordination

| 3. | Notes the Commission’s European Economic Forecast (Autumn 2015), which indicates a modest recovery, although one still below the EU’s growth potential; stresses, however, that this recovery has to be built upon by enhancing the growth fundamentals in order to boost job creation and return to full employment, notes that long-term and very long-term unemployment, notably in the Union's poorest regions and among young people, are still at worrying levels, and the EU is having difficulties with industrial restructuring; notes that disparities in terms of economic development between European regions and Member States persist, and points to the gap between the poorest and the richest of Europeans; notes, furthermore, the appearance of new challenges, such as the risk of slowdown in emerging market economies and global trade, with particular pressure arising from volatility on Chinese markets, the need to tackle the migrant and refugee crisis, and persisting geopolitical tensions; |
| --- | --- |

3.

Notes the Commission’s European Economic Forecast (Autumn 2015), which indicates a modest recovery, although one still below the EU’s growth potential; stresses, however, that this recovery has to be built upon by enhancing the growth fundamentals in order to boost job creation and return to full employment, notes that long-term and very long-term unemployment, notably in the Union's poorest regions and among young people, are still at worrying levels, and the EU is having difficulties with industrial restructuring; notes that disparities in terms of economic development between European regions and Member States persist, and points to the gap between the poorest and the richest of Europeans; notes, furthermore, the appearance of new challenges, such as the risk of slowdown in emerging market economies and global trade, with particular pressure arising from volatility on Chinese markets, the need to tackle the migrant and refugee crisis, and persisting geopolitical tensions;

| 4. | Notes, additionally, the Commission’s Annual Growth Survey for 2016; strongly believes that boosting investment, including through a better coordinated increase in public and private investment with a focus on the Europe 2020 targets, is a proper policy response with a view to a more balanced economic policy; believes that those two elements should be taken into consideration in the preparation of the draft budget for 2017 insofar as this should help identify priorities within an economic context; calls, consequently, for more synergies between the Union dimension of the European Semester for economic policy coordination and the Union budget, which is also the cornerstone for a stable euro area; |
| --- | --- |

4.

Notes, additionally, the Commission’s Annual Growth Survey for 2016; strongly believes that boosting investment, including through a better coordinated increase in public and private investment with a focus on the Europe 2020 targets, is a proper policy response with a view to a more balanced economic policy; believes that those two elements should be taken into consideration in the preparation of the draft budget for 2017 insofar as this should help identify priorities within an economic context; calls, consequently, for more synergies between the Union dimension of the European Semester for economic policy coordination and the Union budget, which is also the cornerstone for a stable euro area;

| 5. | Welcomes, in this context, the Commission’s efforts to enhance the use of the European Structural and Investment Funds in support of key priorities highlighted in the country-specific recommendations; takes note of the Commission’s proposal on the establishment of the Structural Reform Support Programme, and urges the Commission to guarantee that funding will be deployed with a view to strengthening economic, social and territorial cohesion in line with Article 174 TFEU; |
| --- | --- |

5.

Welcomes, in this context, the Commission’s efforts to enhance the use of the European Structural and Investment Funds in support of key priorities highlighted in the country-specific recommendations; takes note of the Commission’s proposal on the establishment of the Structural Reform Support Programme, and urges the Commission to guarantee that funding will be deployed with a view to strengthening economic, social and territorial cohesion in line with Article 174 TFEU;

| 6. | Regrets that the Union budget has in recent years been a collateral victim of Member States’ duplicitous behaviour, which has led them to consider their contribution to the Union budget as a burden and to treat it as an adjustment variable; underlines that the EU budget, as an investment budget, can bring particularly strong added value by boosting growth, competitiveness and job creation in the Member States; draws attention to the need for Member States’ contributions to the Union budget not to be treated as an adjustment variable subject to macroeconomic conditions; reiterates also the added value of the Union budget in terms of synergies and economies of scale; emphasises the special situation of isolated and peripheral regions; |
| --- | --- |

6.

Regrets that the Union budget has in recent years been a collateral victim of Member States’ duplicitous behaviour, which has led them to consider their contribution to the Union budget as a burden and to treat it as an adjustment variable; underlines that the EU budget, as an investment budget, can bring particularly strong added value by boosting growth, competitiveness and job creation in the Member States; draws attention to the need for Member States’ contributions to the Union budget not to be treated as an adjustment variable subject to macroeconomic conditions; reiterates also the added value of the Union budget in terms of synergies and economies of scale; emphasises the special situation of isolated and peripheral regions;

| 7. | Notes and regrets the fact that corporate tax avoidance has caused huge losses of tax income for Member States, and therefore a reduction in their contributions to the EU budget; considers moreover that such unfair tax competition in some cases means GDP transfer from one Member State to another and GNI transfer to non-EU tax havens, thus reducing aggregate Member State contributions to the EU budget; |
| --- | --- |

7.

Notes and regrets the fact that corporate tax avoidance has caused huge losses of tax income for Member States, and therefore a reduction in their contributions to the EU budget; considers moreover that such unfair tax competition in some cases means GDP transfer from one Member State to another and GNI transfer to non-EU tax havens, thus reducing aggregate Member State contributions to the EU budget;

Overcoming crises

| 8. | Highlights the fact that the Union has had to face numerous crises in recent years to which a holistic solution should be found; points out that the refugee crisis, in the Union as well as in neighbouring countries, arising from the Syrian conflict has not been solved yet; notes that this crisis escalated in 2015 and has continued in 2016, with a sudden and massive increase in the numbers of refugees and migrants fleeing to the Union to seek asylum; stresses that this has further impacted on the internal crisis; underlines that the Union budget provided immediate response to the crisis and should be strongly revised upwards in order to effectively finance the implementation of EU policies to deal with this crisis, and should serve as part of a European solution to overcome this emergency in the future; |
| --- | --- |

8.

Highlights the fact that the Union has had to face numerous crises in recent years to which a holistic solution should be found; points out that the refugee crisis, in the Union as well as in neighbouring countries, arising from the Syrian conflict has not been solved yet; notes that this crisis escalated in 2015 and has continued in 2016, with a sudden and massive increase in the numbers of refugees and migrants fleeing to the Union to seek asylum; stresses that this has further impacted on the internal crisis; underlines that the Union budget provided immediate response to the crisis and should be strongly revised upwards in order to effectively finance the implementation of EU policies to deal with this crisis, and should serve as part of a European solution to overcome this emergency in the future;

| 9. | Underlines that the 2017 budget will be impacted by internal and external security challenges, which may also take the form of terrorist threats or extremism, and by the implementation of the shared agenda between the Union and the Member States aimed at securing an EU area of freedom, security and justice; stresses in this context the importance of the EU budgetary instruments, such as the Internal Security Fund (ISF), in order to address the most crucial challenges, including through the strengthening of preventive measures as well as cross-border operational cooperation; |
| --- | --- |

9.

Underlines that the 2017 budget will be impacted by internal and external security challenges, which may also take the form of terrorist threats or extremism, and by the implementation of the shared agenda between the Union and the Member States aimed at securing an EU area of freedom, security and justice; stresses in this context the importance of the EU budgetary instruments, such as the Internal Security Fund (ISF), in order to address the most crucial challenges, including through the strengthening of preventive measures as well as cross-border operational cooperation;

| 10. | Welcomes the adoption of the EFSI, which will serve as one of the main tools for enhancing investments at EU level and will contribute to stimulating the creation of jobs; notes with satisfaction that a significant number of projects and EIF operations have already been approved and synergies between the EFSI and Horizon 2020 could be detected; calls on the Commission to actively facilitate synergies between different EU funds and set up a tracking system to identify cases of combination of EU funding; insists on the need to properly apply the scoreboard; encourages Member States and private entities to make full use of the financial resources available through the EFSI; recalls that the Union budget provides the backbone of the investment plan by making available the EUR 8 billion required in commitment and payment appropriations for the provisioning of the EFSI guarantee fund, out of which a total of EUR 3,38 billion has already been mobilised in the 2015 and 2016 budgets; recalls that the Global Margin for Commitments was fully utilised for this purpose in 2016, and notes that, according to the EFSI legislative financial statement, the Commission foresees a similar scenario for the draft budget for 2017; reiterates its commitment to reinforce Horizon 2020 and the Connecting Europe Facility through the annual budgetary procedure, in order to compensate the cuts agreed during the EFSI negotiations as much as possible; |
| --- | --- |

10.

Welcomes the adoption of the EFSI, which will serve as one of the main tools for enhancing investments at EU level and will contribute to stimulating the creation of jobs; notes with satisfaction that a significant number of projects and EIF operations have already been approved and synergies between the EFSI and Horizon 2020 could be detected; calls on the Commission to actively facilitate synergies between different EU funds and set up a tracking system to identify cases of combination of EU funding; insists on the need to properly apply the scoreboard; encourages Member States and private entities to make full use of the financial resources available through the EFSI; recalls that the Union budget provides the backbone of the investment plan by making available the EUR 8 billion required in commitment and payment appropriations for the provisioning of the EFSI guarantee fund, out of which a total of EUR 3,38 billion has already been mobilised in the 2015 and 2016 budgets; recalls that the Global Margin for Commitments was fully utilised for this purpose in 2016, and notes that, according to the EFSI legislative financial statement, the Commission foresees a similar scenario for the draft budget for 2017; reiterates its commitment to reinforce Horizon 2020 and the Connecting Europe Facility through the annual budgetary procedure, in order to compensate the cuts agreed during the EFSI negotiations as much as possible;

| 11. | Stresses the importance of Horizon 2020, COSME, programmes funding SMEs, Erasmus+, and programmes and policies that support the development of an innovation-friendly environment and contribute to the success of Europe 2020; notes with satisfaction the high absorption rates of Horizon 2020 programmes, but is concerned at the worryingly low average success rate of project financing, which leaves many excellent projects unfinanced; calls on the Member States to explore possibilities of taking over those Horizon 2020 projects that received a positive evaluation but cannot be cofinanced owing to unavailability of budget funds; recalls the important role of small and medium-sized enterprises as the backbone of the European economy; underlines that the EU budget should further facilitate SMEs’ access to markets and funding through existing programmes such as COSME; reiterates that the Union's future is connected to its power to innovate in key strategic sectors in order to achieve European competitiveness in the global economy; |
| --- | --- |

11.

Stresses the importance of Horizon 2020, COSME, programmes funding SMEs, Erasmus+, and programmes and policies that support the development of an innovation-friendly environment and contribute to the success of Europe 2020; notes with satisfaction the high absorption rates of Horizon 2020 programmes, but is concerned at the worryingly low average success rate of project financing, which leaves many excellent projects unfinanced; calls on the Member States to explore possibilities of taking over those Horizon 2020 projects that received a positive evaluation but cannot be cofinanced owing to unavailability of budget funds; recalls the important role of small and medium-sized enterprises as the backbone of the European economy; underlines that the EU budget should further facilitate SMEs’ access to markets and funding through existing programmes such as COSME; reiterates that the Union's future is connected to its power to innovate in key strategic sectors in order to achieve European competitiveness in the global economy;

| 12. | Considers the Youth Employment Initiative (YEI), in particular, to be a fundamental contribution to the Union’s priority objective for jobs and growth; reiterates its commitment to continued funding for this programme with a view to scaling it up and thereby offering a greater number of young people, including young migrants entering the EU, the prospect of effectively entering the labour market by receiving a good quality offer of employment, continued education or apprenticeship; regrets that during the negotiations on the EU budget for 2016 no new commitments were allocated to further finance the YEI, while youth unemployment remains at its highest rates in the EU; recalls that this objective must be considered together with the need to promote mobility among young people, as supported by the Erasmus+ programme; highlights the importance of the joint statement of the three institutions (Parliament, the Council and the Commission) on the budget for 2016 that states that ‘reducing youth unemployment remains a high and shared political priority’, and that to this end the three institutions ‘reaffirm their determination to make the best possible use of budgetary resources available to tackle it, and in particular the Youth Employment Initiative’; notes that despite the initial delays in the implementation of this initiative and the continuing procrastination in designating authorities for YEI operational programmes in many Member States, the current implementation figures indicate a full absorption capacity; calls on the Commission to present its evaluation of the YEI at the latest by the end of April 2016, and at all events in time for the inclusion of a prolongation of the programme in the EU budget for 2017; stresses that a permanent solution for the funding of YEI through new commitment appropriations up to 2020 will be part of the mid-term revision of the MFF; underlines, in this context, the importance of the provision of the European Global Adjustment Fund (EGF) concerning support for young people aged up to 25 who are not in employment, education or training (NEETs), in equal numbers to workers receiving support in regions with high youth unemployment; |
| --- | --- |

12.

Considers the Youth Employment Initiative (YEI), in particular, to be a fundamental contribution to the Union’s priority objective for jobs and growth; reiterates its commitment to continued funding for this programme with a view to scaling it up and thereby offering a greater number of young people, including young migrants entering the EU, the prospect of effectively entering the labour market by receiving a good quality offer of employment, continued education or apprenticeship; regrets that during the negotiations on the EU budget for 2016 no new commitments were allocated to further finance the YEI, while youth unemployment remains at its highest rates in the EU; recalls that this objective must be considered together with the need to promote mobility among young people, as supported by the Erasmus+ programme; highlights the importance of the joint statement of the three institutions (Parliament, the Council and the Commission) on the budget for 2016 that states that ‘reducing youth unemployment remains a high and shared political priority’, and that to this end the three institutions ‘reaffirm their determination to make the best possible use of budgetary resources available to tackle it, and in particular the Youth Employment Initiative’; notes that despite the initial delays in the implementation of this initiative and the continuing procrastination in designating authorities for YEI operational programmes in many Member States, the current implementation figures indicate a full absorption capacity; calls on the Commission to present its evaluation of the YEI at the latest by the end of April 2016, and at all events in time for the inclusion of a prolongation of the programme in the EU budget for 2017; stresses that a permanent solution for the funding of YEI through new commitment appropriations up to 2020 will be part of the mid-term revision of the MFF; underlines, in this context, the importance of the provision of the European Global Adjustment Fund (EGF) concerning support for young people aged up to 25 who are not in employment, education or training (NEETs), in equal numbers to workers receiving support in regions with high youth unemployment;

| 13. | Highlights that according to the recent report by Save the Children, 27 million children are currently at risk of poverty in the EU; recalls Parliament’s resolution of 24 November 2015 (10) advocating the establishment of a child guarantee in order to lift children out of poverty, provide for an environment suitable for their personal development, and avoid their being exploited and socially excluded; welcomes the efforts of those Member States which have recently adopted child poverty reduction strategies with a view to reducing overall poverty levels, including for children and young people; calls on the Commission to ensure that Member States respect the UN Convention on the Rights of the Child and the principles of the Charter of Fundamental Rights of the European Union; considers education, childcare, health services, housing and security to be basic needs to which every European child has the right, including those travelling to Europe among refugees and migrants; |
| --- | --- |

13.

Highlights that according to the recent report by Save the Children, 27 million children are currently at risk of poverty in the EU; recalls Parliament’s resolution of 24 November 2015 (10) advocating the establishment of a child guarantee in order to lift children out of poverty, provide for an environment suitable for their personal development, and avoid their being exploited and socially excluded; welcomes the efforts of those Member States which have recently adopted child poverty reduction strategies with a view to reducing overall poverty levels, including for children and young people; calls on the Commission to ensure that Member States respect the UN Convention on the Rights of the Child and the principles of the Charter of Fundamental Rights of the European Union; considers education, childcare, health services, housing and security to be basic needs to which every European child has the right, including those travelling to Europe among refugees and migrants;

| 14. | Recalls the importance of European agencies in ensuring the implementation of European legislation and thereby accomplishing EU policy objectives related to competitiveness, growth and employment on the one hand, and in managing the current migration and refugee crisis on the other; insists, therefore, that adequate financial and human resources will be provided for both administrative and operational expenditure to allow the agencies to fulfil their assigned tasks and deliver the best possible results; recalls, with regard to the migration and refugee crisis, the increases in staff and appropriations for the Justice and Home Affairs Agencies in the 2015 and 2016 budgets; underlines, however, that further increases will be necessary in the 2017 budget to enable those agencies to cope with their increased workload and additional tasks; calls, furthermore, on the Commission to provide updated and consolidated information and a medium and long-term strategy regarding those agencies; |
| --- | --- |

14.

Recalls the importance of European agencies in ensuring the implementation of European legislation and thereby accomplishing EU policy objectives related to competitiveness, growth and employment on the one hand, and in managing the current migration and refugee crisis on the other; insists, therefore, that adequate financial and human resources will be provided for both administrative and operational expenditure to allow the agencies to fulfil their assigned tasks and deliver the best possible results; recalls, with regard to the migration and refugee crisis, the increases in staff and appropriations for the Justice and Home Affairs Agencies in the 2015 and 2016 budgets; underlines, however, that further increases will be necessary in the 2017 budget to enable those agencies to cope with their increased workload and additional tasks; calls, furthermore, on the Commission to provide updated and consolidated information and a medium and long-term strategy regarding those agencies;

| 15. | Is concerned at the persistence of socio-economic inequalities and the difficulties in reaching the EU's goal of socio-economic convergence; highlights that the Union budget should promote policies of convergence, integration and cohesion, based on safeguarding and promoting entrepreneurship, the creation of decent, quality and stable jobs, sustainable use of natural resources and the protection of the environment by pursuing its objectives under the Europe 2020 strategy for smart, sustainable and inclusive growth; is particularly concerned at the lower than expected implementation of payment appropriations for the Fund for European Aid for the Most Deprived (FEAD); |
| --- | --- |

15.

Is concerned at the persistence of socio-economic inequalities and the difficulties in reaching the EU's goal of socio-economic convergence; highlights that the Union budget should promote policies of convergence, integration and cohesion, based on safeguarding and promoting entrepreneurship, the creation of decent, quality and stable jobs, sustainable use of natural resources and the protection of the environment by pursuing its objectives under the Europe 2020 strategy for smart, sustainable and inclusive growth; is particularly concerned at the lower than expected implementation of payment appropriations for the Fund for European Aid for the Most Deprived (FEAD);

| 16. | Recognises the importance of the school milk and school fruit programmes, and suggests analysing to what extent an increase in their funding would be possible; recalls the numerous crises in recent years, among them the agricultural crisis in particular due to the effects of the Russian embargo; urges further work to make EU agriculture climate-proof while overall reducing agricultural GHG emissions and ensuring the economic viability of the sector; |
| --- | --- |

16.

Recognises the importance of the school milk and school fruit programmes, and suggests analysing to what extent an increase in their funding would be possible; recalls the numerous crises in recent years, among them the agricultural crisis in particular due to the effects of the Russian embargo; urges further work to make EU agriculture climate-proof while overall reducing agricultural GHG emissions and ensuring the economic viability of the sector;

| 17. | Acknowledges that in spite of the mobilisation of significant budgetary means spread over 2015 and 2016 to address the migration and refugee crisis, a solution has still not been found, be it internally within the Union or externally in refugees’ countries of origin; stresses, however, that the budgetary means are insufficient and that substantial additional financial means are required to address this crisis, as the increase in numbers of refugees and migrants cannot be considered a temporary phenomenon; highlights that longer-term solutions should be sought, not only in the annual budgetary procedure, but also in the upcoming interim revision of the MFF; urges the Commission to present a medium- and long-term political and financial plan to deal with the migration crisis and its impact on the 2017 budget; notes that all EU-funded measures should be regarded as investments to tackle the refugee and migration challenges; highlights the need to address the root causes of the migration phenomenon by improving living conditions, particularly through better education and medical services as well as enhanced support for investments in infrastructure in migrants’ countries of origin or countries where they first seek shelter; stresses that the financing of the migration and refugee crisis should not undermine or hinder the implementation of other important EU policies; underlines in this light that solidarity is an underlying principle of the EU budget; is concerned that in the refugee crisis solidarity is being manifested unevenly across the Member States; reiterates the call for the Commission to come up with a proposal as to how the EU budget can prompt Member States towards a more balanced approach to solidarity; |
| --- | --- |

17.

Acknowledges that in spite of the mobilisation of significant budgetary means spread over 2015 and 2016 to address the migration and refugee crisis, a solution has still not been found, be it internally within the Union or externally in refugees’ countries of origin; stresses, however, that the budgetary means are insufficient and that substantial additional financial means are required to address this crisis, as the increase in numbers of refugees and migrants cannot be considered a temporary phenomenon; highlights that longer-term solutions should be sought, not only in the annual budgetary procedure, but also in the upcoming interim revision of the MFF; urges the Commission to present a medium- and long-term political and financial plan to deal with the migration crisis and its impact on the 2017 budget; notes that all EU-funded measures should be regarded as investments to tackle the refugee and migration challenges; highlights the need to address the root causes of the migration phenomenon by improving living conditions, particularly through better education and medical services as well as enhanced support for investments in infrastructure in migrants’ countries of origin or countries where they first seek shelter; stresses that the financing of the migration and refugee crisis should not undermine or hinder the implementation of other important EU policies; underlines in this light that solidarity is an underlying principle of the EU budget; is concerned that in the refugee crisis solidarity is being manifested unevenly across the Member States; reiterates the call for the Commission to come up with a proposal as to how the EU budget can prompt Member States towards a more balanced approach to solidarity;

| 18. | Expresses its deep concern at the lack of adequate protection for unaccompanied minors all along the route to a safe place and calls for a thorough investigation into the case of the 10 000 missing children reported by EUROPOL; |
| --- | --- |

18.

Expresses its deep concern at the lack of adequate protection for unaccompanied minors all along the route to a safe place and calls for a thorough investigation into the case of the 10 000 missing children reported by EUROPOL;

| 19. | Stresses the importance of enhanced financing for resettlement schemes, relocation procedures and return operations, notably under the Asylum, Migration and Immigration Fund (AMIF), in order to achieve an effective European asylum and migration policy while preventing and reducing irregular migration; underlines the need to create possibilities within the EU budget in order to develop resettlement areas and safe zones on the African continent and in the Middle East, in cooperation with the African Union, the Arab League and UNHCR; |
| --- | --- |

19.

Stresses the importance of enhanced financing for resettlement schemes, relocation procedures and return operations, notably under the Asylum, Migration and Immigration Fund (AMIF), in order to achieve an effective European asylum and migration policy while preventing and reducing irregular migration; underlines the need to create possibilities within the EU budget in order to develop resettlement areas and safe zones on the African continent and in the Middle East, in cooperation with the African Union, the Arab League and UNHCR;

| 20. | Notes the setting-up of the Union Regional Trust Fund in Response to the Syrian Crisis and of the Emergency Trust Fund for stability and addressing the root causes of irregular migration and displacement of people in Africa; urges the Member States to stand by their promises and match the EU contribution to these funds, which amounts to EUR 2,3 billion; is deeply concerned at the low level of financial contributions from Member States; stresses that further financial efforts will be needed to provide humanitarian assistance along the transit routes and to manage the challenges posed by increasing numbers of refugees; points out that lack of adequate funding for humanitarian aid, including for health and education measures in camps, has promoted more refugees to embark on the risky journey to the EU; recalls that the above funds were created in response to the lack of flexibility and funding in the EU budget; insists that the actions undertaken to tackle the migration and refugee problem should not come at the cost of the EU’s development policies in other areas, and that the accountability rules for all EU actions in this field have to be followed; |
| --- | --- |

20.

Notes the setting-up of the Union Regional Trust Fund in Response to the Syrian Crisis and of the Emergency Trust Fund for stability and addressing the root causes of irregular migration and displacement of people in Africa; urges the Member States to stand by their promises and match the EU contribution to these funds, which amounts to EUR 2,3 billion; is deeply concerned at the low level of financial contributions from Member States; stresses that further financial efforts will be needed to provide humanitarian assistance along the transit routes and to manage the challenges posed by increasing numbers of refugees; points out that lack of adequate funding for humanitarian aid, including for health and education measures in camps, has promoted more refugees to embark on the risky journey to the EU; recalls that the above funds were created in response to the lack of flexibility and funding in the EU budget; insists that the actions undertaken to tackle the migration and refugee problem should not come at the cost of the EU’s development policies in other areas, and that the accountability rules for all EU actions in this field have to be followed;

| 21. | Underlines that the Member States have reconfirmed their commitment, at the informal meeting of EU Heads of State and Government held to discuss migration on 23 September 2015, the European Council of 15 October 2015, and the Valletta summit of 11-12 November 2015; attaches utmost importance to the Council's public statements concerning the response to the unprecedented migration and refugee crisis; expects the Council to fulfil the expectations raised by its own statements and decisions, particularly related to Member States’ contributions matching the EU budget support to the Madad and the Africa Trust Funds, as well as fully implementing the Commission's proposal on the Refugee Facility for Turkey; acknowledges that some Member States additionally contribute via other humanitarian aid schemes, such as the World Food Programme and UNHCR; |
| --- | --- |

21.

Underlines that the Member States have reconfirmed their commitment, at the informal meeting of EU Heads of State and Government held to discuss migration on 23 September 2015, the European Council of 15 October 2015, and the Valletta summit of 11-12 November 2015; attaches utmost importance to the Council's public statements concerning the response to the unprecedented migration and refugee crisis; expects the Council to fulfil the expectations raised by its own statements and decisions, particularly related to Member States’ contributions matching the EU budget support to the Madad and the Africa Trust Funds, as well as fully implementing the Commission's proposal on the Refugee Facility for Turkey; acknowledges that some Member States additionally contribute via other humanitarian aid schemes, such as the World Food Programme and UNHCR;

| 22. | Welcomes the principle and objectives of the envisaged EUR 3 billion Facility for Refugees in Turkey, and urges each Member State to fulfil its political pledges and provide adequate financial support in the package of the Facility for Refugees in Turkey; is strongly determined to apply all political and institutional means of pressure in order to ensure that Member States deliver on their commitment regarding their contributions to the Regional Trust Fund for Syria, the Emergency Trust Fund for Africa and the Refugee Facility for Turkey; expects the Commission to explain how the Union contribution should be made available within the respective ceilings of the Union budget for 2016 and 2017; criticises the fact that the Council and Commission excluded Parliament from the deliberations on the setting-up of the facility and the mobilisation of the Union’s contribution, as shown by the Commission’s announcement of its intention to finance the Union contribution by redeployment from the recently adopted Union budget for 2016 and by pre-empting the margins of the 2017 budget; underlines, in addition, the need to increase the impact of EU external spending; calls on the Commission to draw up proposals as to how the synergies between the EU external funding instruments can be enhanced and their strategic approach made more coherent; considers those trust funds, as well as the Facility for Refugees, to be neither inside nor outside the EU budget, therefore lacking the necessary accountability and democratic process prescribed by the Community method, and intends therefore to closely monitor the setting up of the funds and facility and their implementation; underlines that the above actions are a clear infringement of Parliament’s rights as an arm of the budgetary authority; |
| --- | --- |

22.

Welcomes the principle and objectives of the envisaged EUR 3 billion Facility for Refugees in Turkey, and urges each Member State to fulfil its political pledges and provide adequate financial support in the package of the Facility for Refugees in Turkey; is strongly determined to apply all political and institutional means of pressure in order to ensure that Member States deliver on their commitment regarding their contributions to the Regional Trust Fund for Syria, the Emergency Trust Fund for Africa and the Refugee Facility for Turkey; expects the Commission to explain how the Union contribution should be made available within the respective ceilings of the Union budget for 2016 and 2017; criticises the fact that the Council and Commission excluded Parliament from the deliberations on the setting-up of the facility and the mobilisation of the Union’s contribution, as shown by the Commission’s announcement of its intention to finance the Union contribution by redeployment from the recently adopted Union budget for 2016 and by pre-empting the margins of the 2017 budget; underlines, in addition, the need to increase the impact of EU external spending; calls on the Commission to draw up proposals as to how the synergies between the EU external funding instruments can be enhanced and their strategic approach made more coherent; considers those trust funds, as well as the Facility for Refugees, to be neither inside nor outside the EU budget, therefore lacking the necessary accountability and democratic process prescribed by the Community method, and intends therefore to closely monitor the setting up of the funds and facility and their implementation; underlines that the above actions are a clear infringement of Parliament’s rights as an arm of the budgetary authority;

| 23. | Draws attention to the fact that the geopolitical situation in the Eastern Neighbourhood is fragile, and calls on the EU to provide enhanced support to countries that are currently implementing Association Agreements, in order to advance reforms and ensure the deepening of the relations between the EU and the respective countries; |
| --- | --- |

23.

Draws attention to the fact that the geopolitical situation in the Eastern Neighbourhood is fragile, and calls on the EU to provide enhanced support to countries that are currently implementing Association Agreements, in order to advance reforms and ensure the deepening of the relations between the EU and the respective countries;

Payments

| 24. | Recalls that in the budgets for 2015 and 2016 the Commission has in many cases refrained from asking for additional payment appropriations for a number of its crisis responses (frontloading of EUR 2 billion for Greece, first initiatives in the area of migration), instead reverting to the redeployment of already existing resources; stresses that this has increased the burden on payment appropriations in 2016 and beyond, potentially re-creating a situation where appropriations may not be sufficient to meet the actual needs of financial programmes across headings, impacting project leaders and citizens directly; is concerned that this situation, added to the delay in starting the implementation of programmes under shared management, could re-create the conditions which led, at the end of the last MFF, to an unprecedented level of RALs and an unsustainable backlog of outstanding payment claims; recalls its longstanding position that unforeseen payment needs should be financed with fresh appropriations; |
| --- | --- |

24.

Recalls that in the budgets for 2015 and 2016 the Commission has in many cases refrained from asking for additional payment appropriations for a number of its crisis responses (frontloading of EUR 2 billion for Greece, first initiatives in the area of migration), instead reverting to the redeployment of already existing resources; stresses that this has increased the burden on payment appropriations in 2016 and beyond, potentially re-creating a situation where appropriations may not be sufficient to meet the actual needs of financial programmes across headings, impacting project leaders and citizens directly; is concerned that this situation, added to the delay in starting the implementation of programmes under shared management, could re-create the conditions which led, at the end of the last MFF, to an unprecedented level of RALs and an unsustainable backlog of outstanding payment claims; recalls its longstanding position that unforeseen payment needs should be financed with fresh appropriations;

| 25. | Calls for the full implementation of the joint statements on payments agreed between Parliament, the Council and the Commission in 2015 and 2016; recalls the commitment to hold in the course of this year at least three interinstitutional meetings on payments in order to take stock of payment implementation and revised forecasts; notes that the Commission has announced a 2015 end-of-year backlog of EUR 8,2 billion, which is almost half of what it had originally anticipated; intends to raise this issue at the first interinstitutional meeting on payments in March 2016, in order to determine the causes of this divergence and the possible long-term impact on payment forecasts; expects that in its reading of the 2017 Union budget the Council will take on board and fully respect the amounts confirmed at the April 2016 meeting; urges the Commission to provide Parliament and the Council, as agreed in the joint statement adopted in the framework of the budgetary procedure for 2016, with longer-term forecasts for the expected evolution of payments up to the end of the MFF 2014-2020, in order to avoid a payment backlog in the second half of the MFF; |
| --- | --- |

25.

Calls for the full implementation of the joint statements on payments agreed between Parliament, the Council and the Commission in 2015 and 2016; recalls the commitment to hold in the course of this year at least three interinstitutional meetings on payments in order to take stock of payment implementation and revised forecasts; notes that the Commission has announced a 2015 end-of-year backlog of EUR 8,2 billion, which is almost half of what it had originally anticipated; intends to raise this issue at the first interinstitutional meeting on payments in March 2016, in order to determine the causes of this divergence and the possible long-term impact on payment forecasts; expects that in its reading of the 2017 Union budget the Council will take on board and fully respect the amounts confirmed at the April 2016 meeting; urges the Commission to provide Parliament and the Council, as agreed in the joint statement adopted in the framework of the budgetary procedure for 2016, with longer-term forecasts for the expected evolution of payments up to the end of the MFF 2014-2020, in order to avoid a payment backlog in the second half of the MFF;

| 26. | Highlights that the implementation of the European Structural and Investment Funds is expected to reach cruising speed in 2017, and warns against an underbudgeting of payment appropriations to match this increased absorption level; encourages the Commission to set the payments at the necessary levels in its draft budget; expresses its concern at the late adoption of the operational programmes and at the risk of build-up of a new backlog of unpaid bills over the second half of the MFF; encourages the Commission to work actively with the Member States, and urges the latter to make every effort to ensure the swift designation of programme authorities, the absence of which has been the main cause of the current delays; welcomes the Commission's availability to collaborate closely with Member States upon request, in particular regarding the adjustment, as appropriate, of the operational programmes to allow for a stronger synergy between the European Structural and Investment Funds and the domestic challenges linked to the refugee crisis; |
| --- | --- |

26.

Highlights that the implementation of the European Structural and Investment Funds is expected to reach cruising speed in 2017, and warns against an underbudgeting of payment appropriations to match this increased absorption level; encourages the Commission to set the payments at the necessary levels in its draft budget; expresses its concern at the late adoption of the operational programmes and at the risk of build-up of a new backlog of unpaid bills over the second half of the MFF; encourages the Commission to work actively with the Member States, and urges the latter to make every effort to ensure the swift designation of programme authorities, the absence of which has been the main cause of the current delays; welcomes the Commission's availability to collaborate closely with Member States upon request, in particular regarding the adjustment, as appropriate, of the operational programmes to allow for a stronger synergy between the European Structural and Investment Funds and the domestic challenges linked to the refugee crisis;

Further issues of particular relevance

| 27. | Recalls the importance of gender mainstreaming, which should underpin Union policies as a horizontal principle; calls on the Commission to put the principle of gender mainstreaming into practice when preparing the draft budget for 2017, as appropriate; |
| --- | --- |

27.

Recalls the importance of gender mainstreaming, which should underpin Union policies as a horizontal principle; calls on the Commission to put the principle of gender mainstreaming into practice when preparing the draft budget for 2017, as appropriate;

| 28. | Welcomes the agreement reached on 12 December 2015 in Paris by the 196 parties to the UN Framework Convention on Climate Change on a universal, binding, dynamic and differentiated agreement to face the challenge of climate change; regrets, however, the fact that there is no clarity on how donor countries will meet the yearly USD 100 billion goal to support developing countries, or in particular on how they will agree on a common methodology to account for climate finance; notes that this issue is to be resolved before COP 22 in Marrakesh, and expects the Commission to deliver a consolidated EU regulatory framework which fully complies with all the commitments made in Paris and anticipates such financing in its draft budget for 2017; recalls that the EU has agreed that at least 20 % of its budget for 2014-2020, in other words as much as EUR 180 billion, should be spent on climate-related actions and that a ‘climate fine-tuning’ of the EU budget is needed; asks the Commission to continue supporting EU spending on sustainable efficient infrastructure and sustainable modes of transport; encourages the Commission to swiftly implement the Council conclusions of 17 November 2015 with regard to climate and cohesion policy funds; |
| --- | --- |

28.

Welcomes the agreement reached on 12 December 2015 in Paris by the 196 parties to the UN Framework Convention on Climate Change on a universal, binding, dynamic and differentiated agreement to face the challenge of climate change; regrets, however, the fact that there is no clarity on how donor countries will meet the yearly USD 100 billion goal to support developing countries, or in particular on how they will agree on a common methodology to account for climate finance; notes that this issue is to be resolved before COP 22 in Marrakesh, and expects the Commission to deliver a consolidated EU regulatory framework which fully complies with all the commitments made in Paris and anticipates such financing in its draft budget for 2017; recalls that the EU has agreed that at least 20 % of its budget for 2014-2020, in other words as much as EUR 180 billion, should be spent on climate-related actions and that a ‘climate fine-tuning’ of the EU budget is needed; asks the Commission to continue supporting EU spending on sustainable efficient infrastructure and sustainable modes of transport; encourages the Commission to swiftly implement the Council conclusions of 17 November 2015 with regard to climate and cohesion policy funds;

| 29. | Welcomes the Commission’s efforts in developing the ‘EU Budget Focused on Results’ strategy; calls on the Commission to demonstrate progress in the field of simplification of EU funding, especially with regard to reducing the burden of implementation and management of EU-funded projects; stresses that particular attention should be paid to the performance of financial instruments which can reach out to important target groups, such as SMEs, innovative enterprises and microenterprises under the Union funding programmes; believes, furthermore, that, apart from the Union institutions, considerable responsibility also lies with the Member States, given the fact that 80 % of the budget is under ‘shared management’; calls on the Member States, therefore, to do their utmost to guarantee sound financial management and the reduction of errors, and to avoid any delays in the implementation of programmes under their responsibility; emphasises the need to focus more on developing suitable quantitative and qualitative output indicators in order to measure performance and evolve a concrete picture of the effect of EU spending in the real economy; calls on all Member States to promote and put in place concrete measures for actively fighting corruption in public procurements and tenders; |
| --- | --- |

29.

Welcomes the Commission’s efforts in developing the ‘EU Budget Focused on Results’ strategy; calls on the Commission to demonstrate progress in the field of simplification of EU funding, especially with regard to reducing the burden of implementation and management of EU-funded projects; stresses that particular attention should be paid to the performance of financial instruments which can reach out to important target groups, such as SMEs, innovative enterprises and microenterprises under the Union funding programmes; believes, furthermore, that, apart from the Union institutions, considerable responsibility also lies with the Member States, given the fact that 80 % of the budget is under ‘shared management’; calls on the Member States, therefore, to do their utmost to guarantee sound financial management and the reduction of errors, and to avoid any delays in the implementation of programmes under their responsibility; emphasises the need to focus more on developing suitable quantitative and qualitative output indicators in order to measure performance and evolve a concrete picture of the effect of EU spending in the real economy; calls on all Member States to promote and put in place concrete measures for actively fighting corruption in public procurements and tenders;

| 30. | Confirms its support for the international ITER research and engineering programme, and is committed to securing appropriate financing for it; is concerned, however, that further delays and additional costs may arise regarding this programme, as well as at the related potential repercussions for the Union budget; regrets, therefore, that it was unable to assess the level of the 2016 ITER appropriations against the updated payment plan and schedule; expects this revised plan to be included in the preparation of the draft budget for 2017; calls for a proper accountability mechanism that will offer a clear overview of the amount in financial resources provided for the international project and will evaluate the efficiency of their use; |
| --- | --- |

30.

Confirms its support for the international ITER research and engineering programme, and is committed to securing appropriate financing for it; is concerned, however, that further delays and additional costs may arise regarding this programme, as well as at the related potential repercussions for the Union budget; regrets, therefore, that it was unable to assess the level of the 2016 ITER appropriations against the updated payment plan and schedule; expects this revised plan to be included in the preparation of the draft budget for 2017; calls for a proper accountability mechanism that will offer a clear overview of the amount in financial resources provided for the international project and will evaluate the efficiency of their use;

| 31. | Recalls that the final agreement on the MFF 2014-2020, as enshrined in Article 2 of the MFF Regulation, includes a compulsory review of the MFF 2014-2020, to be accompanied by a legislative proposal for revision of the MFF by the end of 2016; stresses that the purpose of the review/revision is to assess the qualitative and quantitative functioning of the MFF and to address systemic shortcomings of the Union budget, as well as to ensure that the Union is granted sufficient resources to effectively address internal and external crises and finance evolving political priorities for the second half of the current MFF; stresses that the Council should live up to the expectations raised by the statements and decisions of the European Council; underlines in this respect that the Council should take on responsibility for ensuring that the necessary appropriations are made available to respond to the financing of new tasks and unforeseen circumstances, including through an upward revision of the MFF ceilings; intends to take a consistent approach in the negotiations on the 2017 budget and the revision of the MFF; expresses its strong doubts whether the crises in question can be funded within the constraints of the current MFF; highlights in addition that the revision of the MFF in 2016 is an opportunity to adapt its means and to extend flexibility within it; |
| --- | --- |

31.

Recalls that the final agreement on the MFF 2014-2020, as enshrined in Article 2 of the MFF Regulation, includes a compulsory review of the MFF 2014-2020, to be accompanied by a legislative proposal for revision of the MFF by the end of 2016; stresses that the purpose of the review/revision is to assess the qualitative and quantitative functioning of the MFF and to address systemic shortcomings of the Union budget, as well as to ensure that the Union is granted sufficient resources to effectively address internal and external crises and finance evolving political priorities for the second half of the current MFF; stresses that the Council should live up to the expectations raised by the statements and decisions of the European Council; underlines in this respect that the Council should take on responsibility for ensuring that the necessary appropriations are made available to respond to the financing of new tasks and unforeseen circumstances, including through an upward revision of the MFF ceilings; intends to take a consistent approach in the negotiations on the 2017 budget and the revision of the MFF; expresses its strong doubts whether the crises in question can be funded within the constraints of the current MFF; highlights in addition that the revision of the MFF in 2016 is an opportunity to adapt its means and to extend flexibility within it;

| 32. | Reiterates its position in favour of the necessary in-depth reform of the system of Union own resources, and gives the highest political importance to the work of the High Level Group on Own Resources created as part of the MFF 2014-2020 agreement; expects the Commission and the Council to take on board the final outcome, which is expected by the end of 2016, including any new candidate for own resources; recalls that the leading idea behind the own resources reform is to make the revenue side of the Union budget more autonomous as well as more stable, simpler, fairer, more sustainable and more predictable, while also alleviating the burden of excessive spending from national budgets and improving transparency and visibility for the citizens without increasing the overall tax burden for citizens; believes that if there is to be a completely independent EU budget, genuine own resources have to be put in place; |
| --- | --- |

32.

Reiterates its position in favour of the necessary in-depth reform of the system of Union own resources, and gives the highest political importance to the work of the High Level Group on Own Resources created as part of the MFF 2014-2020 agreement; expects the Commission and the Council to take on board the final outcome, which is expected by the end of 2016, including any new candidate for own resources; recalls that the leading idea behind the own resources reform is to make the revenue side of the Union budget more autonomous as well as more stable, simpler, fairer, more sustainable and more predictable, while also alleviating the burden of excessive spending from national budgets and improving transparency and visibility for the citizens without increasing the overall tax burden for citizens; believes that if there is to be a completely independent EU budget, genuine own resources have to be put in place;

o

o o

| 33. | Instructs its President to forward this resolution to the Council, the Commission and the European Court of Auditors. |
| --- | --- |

33.

Instructs its President to forward this resolution to the Council, the Commission and the European Court of Auditors.

---

(1)  OJ L 347, 20.12.2013, p. 884.

(2)  OJ C 373, 20.12.2013, p. 1.

(3)  OJ L 298, 26.10.2012, p. 1.

(4)  Texts adopted, P8_TA(2015)0407.

(5)  OJ L 48, 24.2.2016.

(6)  See Annex to Parliament’s legislative resolution of 25 November 2015 (Texts adopted, P8_TA(2015)0407).

(7)  See Annex II to Parliament’s resolution of 8 July 2015 (Texts adopted, P8_TA(2015)0263).

(8)  http://ec.europa.eu/economy_finance/publications/eeip/pdf/ip011_en.pdf

(9)  http://ec.europa.eu/europe2020/pdf/2016/ags2016_annual_growth_survey.pdf

(10)  Texts adopted, P8_TA(2015)0401.

---

Thursday 10 March 2016

| 9.2.2018 | EN | Official Journal of the European Union | C 50/165 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/165

---

P8_TA(2016)0086

Introduction of emergency autonomous trade measures for Tunisia ***I

European Parliament legislative resolution of 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia (COM(2015)0460 — C8-0273/2015 — 2015/0218(COD))

(Ordinary legislative procedure: first reading)

(2018/C 050/25)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2015)0460), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2015)0460),

| — | having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0273/2015), |
| --- | --- |

—

having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0273/2015),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the undertaking given by the Council representative by letter of 9 March 2016 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the undertaking given by the Council representative by letter of 9 March 2016 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on International Trade and the opinion of the Committee on Agriculture and Rural Development (A8-0013/2016), |
| --- | --- |

—

having regard to the report of the Committee on International Trade and the opinion of the Committee on Agriculture and Rural Development (A8-0013/2016),

| 1. | Adopts its position at first reading hereinafter set out (1); |
| --- | --- |

1.

Adopts its position at first reading hereinafter set out (1);

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
| --- | --- |

2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

---

(1)  This position corresponds to the amendments adopted on 25 February 2016. (Texts adopted P8_TA(2016)0056).

---

P8_TC1-COD(2015)0218

Position of the European Parliament adopted at first reading on 10 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2016/580.)

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/166 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/166

---

P8_TA(2016)0087

Veterinary medicinal products ***I

Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014)0558 — C8-0164/2014 — 2014/0257(COD)) (1)

(Ordinary legislative procedure: first reading)

(2018/C 050/26)

Amendment 1

Proposal for a regulation

Recital 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| (2) | In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality. |

Text proposed by the Commission

Amendment

(2)

In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality.

| (2) | In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality
  , with respect to animals, nature and their interaction with man
  . |
| --- | --- |

(2)

In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality
  , with respect to animals, nature and their interaction with man
  .

Amendment 2

Proposal for a regulation

Recital 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| (6) | Animals may suffer from a broad range of diseases which
  can
  be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors. |

Text proposed by the Commission

Amendment

(6)

Animals may suffer from a broad range of diseases which
  can
  be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.

| (6) | Despite the measures that farmers take on good hygiene, feed, management and biosecurity,
  animals may suffer from a broad range of diseases which
  need to
  be prevented or treated
  by veterinary medicinal products for both animal health and welfare reasons
  . The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.
  To that end, good husbandry and management practices should be put in place in order to improve animal welfare, limit the spread of diseases, prevent antimicrobial resistance and ensure proper nutrition of livestock. |
| --- | --- |

(6)

Despite the measures that farmers take on good hygiene, feed, management and biosecurity,
  animals may suffer from a broad range of diseases which
  need to
  be prevented or treated
  by veterinary medicinal products for both animal health and welfare reasons
  . The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.
  To that end, good husbandry and management practices should be put in place in order to improve animal welfare, limit the spread of diseases, prevent antimicrobial resistance and ensure proper nutrition of livestock.

Amendment 3

Proposal for a regulation

Recital 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| (7) | This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market. |

Text proposed by the Commission

Amendment

(7)

This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.

| (7) | This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health
  and the environment
  . At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market. |
| --- | --- |

(7)

This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health
  and the environment
  . At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.

Amendment 4

Proposal for a regulation

Recital 7 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (7a) | This Regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. Therefore, the precautionary principle should be applied. This Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no harmful effects on human or animal health nor have any unacceptable effects on the environment. |

Text proposed by the Commission

Amendment

(7a)

This Regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. Therefore, the precautionary principle should be applied. This Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no harmful effects on human or animal health nor have any unacceptable effects on the environment.

Amendment 5

Proposal for a regulation

Recital 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| (9) | The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products. |

Text proposed by the Commission

Amendment

(9)

The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.

| (9) | The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.
  The use of the centralised procedure should be encouraged in every way, in particular by facilitating access for small and medium-sized enterprises (SMEs). |
| --- | --- |

(9)

The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.
  The use of the centralised procedure should be encouraged in every way, in particular by facilitating access for small and medium-sized enterprises (SMEs).

Amendment 6

Proposal for a regulation

Recital 14

| Text proposed by the Commission | Amendment |
| --- | --- |
| (14) | Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment. |

Text proposed by the Commission

Amendment

(14)

Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment.

| (14) | Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment.
  The authorisation procedure for veterinary medicinal products should be adjusted so as to eliminate other administrative procedures that might hamper the development of research and innovation for the purpose of identifying new medicines. |
| --- | --- |

(14)

Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment.
  The authorisation procedure for veterinary medicinal products should be adjusted so as to eliminate other administrative procedures that might hamper the development of research and innovation for the purpose of identifying new medicines.

Amendment 7

Proposal for a regulation

Recital 17

| Text proposed by the Commission | Amendment |
| --- | --- |
| (17) | However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain. |

Text proposed by the Commission

Amendment

(17)

However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.

| (17) | However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only.
  In such cases, antimicrobial medicinal products for human use could be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question
  . In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain
  , and particular care should therefore be taken when administering antibiotics to food-producing animals. |
| --- | --- |

(17)

However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only.
  In such cases, antimicrobial medicinal products for human use could be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question
  . In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain
  , and particular care should therefore be taken when administering antibiotics to food-producing animals.

Amendment 8

Proposal for a regulation

Recital 18

| Text proposed by the Commission | Amendment |
| --- | --- |
| (18) | Member States should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires. |

Text proposed by the Commission

Amendment

(18)

Member States should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires.

| (18) | Member States should be able to allow
  temporary
  exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases
  or new diseases
  and where the health situation in a Member State so requires. |
| --- | --- |

(18)

Member States should be able to allow
  temporary
  exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases
  or new diseases
  and where the health situation in a Member State so requires.

Amendment 9

Proposal for a regulation

Recital 20

| Text proposed by the Commission | Amendment |
| --- | --- |
| (20) | Directive 2010/63/EU of the European Parliament and of the Council (15) lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be
  such as
  to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be
  the least likely to cause
  pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU. |

Text proposed by the Commission

Amendment

(20)

Directive 2010/63/EU of the European Parliament and of the Council (15) lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be
  such as
  to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be
  the least likely to cause
  pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.

| (20) | Directive 2010/63/EU of the European Parliament and of the Council (15) lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be
  optimised in order
  to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be
  designed to avoid causing
  pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU. |
| --- | --- |

(20)

Directive 2010/63/EU of the European Parliament and of the Council (15) lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be
  optimised in order
  to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be
  designed to avoid causing
  pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.

Amendment 10

Proposal for a regulation

Recital 23

| Text proposed by the Commission | Amendment |
| --- | --- |
| (23) | Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in
  some
  cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas. |

Text proposed by the Commission

Amendment

(23)

Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in
  some
  cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas.

| (23) | Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in
  exceptional
  cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas.
  Such products should only be used on the basis of a prescription. |
| --- | --- |

(23)

Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in
  exceptional
  cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas.
  Such products should only be used on the basis of a prescription.

Amendment 11

Proposal for a regulation

Recital 25

| Text proposed by the Commission | Amendment |
| --- | --- |
| (25) | Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition. |

Text proposed by the Commission

Amendment

(25)

Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.

| (25) | Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation,
  in particular on veterinary medicinal products for minor species and antimicrobials,
  so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition. |
| --- | --- |

(25)

Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation,
  in particular on veterinary medicinal products for minor species and antimicrobials,
  so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.

Amendment 311

Proposal for a regulation

Recital 25 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (25a) | Research should be incentivised, not only through the commercial protection of innovative active substances, but also through the protection of significant investments in data generated to improve or maintain on the market an existing veterinary medicinal product. In such cases, only the new data package would benefit from the period of protection and not the active substance or any associated products. |

Text proposed by the Commission

Amendment

(25a)

Research should be incentivised, not only through the commercial protection of innovative active substances, but also through the protection of significant investments in data generated to improve or maintain on the market an existing veterinary medicinal product. In such cases, only the new data package would benefit from the period of protection and not the active substance or any associated products.

Amendment 13

Proposal for a regulation

Recital 27

| Text proposed by the Commission | Amendment |
| --- | --- |
| (27) | It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals. |

Text proposed by the Commission

Amendment

(27)

It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals.

| (27) | It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals.
  The current impact assessment system results in repetitive and potentially divergent assessments of substances' environmental properties. That can lead to divergent decisions being taken on products with similar effects on the environment, especially in the case of products authorised before the environmental impact assessment was carried out. The establishment of a single centralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system could be a potential alternative. The Commission should therefore submit a report to the European Parliament and the Council examining the feasibility of monographs and potential alternative options as soon as possible. |
| --- | --- |

(27)

It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals.
  The current impact assessment system results in repetitive and potentially divergent assessments of substances' environmental properties. That can lead to divergent decisions being taken on products with similar effects on the environment, especially in the case of products authorised before the environmental impact assessment was carried out. The establishment of a single centralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system could be a potential alternative. The Commission should therefore submit a report to the European Parliament and the Council examining the feasibility of monographs and potential alternative options as soon as possible.

Amendment 14

Proposal for a regulation

Recital 27 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27a) | In accordance with Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should therefore be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of products, wherever possible. |

Text proposed by the Commission

Amendment

(27a)

In accordance with Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should therefore be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of products, wherever possible.

Amendment 15

Proposal for a regulation

Recital 31

| Text proposed by the Commission | Amendment |
| --- | --- |
| (31) | It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls. |

Text proposed by the Commission

Amendment

(31)

It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.

| (31) | It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should
  also
  be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls. |
| --- | --- |

(31)

It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should
  also
  be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.

Amendment 16

Proposal for a regulation

Recital 32

| Text proposed by the Commission | Amendment |
| --- | --- |
| (32) | In certain circumstances where a significant animal or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle (17). In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time. |

Text proposed by the Commission

Amendment

(32)

In certain circumstances where a significant animal or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle (17). In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.

| (32) | In certain circumstances where a significant animal
  , environmental
  or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle (17). In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time. |
| --- | --- |

(32)

In certain circumstances where a significant animal
  , environmental
  or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle (17). In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.

Amendment 17

Proposal for a regulation

Recital 33

| Text proposed by the Commission | Amendment |
| --- | --- |
| (33) | Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials
  . Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector
  . The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products. |

Text proposed by the Commission

Amendment

(33)

Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials
  . Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector
  . The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.

| (33) | Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide
  , thus involving a common responsibility of all actors concerned
  . Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are
  highly
  critical for preventing or treating life-threatening infections in humans
  and their use on animals, whether or not covered by the terms of a marketing authorisation, should be prohibited
  . In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that
  measures are proportionally applied in both the human and animal sectors and that
  appropriate warnings and guidance are included on the labels of
  human and
  veterinary antimicrobials. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products. |
| --- | --- |

(33)

Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide
  , thus involving a common responsibility of all actors concerned
  . Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are
  highly
  critical for preventing or treating life-threatening infections in humans
  and their use on animals, whether or not covered by the terms of a marketing authorisation, should be prohibited
  . In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that
  measures are proportionally applied in both the human and animal sectors and that
  appropriate warnings and guidance are included on the labels of
  human and
  veterinary antimicrobials. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.

Amendment 18

Proposal for a regulation

Recital 34 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (34a) | The routine prophylactic and metaphylactic use of antimicrobials on groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing, and sound management practices. |

Text proposed by the Commission

Amendment

(34a)

The routine prophylactic and metaphylactic use of antimicrobials on groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing, and sound management practices.

Amendment 19

Proposal for a regulation

Recital 35

| Text proposed by the Commission | Amendment |
| --- | --- |
| (35) | The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised where evidence is provided that the benefit-risk balance of the combination is favourable. |

Text proposed by the Commission

Amendment

(35)

The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised where evidence is provided that the benefit-risk balance of the combination is favourable.

| (35) | The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised
  exceptionally
  where evidence is provided that the
  long-term
  benefit-risk balance of the combination is favourable. |
| --- | --- |

(35)

The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised
  exceptionally
  where evidence is provided that the
  long-term
  benefit-risk balance of the combination is favourable.

Amendment 20

Proposal for a regulation

Recital 36

| Text proposed by the Commission | Amendment |
| --- | --- |
| (36) | The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in
  veterinary
  medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed. |

Text proposed by the Commission

Amendment

(36)

The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in
  veterinary
  medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed.

| (36) | The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore, the misuse of antimicrobials should not be allowed.
  Preventive treatments using antimicrobials should be regulated more strictly and recommended only in certain specific, well-defined cases, in compliance with animal health, biosecurity and nutritional requirements. |
| --- | --- |

(36)

The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore, the misuse of antimicrobials should not be allowed.
  Preventive treatments using antimicrobials should be regulated more strictly and recommended only in certain specific, well-defined cases, in compliance with animal health, biosecurity and nutritional requirements.

Amendment 21

Proposal for a regulation

Recital 37

| Text proposed by the Commission | Amendment |
| --- | --- |
| (37) | In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it
  may be
  necessary to reserve those antimicrobials for humans only.
  Therefore
  it should be possible to decide that
  certain
  antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector. |

Text proposed by the Commission

Amendment

(37)

In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it
  may be
  necessary to reserve those antimicrobials for humans only.
  Therefore
  it should be possible to decide that
  certain
  antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.

| (37) | In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it
  is
  necessary to reserve those antimicrobials for humans only.
  As a baseline, that should apply for the highest priority critically important antimicrobials identified by the World Health Organisation (WHO). Moreover,
  it should be possible to decide that
  other critically important
  antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector. |
| --- | --- |

(37)

In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it
  is
  necessary to reserve those antimicrobials for humans only.
  As a baseline, that should apply for the highest priority critically important antimicrobials identified by the World Health Organisation (WHO). Moreover,
  it should be possible to decide that
  other critically important
  antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.

Amendment 22

Proposal for a regulation

Recital 37 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (37a) | As antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, action also needs to be taken in the field of human medicine, for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this Regulation. |

Text proposed by the Commission

Amendment

(37a)

As antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, action also needs to be taken in the field of human medicine, for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this Regulation.

Amendment 23

Proposal for a regulation

Recital 38

| Text proposed by the Commission | Amendment |
| --- | --- |
| (38) | If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials
  and consequently
  they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by
  those health professionals
  should be restricted to the amount required for treatment of the animals under their care. |

Text proposed by the Commission

Amendment

(38)

If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials
  and consequently
  they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by
  those health professionals
  should be restricted to the amount required for treatment of the animals under their care.

| (38) | If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials.
  Veterinarians have a legal obligation, which is part of their professional code of conduct, to ensure responsible use of veterinary medicinal products.
  They should not be influenced, directly or indirectly, by economic incentives when prescribing those products.
  The animal health industry and veterinarians should together promote responsible use.
  Therefore the supply of veterinary antimicrobials by
  veterinarians or other persons authorised under national law
  should be restricted to the amount required for treatment of the animals under their care
  , and only once a veterinary diagnosis has been established following a clinical examination of the animal, or, in exceptional cases, in the light of continuous health checks on the animal
  . |
| --- | --- |

(38)

If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials.
  Veterinarians have a legal obligation, which is part of their professional code of conduct, to ensure responsible use of veterinary medicinal products.
  They should not be influenced, directly or indirectly, by economic incentives when prescribing those products.
  The animal health industry and veterinarians should together promote responsible use.
  Therefore the supply of veterinary antimicrobials by
  veterinarians or other persons authorised under national law
  should be restricted to the amount required for treatment of the animals under their care
  , and only once a veterinary diagnosis has been established following a clinical examination of the animal, or, in exceptional cases, in the light of continuous health checks on the animal
  .

Amendment 24

Proposal for a regulation

Recital 38 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (38a) | Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for the prudent use of antimicrobials in veterinary medicine, elaborated by the Commission, need to be considered by Member States. |

Text proposed by the Commission

Amendment

(38a)

Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for the prudent use of antimicrobials in veterinary medicine, elaborated by the Commission, need to be considered by Member States.

Amendment 25

Proposal for a regulation

Recital 38 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (38b) | In order to facilitate responsible use of antimicrobials, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease and to perform antibiotic sensitivity testing. That would facilitate correct diagnosis, allow for a targeted use of antimicrobials, support using as little as possible critically important antimicrobials and therefore, inhibit the development of antimicrobial resistance. There is clear need for future innovation specifically for pen-site diagnosis, and a need to consider carefully whether there is a case for more harmonisation and regulation in this sector. |

Text proposed by the Commission

Amendment

(38b)

In order to facilitate responsible use of antimicrobials, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease and to perform antibiotic sensitivity testing. That would facilitate correct diagnosis, allow for a targeted use of antimicrobials, support using as little as possible critically important antimicrobials and therefore, inhibit the development of antimicrobial resistance. There is clear need for future innovation specifically for pen-site diagnosis, and a need to consider carefully whether there is a case for more harmonisation and regulation in this sector.

Amendment 26

Proposal for a regulation

Recital 39

| Text proposed by the Commission | Amendment |
| --- | --- |
| (39) | It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union.
  Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover,
  antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore,
  measures restricting the use of veterinary antimicrobials in
  the Union should be
  based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing
  antimicrobial resistance
  in order the ensure consistency with their activities and policies
  . |

Text proposed by the Commission

Amendment

(39)

It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union.
  Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover,
  antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore,
  measures restricting the use of veterinary antimicrobials in
  the Union should be
  based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing
  antimicrobial resistance
  in order the ensure consistency with their activities and policies
  .

| (39) | It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, the Union should be
  active in advocating the creation of an international strategy to combat
  antimicrobial resistance
  , in line with the recent Global Action Plan adopted by the WHO
  . |
| --- | --- |

(39)

It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, the Union should be
  active in advocating the creation of an international strategy to combat
  antimicrobial resistance
  , in line with the recent Global Action Plan adopted by the WHO
  .

Amendment 27

Proposal for a regulation

Recital 40

| Text proposed by the Commission | Amendment |
| --- | --- |
| (40) | There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency. |

Text proposed by the Commission

Amendment

(40)

There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.

| (40) | There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food.
  Better data are needed on how, when, where and why antimicrobials are being used. Therefore, the data collected should be broken down by type of antimicrobial, species, disease or infection treated.
  To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency. |
| --- | --- |

(40)

There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food.
  Better data are needed on how, when, where and why antimicrobials are being used. Therefore, the data collected should be broken down by type of antimicrobial, species, disease or infection treated.
  To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.

Amendment 28

Proposal for a regulation

Recital 40 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (40a) | Commercial sensitivity should not be used as an excuse to deny citizens access to information about chemicals affecting their bodies or those of other non-target species in the wider environment. Maximum transparency should be ensured while protecting the most commercially sensitive information. |

Text proposed by the Commission

Amendment

(40a)

Commercial sensitivity should not be used as an excuse to deny citizens access to information about chemicals affecting their bodies or those of other non-target species in the wider environment. Maximum transparency should be ensured while protecting the most commercially sensitive information.

Amendment 29

Proposal for a regulation

Recital 49

| Text proposed by the Commission | Amendment |
| --- | --- |
| (49) | It is necessary,
  in specific cases
  , or
  from a public health
  and
  animal health perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder. |

Text proposed by the Commission

Amendment

(49)

It is necessary,
  in specific cases
  , or
  from a public health
  and
  animal health perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.

| (49) | In specific cases
  it is necessary,
  from a public health, animal health
  or environmental
  perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder. |
| --- | --- |

(49)

In specific cases
  it is necessary,
  from a public health, animal health
  or environmental
  perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.

Amendment 30

Proposal for a regulation

Recital 50

| Text proposed by the Commission | Amendment |
| --- | --- |
| (50) | A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities. |

Text proposed by the Commission

Amendment

(50)

A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities.

| (50) | A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities
  and other concerned authorities, including environmental protection agencies and food safety authorities both at national and Union level
  . |
| --- | --- |

(50)

A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities
  and other concerned authorities, including environmental protection agencies and food safety authorities both at national and Union level
  .

Amendment 314

Proposal for a regulation

Recital 52 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (52a) | In order to ensure that the imports from third countries of veterinary medicinal products, active substances, intermediate products and excipients used as starting materials have been manufactured in accordance with the animal welfare standards established in the Union, unlike for instance the current production method utilised in third countries for ‘pregnant mare serum gonadotropin’ (PMSG), the Commission should revise Directive 91/412/EEC and include animal welfare standards in the good manufacturing practice for veterinary medicinal products. |

Text proposed by the Commission

Amendment

(52a)

In order to ensure that the imports from third countries of veterinary medicinal products, active substances, intermediate products and excipients used as starting materials have been manufactured in accordance with the animal welfare standards established in the Union, unlike for instance the current production method utilised in third countries for ‘pregnant mare serum gonadotropin’ (PMSG), the Commission should revise Directive 91/412/EEC and include animal welfare standards in the good manufacturing practice for veterinary medicinal products.

Amendment 31

Proposal for a regulation

Recital 56

| Text proposed by the Commission | Amendment |
| --- | --- |
| (56) | The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States. |

Text proposed by the Commission

Amendment

(56)

The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States.

| (56) | The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by
  veterinarians or other
  persons authorised to do so by the Member State where they are established
  . However, Member States which do not allow prescriptions to be issued by persons other than veterinarians could refuse to recognise prescriptions issued by persons other than veterinarians in other Member States in accordance with their national laws
  . At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products
  , except for antimicrobials,
  via the Internet to buyers in
  their own or
  other Member States.
  In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited
  . |
| --- | --- |

(56)

The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by
  veterinarians or other
  persons authorised to do so by the Member State where they are established
  . However, Member States which do not allow prescriptions to be issued by persons other than veterinarians could refuse to recognise prescriptions issued by persons other than veterinarians in other Member States in accordance with their national laws
  . At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products
  , except for antimicrobials,
  via the Internet to buyers in
  their own or
  other Member States.
  In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited
  .

Amendment 32

Proposal for a regulation

Recital 56 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (56a) | In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, the professionally qualified animal medicines advisors should continue to prescribe and supply certain veterinary medicines. |

Text proposed by the Commission

Amendment

(56a)

In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, the professionally qualified animal medicines advisors should continue to prescribe and supply certain veterinary medicines.

Amendment 33

Proposal for a regulation

Recital 56 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (56b) | Any ban on veterinarians supplying medicines could make it impossible for some Member States to maintain a network of veterinarians covering all of their territory. Such territorial coverage is of key importance in ensuring high-quality epidemiological monitoring of existing and emerging diseases. |

Text proposed by the Commission

Amendment

(56b)

Any ban on veterinarians supplying medicines could make it impossible for some Member States to maintain a network of veterinarians covering all of their territory. Such territorial coverage is of key importance in ensuring high-quality epidemiological monitoring of existing and emerging diseases.

Amendment 34

Proposal for a regulation

Recital 57

| Text proposed by the Commission | Amendment |
| --- | --- |
| (57) | The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way.
  It is necessary to address this threat.
  Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level
  and, therefore
  , Member States
  may
  impose conditions for supplying medicinal products to the public within the limits of the Treaty. |

Text proposed by the Commission

Amendment

(57)

The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way.
  It is necessary to address this threat.
  Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level
  and, therefore
  , Member States
  may
  impose conditions for supplying medicinal products to the public within the limits of the Treaty.

| (57) | The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way.
  A system should be introduced to ensure that such products are properly sold and that controls are placed on the distribution and falsification of substances that are potentially dangerous for human use.
  Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level.
  To minimise the risks to animal and human health, the online sale of antimicrobials should be prohibited.
  Member States
  might
  impose conditions for supplying medicinal products to the public within the limits of the Treaty. |
| --- | --- |

(57)

The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way.
  A system should be introduced to ensure that such products are properly sold and that controls are placed on the distribution and falsification of substances that are potentially dangerous for human use.
  Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level.
  To minimise the risks to animal and human health, the online sale of antimicrobials should be prohibited.
  Member States
  might
  impose conditions for supplying medicinal products to the public within the limits of the Treaty.

Amendment 35

Proposal for a regulation

Recital 58 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (58a) | Member States should, after informing the Commission, be able to subject the supply of veterinary medicinal products offered for sale to stricter conditions justified by the protection of public health, animal health and the environment, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market. |

Text proposed by the Commission

Amendment

(58a)

Member States should, after informing the Commission, be able to subject the supply of veterinary medicinal products offered for sale to stricter conditions justified by the protection of public health, animal health and the environment, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.

Amendment 36

Proposal for a regulation

Recital 62

| Text proposed by the Commission | Amendment |
| --- | --- |
| (62) | Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a 
  member of a regulated animal health profession
  for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription. |

Text proposed by the Commission

Amendment

(62)

Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a 
  member of a regulated animal health profession
  for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.

| (62) | Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a 
  veterinarian or other persons authorised to do so under national law
  for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State
  , provided that the other Member State authorises persons with similar qualifications to issue prescriptions
  . The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription. |
| --- | --- |

(62)

Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a 
  veterinarian or other persons authorised to do so under national law
  for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State
  , provided that the other Member State authorises persons with similar qualifications to issue prescriptions
  . The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.

Amendment 295

Proposal for a regulation

Recital 65

| Text proposed by the Commission | Amendment |
| --- | --- |
| (65) | The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products. In order to preserve the effectiveness of the inspections,
  authorities should have the possibility to perform
  unannounced inspections. |

Text proposed by the Commission

Amendment

(65)

The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products. In order to preserve the effectiveness of the inspections,
  authorities should have the possibility to perform
  unannounced inspections.

| (65) | The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products
  and should publish annual inspection reports
  . In order to preserve the effectiveness of the inspections,
  all inspections should be
  unannounced inspections. |
| --- | --- |

(65)

The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products
  and should publish annual inspection reports
  . In order to preserve the effectiveness of the inspections,
  all inspections should be
  unannounced inspections.

Amendment 38

Proposal for a regulation

Recital 67

| Text proposed by the Commission | Amendment |
| --- | --- |
| (67) | In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment.
  To
  ensure a harmonised approach to inspections throughout the Union,
  the Commission
  should be able to carry out audits in the Member States to verify the functioning of national control systems. |

Text proposed by the Commission

Amendment

(67)

In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment.
  To
  ensure a harmonised approach to inspections throughout the Union,
  the Commission
  should be able to carry out audits in the Member States to verify the functioning of national control systems.

| (67) | In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment.
  The Commission should
  ensure a harmonised approach to inspections throughout the Union,
  and
  should be able to carry out audits in the Member States to verify the functioning of national control systems. |
| --- | --- |

(67)

In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment.
  The Commission should
  ensure a harmonised approach to inspections throughout the Union,
  and
  should be able to carry out audits in the Member States to verify the functioning of national control systems.

Amendment 39

Proposal for a regulation

Recital 71

| Text proposed by the Commission | Amendment |
| --- | --- |
| (71) | Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules. |

Text proposed by the Commission

Amendment

(71)

Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules.

| (71) | Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules.
  Furthermore, it is desirable to generally allow, under specific conditions, the use of homeopathic medicinal products designed for human use, including immunological homeopathic products that have a potency starting from D4, on all animals, including food producing animals
  . |
| --- | --- |

(71)

Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules.
  Furthermore, it is desirable to generally allow, under specific conditions, the use of homeopathic medicinal products designed for human use, including immunological homeopathic products that have a potency starting from D4, on all animals, including food producing animals
  .

Amendment 40

Proposal for a regulation

Recital 71 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (71a) | The usual rules governing the authorisation to market veterinary medicinal products should be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which might present risks which should be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify these rules to the Commission. |

Text proposed by the Commission

Amendment

(71a)

The usual rules governing the authorisation to market veterinary medicinal products should be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which might present risks which should be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify these rules to the Commission.

Amendment 41

Proposal for a regulation

Recital 73

| Text proposed by the Commission | Amendment |
| --- | --- |
| (73) | In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks should be funded through fees charged to enterprises. Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level. |

Text proposed by the Commission

Amendment

(73)

In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks should be funded through fees charged to enterprises. Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level.

| (73) | In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks
  , including the establishment of new information technology services with the aim of reducing bureaucracy,
  should be funded through fees charged to enterprises
  and through an increased financial contribution from the Commission
  . Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level. |
| --- | --- |

(73)

In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks
  , including the establishment of new information technology services with the aim of reducing bureaucracy,
  should be funded through fees charged to enterprises
  and through an increased financial contribution from the Commission
  . Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level.

Amendment 42

Proposal for a regulation

Article 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| This Regulation lays down rules for the placing on the market, manufacture, import, export, supply, pharmacovigilance, control and use of veterinary medicinal products. | This Regulation lays down rules for the placing on the market,
  development,
  manufacture, import, export,
  wholesale distribution, retail
  supply, pharmacovigilance, control and use of veterinary medicinal products. |

Text proposed by the Commission

Amendment

This Regulation lays down rules for the placing on the market, manufacture, import, export, supply, pharmacovigilance, control and use of veterinary medicinal products.

This Regulation lays down rules for the placing on the market,
  development,
  manufacture, import, export,
  wholesale distribution, retail
  supply, pharmacovigilance, control and use of veterinary medicinal products.

Amendment 43

Proposal for a regulation

Article 1 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Member States may impose stricter conditions, justified on grounds of public health, animal health and environmental protection, for the use and retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market. |

Text proposed by the Commission

Amendment

Member States may impose stricter conditions, justified on grounds of public health, animal health and environmental protection, for the use and retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.

Amendment 44

Proposal for a regulation

Article 1 — paragraph 1 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The Member States shall notify the measures referred to in paragraph 1a to the Commission. |

Text proposed by the Commission

Amendment

The Member States shall notify the measures referred to in paragraph 1a to the Commission.

Amendment 45

Proposal for a regulation

Article 2 — paragraph 4 — point e a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ea) | substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them; |

Text proposed by the Commission

Amendment

(ea)

substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them;

Amendment 46

Proposal for a regulation

Article 2 — paragraph 4 — point e b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (eb) | medicated feed and intermediate products as defined, respectively, in points (a) and (b) of Article 2(2) of Regulation (EÚ) .../... of the European Parliament and of the Council

   (1a)

  ; |

Text proposed by the Commission

Amendment

(eb)

medicated feed and intermediate products as defined, respectively, in points (a) and (b) of Article 2(2) of Regulation (EÚ) .../... of the European Parliament and of the Council

   (1a)

  ;

Amendment 47

Proposal for a regulation

Article 2 — paragraph 4 — point e c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ec) | feedingstuffs as defined in Regulation (EC) No 767/2009 of the European Parliament and of the Council. |

Text proposed by the Commission

Amendment

(ec)

feedingstuffs as defined in Regulation (EC) No 767/2009 of the European Parliament and of the Council.

Amendment 48

Proposal for a regulation

Article 3 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1a.
     
  In cases of doubt, taking into account all its characteristics, as to whether a product may fall within the definition of a veterinary medicinal product within the meaning of Article 4(1), or within the definition of a product covered by other Union legislation, the provisions of this Regulation shall prevail. |

Text proposed by the Commission

Amendment

1a.
     
  In cases of doubt, taking into account all its characteristics, as to whether a product may fall within the definition of a veterinary medicinal product within the meaning of Article 4(1), or within the definition of a product covered by other Union legislation, the provisions of this Regulation shall prevail.

Amendment 49

Proposal for a regulation

Article 4 — paragraph 1 — point 1 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | its purpose is to
  be used in or administered to animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis; |

Text proposed by the Commission

Amendment

(b)

its purpose is to
  be used in or administered to animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

| (b) | it may
  be used in, or administered to, animals with a view
  either
  to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis; |
| --- | --- |

(b)

it may
  be used in, or administered to, animals with a view
  either
  to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

Amendment 50

Proposal for a regulation

Article 4 — paragraph 1 — point 1 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | its purpose is to
  be used for euthanasia
  of
  animals; |

Text proposed by the Commission

Amendment

(c)

its purpose is to
  be used for euthanasia
  of
  animals;

| (c) | it may
  be used for euthanasia
  in
  animals; |
| --- | --- |

(c)

it may
  be used for euthanasia
  in
  animals;

Amendment 51

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| (2) | ‘substance’ means any matter
  of the following
  origin: |

Text proposed by the Commission

Amendment

(2)

‘substance’ means any matter
  of the following
  origin:

| (2) | ‘substance’ means any matter
  irrespective of its
  origin
  which may be: |
| --- | --- |

(2)

‘substance’ means any matter
  irrespective of its
  origin
  which may be:

Amendment 52

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | human, |

Text proposed by the Commission

Amendment

(a)

human,

| (a) | human,
  for example human blood and human blood products; |
| --- | --- |

(a)

human,
  for example human blood and human blood products;

Amendment 53

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | animal, |

Text proposed by the Commission

Amendment

(b)

animal,

| (b) | animal,
  for example micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; |
| --- | --- |

(b)

animal,
  for example micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;

Amendment 54

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | vegetable, |

Text proposed by the Commission

Amendment

(c)

vegetable,

| (c) | vegetable,
  for example micro-organisms, plants, parts of plants, vegetable secretions, extracts; |
| --- | --- |

(c)

vegetable,
  for example micro-organisms, plants, parts of plants, vegetable secretions, extracts;

Amendment 55

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — point c a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ca) | fungal; |

Text proposed by the Commission

Amendment

(ca)

fungal;

Amendment 56

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — point c b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (cb) | microbial; |

Text proposed by the Commission

Amendment

(cb)

microbial;

Amendment 57

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — point d

| Text proposed by the Commission | Amendment |
| --- | --- |
| (d) | chemical; |

Text proposed by the Commission

Amendment

(d)

chemical;

| (d) | chemical
  , for example elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis; |
| --- | --- |

(d)

chemical
  , for example elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

Amendment 58

Proposal for a regulation

Article 4 — paragraph 1 — point 2 — point d a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (da) | mineral. |

Text proposed by the Commission

Amendment

(da)

mineral.

Amendment 59

Proposal for a regulation

Article 4 — paragraph 1 — point 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (2a) | ‘active substance’ means a substance with a pharmacological activity; |

Text proposed by the Commission

Amendment

(2a)

‘active substance’ means a substance with a pharmacological activity;

Amendment 60

Proposal for a regulation

Article 4 — paragraph 1 — point 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| (3) | ‘immunological veterinary medicinal product’ means a veterinary medicinal product
  consisting of
  vaccines, toxins, sera or allergen products
  and
  intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity; |

Text proposed by the Commission

Amendment

(3)

‘immunological veterinary medicinal product’ means a veterinary medicinal product
  consisting of
  vaccines, toxins, sera or allergen products
  and
  intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;

| (3) | ‘immunological veterinary medicinal product’ means a veterinary medicinal product,
  such as
  vaccines, toxins, sera or allergen products intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity; |
| --- | --- |

(3)

‘immunological veterinary medicinal product’ means a veterinary medicinal product,
  such as
  vaccines, toxins, sera or allergen products intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;

Amendment 61

Proposal for a regulation

Article 4 — paragraph 1 — point 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| (7) | ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared
  from homeopathic stocks
  in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; |

Text proposed by the Commission

Amendment

(7)

‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared
  from homeopathic stocks
  in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;

| (7) | ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;
  a homeopathic veterinary medicinal product may contain a number of active ingredients; |
| --- | --- |

(7)

‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;
  a homeopathic veterinary medicinal product may contain a number of active ingredients;

Amendment 62

Proposal for a regulation

Article 4 — paragraph 1 — point 7 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (7a) | ‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations; |

Text proposed by the Commission

Amendment

(7a)

‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;

Amendment 63

Proposal for a regulation

Article 4 — paragraph 1 — point 8

| Text proposed by the Commission | Amendment |
| --- | --- |
| (8) | ‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to
  inhibit
  or kill microorganisms of the same species; |

Text proposed by the Commission

Amendment

(8)

‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to
  inhibit
  or kill microorganisms of the same species;

| (8) | ‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to
  halt the growth of
  or kill microorganisms of the same species; |
| --- | --- |

(8)

‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to
  halt the growth of
  or kill microorganisms of the same species;

Amendment 64

Proposal for a regulation

Article 4 — paragraph 1 — point 8 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (8a) | ‘antimicrobial’ means any compound with a direct action on micro-organisms used for treatment or prevention of infections; antimicrobials include anti-bacterials, anti-virals, anti-fungals and anti-protozoals; in the context of this Regulation, an antimicrobial substance refers to an antibacterial; |

Text proposed by the Commission

Amendment

(8a)

‘antimicrobial’ means any compound with a direct action on micro-organisms used for treatment or prevention of infections; antimicrobials include anti-bacterials, anti-virals, anti-fungals and anti-protozoals; in the context of this Regulation, an antimicrobial substance refers to an antibacterial;

Amendment 65

Proposal for a regulation

Article 4 — paragraph 1 — point 8 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (8b) | ‘antiparasitic’ means a medicinal product or substance used in the treatment of parasitic diseases attributable to various causes; |

Text proposed by the Commission

Amendment

(8b)

‘antiparasitic’ means a medicinal product or substance used in the treatment of parasitic diseases attributable to various causes;

Amendment 66

Proposal for a regulation

Article 4 — paragraph 1 — point 8 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (8c) | ‘antibacterial’ means a compound with a direct action on bacteria used for treatment or prevention of infections; |

Text proposed by the Commission

Amendment

(8c)

‘antibacterial’ means a compound with a direct action on bacteria used for treatment or prevention of infections;

Amendment 67

Proposal for a regulation

Article 4 — paragraph 1 — point 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| (9) | ‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice
  for the purpose of obtaining a marketing authorisation or a change thereof
  ; |

Text proposed by the Commission

Amendment

(9)

‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice
  for the purpose of obtaining a marketing authorisation or a change thereof
  ;

| (9) | ‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice; |
| --- | --- |

(9)

‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice;

Amendment 68

Proposal for a regulation

Article 4 — paragraph 1 — point 10

| Text proposed by the Commission | Amendment |
| --- | --- |
| (10) | ‘pre-clinical study’ means a study not covered by the definition of clinical trial
  which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof
  ; |

Text proposed by the Commission

Amendment

(10)

‘pre-clinical study’ means a study not covered by the definition of clinical trial
  which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof
  ;

| (10) | ‘pre-clinical study’ means a study not covered by the definition of clinical trial; |
| --- | --- |

(10)

‘pre-clinical study’ means a study not covered by the definition of clinical trial;

Amendment 69

Proposal for a regulation

Article 4 — paragraph 1 — point 11 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| (11) | ‘benefit-risk balance’ means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product: |

Text proposed by the Commission

Amendment

(11)

‘benefit-risk balance’ means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:

| (11) | ‘benefit-risk balance’ means an evaluation of the positive
  therapeutic
  effects of the veterinary medicinal product in relation to the following risks relating to the use of that product: |
| --- | --- |

(11)

‘benefit-risk balance’ means an evaluation of the positive
  therapeutic
  effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:

Amendment 70

Proposal for a regulation

Article 4 — paragraph 1 — point 12

| Text proposed by the Commission | Amendment |
| --- | --- |
| (12) | ‘common name’ means the international non-proprietary name recommended by the World Health Organisation
  for a veterinary medicinal product
  , or, if one does not exist, the name
  generally used
  ; |

Text proposed by the Commission

Amendment

(12)

‘common name’ means the international non-proprietary name recommended by the World Health Organisation
  for a veterinary medicinal product
  , or, if one does not exist, the name
  generally used
  ;

| (12) | ‘common name’ means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the
  usual common
  name; |
| --- | --- |

(12)

‘common name’ means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the
  usual common
  name;

Amendment 71

Proposal for a regulation

Article 4 — paragraph 1 — point 18

| Text proposed by the Commission | Amendment |
| --- | --- |
| (18) | ‘package leaflet’ means
  a documentation leaflet on a
  veterinary medicinal product which contains information to ensure its safe and efficacious use; |

Text proposed by the Commission

Amendment

(18)

‘package leaflet’ means
  a documentation leaflet on a
  veterinary medicinal product which contains information to ensure its safe and efficacious use;

| (18) | ‘package leaflet’ means
  an information leaflet attached to a veterinary medicinal product which is intended for a user of the
  veterinary medicinal product
  and
  which contains information to ensure its safe and efficacious use
  which are compliant with the information provided for in the summary of product characteristics of the veterinary medicinal product
  ; |
| --- | --- |

(18)

‘package leaflet’ means
  an information leaflet attached to a veterinary medicinal product which is intended for a user of the
  veterinary medicinal product
  and
  which contains information to ensure its safe and efficacious use
  which are compliant with the information provided for in the summary of product characteristics of the veterinary medicinal product
  ;

Amendment 72

Proposal for a regulation

Article 4 — paragraph 1 — point 20 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | veterinary medicinal products for animal species other than cattle,
  sheep,
  pigs, chickens, dogs and
  cats
  ; |

Text proposed by the Commission

Amendment

(b)

veterinary medicinal products for animal species other than cattle,
  sheep,
  pigs, chickens, dogs and
  cats
  ;

| (b) | veterinary medicinal products for animal species other than cattle, pigs, chickens, dogs
  , cats, salmon
  and
  sheep reared for their meat
  ; |
| --- | --- |

(b)

veterinary medicinal products for animal species other than cattle, pigs, chickens, dogs
  , cats, salmon
  and
  sheep reared for their meat
  ;

Amendment 73

Proposal for a regulation

Article 4 — paragraph 1 — point 21

| Text proposed by the Commission | Amendment |
| --- | --- |
| (21) | ‘pharmacovigilance’ means
  the process of monitoring and investigating
  adverse events; |

Text proposed by the Commission

Amendment

(21)

‘pharmacovigilance’ means
  the process of monitoring and investigating
  adverse events;

| (21) | ‘pharmacovigilance’ means
  scientific, control and administrative activities relating to detection, reporting, assessment, understanding, prevention and communication of
  adverse events
  which include continuous evaluation of the risk-benefit balance of veterinary medicinal products
  ; |
| --- | --- |

(21)

‘pharmacovigilance’ means
  scientific, control and administrative activities relating to detection, reporting, assessment, understanding, prevention and communication of
  adverse events
  which include continuous evaluation of the risk-benefit balance of veterinary medicinal products
  ;

Amendment 74

Proposal for a regulation

Article 4 — paragraph 1 — point 24

| Text proposed by the Commission | Amendment |
| --- | --- |
| (24) | ‘veterinary prescription’ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law; |

Text proposed by the Commission

Amendment

(24)

‘veterinary prescription’ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law;

| (24) | ‘veterinary prescription’ means any prescription for a veterinary medicinal product issued by a 
  veterinarian or another
  professional person qualified to do so in accordance with applicable national law
  once a veterinary diagnosis has been established following a clinical examination of the animal
  ; |
| --- | --- |

(24)

‘veterinary prescription’ means any prescription for a veterinary medicinal product issued by a 
  veterinarian or another
  professional person qualified to do so in accordance with applicable national law
  once a veterinary diagnosis has been established following a clinical examination of the animal
  ;

Amendment 75

Proposal for a regulation

Article 4 — paragraph 1 — point 25

| Text proposed by the Commission | Amendment |
| --- | --- |
| (25) | ‘withdrawal period’ means the
  minimum
  period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal
  which under normal conditions of use is necessary to ensure
  that such foodstuffs do not contain residues in quantities
  harmful to public health
  ; |

Text proposed by the Commission

Amendment

(25)

‘withdrawal period’ means the
  minimum
  period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal
  which under normal conditions of use is necessary to ensure
  that such foodstuffs do not contain residues in quantities
  harmful to public health
  ;

| (25) | ‘withdrawal period’ means the period
  necessary
  between the last administration of a veterinary medicinal product to an animal
  under normal conditions of use,
  and the production of foodstuffs from that animal
  , for the purpose of ensuring
  that such foodstuffs do not contain residues in quantities
  greater than the maximum limits established under Regulation (EC) No 470/2009 of the European Parliament and of the Council

   (1a); |
| --- | --- |

(25)

‘withdrawal period’ means the period
  necessary
  between the last administration of a veterinary medicinal product to an animal
  under normal conditions of use,
  and the production of foodstuffs from that animal
  , for the purpose of ensuring
  that such foodstuffs do not contain residues in quantities
  greater than the maximum limits established under Regulation (EC) No 470/2009 of the European Parliament and of the Council

   (1a);

Amendment 76

Proposal for a regulation

Article 4 — paragraph 1 — point 26

| Text proposed by the Commission | Amendment |
| --- | --- |
| (26) | ‘making available on the market’ means any supply of a veterinary medicinal product for distribution, consumption or use on the
  Union
  market in the course of a commercial activity, whether in return for payment or free of charge; |

Text proposed by the Commission

Amendment

(26)

‘making available on the market’ means any supply of a veterinary medicinal product for distribution, consumption or use on the
  Union
  market in the course of a commercial activity, whether in return for payment or free of charge;

| (26) | ‘making available on the market’ means any supply of a veterinary medicinal product for distribution, consumption or use on the market
  of a Member State
  in the course of a commercial activity, whether in return for payment or free of charge; |
| --- | --- |

(26)

‘making available on the market’ means any supply of a veterinary medicinal product for distribution, consumption or use on the market
  of a Member State
  in the course of a commercial activity, whether in return for payment or free of charge;

Amendment 77

Proposal for a regulation

Article 4 — paragraph 1 — point 27 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27a) | ‘
  essentially similar product
  ’
  means a generic product that satisfies the criteria of having the same qualitative and quantitative composition in terms of active substances, of having the same pharmaceutical form, and of being bioequivalent to the original product, unless it is apparent in the light of scientific knowledge that it differs from the original product as regards safety and efficacy; |

Text proposed by the Commission

Amendment

(27a)

‘
  essentially similar product
  ’
  means a generic product that satisfies the criteria of having the same qualitative and quantitative composition in terms of active substances, of having the same pharmaceutical form, and of being bioequivalent to the original product, unless it is apparent in the light of scientific knowledge that it differs from the original product as regards safety and efficacy;

Amendment 78

Proposal for a regulation

Article 4 — paragraph 1 — point 27 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27b) | ‘marketing authorisation holder’ means the holder of a marketing authorisation granted in accordance with this Regulation; |

Text proposed by the Commission

Amendment

(27b)

‘marketing authorisation holder’ means the holder of a marketing authorisation granted in accordance with this Regulation;

Amendment 79

Proposal for a regulation

Article 4 — paragraph 1 — point 27 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27c) | ‘good animal husbandry’ means the management and care of farm animals by humans for profit whilst ensuring the health and welfare of these animals by respecting and safeguarding the specific needs of each species and by minimising as much as possible the need to use veterinary pharmaceutical products; |

Text proposed by the Commission

Amendment

(27c)

‘good animal husbandry’ means the management and care of farm animals by humans for profit whilst ensuring the health and welfare of these animals by respecting and safeguarding the specific needs of each species and by minimising as much as possible the need to use veterinary pharmaceutical products;

Amendment 80

Proposal for a regulation

Article 4 — paragraph 1 — point 27 d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27d) | ‘responsible use of veterinary medicinal products’ means ensuring good husbandry and management practices such as biosecurity measures aiming to keep groups of animals healthy or to limit the spread of disease within an animal population, as well as asking veterinary advice, following vaccination programmes and prescription instructions, and ensuring good hygiene, appropriate nutrition and regular monitoring of health and welfare; |

Text proposed by the Commission

Amendment

(27d)

‘responsible use of veterinary medicinal products’ means ensuring good husbandry and management practices such as biosecurity measures aiming to keep groups of animals healthy or to limit the spread of disease within an animal population, as well as asking veterinary advice, following vaccination programmes and prescription instructions, and ensuring good hygiene, appropriate nutrition and regular monitoring of health and welfare;

Amendment 81

Proposal for a regulation

Article 4 — paragraph 1 — point 27 e (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27e) | ‘adverse events’ means any of the undesirable events set out in Article 73(2); |

Text proposed by the Commission

Amendment

(27e)

‘adverse events’ means any of the undesirable events set out in Article 73(2);

Amendment 82

Proposal for a regulation

Article 4 — paragraph 1 — point 27 f (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27f) | ‘serious adverse events’ means any adverse event which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or which results in permanent or prolonged signs in the animals treated; |

Text proposed by the Commission

Amendment

(27f)

‘serious adverse events’ means any adverse event which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or which results in permanent or prolonged signs in the animals treated;

Amendment 83

Proposal for a regulation

Article 4 — paragraph 1 — point 27 g (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27 g) | ‘curative (therapeutic) treatment’ means the treatment of an ill animal or group of animals, when the diagnosis of disease or infection has been made; |

Text proposed by the Commission

Amendment

(27 g)

‘curative (therapeutic) treatment’ means the treatment of an ill animal or group of animals, when the diagnosis of disease or infection has been made;

Amendment 84

Proposal for a regulation

Article 4 — paragraph 1 — point 27 h (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27h) | ‘control treatment (metaphylaxis)’ means the treatment of a group of animals after the diagnosis of clinical disease in part of the group, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk which may already be subclinically infected; the presence of such a disease in the group shall be established before the product is used; |

Text proposed by the Commission

Amendment

(27h)

‘control treatment (metaphylaxis)’ means the treatment of a group of animals after the diagnosis of clinical disease in part of the group, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk which may already be subclinically infected; the presence of such a disease in the group shall be established before the product is used;

Amendment 85

Proposal for a regulation

Article 4 — paragraph 1 — point 27 i (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27i) | ‘preventive treatment (prophylaxis)’ means the treatment of an animal or a group of animals before clinical signs of disease emerge, in order to prevent the occurrence of disease or infection; |

Text proposed by the Commission

Amendment

(27i)

‘preventive treatment (prophylaxis)’ means the treatment of an animal or a group of animals before clinical signs of disease emerge, in order to prevent the occurrence of disease or infection;

Amendment 86

Proposal for a regulation

Article 4 — paragraph 1 — point 27 j (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27j) | ‘parallel importation’ means the importation into a Member State of a veterinary medicinal product authorised in another Member State in accordance with this Regulation and having the same characteristics as the veterinary medicinal product authorised in the Member State of import, in particular with:










  (a) | the same qualitative and quantitative composition in terms of active substances and excipients and the same pharmaceutical form; |

Text proposed by the Commission

Amendment

(27j)

‘parallel importation’ means the importation into a Member State of a veterinary medicinal product authorised in another Member State in accordance with this Regulation and having the same characteristics as the veterinary medicinal product authorised in the Member State of import, in particular with:

(a)

the same qualitative and quantitative composition in terms of active substances and excipients and the same pharmaceutical form;

| (b) | the same therapeutic indications and target species. |
| --- | --- |

(b)

the same therapeutic indications and target species.

Amendment 87

Proposal for a regulation

Article 4 — paragraph 1 — point 27 k (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27k) | ‘parallel distribution’ means distribution from one Member State to another Member State of a veterinary medicinal product authorised under a centralised procedure by an establishment authorised as referred to in Article 105 which is independent of the holder of the marketing authorisation; |

Text proposed by the Commission

Amendment

(27k)

‘parallel distribution’ means distribution from one Member State to another Member State of a veterinary medicinal product authorised under a centralised procedure by an establishment authorised as referred to in Article 105 which is independent of the holder of the marketing authorisation;

Amendment 88

Proposal for a regulation

Article 4 — paragraph 1 — point 27 l (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27l) | ‘wholesale distribution’ means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products, whether in return for payment or free of charge, apart from retail supply; such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in accordance with applicable national law; |

Text proposed by the Commission

Amendment

(27l)

‘wholesale distribution’ means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products, whether in return for payment or free of charge, apart from retail supply; such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in accordance with applicable national law;

Amendment 89

Proposal for a regulation

Article 4 — paragraph 1 — point 27 m (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27m) | ‘name of veterinary medicinal product’ means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder; |

Text proposed by the Commission

Amendment

(27m)

‘name of veterinary medicinal product’ means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;

Amendment 90

Proposal for a regulation

Article 4 — paragraph 1 — point 27 n (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27n) | ‘pre-mix for medicated feedingstuffs’ means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs in accordance with Regulation (EU) .../... of the European Parliament and of the Council

   (*1)

  . |

Text proposed by the Commission

Amendment

(27n)

‘pre-mix for medicated feedingstuffs’ means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs in accordance with Regulation (EU) .../... of the European Parliament and of the Council

   (*1)

  .

Amendment 91

Proposal for a regulation

Article 5 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   A veterinary medicinal product shall be placed on the market only when a marketing authorisation has been granted in respect of the product by a competent authority
  in accordance with Articles 44, 46 or 48
  or by the Commission in accordance with
  Article 40
  . | 1.   
  Without prejudice to other provisions of this Regulation,
  a veterinary medicinal product shall be placed on the market
  of a Member State
  only when a marketing authorisation has been granted in respect of the product by a competent authority
  of that Member State
  or by the Commission in accordance with
  this Regulation
  . |

Text proposed by the Commission

Amendment

1.   A veterinary medicinal product shall be placed on the market only when a marketing authorisation has been granted in respect of the product by a competent authority
  in accordance with Articles 44, 46 or 48
  or by the Commission in accordance with
  Article 40
  .

1.   
  Without prejudice to other provisions of this Regulation,
  a veterinary medicinal product shall be placed on the market
  of a Member State
  only when a marketing authorisation has been granted in respect of the product by a competent authority
  of that Member State
  or by the Commission in accordance with
  this Regulation
  .

Amendment 92

Proposal for a regulation

Article 5 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time. | 2.   A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time
  , unless risks to public health, animal health and the environment are detected or new scientific knowledge gives grounds for re-examination of the benefit risk balance. In such situations Member States or the Commission shall refer the matter to the Agency in accordance with the procedure described in Article 84. |
| | When a previously authorised veterinary medicinal product has not been present on the market in any Member State for a period of five consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid. |
| | The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant an exemption from the termination of validity referred to in the second subparagraph. Such exemptions shall be duly justified. |
| | The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of its legal responsibility. |

Text proposed by the Commission

Amendment

2.   A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.

2.   A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time
  , unless risks to public health, animal health and the environment are detected or new scientific knowledge gives grounds for re-examination of the benefit risk balance. In such situations Member States or the Commission shall refer the matter to the Agency in accordance with the procedure described in Article 84.

When a previously authorised veterinary medicinal product has not been present on the market in any Member State for a period of five consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid.

The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant an exemption from the termination of validity referred to in the second subparagraph. Such exemptions shall be duly justified.

The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of its legal responsibility.

Amendment 93

Proposal for a regulation

Article 6 — paragraph 1 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | the mutual recognition procedure laid down in Articles 47
  and
  48. |

Text proposed by the Commission

Amendment

(c)

the mutual recognition procedure laid down in Articles 47
  and
  48.

| (c) | the mutual recognition procedure laid down in Articles 47, 48
  and 57
  . |
| --- | --- |

(c)

the mutual recognition procedure laid down in Articles 47, 48
  and 57
  .

Amendment 94

Proposal for a regulation

Article 6 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   Applications shall be submitted electronically
  . For applications submitted in accordance
  with the
  centralised marketing authorisation procedure, the formats made available by
  the Agency shall
  be used
  . | 3.   Applications shall be submitted electronically
  or saved in exceptional circumstances and following agreement with a competent authority or in the case of centralised application,
  with the
  Agency. The Commission, in collaboration with the Member States and with
  the Agency shall
  adopt detailed guidelines on the format of electronic applications
  . |

Text proposed by the Commission

Amendment

3.   Applications shall be submitted electronically
  . For applications submitted in accordance
  with the
  centralised marketing authorisation procedure, the formats made available by
  the Agency shall
  be used
  .

3.   Applications shall be submitted electronically
  or saved in exceptional circumstances and following agreement with a competent authority or in the case of centralised application,
  with the
  Agency. The Commission, in collaboration with the Member States and with
  the Agency shall
  adopt detailed guidelines on the format of electronic applications
  .

Amendment 95

Proposal for a regulation

Article 6 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.   
  Within 15 days of receipt of the application
  , the competent authority or the Agency shall notify the applicant of whether
  all data required in accordance with Article 7
  have been
  presented
  . | 5.   
  Without prejudice to specific provisions related to the mutual recognition procedure or the decentralised procedure
  , the competent authority or the Agency shall
  , within 15 days of receipt of the application,
  notify the applicant whether
  the formal requirements laid down in this Regulation for the application concerned
  have been
  met and whether the application can be subject to scientific assessment
  . |

Text proposed by the Commission

Amendment

5.   
  Within 15 days of receipt of the application
  , the competent authority or the Agency shall notify the applicant of whether
  all data required in accordance with Article 7
  have been
  presented
  .

5.   
  Without prejudice to specific provisions related to the mutual recognition procedure or the decentralised procedure
  , the competent authority or the Agency shall
  , within 15 days of receipt of the application,
  notify the applicant whether
  the formal requirements laid down in this Regulation for the application concerned
  have been
  met and whether the application can be subject to scientific assessment
  .

Amendment 96

Proposal for a regulation

Article 7 — paragraph 2 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals, |

Text proposed by the Commission

Amendment

(a)

documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals,

| (a) | documentation on the direct or indirect risks to public or animal health
  or the environment
  of use of the antimicrobial veterinary medicinal product in animals, |
| --- | --- |

(a)

documentation on the direct or indirect risks to public or animal health
  or the environment
  of use of the antimicrobial veterinary medicinal product in animals,

Amendment 97

Proposal for a regulation

Article 7 — paragraph 2 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product. |

Text proposed by the Commission

Amendment

(b)

information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product.

| (b) | information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product
  , including specifications that the product is not to be used as a routine prophylactic or metaphylactic measure in food-producing animals, and is not to be used in prophylactic group treatments where there has been no diagnosis of disease
  . |
| --- | --- |

(b)

information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product
  , including specifications that the product is not to be used as a routine prophylactic or metaphylactic measure in food-producing animals, and is not to be used in prophylactic group treatments where there has been no diagnosis of disease
  .

Amendment 98

Proposal for a regulation

Article 7 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (22)

  shall be submitted in addition to the information listed in paragraph 1. | 3.   Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document
  shall be submitted in addition to the information listed in paragraph 1 of this Article
  certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (22)

  and that at least six months has elapsed from submission of such application. |

Text proposed by the Commission

Amendment

3.   Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (22)

  shall be submitted in addition to the information listed in paragraph 1.

3.   Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document
  shall be submitted in addition to the information listed in paragraph 1 of this Article
  certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (22)

  and that at least six months has elapsed from submission of such application.

Amendment 100

Proposal for a regulation

Article 8 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   
  Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain unless: | 2.   
  Member States shall not permit test animals to be used as a source of foodstuffs for human consumption unless the competent authorities have established an appropriate withdrawal period. Such period shall either: |
| (a) | the tested product is a veterinary medicinal product authorised for the food-producing species used in the clinical trial, and the withdrawal period set out in the summary of the product characteristics is respected, or |

Text proposed by the Commission

Amendment

2.   
  Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain unless:

2.   
  Member States shall not permit test animals to be used as a source of foodstuffs for human consumption unless the competent authorities have established an appropriate withdrawal period. Such period shall either:

(a)

the tested product is a veterinary medicinal product authorised for the food-producing species used in the clinical trial, and the withdrawal period set out in the summary of the product characteristics is respected, or

| (a) | be at least as long as the withdrawal period laid down in Article 117, including, where appropriate, a safety factor reflecting the nature of the substance being tested; or |
| --- | --- |

(a)

be at least as long as the withdrawal period laid down in Article 117, including, where appropriate, a safety factor reflecting the nature of the substance being tested; or

| (b) | the tested product is an authorised veterinary medicinal product for target species other than the food-producing species used in the clinical trial and the withdrawal period set out in accordance with Article 117 is respected. |
| --- | --- |

(b)

the tested product is an authorised veterinary medicinal product for target species other than the food-producing species used in the clinical trial and the withdrawal period set out in accordance with Article 117 is respected.

| (b) | if maximum residue limits have been established by the Union in accordance with Regulation (EC) No 470/2009, the period shall be such as to ensure that those residue limits will not be exceeded in foodstuffs. |
| --- | --- |

(b)

if maximum residue limits have been established by the Union in accordance with Regulation (EC) No 470/2009, the period shall be such as to ensure that those residue limits will not be exceeded in foodstuffs.

Amendment 101

Proposal for a regulation

Article 8 — paragraph 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4a.
     
  The principles of replacement, reduction and refinement concerning the care and use of live animals for scientific purposes shall be taken into account during the design and performance of clinical trials. |

Text proposed by the Commission

Amendment

4a.
     
  The principles of replacement, reduction and refinement concerning the care and use of live animals for scientific purposes shall be taken into account during the design and performance of clinical trials.

Amendment 102

Proposal for a regulation

Article 8 — paragraph 6 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 6a.
     
  The holder of the clinical trial authorisation shall notify the competent authority of every serious adverse event and all human adverse reactions shall be notified promptly and in any case not later than 15 days following receipt of the information. |

Text proposed by the Commission

Amendment

6a.
     
  The holder of the clinical trial authorisation shall notify the competent authority of every serious adverse event and all human adverse reactions shall be notified promptly and in any case not later than 15 days following receipt of the information.

Amendment 103

Proposal for a regulation

Article 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| Labelling of the immediate packaging of veterinary medicinal products | Labelling of the immediate packaging of veterinary medicinal products |
| 1.   The immediate packaging of a veterinary medicinal product shall contain only the following information: | 1.   The immediate packaging of a veterinary medicinal product shall contain only the following information: |
| (a) | the name of the veterinary medicinal product, followed by its strength and pharmaceutical form; |

Text proposed by the Commission

Amendment

Labelling of the immediate packaging of veterinary medicinal products

Labelling of the immediate packaging of veterinary medicinal products

1.   The immediate packaging of a veterinary medicinal product shall contain only the following information:

1.   The immediate packaging of a veterinary medicinal product shall contain only the following information:

(a)

the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

| (a) | the name of the veterinary medicinal product, followed by its strength and pharmaceutical form; |
| --- | --- |

(a)

the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

| (b) | a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names; |
| --- | --- |

(b)

a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

| (b) | a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names; |
| --- | --- |

(b)

a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

| (c) | the batch number, preceded by the word ‘Lot’; |
| --- | --- |

(c)

the batch number, preceded by the word ‘Lot’;

| (c) | the batch number, preceded by the word ‘Lot’; |
| --- | --- |

(c)

the batch number, preceded by the word ‘Lot’;

| (d) | the name or corporate name or logo name of the marketing authorisation holder; |
| --- | --- |

(d)

the name or corporate name or logo name of the marketing authorisation holder;

| (d) | the name or corporate name or logo name of the marketing authorisation holder; |
| --- | --- |

(d)

the name or corporate name or logo name of the marketing authorisation holder;

| (e) | the target species; |
| --- | --- |

(e)

the target species;

| (e) | the target species; |
| --- | --- |

(e)

the target species;

| (f) | the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’; |
| --- | --- |

(f)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;

| (f) | the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’; |
| --- | --- |

(f)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;

| (g) | special storage precautions, if any. |
| --- | --- |

(g)

special storage precautions, if any.

| (g) | special storage precautions, if any. |
| --- | --- |

(g)

special storage precautions, if any.

1a.
     
  In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure the safe and correct administration of the product.

2.   The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.

2.   The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.

2a.
     
  In addition, all the information listed in points (a) to (g) of paragraph 1 shall also appear in a format that is electronically readable, such as a barcode. Data shall be made available for other documentation systems through standards interface.

Amendment 104

Proposal for a regulation

Article 10

| Text proposed by the Commission | Amendment |
| --- | --- |
| Labelling of the outer packaging of veterinary medicinal products | Labelling of the outer packaging of veterinary medicinal products |
| 1.   The outer packaging of a veterinary medicinal product shall contain only the following information: | 1.   The outer packaging of a veterinary medicinal product shall contain only the following information: |
| (a) | the information listed in Article 9(1); |

Text proposed by the Commission

Amendment

Labelling of the outer packaging of veterinary medicinal products

Labelling of the outer packaging of veterinary medicinal products

1.   The outer packaging of a veterinary medicinal product shall contain only the following information:

1.   The outer packaging of a veterinary medicinal product shall contain only the following information:

(a)

the information listed in Article 9(1);

| (a) | the information listed in Article 9(1); |
| --- | --- |

(a)

the information listed in Article 9(1);

| (b) | the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product; |
| --- | --- |

(b)

the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;

| (b) | the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product; |
| --- | --- |

(b)

the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;

| (c) | warning that the veterinary medicinal product must be kept out of the sight and reach of children; |
| --- | --- |

(c)

warning that the veterinary medicinal product must be kept out of the sight and reach of children;

| (c) | warning that the veterinary medicinal product must be kept out of the sight and reach of children; |
| --- | --- |

(c)

warning that the veterinary medicinal product must be kept out of the sight and reach of children;

| (d) | warning that the veterinary medicinal product is for animal treatment only; |
| --- | --- |

(d)

warning that the veterinary medicinal product is for animal treatment only;

| (d) | a common pictogram
  warning that the veterinary medicinal product is for animal treatment only; |
| --- | --- |

(d)

a common pictogram
  warning that the veterinary medicinal product is for animal treatment only;

| (e) | recommendation to read the package leaflet; |
| --- | --- |

(e)

recommendation to read the package leaflet;

| (e) | recommendation to read the package leaflet; |
| --- | --- |

(e)

recommendation to read the package leaflet;

| (f) | requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products; |
| --- | --- |

(f)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;

| (f) | requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  in accordance with the applicable law; |
| --- | --- |

(f)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  in accordance with the applicable law;

| (g) | in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’. |
| --- | --- |

(g)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’.

| (g) | in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’. |
| --- | --- |

(g)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’.

1a.
     
  In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure safe and correct administration of the product.

2.   The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.

2.   The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters,
  as well as in machine-readable format
  , or, where appropriate, abbreviations or pictograms common throughout the Union.

3.   Where there is no outer packaging, all the particulars listed in paragraph 1 shall appear on the immediate packaging.

3.   Where there is no outer packaging, all the particulars listed in paragraph 1 shall appear on the immediate packaging.

Amendment 105

Proposal for a regulation

Article 11

| Text proposed by the Commission | Amendment |
| --- | --- |
| Labelling of small immediate packaging units of veterinary medicinal products | Labelling of small immediate packaging units of veterinary medicinal products |
| By way of derogation from Article 9, small immediate packaging units shall contain only the following information: | By way of derogation from Article 9, small immediate packaging units shall contain only the following information: |
| (a) | the name of veterinary medicinal product; |

Text proposed by the Commission

Amendment

Labelling of small immediate packaging units of veterinary medicinal products

Labelling of small immediate packaging units of veterinary medicinal products

By way of derogation from Article 9, small immediate packaging units shall contain only the following information:

By way of derogation from Article 9, small immediate packaging units shall contain only the following information:

(a)

the name of veterinary medicinal product;

| (a) | the name of veterinary medicinal product; |
| --- | --- |

(a)

the name of veterinary medicinal product;

| (b) | the quantitative particulars of the active substances; |
| --- | --- |

(b)

the quantitative particulars of the active substances;

| (b) | the quantitative particulars of the active substances,
  unless the product exists in only one concentration or the concentration is reflected in the name; |
| --- | --- |

(b)

the quantitative particulars of the active substances,
  unless the product exists in only one concentration or the concentration is reflected in the name;

| (c) | the batch number, preceded by the word ‘Lot’; |
| --- | --- |

(c)

the batch number, preceded by the word ‘Lot’;

| (c) | the batch number, preceded by the word ‘Lot’; |
| --- | --- |

(c)

the batch number, preceded by the word ‘Lot’;

| (d) | the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’ |
| --- | --- |

(d)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’

| (d) | the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’. |
| --- | --- |

(d)

the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’.

In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure safe and correct administration of the product.

Amendment 106

Proposal for a regulation

Article 12

| Text proposed by the Commission | Amendment |
| --- | --- |
| Package leaflet of veterinary medicinal products | Package leaflet of veterinary medicinal products |
| 1.   The package leaflet shall be available
  for
  each veterinary medicinal product and shall contain at least the following information: | 1.   The package leaflet shall be
  directly
  available
  with
  each veterinary medicinal product and shall contain at least the following information: |
| (a) | the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder; |

Text proposed by the Commission

Amendment

Package leaflet of veterinary medicinal products

Package leaflet of veterinary medicinal products

1.   The package leaflet shall be available
  for
  each veterinary medicinal product and shall contain at least the following information:

1.   The package leaflet shall be
  directly
  available
  with
  each veterinary medicinal product and shall contain at least the following information:

(a)

the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;

| (a) | the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder; |
| --- | --- |

(a)

the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;

| (b) | the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States; |
| --- | --- |

(b)

the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

| (b) | the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States; |
| --- | --- |

(b)

the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

| (c) | the strength and pharmaceutical form of the veterinary medicinal product; |
| --- | --- |

(c)

the strength and pharmaceutical form of the veterinary medicinal product;

| (c) | the strength and pharmaceutical form of the veterinary medicinal product; |
| --- | --- |

(c)

the strength and pharmaceutical form of the veterinary medicinal product;

| (d) | the target species, the dosage for each species, the method and route of administration and advice on correct administration
  , if necessary
  ; |
| --- | --- |

(d)

the target species, the dosage for each species, the method and route of administration and advice on correct administration
  , if necessary
  ;

| (d) | the target species, the dosage for each species, the method and route of administration and
  , if necessary,
  advice on correct administration; |
| --- | --- |

(d)

the target species, the dosage for each species, the method and route of administration and
  , if necessary,
  advice on correct administration;

| (e) | the therapeutic indications; |
| --- | --- |

(e)

the therapeutic indications;

| (e) | the therapeutic indications; |
| --- | --- |

(e)

the therapeutic indications;

| (f) | the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product; |
| --- | --- |

(f)

the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;

| (f) | the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product; |
| --- | --- |

(f)

the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;

| (g) | the withdrawal period, even if this is nil, in the event that the target species are food-producing animals; |
| --- | --- |

(g)

the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;

| (g) | the withdrawal period, even if this is nil, in the event that the target species are food-producing animals; |
| --- | --- |

(g)

the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;

| (h) | special storage precautions, if any; |
| --- | --- |

(h)

special storage precautions, if any;

| (h) | special storage precautions, if any; |
| --- | --- |

(h)

special storage precautions, if any;

| (i) | information essential for safety or health protection, including any special precautions relating to use and any other warnings; |
| --- | --- |

(i)

information essential for safety or health protection, including any special precautions relating to use and any other warnings;

| (i) | information essential for safety or health protection, including any special precautions relating to use and any other warnings; |
| --- | --- |

(i)

information essential for safety or health protection, including any special precautions relating to use and any other warnings;

| (j) | requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products; |
| --- | --- |

(j)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;

| (j) | requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  in accordance with the applicable law; |
| --- | --- |

(j)

requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
  in accordance with the applicable law;

| (k) | the marketing authorisation number; |
| --- | --- |

(k)

the marketing authorisation number;

| (l) | in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’; |
| --- | --- |

(l)

in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;

| (l) | in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’; |
| --- | --- |

(l)

in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;

| (m) | in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’. |
| --- | --- |

(m)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’.

| (m) | in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’; |
| --- | --- |

(m)

in case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’;

| (ma) | qualitative and quantitative composition. |
| --- | --- |

(ma)

qualitative and quantitative composition.

2.   The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. This additional information shall appear in the package leaflet clearly separated from the information referred to in paragraph 1.

2.   The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. This additional information shall appear in the package leaflet clearly separated from the information referred to in paragraph 1.

3.   The package leaflet shall be written and designed to be clear and understandable, in terms that are comprehensible to the general public.

3.   The package leaflet shall be written and designed to be clear
  , readable
  and understandable, in terms that are comprehensible to the general public.

Amendment 107

Proposal for a regulation

Article 13

| Text proposed by the Commission | Amendment |
| --- | --- |
| Package leaflet of homeopathic veterinary medicinal products | Package leaflet of homeopathic veterinary medicinal products |
| By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information: | By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information: |
| (a) | the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States; |

Text proposed by the Commission

Amendment

Package leaflet of homeopathic veterinary medicinal products

Package leaflet of homeopathic veterinary medicinal products

By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information:

By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information:

(a)

the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States;

| (a) | the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States;
  if the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks may be supplemented by a brand name in the label; |
| --- | --- |

(a)

the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States;
  if the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks may be supplemented by a brand name in the label;

| (b) | name and address of the marketing authorisation holder and, where appropriate, of the manufacturer; |
| --- | --- |

(b)

name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;

| (b) | name and address of the marketing authorisation holder and, where appropriate, of the manufacturer; |
| --- | --- |

(b)

name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;

| (c) | method of administration and, if necessary, route; |
| --- | --- |

(c)

method of administration and, if necessary, route;

| (c) | method of administration and, if necessary, route; |
| --- | --- |

(c)

method of administration and, if necessary, route;

| (d) | the expiry date, in the format ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’; |
| --- | --- |

(d)

the expiry date, in the format ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;

| (e) | pharmaceutical form; |
| --- | --- |

(e)

pharmaceutical form;

| (e) | pharmaceutical form; |
| --- | --- |

(e)

pharmaceutical form;

| (f) | special storage precautions, if any; |
| --- | --- |

(f)

special storage precautions, if any;

| (f) | special storage precautions, if any; |
| --- | --- |

(f)

special storage precautions, if any;

| (g) | target species; |
| --- | --- |

(g)

target species;

| (g) | target species,
  as well as dosage levels for the different target species; |
| --- | --- |

(g)

target species,
  as well as dosage levels for the different target species;

| (h) | a special warning if necessary for the medicinal product; |
| --- | --- |

(h)

a special warning if necessary for the medicinal product;

| (h) | a special warning if necessary for the medicinal product; |
| --- | --- |

(h)

a special warning if necessary for the medicinal product;

| (i) | the batch number, preceded by the word ‘Lot’; |
| --- | --- |

(i)

the batch number, preceded by the word ‘Lot’;

| (j) | registration number; |
| --- | --- |

(j)

registration number;

| (j) | registration number; |
| --- | --- |

(j)

registration number;

| (k) | withdrawal period, if applicable. |
| --- | --- |

(k)

withdrawal period, if applicable.

| (k) | withdrawal period, if applicable; |
| --- | --- |

(k)

withdrawal period, if applicable;

| (l) | the statement ‘homeopathic veterinary medicinal product’. |
| --- | --- |

(l)

the statement ‘homeopathic veterinary medicinal product’.

| (l) | the statement ‘homeopathic veterinary medicinal product’. |
| --- | --- |

(l)

the statement ‘homeopathic veterinary medicinal product’.

Amendment 108

Proposal for a regulation

Article 16 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety
  or
  efficacy. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product. | 2.   For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety, efficacy
  and behaviour of residues
  . Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product. |

Text proposed by the Commission

Amendment

2.   For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety
  or
  efficacy. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.

2.   For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety, efficacy
  and behaviour of residues
  . Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.

Amendment 109

Proposal for a regulation

Article 16 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6.   
  A
  competent authority or the Agency
  may require the applicant to provide
  safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment
  in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal
  product. | 6.   
  The applicant shall submit to the
  competent authority or the Agency
  , on their request,
  safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment
  if there are well founded reasons to believe that authorisation can result in an increased risk to the environment from the generic product as compared to the reference
  product. |

Text proposed by the Commission

Amendment

6.   
  A
  competent authority or the Agency
  may require the applicant to provide
  safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment
  in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal
  product.

6.   
  The applicant shall submit to the
  competent authority or the Agency
  , on their request,
  safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment
  if there are well founded reasons to believe that authorisation can result in an increased risk to the environment from the generic product as compared to the reference
  product.

Amendment 110

Proposal for a regulation

Article 17 — paragraph 1 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products
  , but have not hitherto been authorised in that combination (‘combination veterinary medicinal product’)
  shall satisfy the following criteria: | By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products shall satisfy the following criteria: |

Text proposed by the Commission

Amendment

By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products
  , but have not hitherto been authorised in that combination (‘combination veterinary medicinal product’)
  shall satisfy the following criteria:

By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products shall satisfy the following criteria:

Amendment 111

Proposal for a regulation

Article 21

| Text proposed by the Commission | Amendment |
| --- | --- |
| Reduced data requirements for applications for limited markets | Reduced data requirements for applications for limited markets |
| 1.   By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted
  although
  the quality and/or efficacy documentation required in accordance with Annex II
  has not been provided, if all the
  following conditions
  are met
  : | 1.   By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted
  even when
  ,
  for objective, verifiable reasons, the applicant is unable to provide
  the quality and/or efficacy documentation required in accordance with Annex II
  , subject to the
  following conditions: |
| (a) | the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided; |

Text proposed by the Commission

Amendment

Reduced data requirements for applications for limited markets

Reduced data requirements for applications for limited markets

1.   By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted
  although
  the quality and/or efficacy documentation required in accordance with Annex II
  has not been provided, if all the
  following conditions
  are met
  :

1.   By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted
  even when
  ,
  for objective, verifiable reasons, the applicant is unable to provide
  the quality and/or efficacy documentation required in accordance with Annex II
  , subject to the
  following conditions:

(a)

the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

| (a) | the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided; |
| --- | --- |

(a)

the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

| (b) | the applicant provides the evidence that the veterinary medicinal product is intended for a limited market. |
| --- | --- |

(b)

the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

| (b) | the applicant provides the evidence that the veterinary medicinal product is intended for a limited market. |
| --- | --- |

(b)

the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

2.   By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of
  3
  years.

2.   By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of
  five
  years.
  At the end of that period, the holder may request, in the light of scientific data and on grounds of pharmacovigilance and efficiency, that this authorisation be converted into an open-ended authorisation.

3.   Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only
  a
  limited
  assessment of
  quality
  and/or
  efficacy has been
  conducted due to the lack of comprehensive efficacy and/or quality data
  .

3.   Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only limited
  information on its
  quality
  and
  efficacy has been
  submitted
  .
  The packaging shall bear a warning with the same information.

3a.
     
  A veterinary medicinal product that has been granted marketing authorisation in accordance with this Article may only be issued on the basis of a prescription.

Amendment 113

Proposal for a regulation

Article 22

| Text proposed by the Commission | Amendment |
| --- | --- |
| Data requirements for applications in exceptional circumstances | Data requirements for applications in exceptional circumstances |
| 1.   By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health, where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following: | 1.   By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health,
  including unmet needs with respect to animal health,
  where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following: |
| (a) | a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product; |

Text proposed by the Commission

Amendment

Data requirements for applications in exceptional circumstances

Data requirements for applications in exceptional circumstances

1.   By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health, where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following:

1.   By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health,
  including unmet needs with respect to animal health,
  where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following:

(a)

a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;

| (a) | a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product; |
| --- | --- |

(a)

a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;

| (b) | a requirement to notify the competent authorities of any
  incident
  relating to the use of the veterinary medicinal product; |
| --- | --- |

(b)

a requirement to notify the competent authorities of any
  incident
  relating to the use of the veterinary medicinal product;

| (b) | a requirement to notify the competent authorities of any
  adverse event
  relating to the use of the veterinary medicinal product; |
| --- | --- |

(b)

a requirement to notify the competent authorities of any
  adverse event
  relating to the use of the veterinary medicinal product;

| (c) | a requirement to
  conduct
  post-authorisation studies. |
| --- | --- |

(c)

a requirement to
  conduct
  post-authorisation studies.

| (c) | a requirement to
  provide further data based on either
  post-authorisation studies
  or on data collected on the performance of the product in the field, where data from the field is identified as more appropriate based on a risk-benefit assessment. |
| --- | --- |

(c)

a requirement to
  provide further data based on either
  post-authorisation studies
  or on data collected on the performance of the product in the field, where data from the field is identified as more appropriate based on a risk-benefit assessment.

2.   
  By way of derogation from Article 5(2),
  a marketing authorisation
  in exceptional circumstances
  shall be
  granted for a period of 1 year
  .

2.   
  The continuation of
  a marketing authorisation
  granted in accordance with paragraph 1
  shall be
  tied to an annual review of the conditions set out in that paragraph, until all those conditions are fulfilled
  .

3.   Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data.

3.   Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data.
  The packaging shall bear a warning with the same information.

3a.
     
  The competent authority or the Commission may at any time grant a valid marketing authorisation for an unlimited period of time, provided that no safety or efficacy problems have been reported with the product in use and the marketing authorisation holder has supplied the missing quality, safety and efficacy information set out in paragraph 1.

3b.
     
  A veterinary medicinal product that has been granted marketing authorisation in accordance with this Article may only be issued on the basis of a prescription.

Amendment 114

Proposal for a regulation

Article 25 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1). | The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries
  comply with applicable Union law,
  are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1)
  and that they minimise environmental pollution
  . |

Text proposed by the Commission

Amendment

The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1).

The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries
  comply with applicable Union law,
  are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1)
  and that they minimise environmental pollution
  .

Amendment 115

Proposal for a regulation

Article 28 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission
  may
  require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance. | 3.   Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission
  shall
  require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance. |

Text proposed by the Commission

Amendment

3.   Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission
  may
  require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.

3.   Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission
  shall
  require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.

Amendments 116 and 298

Proposal for a regulation

Article 29

| Text proposed by the Commission | Amendment |
| --- | --- |
| Requirement for a veterinary prescription | Requirement for a veterinary prescription |
| 1.   
  A competent authority or the Commission shall classify the
  following veterinary medicinal products
  as
  subject to veterinary prescription: | 1.   
  The
  following veterinary medicinal products
  shall be
  subject to
  mandatory
  veterinary prescription: |
| (a) | veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971; |

Text proposed by the Commission

Amendment

Requirement for a veterinary prescription

Requirement for a veterinary prescription

1.   
  A competent authority or the Commission shall classify the
  following veterinary medicinal products
  as
  subject to veterinary prescription:

1.   
  The
  following veterinary medicinal products
  shall be
  subject to
  mandatory
  veterinary prescription:

(a)

veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;

| (a) | veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971; |
| --- | --- |

(a)

veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;

| (b) | veterinary medicinal products for food-producing animals; |
| --- | --- |

(b)

veterinary medicinal products for food-producing animals;

| (b) | veterinary medicinal products for food-producing animals; |
| --- | --- |

(b)

veterinary medicinal products for food-producing animals;

| (c) | antimicrobial veterinary medicinal products; |
| --- | --- |

(c)

antimicrobial veterinary medicinal products;

| (c) | antimicrobial veterinary medicinal products; |
| --- | --- |

(c)

antimicrobial veterinary medicinal products;

| (d) | products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures; |
| --- | --- |

(d)

products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;

| (d) | products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures; |
| --- | --- |

(d)

products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;

| (e) | officinal formulae intended for food-producing animals; |
| --- | --- |

(e)

officinal formulae intended for food-producing animals;

| (e) | officinal formulae intended for food-producing animals; |
| --- | --- |

(e)

officinal formulae intended for food-producing animals;

| (f) | veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union. |
| --- | --- |

(f)

veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union.

| (f) | veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union; |
| --- | --- |

(f)

veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union;

| (fa) | veterinary medicinal products for which marketing authorisations have been granted in accordance with Article 21 and/or 22. |
| --- | --- |

(fa)

veterinary medicinal products for which marketing authorisations have been granted in accordance with Article 21 and/or 22.

1a.
     
  Member States may on their territories provide for additional legal subcategories in accordance with the respective national law.

2.   
  A competent authority or the Commission may classify a
  veterinary medicinal product as subject to veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:

2.   A veterinary medicinal product
  may be classified
  as subject to
  mandatory
  veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:

| (a) | the target species, |
| --- | --- |

(a)

the target species,

| (a) | the target species, |
| --- | --- |

(a)

the target species,

| (b) | the person administering the products to the animal, |
| --- | --- |

(b)

the person administering the products to the animal,

| (b) | the person administering the products to the animal, |
| --- | --- |

(b)

the person administering the products to the animal,

| (c) | the environment |
| --- | --- |

(c)

the environment

| (c) | the environment. |
| --- | --- |

(c)

the environment.

3.   By the way of derogation from paragraph 1, a competent authority or the
  Agency
  may
  not classify
  a veterinary medicinal product
  as subject to
  veterinary prescription if all of the following conditions are fulfilled:

3.   By the way of derogation from paragraph 1, a competent authority or the
  Commission
  may
  exempt
  a veterinary medicinal product
  from a mandatory
  veterinary prescription if all of the following conditions are fulfilled:

| (a) | the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products; |
| --- | --- |

(a)

the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;

| (a) | the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products; |
| --- | --- |

(a)

the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;

| (b) | the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment; |
| --- | --- |

(b)

the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;

| (b) | the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment; |
| --- | --- |

(b)

the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;

| (c) | the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious
  side effects
  deriving from its correct use; |
| --- | --- |

(c)

the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious
  side effects
  deriving from its correct use;

| (c) | the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious
  adverse events
  deriving from its correct use; |
| --- | --- |

(c)

the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious
  adverse events
  deriving from its correct use;

| (d) | neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting; |
| --- | --- |

(d)

neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;

| (d) | neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting; |
| --- | --- |

(d)

neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;

| (e) | the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription; |
| --- | --- |

(e)

the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;

| (e) | the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription; |
| --- | --- |

(e)

the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;

| (f) | the veterinary medicinal product is not subject to special storage conditions; |
| --- | --- |

(f)

the veterinary medicinal product is not subject to special storage conditions;

| (g) | there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly; |
| --- | --- |

(g)

there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

| (g) | there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly; |
| --- | --- |

(g)

there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

| (h) | there is no risk to public or animal health as regards the development of resistance
  to anthelmintic substances
  even where the veterinary medicinal products containing those substances are used incorrectly. |
| --- | --- |

(h)

there is no risk to public or animal health as regards the development of resistance
  to anthelmintic substances
  even where the veterinary medicinal products containing those substances are used incorrectly.

| (h) | there is no risk to public or animal health as regards the development of
  antiparasitic
  resistance even where the veterinary medicinal products containing those substances are used incorrectly. |
| --- | --- |

(h)

there is no risk to public or animal health as regards the development of
  antiparasitic
  resistance even where the veterinary medicinal products containing those substances are used incorrectly.

Amendment 117

Proposal for a regulation

Article 29 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  Notwithstanding paragraph 1, medicinal products for veterinary use may be used without prescription if: |
| | (a) | they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000 ) and are not produced using alcohol; |

Text proposed by the Commission

Amendment

3a.
     
  Notwithstanding paragraph 1, medicinal products for veterinary use may be used without prescription if:

(a)

they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000 ) and are not produced using alcohol;

| (b) | they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol. |
| --- | --- |

(b)

they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol.

Amendment 118

Proposal for a regulation

Article 30 — paragraph 1 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | qualitative and quantitative composition of the active substances
  or other
  constituents stating the common name or the chemical description of the substances or other constituents; |

Text proposed by the Commission

Amendment

(b)

qualitative and quantitative composition of the active substances
  or other
  constituents stating the common name or the chemical description of the substances or other constituents;

| (b) | qualitative and quantitative composition of the active substances
  and all the essential
  constituents, stating the common name or the chemical description of the substances or other constituents; |
| --- | --- |

(b)

qualitative and quantitative composition of the active substances
  and all the essential
  constituents, stating the common name or the chemical description of the substances or other constituents;

Amendment 119

Proposal for a regulation

Article 30 — paragraph 1 — point c — point vi

| Text proposed by the Commission | Amendment |
| --- | --- |
| (vi) | frequency and seriousness of adverse
  events
  , |

Text proposed by the Commission

Amendment

(vi)

frequency and seriousness of adverse
  events
  ,

| (vi) | frequency and seriousness of adverse
  reactions
  , |
| --- | --- |

(vi)

frequency and seriousness of adverse
  reactions
  ,

Amendment 120

Proposal for a regulation

Article 30 — paragraph 1 — point c — point xiii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (xiii) | special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, |

Text proposed by the Commission

Amendment

(xiii)

special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance,

| (xiii) | special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance,
  and specifying that the product is not allowed to be used as a routine preventive measure, |
| --- | --- |

(xiii)

special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance,
  and specifying that the product is not allowed to be used as a routine preventive measure,

Amendment 121

Proposal for a regulation

Article 30 — paragraph 1 — point e — point iii a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iiia) | list of excipients, |

Text proposed by the Commission

Amendment

(iiia)

list of excipients,

Amendment 122

Proposal for a regulation

Article 30 — paragraph 1 — point e a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ea) | information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water; |

Text proposed by the Commission

Amendment

(ea)

information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water;

Amendment 123

Proposal for a regulation

Article 30 — paragraph 1 — point j a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ja) | when the veterinary medical product is authorised to be administered via medicated feed, information on the possibility to have interaction between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed shall be provided through a list of incompatibilities. |

Text proposed by the Commission

Amendment

(ja)

when the veterinary medical product is authorised to be administered via medicated feed, information on the possibility to have interaction between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed shall be provided through a list of incompatibilities.

Amendment 124

Proposal for a regulation

Article 31 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  Where two products have the same therapeutic effect, comparative assessments may be carried out. In such a case, the products that are hazardous to the environment or to the treated animals shall be substituted by the less hazardous products having the same therapeutic effects. |

Text proposed by the Commission

Amendment

2a.
     
  Where two products have the same therapeutic effect, comparative assessments may be carried out. In such a case, the products that are hazardous to the environment or to the treated animals shall be substituted by the less hazardous products having the same therapeutic effects.

Amendment 125

Proposal for a regulation

Article 32 — paragraph 1 — point d

| Text proposed by the Commission | Amendment |
| --- | --- |
| (d) | the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals; |

Text proposed by the Commission

Amendment

(d)

the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;

| (d) | the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to increase yields from treated animals
  , or as a routine prophylactic in food producing animals, or to be added to feed or water for mass medication when no disease has been diagnosed in any of the animals; |
| --- | --- |

(d)

the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to increase yields from treated animals
  , or as a routine prophylactic in food producing animals, or to be added to feed or water for mass medication when no disease has been diagnosed in any of the animals;

Amendment 126

Proposal for a regulation

Article 32 — paragraph 1 — point e

| Text proposed by the Commission | Amendment |
| --- | --- |
| (e) | the withdrawal period is not
  long enough to ensure food safety
  ; |

Text proposed by the Commission

Amendment

(e)

the withdrawal period is not
  long enough to ensure food safety
  ;

| (e) | the
  proposed
  withdrawal period
  to ensure food safety
  is not
  well justified, or the proposed withdrawal period by the Agency or by the competent authorities is not taken into account
  ; |
| --- | --- |

(e)

the
  proposed
  withdrawal period
  to ensure food safety
  is not
  well justified, or the proposed withdrawal period by the Agency or by the competent authorities is not taken into account
  ;

Amendment 127

Proposal for a regulation

Article 32 — paragraph 1 — point g a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ga) | the product is a substance of high concern; |

Text proposed by the Commission

Amendment

(ga)

the product is a substance of high concern;

Amendment 128

Proposal for a regulation

Article 32 — paragraph 1 — point g b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (gb) | active substances within the product which meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to EMA guidelines, or are considered as having endocrine-disrupting properties that risk causing adverse effects in the environment; |

Text proposed by the Commission

Amendment

(gb)

active substances within the product which meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to EMA guidelines, or are considered as having endocrine-disrupting properties that risk causing adverse effects in the environment;

Amendment 129

Proposal for a regulation

Article 32 — paragraph 1 — point h a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ha) | the product poses significantly higher risks to the treated animal, public health or the environment compared to the standard reference treatment; |

Text proposed by the Commission

Amendment

(ha)

the product poses significantly higher risks to the treated animal, public health or the environment compared to the standard reference treatment;

Amendment 130

Proposal for a regulation

Article 32 — paragraph 1 — point h b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (hb) | unacceptable side effects or secondary effects on the treated animal; |

Text proposed by the Commission

Amendment

(hb)

unacceptable side effects or secondary effects on the treated animal;

Amendment 132

Proposal for a regulation

Article 32 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans. | 2.   A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans
  within the meaning of paragraph 4
  . |

Text proposed by the Commission

Amendment

2.   A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans.

2.   A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans
  within the meaning of paragraph 4
  .

Amendment 133

Proposal for a regulation

Article 32 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans. | 3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 146
  and taking into consideration the scientific advice of the Agency
  in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans. |
| | The Agency, in its advice, shall consider appropriate designations at the class, substance or even the indication level and shall consider also the route of administration. |
| | Member States which implement or wish to implement stricter rules shall be allowed to do so. |

Text proposed by the Commission

Amendment

3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans.

3.   The Commission shall be empowered to adopt delegated acts in accordance with Article 146
  and taking into consideration the scientific advice of the Agency
  in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans.

The Agency, in its advice, shall consider appropriate designations at the class, substance or even the indication level and shall consider also the route of administration.

Member States which implement or wish to implement stricter rules shall be allowed to do so.

Amendment 134

Proposal for a regulation

Article 32 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). | 4.   The Commission shall, by means of implementing acts
  and taking into consideration the scientific advice of the Agency as well as the work already carried out by the WHO
  , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). |
| | Such designations, where relevant, shall be done at the class, substance or even the indication level and shall consider also the route of administration. |

Text proposed by the Commission

Amendment

4.   The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

4.   The Commission shall, by means of implementing acts
  and taking into consideration the scientific advice of the Agency as well as the work already carried out by the WHO
  , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Such designations, where relevant, shall be done at the class, substance or even the indication level and shall consider also the route of administration.

Amendment 301

Proposal for a regulation

Article 33 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  Safety information with regard to the environmental effects of veterinary medicinal products shall not be protected. |

Text proposed by the Commission

Amendment

3a.
     
  Safety information with regard to the environmental effects of veterinary medicinal products shall not be protected.

Amendment 136

Proposal for a regulation

Article 34

| Text proposed by the Commission | Amendment |
| --- | --- |
| Periods of the protection of technical documentation | Periods of the protection of technical documentation |
| 1.   The period of the protection of technical documentation shall be: | 1.   The period of the protection of technical documentation shall be: |
| (a) | 10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats; |

Text proposed by the Commission

Amendment

Periods of the protection of technical documentation

Periods of the protection of technical documentation

1.   The period of the protection of technical documentation shall be:

1.   The period of the protection of technical documentation shall be:

(a)

10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats;

| (a) | 10 years for the veterinary medicinal products for cattle, sheep
  (reared for meat)
  , pigs, chickens,
  salmon,
  dogs and cats; |
| --- | --- |

(a)

10 years for the veterinary medicinal products for cattle, sheep
  (reared for meat)
  , pigs, chickens,
  salmon,
  dogs and cats;

| (b) | 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application; |
| --- | --- |

(b)

14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

| (b) | 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens,
  salmon
  , dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application; |
| --- | --- |

(b)

14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens,
  salmon
  , dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

| (c) | 18
  years for veterinary medicinal products for bees; |
| --- | --- |

(c)

18
  years for veterinary medicinal products for bees;

| (c) | 20
  years for veterinary medicinal products for bees; |
| --- | --- |

(c)

20
  years for veterinary medicinal products for bees;

| (d) | 14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c). |
| --- | --- |

(d)

14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).

| (d) | 14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c). |
| --- | --- |

(d)

14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).

2.   The protection shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 7.

2.   The protection shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 7.

2a.
     
  Where the veterinary medicinal product has been authorised for more than one species, the period shall be extended in accordance with the prolongation periods provided for in Article 35.

Amendment 312

Proposal for a regulation

Article 34 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 34a |
| | Period of protection of new data packages related to existing veterinary medicinal products |
| | 1.
     
  Any new studies and trials, submitted by the applicant for a marketing authorisation to the competent authorities for an existing veterinary medicinal product no longer covered by any protection period shall benefit from a stand-alone period of protection of four years, provided that they are: |
| | (a) | needed to extend a marketing authorisation in respect of dosages, pharmaceutical forms or routes of administration; |

Text proposed by the Commission

Amendment

Article 34a

Period of protection of new data packages related to existing veterinary medicinal products

1.
     
  Any new studies and trials, submitted by the applicant for a marketing authorisation to the competent authorities for an existing veterinary medicinal product no longer covered by any protection period shall benefit from a stand-alone period of protection of four years, provided that they are:

(a)

needed to extend a marketing authorisation in respect of dosages, pharmaceutical forms or routes of administration;

| (b) | needed for a reevaluation requested by the Agency or the competent authorities post-authorisation, unless they have been requested by competent authorities as a follow-up to post authorisation pharmacovigilance concerns, or requested as a condition of authorisation or as a post-authorisation commitment at the time of authorisation. Each period of protection shall operate independent from any other that may operate concurrently and shall therefore not be cumulated. |
| --- | --- |

(b)

needed for a reevaluation requested by the Agency or the competent authorities post-authorisation, unless they have been requested by competent authorities as a follow-up to post authorisation pharmacovigilance concerns, or requested as a condition of authorisation or as a post-authorisation commitment at the time of authorisation. Each period of protection shall operate independent from any other that may operate concurrently and shall therefore not be cumulated.

2.
     
  No other applicant may use the results of these trials or studies for commercial purposes during that four year period without the written consent of the holder of the marketing authorisation in the form of a letter of access to those trials or studies.

Amendment 138

Proposal for a regulation

Article 35

| Text proposed by the Commission | Amendment |
| --- | --- |
| Prolongation of the periods of the protection of technical documentation | Prolongation of the periods of the protection of technical documentation |
| 1.   Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that
  Article
  shall be prolonged by
  1 year
  for each additional target species, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a). | 1.   Where
  the first marketing authorisation is granted for more than one species or
  a variation is approved in accordance with Article 65, extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that
  Article 34
  shall be prolonged by
  two years
  for each additional target species
  in the original dossiers,
  provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).
  The information on the submission for extension of the marketing authorisation shall be made publicly available. |
| 2.   Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years. | 2.   Where
  the first marketing authorisation is granted for more than one species or
  a variation is approved in accordance with Article 65, extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years
  , provided that the variation has been submitted at least three years before the expiration of the protection period laid down in Article 34
  .
  The information on the submission for extension of the marketing authorisation shall be made publicly available. |
| 3.   The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation (‘overall period of the protection of technical documentation’) shall not exceed
  18
  years. | 3.   The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation (‘overall period of the protection of technical documentation’) shall not exceed
  14
  years
  for products referred to in Article 34(1)(a). For products referred to in Article 34(1)(b) and (d), this period shall not exceed 18 years. |
| 4.   Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use
  those
  trials for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials. | 4.   Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use
  the results of these
  trials
  for commercial purposes
  for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials. |

Text proposed by the Commission

Amendment

Prolongation of the periods of the protection of technical documentation

Prolongation of the periods of the protection of technical documentation

1.   Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that
  Article
  shall be prolonged by
  1 year
  for each additional target species, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).

1.   Where
  the first marketing authorisation is granted for more than one species or
  a variation is approved in accordance with Article 65, extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that
  Article 34
  shall be prolonged by
  two years
  for each additional target species
  in the original dossiers,
  provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).
  The information on the submission for extension of the marketing authorisation shall be made publicly available.

2.   Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years.

2.   Where
  the first marketing authorisation is granted for more than one species or
  a variation is approved in accordance with Article 65, extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years
  , provided that the variation has been submitted at least three years before the expiration of the protection period laid down in Article 34
  .
  The information on the submission for extension of the marketing authorisation shall be made publicly available.

3.   The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation (‘overall period of the protection of technical documentation’) shall not exceed
  18
  years.

3.   The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation (‘overall period of the protection of technical documentation’) shall not exceed
  14
  years
  for products referred to in Article 34(1)(a). For products referred to in Article 34(1)(b) and (d), this period shall not exceed 18 years.

4.   Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use
  those
  trials for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials.

4.   Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use
  the results of these
  trials
  for commercial purposes
  for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials.

Amendment 139

Proposal for a regulation

Article 38 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union. | 1.   Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union
  and considered the priority procedure
  .
  The Commission and the Agency shall develop and encourage use of the centralised procedure, particularly by facilitating access for SMEs. |

Text proposed by the Commission

Amendment

1.   Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union.

1.   Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union
  and considered the priority procedure
  .
  The Commission and the Agency shall develop and encourage use of the centralised procedure, particularly by facilitating access for SMEs.

Amendment 141

Proposal for a regulation

Article 38 — paragraph 2 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application; |

Text proposed by the Commission

Amendment

(c)

veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;

| (c) | veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application
  , with the exception of veterinary medicinal products subject to authorisation under Articles 21 and 22
  ; |
| --- | --- |

(c)

veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application
  , with the exception of veterinary medicinal products subject to authorisation under Articles 21 and 22
  ;

Amendment 142

Proposal for a regulation

Article 38 — paragraph 2 — point e

| Text proposed by the Commission | Amendment |
| --- | --- |
| (e) | generic veterinary medicinal products of reference veterinary medicinal products authorised under the centralised authorisation procedure. |

Text proposed by the Commission

Amendment

(e)

generic veterinary medicinal products of reference veterinary medicinal products authorised under the centralised authorisation procedure.

deleted

Amendment 143

Proposal for a regulation

Article 38 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted
  if no other marketing authorisation has been granted for the veterinary medicinal product within the Union
  . | 3.   For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may
  also
  be granted. |

Text proposed by the Commission

Amendment

3.   For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted
  if no other marketing authorisation has been granted for the veterinary medicinal product within the Union
  .

3.   For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may
  also
  be granted.

Amendment 144

Proposal for a regulation

Article 38 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.
     
  The Commission, taking into account the state of animal and public health in the Union, shall be empowered to adopt delegated acts in accordance with Article 146 in order to amend the list set out in paragraph 2. | deleted |

Text proposed by the Commission

Amendment

4.
     
  The Commission, taking into account the state of animal and public health in the Union, shall be empowered to adopt delegated acts in accordance with Article 146 in order to amend the list set out in paragraph 2.

deleted

Amendment 145

Proposal for a regulation

Article 46 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Applications for decentralised marketing authorisation shall be submitted to the Member State chosen by the applicant (‘reference Member State’). | 1.   Applications
  and the dossier
  for decentralised marketing authorisation shall be submitted to
  all the Member States.
  The Member State chosen by the applicant
  shall be the
  reference Member State. |

Text proposed by the Commission

Amendment

1.   Applications for decentralised marketing authorisation shall be submitted to the Member State chosen by the applicant (‘reference Member State’).

1.   Applications
  and the dossier
  for decentralised marketing authorisation shall be submitted to
  all the Member States.
  The Member State chosen by the applicant
  shall be the
  reference Member State.

Amendment 146

Proposal for a regulation

Article 46 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The application shall list Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned’). | 2.   The application shall list Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned’).
  The applicant shall send to all Member States concerned an application identical to that submitted to the reference Member State, including an identical dossier as provided under Article 7. |

Text proposed by the Commission

Amendment

2.   The application shall list Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned’).

2.   The application shall list Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned’).
  The applicant shall send to all Member States concerned an application identical to that submitted to the reference Member State, including an identical dossier as provided under Article 7.

Amendment 147

Proposal for a regulation

Article 48 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference Member State’). | 1.   Applications
  and the dossier
  for mutual recognition of marketing authorisations shall be submitted to
  all the Member States.
  The Member State that granted the first national marketing authorisation
  shall be the
  reference Member State. |

Text proposed by the Commission

Amendment

1.   Applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference Member State’).

1.   Applications
  and the dossier
  for mutual recognition of marketing authorisations shall be submitted to
  all the Member States.
  The Member State that granted the first national marketing authorisation
  shall be the
  reference Member State.

Amendment 148

Proposal for a regulation

Article 48 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.
     
  A minimum of 6 months shall elapse between the decision granting the first national marketing authorisation and the submission of the application for mutual recognition of the national marketing authorisation. | Deleted |

Text proposed by the Commission

Amendment

2.
     
  A minimum of 6 months shall elapse between the decision granting the first national marketing authorisation and the submission of the application for mutual recognition of the national marketing authorisation.

Deleted

Amendment 149

Proposal for a regulation

Article 48 — paragraph 3 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | an information about the Member States in which an application for a marketing authorisation submitted by the applicant for the same veterinary medicinal product is under examination; |

Text proposed by the Commission

Amendment

(c)

an information about the Member States in which an application for a marketing authorisation submitted by the applicant for the same veterinary medicinal product is under examination;

deleted

Amendment 150

Proposal for a regulation

Article 48 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   Within
  90
  days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all Member States and the applicant
  , together with the list of Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States’)
  . | 4.   Within
  45
  days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all
  concerned
  Member States and the applicant. |

Text proposed by the Commission

Amendment

4.   Within
  90
  days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all Member States and the applicant
  , together with the list of Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States’)
  .

4.   Within
  45
  days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all
  concerned
  Member States and the applicant.

Amendment 151

Proposal for a regulation

Article 49 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142(‘the coordination group’) by the reference Member State. | 1.   If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet,
  on grounds of a potential serious risk to human or animal health or to the environment,
  a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142 (‘the coordination group’) by the reference Member State. |

Text proposed by the Commission

Amendment

1.   If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142(‘the coordination group’) by the reference Member State.

1.   If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet,
  on grounds of a potential serious risk to human or animal health or to the environment,
  a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142 (‘the coordination group’) by the reference Member State.

Amendment 152

Proposal for a regulation

Article 49 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.
     
  Within the coordination group, a rapporteur shall be appointed in order to prepare a second assessment report for the veterinary medicinal product. | deleted |

Text proposed by the Commission

Amendment

2.
     
  Within the coordination group, a rapporteur shall be appointed in order to prepare a second assessment report for the veterinary medicinal product.

deleted

Amendment 153

Proposal for a regulation

Article 49 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   In the event of an opinion in favour of granting a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly. | 4.   In the event of an opinion in favour of granting
  or amending
  a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly. |

Text proposed by the Commission

Amendment

4.   In the event of an opinion in favour of granting a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.

4.   In the event of an opinion in favour of granting
  or amending
  a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.

Amendment 154

Proposal for a regulation

Article 50 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the
  Agency
  requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination. | 1.   Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the
  Coordination group
  requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination. |

Text proposed by the Commission

Amendment

1.   Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the
  Agency
  requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination.

1.   Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the
  Coordination group
  requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination.

Amendment 155

Proposal for a regulation

Article 50 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   
  The re-examination procedure shall deal only with the points of the assessment report identified by the applicant in the written notice. | 3.   
  The Committee shall define the scope of the examination, taking into account the information supplied by the applicant. |

Text proposed by the Commission

Amendment

3.   
  The re-examination procedure shall deal only with the points of the assessment report identified by the applicant in the written notice.

3.   
  The Committee shall define the scope of the examination, taking into account the information supplied by the applicant.

Amendment 156

Proposal for a regulation

Article 50 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   Within 15 days of its adoption, the Agency shall forward the opinion of the Committee to the
  coordination group
  , together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions. Those documents shall be forwarded
  to the Commission,
  to Member States and to the applicant for information purposes. | 4.   Within 15 days of its adoption, the Agency shall forward the opinion of the Committee to the
  Commission
  , together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions. Those documents shall be forwarded to Member States and to the applicant for information purposes. |

Text proposed by the Commission

Amendment

4.   Within 15 days of its adoption, the Agency shall forward the opinion of the Committee to the
  coordination group
  , together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions. Those documents shall be forwarded
  to the Commission,
  to Member States and to the applicant for information purposes.

4.   Within 15 days of its adoption, the Agency shall forward the opinion of the Committee to the
  Commission
  , together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions. Those documents shall be forwarded to Member States and to the applicant for information purposes.

Amendment 157

Proposal for a regulation

Article 50 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.   
  Upon presentation of the Agency ' s opinion, the coordination group shall act by the majority of the votes cast by its members represented at the meeting. The reference Member State shall record the agreement, close the procedure and inform the applicant. Article 49 shall apply accordingly. Where the decision is not in accordance with the opinion of the Agency, the coordination group shall annex a detailed explanation of the reasons for the differences. | 5.   
  Within 15 days of receipt of the opinion, the Commission shall prepare a draft of the decision associated with the procedure. |
| | If the draft decision proposes that a marketing authorisation be granted, the draft shall include or refer to the documents listed in Article 28. |
| | Where the draft decision proposes that a marketing authorisation be refused, the grounds for refusal shall be stated in accordance with Article 32. |
| | Where the draft decision does not concur with the Committee’s opinion, the Commission shall attach detailed explanations of the grounds for these differences. |
| | The Commission may, by means of implementing acts, take a final decision on the granting of a marketing authorisation under the decentralised or mutual recognition procedure. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). |
| | The Agency shall forward to the applicant the documents provided for by Article 28. |
| | The Agency shall make the opinion publicly available, after deleting any commercially confidential information. |

Text proposed by the Commission

Amendment

5.   
  Upon presentation of the Agency ' s opinion, the coordination group shall act by the majority of the votes cast by its members represented at the meeting. The reference Member State shall record the agreement, close the procedure and inform the applicant. Article 49 shall apply accordingly. Where the decision is not in accordance with the opinion of the Agency, the coordination group shall annex a detailed explanation of the reasons for the differences.

5.   
  Within 15 days of receipt of the opinion, the Commission shall prepare a draft of the decision associated with the procedure.

If the draft decision proposes that a marketing authorisation be granted, the draft shall include or refer to the documents listed in Article 28.

Where the draft decision proposes that a marketing authorisation be refused, the grounds for refusal shall be stated in accordance with Article 32.

Where the draft decision does not concur with the Committee’s opinion, the Commission shall attach detailed explanations of the grounds for these differences.

The Commission may, by means of implementing acts, take a final decision on the granting of a marketing authorisation under the decentralised or mutual recognition procedure. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

The Agency shall forward to the applicant the documents provided for by Article 28.

The Agency shall make the opinion publicly available, after deleting any commercially confidential information.

Amendment 158

Proposal for a regulation

Article 51 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   A Union database on veterinary medicinal products (‘product database’) shall be set up and maintained by the Agency. | 1.   A Union-
  wide
  database on veterinary medicinal products (‘product database’) shall be set up and maintained by the Agency. |

Text proposed by the Commission

Amendment

1.   A Union database on veterinary medicinal products (‘product database’) shall be set up and maintained by the Agency.

1.   A Union-
  wide
  database on veterinary medicinal products (‘product database’) shall be set up and maintained by the Agency.

Amendment 159

Proposal for a regulation

Article 51 — paragraph 2 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets and lists of sites where each product is manufactured; |

Text proposed by the Commission

Amendment

(a)

veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets and lists of sites where each product is manufactured;

| (a) | veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets, and lists of sites where each product is manufactured
  and reference numbers to the pharmacovigilance system master file
  ; |
| --- | --- |

(a)

veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets, and lists of sites where each product is manufactured
  and reference numbers to the pharmacovigilance system master file
  ;

Amendment 160

Proposal for a regulation

Article 52 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations. | 2.   Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations
  and limited access to other products
  . |

Text proposed by the Commission

Amendment

2.   Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations.

2.   Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations
  and limited access to other products
  .

Amendment 161

Proposal for a regulation

Article 52 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics
  and
  package leaflets. | 3.   The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics, package leaflets
  and their environmental data, and all safety information
  . |

Text proposed by the Commission

Amendment

3.   The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics
  and
  package leaflets.

3.   The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics, package leaflets
  and their environmental data, and all safety information
  .

Amendment 162

Proposal for a regulation

Article 54 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Member States shall collect relevant
  and
  comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products. | 1.   Member States shall collect relevant comparable
  and sufficiently detailed
  data,
  at per-farm level
  , on the volume of sales
  in terms of weight and cost for each antimicrobial type
  and the use of veterinary antimicrobial medicinal products
  including the species treated, the disease diagnosed and the route of administration
  . |

Text proposed by the Commission

Amendment

1.   Member States shall collect relevant
  and
  comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products.

1.   Member States shall collect relevant comparable
  and sufficiently detailed
  data,
  at per-farm level
  , on the volume of sales
  in terms of weight and cost for each antimicrobial type
  and the use of veterinary antimicrobial medicinal products
  including the species treated, the disease diagnosed and the route of administration
  .

Amendment 163

Proposal for a regulation

Article 54 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall analyse the data and publish an annual report. | 2.   Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall
  cooperate with other European agencies to
  analyse the data and publish an annual report
  which shall also include the corresponding data for human use of antimicrobials as well as the current situation on antimicrobial resistance in the Union and, where appropriate, issue guidelines and recommendations
  . |

Text proposed by the Commission

Amendment

2.   Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall analyse the data and publish an annual report.

2.   Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall
  cooperate with other European agencies to
  analyse the data and publish an annual report
  which shall also include the corresponding data for human use of antimicrobials as well as the current situation on antimicrobial resistance in the Union and, where appropriate, issue guidelines and recommendations
  .

Amendment 164

Proposal for a regulation

Article 54 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  Member States shall collect relevant and comparable data on the volume of sales and the use of anti-parasitic and hormonal veterinary medicinal products, and make these available to the Agency. |

Text proposed by the Commission

Amendment

3a.
     
  Member States shall collect relevant and comparable data on the volume of sales and the use of anti-parasitic and hormonal veterinary medicinal products, and make these available to the Agency.

Amendment 165

Proposal for a regulation

Article 54 — paragraph 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4a.
     
  Data requirements for adopting those implementing acts shall include animal species, the dose, the duration and type of treatment, the number of animals treated and the administration route or routes. In addition, any off-label use of antimicrobials shall be mandatorily reported to national authorities. |

Text proposed by the Commission

Amendment

4a.
     
  Data requirements for adopting those implementing acts shall include animal species, the dose, the duration and type of treatment, the number of animals treated and the administration route or routes. In addition, any off-label use of antimicrobials shall be mandatorily reported to national authorities.

Amendment 166

Proposal for a regulation

Article 54 — paragraph 4 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4b.
     
  The use of antibiotics in drinking water shall be restricted to cases where most of the animals or the whole herd are sick. Five years after the entry into force of this Regulation, the Commission shall publish a report examining the different routes used to administer antibiotics to food-producing animals, and in particular the oral routes used through feed and water, and their subsequent impact on antimicrobial resistance. |

Text proposed by the Commission

Amendment

4b.
     
  The use of antibiotics in drinking water shall be restricted to cases where most of the animals or the whole herd are sick. Five years after the entry into force of this Regulation, the Commission shall publish a report examining the different routes used to administer antibiotics to food-producing animals, and in particular the oral routes used through feed and water, and their subsequent impact on antimicrobial resistance.

Amendment 167

Proposal for a regulation

Section 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Section 2a |
| | Imports, parallel imports and parallel distribution |

Text proposed by the Commission

Amendment

Section 2a

Imports, parallel imports and parallel distribution

Amendment 168

Proposal for a regulation

Article 56 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 56a |
| | Import authorisations |
| | 1.
     
  An import authorisation shall be required for the following actions: |
| | (a) | the importation of veterinary medicinal products used in the context of Article 8, point (a)(ii) of Article 115(1), point (b) of Article 116(1), point (b) of Article 116(2) and point (a) of Article 116(3) by a veterinarian or by any person authorised to deliver veterinary medicinal products in the Member States; |

Text proposed by the Commission

Amendment

Article 56a

Import authorisations

1.
     
  An import authorisation shall be required for the following actions:

(a)

the importation of veterinary medicinal products used in the context of Article 8, point (a)(ii) of Article 115(1), point (b) of Article 116(1), point (b) of Article 116(2) and point (a) of Article 116(3) by a veterinarian or by any person authorised to deliver veterinary medicinal products in the Member States;

| (b) | the parallel importation of veterinary medicinal products by a manufacturer or distributor authorised in a Member State that is independent of the holder of the marketing authorisation. The imported veterinary medicinal product and the national reference medicinal product shall have: |
| --- | --- |

(b)

the parallel importation of veterinary medicinal products by a manufacturer or distributor authorised in a Member State that is independent of the holder of the marketing authorisation. The imported veterinary medicinal product and the national reference medicinal product shall have:

| | (i) | the same qualitative and quantitative composition in terms of active substances and excipients, and the same pharmaceutical form; |
| --- | --- | --- |

(i)

the same qualitative and quantitative composition in terms of active substances and excipients, and the same pharmaceutical form;

| | (ii) | the same therapeutic effects and the same target species. |
| --- | --- | --- |

(ii)

the same therapeutic effects and the same target species.

| | The national reference medicinal product and the veterinary medicinal product imported in parallel are required to have been harmonised under Article 69 or 70, or authorised in accordance with Articles 46 and 48; |
| --- | --- |

The national reference medicinal product and the veterinary medicinal product imported in parallel are required to have been harmonised under Article 69 or 70, or authorised in accordance with Articles 46 and 48;

| (c) | the parallel distribution of veterinary medicinal products by a distributor independently of the holder of the marketing authorisation. |
| --- | --- |

(c)

the parallel distribution of veterinary medicinal products by a distributor independently of the holder of the marketing authorisation.

2.
     
  Applications for authorisation for these activities shall be submitted to the national authorities responsible for authorisation as referred to in points (a) and (b) of paragraph 1, and to the Authorisations Agency referred to in point (c) of paragraph 1.

The competent authorities and the Agency shall register the authorisation of parallel importation or parallel distribution that they have granted in the database on veterinary medicinal products established under Article 51.

3.
     
  The veterinary medicinal product imported in parallel or distributed in parallel shall be marketed in the packaging and with labelling in the language(s) stipulated by each Member State of importation or distribution.

4.
     
  By way of derogation from paragraph 1 of this Article, the authorisation shall not be required for:

| (a) | the importation of veterinary medicinal products by a veterinarian service-provider in accordance with Article 114; |
| --- | --- |

(a)

the importation of veterinary medicinal products by a veterinarian service-provider in accordance with Article 114;

| (b) | the transportation by a holder of a pet animal of veterinary medicinal products required for its treatment other than immunological medicines and within the limit of three months of treatment. |
| --- | --- |

(b)

the transportation by a holder of a pet animal of veterinary medicinal products required for its treatment other than immunological medicines and within the limit of three months of treatment.

Amendment 169

Proposal for a regulation

Article 56 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 56b |
| | Import authorisation applications |
| | 1.
     
  An import authorisation application as referred to in point (a) of Article 56a(1) shall be submitted to the competent authority of the Member State of the importer. |
| | These authorisations shall be granted for a single operation. |
| | Any change in the information submitted in order to obtain authorisation shall be notified to the competent authority, which shall accordingly alter the initial authorisation if necessary. |
| | An import authorisation application shall contain at least the following information: |
| | (a) | the name of the veterinary medicinal product, its strength, its pharmaceutical form and its therapeutic indications; |

Text proposed by the Commission

Amendment

Article 56b

Import authorisation applications

1.
     
  An import authorisation application as referred to in point (a) of Article 56a(1) shall be submitted to the competent authority of the Member State of the importer.

These authorisations shall be granted for a single operation.

Any change in the information submitted in order to obtain authorisation shall be notified to the competent authority, which shall accordingly alter the initial authorisation if necessary.

An import authorisation application shall contain at least the following information:

(a)

the name of the veterinary medicinal product, its strength, its pharmaceutical form and its therapeutic indications;

| (b) | the Member State of origin and details of the marketing authorisation; |
| --- | --- |

(b)

the Member State of origin and details of the marketing authorisation;

| (c) | details of the distributor responsible for the sale of the product; |
| --- | --- |

(c)

details of the distributor responsible for the sale of the product;

| (d) | the quantities imported. |
| --- | --- |

(d)

the quantities imported.

2.
     
  An import authorisation application as referred to in point (b) of Article 56a(1) shall be submitted to the competent authority of the Member State of the importer.

These authorisations shall be granted for a period of five years.

Any change in the information submitted in order to obtain authorisation shall be notified to the competent authority, which shall accordingly alter the initial authorisation if necessary.

A parallel import authorisation application shall contain at least the following information:

| (a) | the name of the veterinary medicinal product, its strength and its pharmaceutical form; |
| --- | --- |

(a)

the name of the veterinary medicinal product, its strength and its pharmaceutical form;

| (b) | details of the imported veterinary medicinal product and of the medicinal product authorised in the Member State of importation, and details of the nature of the relabelling; |
| --- | --- |

(b)

details of the imported veterinary medicinal product and of the medicinal product authorised in the Member State of importation, and details of the nature of the relabelling;

| (c) | the name or company name of the applicant; |
| --- | --- |

(c)

the name or company name of the applicant;

| (d) | the name or company name or logo of the holder of the marketing authorisation or the number of the marketing authorisation of the reference product and of the imported product; |
| --- | --- |

(d)

the name or company name or logo of the holder of the marketing authorisation or the number of the marketing authorisation of the reference product and of the imported product;

| (e) | details of the manufacturing site where the veterinary medicinal products are to be relabelled; |
| --- | --- |

(e)

details of the manufacturing site where the veterinary medicinal products are to be relabelled;

| (f) | the name of the qualified person responsible for pharmacovigilance; |
| --- | --- |

(f)

the name of the qualified person responsible for pharmacovigilance;

| (g) | a declaration that the applicant is independent of the holder of the marketing authorisation. |
| --- | --- |

(g)

a declaration that the applicant is independent of the holder of the marketing authorisation.

3.
     
  An import authorisation application as referred to in point (c) of Article 56a(1) shall be submitted to the Agency.

These authorisations shall be granted for a period of five years.

Any change in the information submitted in order to obtain authorisation shall be notified to the Agency, which shall accordingly alter the initial authorisation if necessary.

The application shall contain information concerning:

| (a) | the name or company name of the applicant, of the manufacturer involved in relabelling, and the parallel distributor; |
| --- | --- |

(a)

the name or company name of the applicant, of the manufacturer involved in relabelling, and the parallel distributor;

| (b) | the name of the qualified person responsible for pharmacovigilance; |
| --- | --- |

(b)

the name of the qualified person responsible for pharmacovigilance;

| (c) | the Member State of origin and destination. |
| --- | --- |

(c)

the Member State of origin and destination.

4.
     
  The competent authority or the Agency may suspend or withdraw parallel import or parallel distribution authorisations if Article 56a and paragraphs 1, 2 and 3 of this Article are no longer complied with or if the product presents a risk to human or animal health or to the environment.

Amendment 170

Proposal for a regulation

Article 57 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 57a |
| | Subsequent conversion into centralised marketing authorisation |
| | 1.
     
  After completion of a decentralised procedure laid down in Article 46, a mutual recognition procedure laid down in Article 48, or a marketing authorisation harmonisation procedure laid down in Article 69, the marketing authorisation holder may submit an application to convert the existing marketing authorisations for the veterinary medicinal product into a centralised marketing authorisation granted by the Commission which shall be valid throughout the Union. |
| | 2.
     
  The application for the conversion into a centralised marketing authorisation shall be submitted to the Agency and shall include the following: |
| | (a) | a list of all decisions granting marketing authorisations concerning this veterinary medicinal product; |

Text proposed by the Commission

Amendment

Article 57a

Subsequent conversion into centralised marketing authorisation

1.
     
  After completion of a decentralised procedure laid down in Article 46, a mutual recognition procedure laid down in Article 48, or a marketing authorisation harmonisation procedure laid down in Article 69, the marketing authorisation holder may submit an application to convert the existing marketing authorisations for the veterinary medicinal product into a centralised marketing authorisation granted by the Commission which shall be valid throughout the Union.

2.
     
  The application for the conversion into a centralised marketing authorisation shall be submitted to the Agency and shall include the following:

(a)

a list of all decisions granting marketing authorisations concerning this veterinary medicinal product;

| (b) | a list of variations introduced since the first marketing authorisation in the Union was granted; |
| --- | --- |

(b)

a list of variations introduced since the first marketing authorisation in the Union was granted;

| (c) | a summary report on pharmacovigilance data. |
| --- | --- |

(c)

a summary report on pharmacovigilance data.

3.
     
  Within 30 days of receipt of the documents listed in paragraph 2, the Commission shall prepare a draft of the decision granting the Union marketing authorisation in conformity with the assessment report referred to in Articles 46(3), 48(4) and 69(3) or, where appropriate, an updated assessment report, a summary of the product characteristics, and a labelling and package leaflet.

4.
     
  The Commission shall, by means of implementing acts, take a final decision on the granting of the centralised marketing authorisation.

This Article shall only apply to veterinary medicinal products that have been authorised through a mutual recognition procedure, a decentralised procedure or a marketing authorisation harmonisation procedure after the date of the application of this Regulation.

Amendment 171

Proposal for a regulation

Article 64 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application. | 1.   If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application
  in 15 days
  . |

Text proposed by the Commission

Amendment

1.   If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application.

1.   If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application
  in 15 days
  .

Amendment 172

Proposal for a regulation

Article 68

| Text proposed by the Commission | Amendment |
| --- | --- |
| Preparatory phase of the harmonisation exercise | Preparatory phase of the harmonisation exercise |
| | -1a.
     
  A single marketing authorisation holder or a group of marketing authorisation holders may, in accordance with Article 69, request a harmonisation of different national marketing authorisations that have been granted for a particular veterinary medicinal product. |
| | -1b.
     
  A harmonised summary of product characteristics shall be prepared for the particular veterinary medicinal product, for which national marketing authorisations have been granted


  in different Member States. The coordination group shall draw up detailed rules of procedure for harmonisation
  . |
| | -1c.
     
  National marketing authorisations may be harmonised with decentralised and/or mutual recognition marketing authorisations if they are for the same product or for essentially similar products |
| 1.   
  A
  harmonised
  summary of product characteristics
  shall be prepared in accordance with the procedure laid down in Article 69 for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different Member States
  before 1 January 2004 (‘similar products’). | 1.   Harmonised
  conditions of use


  as set out in Article 69(4)
  shall be prepared in accordance with the procedure laid down in Article 69 for
  groups of essentially similar
  veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form
  and have been shown to be bio-equivalent (‘essentially similar’ products)
  and for which national marketing authorisations have been granted in different Member States
  before the entry into force of this Regulation. |
| 2.   For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy. | 2.   For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy. |

Text proposed by the Commission

Amendment

Preparatory phase of the harmonisation exercise

Preparatory phase of the harmonisation exercise

-1a.
     
  A single marketing authorisation holder or a group of marketing authorisation holders may, in accordance with Article 69, request a harmonisation of different national marketing authorisations that have been granted for a particular veterinary medicinal product.

-1b.
     
  A harmonised summary of product characteristics shall be prepared for the particular veterinary medicinal product, for which national marketing authorisations have been granted


  in different Member States. The coordination group shall draw up detailed rules of procedure for harmonisation
  .

-1c.
     
  National marketing authorisations may be harmonised with decentralised and/or mutual recognition marketing authorisations if they are for the same product or for essentially similar products

1.   
  A
  harmonised
  summary of product characteristics
  shall be prepared in accordance with the procedure laid down in Article 69 for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different Member States
  before 1 January 2004 (‘similar products’).

1.   Harmonised
  conditions of use


  as set out in Article 69(4)
  shall be prepared in accordance with the procedure laid down in Article 69 for
  groups of essentially similar
  veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form
  and have been shown to be bio-equivalent (‘essentially similar’ products)
  and for which national marketing authorisations have been granted in different Member States
  before the entry into force of this Regulation.

2.   For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy.

2.   For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy.

Amendment 173

Proposal for a regulation

Article 69

| Text proposed by the Commission | Amendment |
| --- | --- |
| Procedure for harmonisation of summaries of products characteristics | Procedure for harmonisation of summaries of products characteristics |
| 1.   By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted
  before 1 January 2004
  . | 1.   By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted. |
| 2.   The coordination group shall establish groups of similar products. For each of
  the
  groups of similar products, the coordination group shall appoint one member to act as a rapporteur. | 2.   The coordination group shall establish groups of
  essentially
  similar products
  as identified in point (b) of Article 68(4).
  For each of
  these
  groups of
  essentially
  similar products, the coordination group shall appoint one member to act as a rapporteur. |
| 3.   Within 120 days of his appointment, the rapporteur shall present the coordination group a report
  regarding possible
  harmonisation of
  summaries of product characteristics for the
  similar veterinary medicinal products
  in the group and propose a harmonised summary of products characteristics. | 3.   Within 120 days of his appointment, the rapporteur shall present to the coordination group a report
  proposing
  harmonisation of
  the conditions of use for the group of essentially
  similar veterinary medicinal products
  or of the marketing authorisation of a particular veterinary medicinal product. |
| 4.   Harmonised
  summaries of product characteristics for veterinary medicinal products
  shall contain
  all of
  the following information: | 4.   Harmonised
  conditions of use
  shall contain
  at least
  the following information: |
| (a) | all species mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group; |

Text proposed by the Commission

Amendment

Procedure for harmonisation of summaries of products characteristics

Procedure for harmonisation of summaries of products characteristics

1.   By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted
  before 1 January 2004
  .

1.   By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted.

2.   The coordination group shall establish groups of similar products. For each of
  the
  groups of similar products, the coordination group shall appoint one member to act as a rapporteur.

2.   The coordination group shall establish groups of
  essentially
  similar products
  as identified in point (b) of Article 68(4).
  For each of
  these
  groups of
  essentially
  similar products, the coordination group shall appoint one member to act as a rapporteur.

3.   Within 120 days of his appointment, the rapporteur shall present the coordination group a report
  regarding possible
  harmonisation of
  summaries of product characteristics for the
  similar veterinary medicinal products
  in the group and propose a harmonised summary of products characteristics.

3.   Within 120 days of his appointment, the rapporteur shall present to the coordination group a report
  proposing
  harmonisation of
  the conditions of use for the group of essentially
  similar veterinary medicinal products
  or of the marketing authorisation of a particular veterinary medicinal product.

4.   Harmonised
  summaries of product characteristics for veterinary medicinal products
  shall contain
  all of
  the following information:

4.   Harmonised
  conditions of use
  shall contain
  at least
  the following information:

(a)

all species mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;

| (a) | all species mentioned in the marketing authorisations granted by Member States in respect of the
  essentially
  similar products in the group; |
| --- | --- |

(a)

all species mentioned in the marketing authorisations granted by Member States in respect of the
  essentially
  similar products in the group;

| (b) | all therapeutic indications mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group; |
| --- | --- |

(b)

all therapeutic indications mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;

| (b) | all therapeutic indications
  and posology
  mentioned in the marketing authorisations granted by Member States in respect of the
  essentially
  similar products in the group; |
| --- | --- |

(b)

all therapeutic indications
  and posology
  mentioned in the marketing authorisations granted by Member States in respect of the
  essentially
  similar products in the group;

| (c) | the shortest
  withdrawal period
  of those stated in the summaries of the product characteristics. |
| --- | --- |

(c)

the shortest
  withdrawal period
  of those stated in the summaries of the product characteristics.

| (c) | a
  withdrawal period
  which ensures that consumers are adequately protected; |
| --- | --- |

(c)

a
  withdrawal period
  which ensures that consumers are adequately protected;

| (ca) | special precautions regarding impact on the environment. |
| --- | --- |

(ca)

special precautions regarding impact on the environment.

4a.
     
  Further than the conditions of use, other elements of the summary of product characteristics and data quality set, may be harmonised.

5.   Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly.

5.   Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly.

6.   In the event of an opinion in favour of adopting
  a
  harmonised
  summary of the product characteristics
  , each Member State shall vary
  a
  marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur.

6.   In the event of an opinion in favour of adopting harmonised
  conditions of use
  , each Member State shall vary
  the
  marketing authorisation
  or authorisations of the products in their territory so that the elements listed in paragraph 4, where they are already included in the summaries of characteristics for a product belonging to that group, are
  in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur.
  Once an opinion in favour of adopting harmonised conditions of use has been issued, marketing authorisations for a particular product shall be eligible to be considered to be mutual recognition marketing authorisations granted under this Regulation.

7.   In the event of an unfavourable opinion, the procedure referred to in Article 49 shall apply.

7.   In the event of an unfavourable opinion, the procedure referred to in Article 49 shall apply.

Amendment 174

Proposal for a regulation

Article 70

| Text proposed by the Commission | Amendment |
| --- | --- |
| Harmonisation of summary of products characteristics following reassessment | Harmonisation of summary of products characteristics following reassessment |
| 1.   By way of derogation from Article 69, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before a harmonised
  summary of the product characteristics is
  prepared. | 1.   By way of derogation from Article 69,
  and where harmonisation of the conditions of use of a group of products is in the interests of public or animal health at Union level,
  the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before harmonised
  conditions of use are
  prepared. |
| | 1a.
     
  For the purpose of harmonisation under this Article similar veterinary medicinal products shall refer to products, not all of which are bioequivalent, and other than homeopathic veterinary medicinal products, that have the same active substance or active substances and the same pharmaceutical form or a range of veterinary medicinal products belonging to the same therapeutic class. |
| 2.   The Commission shall, by means of implementing acts, adopt decisions on groups of product for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). | 2.   The Commission shall, by means of implementing acts, adopt decisions on groups of
  similar
  products for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). |
| 3.   By way of derogation from Article 69, veterinary medicinal products
  authorised before 20 July 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment
  shall be
  reassessed
  before
  a
  harmonised
  summary of the product characteristics is
  prepared. | 3.   By way of derogation from Article 69, veterinary medicinal products
  which have not been subject to an environmental risk assessment in the Union
  shall be
  assessed in accordance with Annex II
  before harmonised
  conditions of use are
  prepared.
  For that purpose, marketing authorisation holders shall update accordingly the documentation mentioned in point (b) of Article 7(1). |
| | 3a.
     
  By way of derogation from Article 69, antimicrobial veterinary medicinal products shall be reassessed within five years of the entry into force of this Regulation. |
| 4.   For the purposes of paragraphs 1 and 3, the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly. | 4.   For the purposes of paragraphs 1, 3
  and 3a
  the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly. |

Text proposed by the Commission

Amendment

Harmonisation of summary of products characteristics following reassessment

Harmonisation of summary of products characteristics following reassessment

1.   By way of derogation from Article 69, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before a harmonised
  summary of the product characteristics is
  prepared.

1.   By way of derogation from Article 69,
  and where harmonisation of the conditions of use of a group of products is in the interests of public or animal health at Union level,
  the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before harmonised
  conditions of use are
  prepared.

1a.
     
  For the purpose of harmonisation under this Article similar veterinary medicinal products shall refer to products, not all of which are bioequivalent, and other than homeopathic veterinary medicinal products, that have the same active substance or active substances and the same pharmaceutical form or a range of veterinary medicinal products belonging to the same therapeutic class.

2.   The Commission shall, by means of implementing acts, adopt decisions on groups of product for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

2.   The Commission shall, by means of implementing acts, adopt decisions on groups of
  similar
  products for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

3.   By way of derogation from Article 69, veterinary medicinal products
  authorised before 20 July 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment
  shall be
  reassessed
  before
  a
  harmonised
  summary of the product characteristics is
  prepared.

3.   By way of derogation from Article 69, veterinary medicinal products
  which have not been subject to an environmental risk assessment in the Union
  shall be
  assessed in accordance with Annex II
  before harmonised
  conditions of use are
  prepared.
  For that purpose, marketing authorisation holders shall update accordingly the documentation mentioned in point (b) of Article 7(1).

3a.
     
  By way of derogation from Article 69, antimicrobial veterinary medicinal products shall be reassessed within five years of the entry into force of this Regulation.

4.   For the purposes of paragraphs 1 and 3, the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly.

4.   For the purposes of paragraphs 1, 3
  and 3a
  the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly.

Amendment 175

Proposal for a regulation

Article 71

| Text proposed by the Commission | Amendment |
| --- | --- |
| Position of marketing authorisation holder | Position of marketing authorisation holder |
| Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products. | Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of products identified for a harmonisation of the summaries of the product characteristics
  or the holders of a particular product identified for harmonisation of marketing authorisations
  shall submit information concerning their products |

Text proposed by the Commission

Amendment

Position of marketing authorisation holder

Position of marketing authorisation holder

Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products.

Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of products identified for a harmonisation of the summaries of the product characteristics
  or the holders of a particular product identified for harmonisation of marketing authorisations
  shall submit information concerning their products

Amendment 176

Proposal for a regulation

Article 72 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Marketing authorisation holders shall elaborate and maintain a system for collecting information on the
  risks
  of veterinary medicinal products as regards animal health, public health and the environment
  enabling them
  to fulfil
  their
  pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system’). | 1.   Marketing authorisation holders shall
  ensure that risk-benefit balance of authorised veterinary medicinal products is evaluated on a continuous basis and that appropriate measure are taken by the marketing authorisation holders in order to ensure that this balance remains positive for the authorised veterinary medicinal products. To this end, the marketing authorisation holders shall
  elaborate and maintain a system for collecting
  , investigating, assessment and communicating of
  information on the
  adverse events
  of veterinary medicinal products as regards animal health, public health and the environment
  . The system shall serve to coordinate the necessary measures
  to fulfil
  the
  pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system’). |

Text proposed by the Commission

Amendment

1.   Marketing authorisation holders shall elaborate and maintain a system for collecting information on the
  risks
  of veterinary medicinal products as regards animal health, public health and the environment
  enabling them
  to fulfil
  their
  pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system’).

1.   Marketing authorisation holders shall
  ensure that risk-benefit balance of authorised veterinary medicinal products is evaluated on a continuous basis and that appropriate measure are taken by the marketing authorisation holders in order to ensure that this balance remains positive for the authorised veterinary medicinal products. To this end, the marketing authorisation holders shall
  elaborate and maintain a system for collecting
  , investigating, assessment and communicating of
  information on the
  adverse events
  of veterinary medicinal products as regards animal health, public health and the environment
  . The system shall serve to coordinate the necessary measures
  to fulfil
  the
  pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system’).

Amendment 177

Proposal for a regulation

Article 72 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders. | 2.   Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders
  and shall not have any conflict of interest with regard to the marketing authorisation holder. |

Text proposed by the Commission

Amendment

2.   Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders.

2.   Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders
  and shall not have any conflict of interest with regard to the marketing authorisation holder.

Amendment 178

Proposal for a regulation

Article 73 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Member States, the Commission, the Agency
  and marketing authorisation holders
  shall collaborate in setting up
  and maintaining a system
  to monitor the safety of authorised veterinary medicinal products
  , enabling them
  to fulfil their responsibilities as listed in
  Articles 77 and
  79
  (‘Union pharmacovigilance system’)
  . | 1.   Member States, the Commission
  and
  the Agency shall collaborate in setting up
  , interconnecting and further developing their systems
  to monitor the safety
  , effectiveness and quality
  of authorised veterinary medicinal products
  in order
  to fulfil their responsibilities as listed in
  Article
  79.
  Marketing authorisation holders shall set up and maintain a system to monitor the safety, effectiveness and quality of their products, enabling them to fulfil their responsibilities as listed in Articles 77 and 78
  . |

Text proposed by the Commission

Amendment

1.   Member States, the Commission, the Agency
  and marketing authorisation holders
  shall collaborate in setting up
  and maintaining a system
  to monitor the safety of authorised veterinary medicinal products
  , enabling them
  to fulfil their responsibilities as listed in
  Articles 77 and
  79
  (‘Union pharmacovigilance system’)
  .

1.   Member States, the Commission
  and
  the Agency shall collaborate in setting up
  , interconnecting and further developing their systems
  to monitor the safety
  , effectiveness and quality
  of authorised veterinary medicinal products
  in order
  to fulfil their responsibilities as listed in
  Article
  79.
  Marketing authorisation holders shall set up and maintain a system to monitor the safety, effectiveness and quality of their products, enabling them to fulfil their responsibilities as listed in Articles 77 and 78
  .

Amendment 179

Proposal for a regulation

Article 73 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals
  and
  animal holders different means of reporting to them the following events whether or not the event is considered to be product-related
  (‘adverse events’)
  : | 2.   Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals, animal holders
  , environmental authorities of the Member States and other interested parties
  different means of reporting to them the following events
  (‘adverse events’)
  whether or not the event is considered to be product-related: |
| (a) | any response in an animal to a veterinary or human medicinal product, that is noxious and unintended; |

Text proposed by the Commission

Amendment

2.   Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals
  and
  animal holders different means of reporting to them the following events whether or not the event is considered to be product-related
  (‘adverse events’)
  :

2.   Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals, animal holders
  , environmental authorities of the Member States and other interested parties
  different means of reporting to them the following events
  (‘adverse events’)
  whether or not the event is considered to be product-related:

(a)

any response in an animal to a veterinary or human medicinal product, that is noxious and unintended;

| (a) | any response in an animal to a veterinary or human medicinal product, that is noxious and unintended
  , regardless of whether or not the event is considered to be product-related and whether or not the product was administered in accordance with the summary of product characteristics; |
| --- | --- |

(a)

any response in an animal to a veterinary or human medicinal product, that is noxious and unintended
  , regardless of whether or not the event is considered to be product-related and whether or not the product was administered in accordance with the summary of product characteristics;

| (b) | any observation of a lack of efficacy of a veterinary medicinal product following
  administration to
  an animal
  in accordance with the summary of product characteristics
  ; |
| --- | --- |

(b)

any observation of a lack of efficacy of a veterinary medicinal product following
  administration to
  an animal
  in accordance with the summary of product characteristics
  ;

| (b) | any observation of a lack of efficacy of a veterinary medicinal product
  , including potential signs of antimicrobial resistance,
  following
  its use on
  an animal; |
| --- | --- |

(b)

any observation of a lack of efficacy of a veterinary medicinal product
  , including potential signs of antimicrobial resistance,
  following
  its use on
  an animal;

| (c) | any
  environmental incidents observed
  following administration of a veterinary medicinal product to an animal; |
| --- | --- |

(c)

any
  environmental incidents observed
  following administration of a veterinary medicinal product to an animal;

| (c) | any
  adverse, unforeseen, or unintended impact in the environment (including ground and surface water)
  following administration of a veterinary medicinal product to an animal; |
| --- | --- |

(c)

any
  adverse, unforeseen, or unintended impact in the environment (including ground and surface water)
  following administration of a veterinary medicinal product to an animal;

| (d) | any infringements of withdrawal period following administration to an animal of a veterinary
  or human
  medicinal product; |
| --- | --- |

(d)

any infringements of withdrawal period following administration to an animal of a veterinary
  or human
  medicinal product;

| (d) | any infringements of withdrawal period following administration to an animal of a veterinary medicinal product; |
| --- | --- |

(d)

any infringements of withdrawal period following administration to an animal of a veterinary medicinal product;

| (e) | any noxious
  response
  in humans to a veterinary medicinal product; |
| --- | --- |

(e)

any noxious
  response
  in humans to a veterinary medicinal product;

| (e) | any noxious
  reaction
  in humans to a veterinary medicinal product; |
| --- | --- |

(e)

any noxious
  reaction
  in humans to a veterinary medicinal product;

| (f) | any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009. |
| --- | --- |

(f)

any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009.

| (f) | any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009; |
| --- | --- |

(f)

any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009;

| (fa) | any suspected unintended transmission via a veterinary medicinal product of any infectious agent. |
| --- | --- |

(fa)

any suspected unintended transmission via a veterinary medicinal product of any infectious agent.

Amendment 180

Proposal for a regulation

Article 73 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  Competent authorities and the Agency shall, in addition to the events provided under paragraph 2, make available to healthcare professionals and animal holders different means of reporting to them any response in an animal to a human medicinal product. |

Text proposed by the Commission

Amendment

2a.
     
  Competent authorities and the Agency shall, in addition to the events provided under paragraph 2, make available to healthcare professionals and animal holders different means of reporting to them any response in an animal to a human medicinal product.

Amendment 181

Proposal for a regulation

Article 73 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 73a |
| | No later than six months before the date of application of this Regulation, the Commission shall present a report to the European Parliament and the Council on a feasibility study of a substance-based review system (‘monographs’) and other potential alternatives for the environmental risk assessment of veterinary medicinal products, to be accompanied, if appropriate, by a legislative proposal. |

Text proposed by the Commission

Amendment

Article 73a

No later than six months before the date of application of this Regulation, the Commission shall present a report to the European Parliament and the Council on a feasibility study of a substance-based review system (‘monographs’) and other potential alternatives for the environmental risk assessment of veterinary medicinal products, to be accompanied, if appropriate, by a legislative proposal.

Amendment 182

Proposal for a regulation

Article 74 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘pharmacovigilance database’). | 1.   The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘pharmacovigilance database’)
  , linked to the database on veterinary medicinal products
  .
  The Union database on veterinary medicinal products shall be the only data entry point for adverse events reported by the holders of marketing authorisations. Maintaining the database shall include electronic archiving of the original reports, related subsequent reports and continuous quality control of the data. |

Text proposed by the Commission

Amendment

1.   The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘pharmacovigilance database’).

1.   The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘pharmacovigilance database’)
  , linked to the database on veterinary medicinal products
  .
  The Union database on veterinary medicinal products shall be the only data entry point for adverse events reported by the holders of marketing authorisations. Maintaining the database shall include electronic archiving of the original reports, related subsequent reports and continuous quality control of the data.

Amendment 183

Proposal for a regulation

Article 74 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The Agency shall, in
  collaboration
  with the Member States
  and
  the Commission, draw up the functional specifications for the pharmacovigilance database. | 2.   The Agency shall, in
  consultation
  with the Member States, the Commission
  and interested parties
  , draw up the functional specifications for the pharmacovigilance database.
  These shall include environmental monitoring data which would report undesirable effects on non-target species in the ecosystem, and extend sources of inputs to the pharmacovigilance system to include observation and monitoring by specialists who are not necessarily veterinarians. |

Text proposed by the Commission

Amendment

2.   The Agency shall, in
  collaboration
  with the Member States
  and
  the Commission, draw up the functional specifications for the pharmacovigilance database.

2.   The Agency shall, in
  consultation
  with the Member States, the Commission
  and interested parties
  , draw up the functional specifications for the pharmacovigilance database.
  These shall include environmental monitoring data which would report undesirable effects on non-target species in the ecosystem, and extend sources of inputs to the pharmacovigilance system to include observation and monitoring by specialists who are not necessarily veterinarians.

Amendment 184

Proposal for a regulation

Article 74 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with Article 75. | 3.   The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made
  publicly
  accessible in accordance with Article 75. |

Text proposed by the Commission

Amendment

3.   The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with Article 75.

3.   The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made
  publicly
  accessible in accordance with Article 75.

Amendment 185

Proposal for a regulation

Article 74 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  The Agency shall ensure that the transfer of information between its pharmacovigilance database and the national pharmacovigilance databases of the individual Member States is safeguarded. |

Text proposed by the Commission

Amendment

3a.
     
  The Agency shall ensure that the transfer of information between its pharmacovigilance database and the national pharmacovigilance databases of the individual Member States is safeguarded.

Amendment 186

Proposal for a regulation

Article 75 — paragraph 3 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | the number of adverse events reported each year, broken down by product, animal species and type of adverse event; |

Text proposed by the Commission

Amendment

(a)

the number of adverse events reported each year, broken down by product, animal species and type of adverse event;

| (a) | the number of adverse events reported each year, broken down by
  type of
  product
  and active substance
  , animal species and type of adverse event; |
| --- | --- |

(a)

the number of adverse events reported each year, broken down by
  type of
  product
  and active substance
  , animal species and type of adverse event;

Amendment 187

Proposal for a regulation

Article 75 — paragraph 3 — point b a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ba) | information about incidence of adverse events. |

Text proposed by the Commission

Amendment

(ba)

information about incidence of adverse events.

Amendment 188

Proposal for a regulation

Article 75 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  Health professionals shall have access to the pharmacovigilance database as regards the following information: |
| | (a) | the number of adverse events reported each year, broken down by product, animal species and type of adverse event; |

Text proposed by the Commission

Amendment

3a.
     
  Health professionals shall have access to the pharmacovigilance database as regards the following information:

(a)

the number of adverse events reported each year, broken down by product, animal species and type of adverse event;

| (b) | previous declarations made concerning the same product and the number of cases per species in the previous six months; |
| --- | --- |

(b)

previous declarations made concerning the same product and the number of cases per species in the previous six months;

| (c) | information on the results of the signal detection system for veterinary medicinal products and groups of products. |
| --- | --- |

(c)

information on the results of the signal detection system for veterinary medicinal products and groups of products.

Amendment 189

Proposal for a regulation

Article 76 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Competent authorities shall record in the pharmacovigilance database
  all
  adverse
  events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State,
  within
  30
  days following the receipt of
  the
  adverse event report. | 1.   Competent authorities shall record
  and assess all adverse events of which they learn under Article 73 and which occur
  in the
  territory of their Member State and shall enter them immediately, but no later than 15 days following the receipt of the information, in the
  pharmacovigilance database
  . Competent authorities shall record any serious
  adverse
  event in animals, noxious response in humans to a veterinary medicinal product or environmental incident observed following administration of a veterinary medicinal product to an animal
  within
  15
  days following the receipt of
  such an
  adverse event report. |

Text proposed by the Commission

Amendment

1.   Competent authorities shall record in the pharmacovigilance database
  all
  adverse
  events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State,
  within
  30
  days following the receipt of
  the
  adverse event report.

1.   Competent authorities shall record
  and assess all adverse events of which they learn under Article 73 and which occur
  in the
  territory of their Member State and shall enter them immediately, but no later than 15 days following the receipt of the information, in the
  pharmacovigilance database
  . Competent authorities shall record any serious
  adverse
  event in animals, noxious response in humans to a veterinary medicinal product or environmental incident observed following administration of a veterinary medicinal product to an animal
  within
  15
  days following the receipt of
  such an
  adverse event report.

Amendment 190

Proposal for a regulation

Article 76 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within
  30
  days following the receipt of
  the
  adverse event report. | 2.   Marketing authorisation holders shall record in the pharmacovigilance database
  and evaluate
  all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products
  . Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported
  within
  15
  days following the receipt of
  such
  adverse event report.
  Less serious adverse events relating to the use of veterinary medicinal products shall be reported no later than 42 days following receipt of the information. Different requirements shall apply for adverse events observed in clinical trials, as specified in the Good Clinical Practice guidelines for clinical trials
  . |

Text proposed by the Commission

Amendment

2.   Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within
  30
  days following the receipt of
  the
  adverse event report.

2.   Marketing authorisation holders shall record in the pharmacovigilance database
  and evaluate
  all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products
  . Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported
  within
  15
  days following the receipt of
  such
  adverse event report.
  Less serious adverse events relating to the use of veterinary medicinal products shall be reported no later than 42 days following receipt of the information. Different requirements shall apply for adverse events observed in clinical trials, as specified in the Good Clinical Practice guidelines for clinical trials
  .

Amendment 191

Proposal for a regulation

Article 76 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   Competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to
  collect
  specific pharmacovigilance data,
  in particular
  regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product,
  and
  the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof. | 3.   Competent authorities may, on their own initiative or on
  a
  request from the Agency, request the marketing authorisation holder to
  provide
  specific pharmacovigilance data,
  such as, information relating to ongoing risk-benefit balance evaluations
  regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product,
  or
  the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof. |
| | Marketing authorisation holders shall be required to comply with such a request within an appropriate deadline set by the competent authority
  . |

Text proposed by the Commission

Amendment

3.   Competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to
  collect
  specific pharmacovigilance data,
  in particular
  regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product,
  and
  the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.

3.   Competent authorities may, on their own initiative or on
  a
  request from the Agency, request the marketing authorisation holder to
  provide
  specific pharmacovigilance data,
  such as, information relating to ongoing risk-benefit balance evaluations
  regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product,
  or
  the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.

Marketing authorisation holders shall be required to comply with such a request within an appropriate deadline set by the competent authority
  .

Amendment 192

Proposal for a regulation

Article 77 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation. | 1.   The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation
  and shall take all appropriate steps to encourage members of the health professions and animal holders to report adverse events
  . |

Text proposed by the Commission

Amendment

1.   The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation.

1.   The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation
  and shall take all appropriate steps to encourage members of the health professions and animal holders to report adverse events
  .

Amendment 193

Proposal for a regulation

Article 77 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party,
  those arrangements
  shall be set out
  in details
  in the pharmacovigilance system master file. | 2.   Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party
  (contractor)
  ,
  the responsibilities of both parties
  shall be set out
  explicitly in a contract and
  in the pharmacovigilance system master file. |

Text proposed by the Commission

Amendment

2.   Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party,
  those arrangements
  shall be set out
  in details
  in the pharmacovigilance system master file.

2.   Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party
  (contractor)
  ,
  the responsibilities of both parties
  shall be set out
  explicitly in a contract and
  in the pharmacovigilance system master file.

Amendment 194

Proposal for a regulation

Article 77 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  The marketing authorisation holder shall be required to check regularly that the contractor is carrying out the work in accordance with the requirements of the contract. |

Text proposed by the Commission

Amendment

2a.
     
  The marketing authorisation holder shall be required to check regularly that the contractor is carrying out the work in accordance with the requirements of the contract.

Amendment 195

Proposal for a regulation

Article 77 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   The marketing authorisation holder shall permanently have at his disposal
  one or more
  appropriately qualified
  persons
  responsible for pharmacovigilance.
  Those persons
  shall reside and operate in the Union
  . Only one qualified person shall be designated by the marketing authorisation holder per pharmacovigilance system master file
  . | 3.   The marketing authorisation holder shall permanently have at his disposal
  an
  appropriately qualified
  person
  responsible for pharmacovigilance.
  That person
  shall reside and operate in the Union
  . The qualified person responsible for pharmacovigilance may delegate specific areas of work to appropriately trained staff but shall remain responsible for the marketing authorisation holder’s pharmacovigilance system and for the safety profile of his veterinary medicinal products. |

Text proposed by the Commission

Amendment

3.   The marketing authorisation holder shall permanently have at his disposal
  one or more
  appropriately qualified
  persons
  responsible for pharmacovigilance.
  Those persons
  shall reside and operate in the Union
  . Only one qualified person shall be designated by the marketing authorisation holder per pharmacovigilance system master file
  .

3.   The marketing authorisation holder shall permanently have at his disposal
  an
  appropriately qualified
  person
  responsible for pharmacovigilance.
  That person
  shall reside and operate in the Union
  . The qualified person responsible for pharmacovigilance may delegate specific areas of work to appropriately trained staff but shall remain responsible for the marketing authorisation holder’s pharmacovigilance system and for the safety profile of his veterinary medicinal products.

Amendment 196

Proposal for a regulation

Article 77 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party,
  those
  arrangements shall be
  detailed in the
  contract. | 4.   Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party,
  the relevant
  arrangements shall be
  set out explicitly in a
  contract. |

Text proposed by the Commission

Amendment

4.   Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party,
  those
  arrangements shall be
  detailed in the
  contract.

4.   Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party,
  the relevant
  arrangements shall be
  set out explicitly in a
  contract.

Amendment 197

Proposal for a regulation

Article 77 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6.   The marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without
  giving prior notification of his intention
  to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure. | 6.   The marketing authorisation holder shall not communicate information regarding adverse events
  and potential pharmacovigilance concerns
  to the general public in relation to the veterinary medicinal product without
  sending in advance a copy of that communication
  to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure. |

Text proposed by the Commission

Amendment

6.   The marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without
  giving prior notification of his intention
  to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.

6.   The marketing authorisation holder shall not communicate information regarding adverse events
  and potential pharmacovigilance concerns
  to the general public in relation to the veterinary medicinal product without
  sending in advance a copy of that communication
  to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.

Amendment 198

Proposal for a regulation

Article 77 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 77a |
| | Single master file |
| | The organisation of the pharmacovigilance operations conducted by marketing authorisation holders shall be described in a single master file, which shall be subject to authorisation by the Member States. The single evaluation procedures for these authorisations shall be defined by the Member States and the resulting decisions shall be recognised throughout the Union. |
| | The competent authority shall issue a decision on this authorisation within 90 days of the receipt of a complete application. |
| | The single master file shall be addressed to the competent authority of the Member State in which the qualified person designated by the authorisation holder conducts the operations described in this file. The competent authority concerned shall notify its decision to the authorisation holder and shall record it in the Union database on veterinary medicinal products together with a copy of the relevant single master file. |
| | The authorisation holder shall also submit to the competent authority any substantive changes to his single master file. |

Text proposed by the Commission

Amendment

Article 77a

Single master file

The organisation of the pharmacovigilance operations conducted by marketing authorisation holders shall be described in a single master file, which shall be subject to authorisation by the Member States. The single evaluation procedures for these authorisations shall be defined by the Member States and the resulting decisions shall be recognised throughout the Union.

The competent authority shall issue a decision on this authorisation within 90 days of the receipt of a complete application.

The single master file shall be addressed to the competent authority of the Member State in which the qualified person designated by the authorisation holder conducts the operations described in this file. The competent authority concerned shall notify its decision to the authorisation holder and shall record it in the Union database on veterinary medicinal products together with a copy of the relevant single master file.

The authorisation holder shall also submit to the competent authority any substantive changes to his single master file.

Amendment 199

Proposal for a regulation

Article 78

| Text proposed by the Commission | Amendment |
| --- | --- |
| Qualified person responsible for pharmacovigilance | Qualified person responsible for pharmacovigilance |
| Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall
  carry out
  the following tasks: | Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall
  ensure that
  the following tasks
  are carried out: |
| (a) | elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder
  with respect to the veterinary medicinal product for which the authorisation has been granted
  (‘pharmacovigilance system master file’) for all products under their responsibility; |

Text proposed by the Commission

Amendment

Qualified person responsible for pharmacovigilance

Qualified person responsible for pharmacovigilance

Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall
  carry out
  the following tasks:

Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall
  ensure that
  the following tasks
  are carried out:

(a)

elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder
  with respect to the veterinary medicinal product for which the authorisation has been granted
  (‘pharmacovigilance system master file’) for all products under their responsibility;

| (a) | elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder (‘pharmacovigilance system master file’) for all products under their responsibility; |
| --- | --- |

(a)

elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder (‘pharmacovigilance system master file’) for all products under their responsibility;

| (b) | allocating reference numbers to the pharmacovigilance system master file and communicating the reference number of the pharmacovigilance master file
  of each product
  to the product database; |
| --- | --- |

(b)

allocating reference numbers to the pharmacovigilance system master file and communicating the reference number of the pharmacovigilance master file
  of each product
  to the product database;

| (b) | allocating reference numbers to the pharmacovigilance system master file and communicating the
  relevant
  reference number of the pharmacovigilance master file to the product database
  for each product
  ; |
| --- | --- |

(b)

allocating reference numbers to the pharmacovigilance system master file and communicating the
  relevant
  reference number of the pharmacovigilance master file to the product database
  for each product
  ;

| (c) | notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union; |
| --- | --- |

(c)

notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union;

| (c) | notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union; |
| --- | --- |

(c)

notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union;

| (d) | establishing and maintaining a system which ensures that all adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union; |
| --- | --- |

(d)

establishing and maintaining a system which ensures that all adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;

| (d) | establishing and maintaining a system which ensures that all adverse events,
  including on non-target species and the environment
  , which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union; |
| --- | --- |

(d)

establishing and maintaining a system which ensures that all adverse events,
  including on non-target species and the environment
  , which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;

| (e) | preparing the adverse event reports referred to in Article 76; |
| --- | --- |

(e)

preparing the adverse event reports referred to in Article 76;

| (e) | preparing the adverse event reports referred to in Article 76; |
| --- | --- |

(e)

preparing the adverse event reports referred to in Article 76;

| (f) | ensuring that collected adverse event reports are recorded in the pharmacovigilance database; |
| --- | --- |

(f)

ensuring that collected adverse event reports are recorded in the pharmacovigilance database;

| (f) | ensuring that collected adverse event reports are recorded in the pharmacovigilance database; |
| --- | --- |

(f)

ensuring that collected adverse event reports are recorded in the pharmacovigilance database;

| (g) | ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned; |
| --- | --- |

(g)

ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned;

| (g) | ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned; |
| --- | --- |

(g)

ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned;

| (h) | providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies; |
| --- | --- |

(h)

providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;

| (h) | providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies; |
| --- | --- |

(h)

providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;

| (i) | evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary; |
| --- | --- |

(i)

evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary;

| (i) | evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary; |
| --- | --- |

(i)

evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary;

| (j) | monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented; |
| --- | --- |

(j)

monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented;

| (j) | monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented; |
| --- | --- |

(j)

monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented;

| (k) | ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training; |
| --- | --- |

(k)

ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training;

| (k) | ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training
  tailored to their duties, on an ongoing basis; training courses are documented and their effectiveness reviewed; |
| --- | --- |

(k)

ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training
  tailored to their duties, on an ongoing basis; training courses are documented and their effectiveness reviewed;

| (l) | communicating any regulatory measure that is taken in a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information. |
| --- | --- |

(l)

communicating any regulatory measure that is taken in a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information.

| (l) | communicating any regulatory measure that is taken in
  another Member State or
  a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information; |
| --- | --- |

(l)

communicating any regulatory measure that is taken in
  another Member State or
  a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information;

| (la) | conducting for each product an annual risk-benefit review taking into account all pharmacovigilance surveillance data available on the product concerned, including pharmacovigilance signal monitoring. This review shall be documented by the marketing authorisation holder and the outcome recorded in the pharmacovigilance database. The marketing authorisation holder shall provide the documentation supporting the outcome of the review on request from the national competent authority or during the conduct of an inspection carried out in accordance with Article 128; |
| --- | --- |

(la)

conducting for each product an annual risk-benefit review taking into account all pharmacovigilance surveillance data available on the product concerned, including pharmacovigilance signal monitoring. This review shall be documented by the marketing authorisation holder and the outcome recorded in the pharmacovigilance database. The marketing authorisation holder shall provide the documentation supporting the outcome of the review on request from the national competent authority or during the conduct of an inspection carried out in accordance with Article 128;

| (lb) | the authorisation holder shall be required to ensure that the qualified person responsible for pharmacovigilance is authorised to maintain and further develop the pharmacovigilance system and to ensure compliance with requirements. |
| --- | --- |

(lb)

the authorisation holder shall be required to ensure that the qualified person responsible for pharmacovigilance is authorised to maintain and further develop the pharmacovigilance system and to ensure compliance with requirements.

Amendment 200

Proposal for a regulation

Article 79 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Competent authorities shall evaluate all adverse events reported to them by healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary. | 1.   Competent authorities shall evaluate all adverse events reported to them by
  marketing authorisation holders,
  healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary. |

Text proposed by the Commission

Amendment

1.   Competent authorities shall evaluate all adverse events reported to them by healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.

1.   Competent authorities shall evaluate all adverse events reported to them by
  marketing authorisation holders,
  healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.

Amendment 201

Proposal for a regulation

Article 79 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   Competent authorities and the Agency shall
  provide the general
  public
  , veterinarians and other healthcare professionals with
  all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication. | 4.   Competent authorities and the Agency shall
  make
  public all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication.
  Competent authorities and the Agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported
  . |

Text proposed by the Commission

Amendment

4.   Competent authorities and the Agency shall
  provide the general
  public
  , veterinarians and other healthcare professionals with
  all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication.

4.   Competent authorities and the Agency shall
  make
  public all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication.
  Competent authorities and the Agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported
  .

Amendment 203

Proposal for a regulation

Article 80 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent authority in another Member State subject to the written agreement of the latter. | 1.   A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent
  public
  authority in another Member State subject to the written agreement of the latter. |

Text proposed by the Commission

Amendment

1.   A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent authority in another Member State subject to the written agreement of the latter.

1.   A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent
  public
  authority in another Member State subject to the written agreement of the latter.

Amendment 204

Proposal for a regulation

Article 81

| Text proposed by the Commission | Amendment |
| --- | --- |
| Signal management process | Signal management process |
| 1.   Competent authorities and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘signal management process’). | 1.   
  Marketing authorisation holders
  , competent authorities,
  other concerned authorities
  and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘signal management process’). |
| 2.   Competent authorities and the Agency shall establish groups of veterinary medicinal products for which signal management process can be combined with a view of detecting risks to animal health, public health and protection of the environment. | 2.   Competent authorities and the Agency shall establish groups of veterinary medicinal products for which signal management process can be combined with a view of detecting risks to animal health, public health and protection of the environment. |
| 3.   The Agency and the
  coordination
  group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database. For each group of veterinary medicinal products a competent authority or the Agency shall be appointed as responsible for the monitoring thereof (‘lead authority’). | 3.   The Agency and the
  veterinary pharmacovigilance
  group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database. For each group of veterinary medicinal products a competent authority or the Agency shall be appointed as responsible for the monitoring thereof (‘lead authority’). |
| 4.   The results of the signal management process shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database. | 4.   
  Given that marketing authorisation holders are the primary source of expertise and information concerning the products under their responsibility, the lead authority may where necessary consult them during the signal management process.
  The results of the signal management process shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database. |
| 5.   Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities or the Commission shall take appropriate measures as referred to in Articles 130 to 135. | 5.   Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities or the Commission shall take appropriate measures as referred to in Articles 130 to 135. |

Text proposed by the Commission

Amendment

Signal management process

Signal management process

1.   Competent authorities and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘signal management process’).

1.   
  Marketing authorisation holders
  , competent authorities,
  other concerned authorities
  and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘signal management process’).

2.   Competent authorities and the Agency shall establish groups of veterinary medicinal products for which signal management process can be combined with a view of detecting risks to animal health, public health and protection of the environment.

2.   Competent authorities and the Agency shall establish groups of veterinary medicinal products for which signal management process can be combined with a view of detecting risks to animal health, public health and protection of the environment.

3.   The Agency and the
  coordination
  group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database. For each group of veterinary medicinal products a competent authority or the Agency shall be appointed as responsible for the monitoring thereof (‘lead authority’).

3.   The Agency and the
  veterinary pharmacovigilance
  group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database. For each group of veterinary medicinal products a competent authority or the Agency shall be appointed as responsible for the monitoring thereof (‘lead authority’).

4.   The results of the signal management process shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database.

4.   
  Given that marketing authorisation holders are the primary source of expertise and information concerning the products under their responsibility, the lead authority may where necessary consult them during the signal management process.
  The results of the signal management process shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database.

5.   Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities or the Commission shall take appropriate measures as referred to in Articles 130 to 135.

5.   Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities or the Commission shall take appropriate measures as referred to in Articles 130 to 135.

Amendment 205

Proposal for a regulation

Article 82 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| Before the expiry of the period of validity of
  3
  years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re-examined on application from the marketing authorisation holder. After the initial re-examination, it shall be re-examined every
  5
  years. | Before the expiry of the period of validity of
  five
  years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re-examined on application from the marketing authorisation holder. After the initial re-examination, it shall be re-examined
  , if necessary,
  every
  five
  years. |

Text proposed by the Commission

Amendment

Before the expiry of the period of validity of
  3
  years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re-examined on application from the marketing authorisation holder. After the initial re-examination, it shall be re-examined every
  5
  years.

Before the expiry of the period of validity of
  five
  years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re-examined on application from the marketing authorisation holder. After the initial re-examination, it shall be re-examined
  , if necessary,
  every
  five
  years.

Amendment 206

Proposal for a regulation

Article 83

| Text proposed by the Commission | Amendment |
| --- | --- |
| Article 83 | deleted |
| Procedure for re-examination of a marketing authorisation in exceptional circumstances | |
| 1.
     
  Before the expiry of the period of validity of 1 year, marketing authorisations granted in accordance with Article 22 shall be re-examined on application from the marketing authorisation holder. | |
| 2.
     
  The application for re-examination shall be submitted to the competent authority that granted the authorisation or the Agency at least 3 months before the expiry of the marketing authorisation. | |
| 3.
     
  When an application for re-examination has been submitted, the marketing authorisation shall remain valid until a decision on the application has been adopted by the competent authority or the Commission. | |
| 4.
     
  The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time, provided that the marketing authorisation holder submits the missing comprehensive safety and efficacy data referred to in Article 22(1). | |

Text proposed by the Commission

Amendment

Article 83

deleted

Procedure for re-examination of a marketing authorisation in exceptional circumstances

1.
     
  Before the expiry of the period of validity of 1 year, marketing authorisations granted in accordance with Article 22 shall be re-examined on application from the marketing authorisation holder.

2.
     
  The application for re-examination shall be submitted to the competent authority that granted the authorisation or the Agency at least 3 months before the expiry of the marketing authorisation.

3.
     
  When an application for re-examination has been submitted, the marketing authorisation shall remain valid until a decision on the application has been adopted by the competent authority or the Commission.

4.
     
  The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time, provided that the marketing authorisation holder submits the missing comprehensive safety and efficacy data referred to in Article 22(1).

Amendment 207

Proposal for a regulation

Article 88 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90. | 1.   By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90.
  Veterinary medicinal products registered or approved in accordance with national rules before 31 December 1993 shall not be affected by this Article. |

Text proposed by the Commission

Amendment

1.   By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90.

1.   By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90.
  Veterinary medicinal products registered or approved in accordance with national rules before 31 December 1993 shall not be affected by this Article.

Amendment 208

Proposal for a regulation

Article 88 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  The veterinary homeopathic medicinal products not subject to Article 89(1) shall be authorised in accordance with the general regulations. Where the safety tests, preclinical and clinical trials of veterinary homeopathic medicinal products are not subject to Article 89(1), a Member State may introduce or retain on its territory specific rules in accordance with the principles and characteristics as practised in that Member State. |

Text proposed by the Commission

Amendment

2a.
     
  The veterinary homeopathic medicinal products not subject to Article 89(1) shall be authorised in accordance with the general regulations. Where the safety tests, preclinical and clinical trials of veterinary homeopathic medicinal products are not subject to Article 89(1), a Member State may introduce or retain on its territory specific rules in accordance with the principles and characteristics as practised in that Member State.

Amendment 209

Proposal for a regulation

Article 89 — paragraph 1 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture; |

Text proposed by the Commission

Amendment

(b)

there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture;

| (b) | there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture
  , unless the ingredients of the medicinal product are included in Table 1 of Regulation (EU) No 37/2010 with the comment ‘No maximum residue level (MRL) required’; |
| --- | --- |

(b)

there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture
  , unless the ingredients of the medicinal product are included in Table 1 of Regulation (EU) No 37/2010 with the comment ‘No maximum residue level (MRL) required’;

Amendment 210

Proposal for a regulation

Article 90 — paragraph 1 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered; |

Text proposed by the Commission

Amendment

(a)

scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;

| (a) | scientific name or other name given in a pharmacopoeia
  or documented in a monograph
  of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered; |
| --- | --- |

(a)

scientific name or other name given in a pharmacopoeia
  or documented in a monograph
  of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;

Amendment 211

Proposal for a regulation

Article 91 — paragraph 1 — point b a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ba) | in addition to a manufacturing authorisation, the manufacturers in question shall be required to have proof and confirmation of compliance with good manufacturing practices (‘GMP’); |

Text proposed by the Commission

Amendment

(ba)

in addition to a manufacturing authorisation, the manufacturers in question shall be required to have proof and confirmation of compliance with good manufacturing practices (‘GMP’);

Amendment 212

Proposal for a regulation

Article 91 — paragraph 2 — subparagraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | A manufacturing authorisation shall also not be required for preparation, filling or changes in packaging or presentation where these processes are carried out solely for dispensing by pharmacists in a pharmacy or by veterinarians in a veterinary practice. |

Text proposed by the Commission

Amendment

A manufacturing authorisation shall also not be required for preparation, filling or changes in packaging or presentation where these processes are carried out solely for dispensing by pharmacists in a pharmacy or by veterinarians in a veterinary practice.

Amendment 302

Proposal for a regulation

Article 92 — paragraph 2 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested; |

Text proposed by the Commission

Amendment

(c)

details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested;

| (c) | details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested
  , including data about emissions, discharges and losses of the active substance and its precursors to the environment
  ; |
| --- | --- |

(c)

details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested
  , including data about emissions, discharges and losses of the active substance and its precursors to the environment
  ;

Amendment 213

Proposal for a regulation

Article 93 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 5.   A manufacturing authorisation may be granted conditionally, subject to a requirement for the applicant to
  undertake actions or introduce specific procedures
  within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with. | 5.   A manufacturing authorisation may be granted conditionally
  where minor shortcomings are identified
  , subject to a requirement for the applicant to
  rectify the shortcomings
  within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with.
  The manufacturing authorisation shall be refused if manufacturing causes unacceptable risks to the environment. |

Text proposed by the Commission

Amendment

5.   A manufacturing authorisation may be granted conditionally, subject to a requirement for the applicant to
  undertake actions or introduce specific procedures
  within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with.

5.   A manufacturing authorisation may be granted conditionally
  where minor shortcomings are identified
  , subject to a requirement for the applicant to
  rectify the shortcomings
  within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with.
  The manufacturing authorisation shall be refused if manufacturing causes unacceptable risks to the environment.

Amendment 214

Proposal for a regulation

Article 98 — paragraph 1 — point c a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ca) | comply with the rules on good manufacturing practice for medicinal products established in the Union and use as starting materials only active substances which have been manufactured in accordance with the rules on good manufacturing practice for starting materials established in the Union; |

Text proposed by the Commission

Amendment

(ca)

comply with the rules on good manufacturing practice for medicinal products established in the Union and use as starting materials only active substances which have been manufactured in accordance with the rules on good manufacturing practice for starting materials established in the Union;

Amendment 215

Proposal for a regulation

Article 104 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   
  Supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution. | 3.   
  The purchase, sale, import or export of veterinary medicinal products or any other kind of commercial transaction concerning these medicinal products, whether for profit or not for profit, shall be subject to the possession of a wholesale distribution authorisation for veterinary medicinal products. Such an authorisation shall not apply to the supply, by a manufacturer, of veterinary medicinal products which it has itself manufactured, nor to the retail sale of veterinary medicinal products by persons entitled to conduct such sales in accordance with Article 107. |

Text proposed by the Commission

Amendment

3.   
  Supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution.

3.   
  The purchase, sale, import or export of veterinary medicinal products or any other kind of commercial transaction concerning these medicinal products, whether for profit or not for profit, shall be subject to the possession of a wholesale distribution authorisation for veterinary medicinal products. Such an authorisation shall not apply to the supply, by a manufacturer, of veterinary medicinal products which it has itself manufactured, nor to the retail sale of veterinary medicinal products by persons entitled to conduct such sales in accordance with Article 107.

Amendment 216

Proposal for a regulation

Article 104 — paragraph 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4a.
     
  On the basis of the best practices model that already exists for medicinal products for human use, the Commission shall adopt, within 24 months of the entry into force of this Regulation, principles and guidelines, to which wholesalers shall be obliged to adhere, for best practices in the wholesale distribution of veterinary medicinal products. |

Text proposed by the Commission

Amendment

4a.
     
  On the basis of the best practices model that already exists for medicinal products for human use, the Commission shall adopt, within 24 months of the entry into force of this Regulation, principles and guidelines, to which wholesalers shall be obliged to adhere, for best practices in the wholesale distribution of veterinary medicinal products.

Amendment 217

Proposal for a regulation

Article 104 — paragraph 4 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4b
  .   
  Wholesalers shall obtain their supplies of medicinal products only from the manufacturer, a person designated by the holder of the marketing authorisation or from persons who themselves hold a wholesale distribution authorisation. |

Text proposed by the Commission

Amendment

4b
  .   
  Wholesalers shall obtain their supplies of medicinal products only from the manufacturer, a person designated by the holder of the marketing authorisation or from persons who themselves hold a wholesale distribution authorisation.

Amendment 218

Proposal for a regulation

Article 104 — paragraph 5 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 5a.
     
  Wholesalers shall comply with the obligations laid down in points (ca) and (cc) of Article 105(3) with regard to supply of medicinal products. |

Text proposed by the Commission

Amendment

5a.
     
  Wholesalers shall comply with the obligations laid down in points (ca) and (cc) of Article 105(3) with regard to supply of medicinal products.

Amendment 219

Proposal for a regulation

Article 105 — paragraph 3 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products; |

Text proposed by the Commission

Amendment

(a)

has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products;

| (a) | has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products
  , and which premises representatives of the competent authority may enter at any time
  ; |
| --- | --- |

(a)

has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products
  , and which premises representatives of the competent authority may enter at any time
  ;

Amendment 220

Proposal for a regulation

Article 105 — paragraph 3 — point c a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ca) | concerning the supply of medicinal products to persons permitted to carry out retail activities in the Member State in accordance with Article 107(1), is able to guarantee permanently an adequate range of medicinal products to meet the requirements of the territory being supplied and to deliver the supplies requested within a very short time over the whole of the territory in question; |

Text proposed by the Commission

Amendment

(ca)

concerning the supply of medicinal products to persons permitted to carry out retail activities in the Member State in accordance with Article 107(1), is able to guarantee permanently an adequate range of medicinal products to meet the requirements of the territory being supplied and to deliver the supplies requested within a very short time over the whole of the territory in question;

Amendment 221

Proposal for a regulation

Article 105 — paragraph 3 — point c b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (cb) | within the limits of his responsibility, ensure appropriate and continued supplies of medicinal products to persons authorised to carry out retail activities in the Member State in accordance with Article 107(1) so that animal health needs in the Member State in question are covered; |

Text proposed by the Commission

Amendment

(cb)

within the limits of his responsibility, ensure appropriate and continued supplies of medicinal products to persons authorised to carry out retail activities in the Member State in accordance with Article 107(1) so that animal health needs in the Member State in question are covered;

Amendment 222

Proposal for a regulation

Article 105 — paragraph 3 — point c c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (cc) | is able to notify the competent authority of any shortage of stock likely to be detrimental to animal health needs in the Member State in question. |

Text proposed by the Commission

Amendment

(cc)

is able to notify the competent authority of any shortage of stock likely to be detrimental to animal health needs in the Member State in question.

Amendment 223

Proposal for a regulation

Article 106 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 106a |
| | Qualified persons |
| | 1.
     
  The holder of a wholesale distribution authorisation shall make permanent and continuous use of the services of at least one qualified person satisfying the conditions set out in this Article, who shall be responsible, in particular, for performing the task specified in Article 104. |
| | 2.
     
  Qualified persons shall hold a diploma, certificate, or any other form of proof serving to demonstrate that they are properly qualified and have acquired sufficient experience of wholesale distribution. The holder of the authorisation may assume the responsibility referred to in paragraph 1, if that person personally fulfils those conditions as specified above. |
| | 3.
     
  The competent authority shall ensure that the obligations of qualified persons referred to in this Article are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct. The competent authority may temporarily suspend such persons upon the commencement of administrative or disciplinary proceedings against them for failure to fulfil their obligations. |

Text proposed by the Commission

Amendment

Article 106a

Qualified persons

1.
     
  The holder of a wholesale distribution authorisation shall make permanent and continuous use of the services of at least one qualified person satisfying the conditions set out in this Article, who shall be responsible, in particular, for performing the task specified in Article 104.

2.
     
  Qualified persons shall hold a diploma, certificate, or any other form of proof serving to demonstrate that they are properly qualified and have acquired sufficient experience of wholesale distribution. The holder of the authorisation may assume the responsibility referred to in paragraph 1, if that person personally fulfils those conditions as specified above.

3.
     
  The competent authority shall ensure that the obligations of qualified persons referred to in this Article are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct. The competent authority may temporarily suspend such persons upon the commencement of administrative or disciplinary proceedings against them for failure to fulfil their obligations.

Amendment 224

Proposal for a regulation

Article 107 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned. | 2.   Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their
  immediate
  care,
  subject to an appropriate veterinary diagnosis and examination of the animal(s) concerned,
  and only in the amount required for the treatment concerned
  . In the case of food-producing animals, the continuation of the treatment with antimicrobial products shall be decided based on a renewed clinical examination by a veterinarian. |

Text proposed by the Commission

Amendment

2.   Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.

2.   Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their
  immediate
  care,
  subject to an appropriate veterinary diagnosis and examination of the animal(s) concerned,
  and only in the amount required for the treatment concerned
  . In the case of food-producing animals, the continuation of the treatment with antimicrobial products shall be decided based on a renewed clinical examination by a veterinarian.

Amendment 225

Proposal for a regulation

Article 107 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  Member States may impose stricter conditions, justified on grounds of public health, animal health and environment protection, for the retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market. |

Text proposed by the Commission

Amendment

2a.
     
  Member States may impose stricter conditions, justified on grounds of public health, animal health and environment protection, for the retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.

Amendment 226

Proposal for a regulation

Article 107 — paragraph 2 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2b.
     
  Any commercial participation in companies which trade in, manufacture or import veterinary medicinal products shall be prohibited. |

Text proposed by the Commission

Amendment

2b.
     
  Any commercial participation in companies which trade in, manufacture or import veterinary medicinal products shall be prohibited.

Amendment 227

Proposal for a regulation

Article 107 — paragraph 2 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2c.
     
  Given the risks associated with antimicrobial resistance, no economic incentives may be provided in any form, directly or indirectly, by pharmaceutical companies to persons who prescribe veterinary medicinal products. |

Text proposed by the Commission

Amendment

2c.
     
  Given the risks associated with antimicrobial resistance, no economic incentives may be provided in any form, directly or indirectly, by pharmaceutical companies to persons who prescribe veterinary medicinal products.

Amendment 228

Proposal for a regulation

Article 107 — paragraph 3 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products: | 3.   Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products
  obtainable only on prescription
  : |

Text proposed by the Commission

Amendment

3.   Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products:

3.   Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products
  obtainable only on prescription
  :

Amendment 229

Proposal for a regulation

Article 107 — paragraph 3 — subparagraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Where they consider it necessary, Member States may require that the obligation to keep the above records likewise apply to the purchase and sale of non-prescription veterinary medicinal products. |

Text proposed by the Commission

Amendment

Where they consider it necessary, Member States may require that the obligation to keep the above records likewise apply to the purchase and sale of non-prescription veterinary medicinal products.

Amendment 230

Proposal for a regulation

Article 108

| Text proposed by the Commission | Amendment |
| --- | --- |
| Retail of veterinary medicinal products at a distance | Retail of veterinary medicinal products at a distance |
| 1.   Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products
  by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council

   (28) to natural or legal persons established in the Union under the condition that
  those medicinal products comply with the legislation of the destination Member State. | 1.   Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products,
  with the exception of antimicrobials, psychotropic and biological or immunological veterinary medicinal products, on the internet
  to natural or legal persons established in the Union under the condition that: |
| | (a) | the veterinary medicinal products and the prescriptions comply with the law of the destination Member State; |

Text proposed by the Commission

Amendment

Retail of veterinary medicinal products at a distance

Retail of veterinary medicinal products at a distance

1.   Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products
  by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council

   (28) to natural or legal persons established in the Union under the condition that
  those medicinal products comply with the legislation of the destination Member State.

1.   Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products,
  with the exception of antimicrobials, psychotropic and biological or immunological veterinary medicinal products, on the internet
  to natural or legal persons established in the Union under the condition that:

(a)

the veterinary medicinal products and the prescriptions comply with the law of the destination Member State;

| (b) | the natural or legal person offering veterinary medicinal products is permitted or qualified to supply prescription and non-prescription veterinary medicinal products to the public, including at a distance, in accordance with the national law of the Member State in which that person is established; |
| --- | --- |

(b)

the natural or legal person offering veterinary medicinal products is permitted or qualified to supply prescription and non-prescription veterinary medicinal products to the public, including at a distance, in accordance with the national law of the Member State in which that person is established;

| (c) | the person referred to in point (a) has notified at least the following information to the Member State of establishment: |
| --- | --- |

(c)

the person referred to in point (a) has notified at least the following information to the Member State of establishment:

| (i) | the name or corporate name and the permanent address of the place of business from where the veterinary medicinal products are supplied; |
| --- | --- |

(i)

the name or corporate name and the permanent address of the place of business from where the veterinary medicinal products are supplied;

| (ii) | the date on which veterinary medicinal products were first offered for sale at a distance to the public on the internet; |
| --- | --- |

(ii)

the date on which veterinary medicinal products were first offered for sale at a distance to the public on the internet;

| (iii) | the address of the website used for that purpose and all information necessary to identify that website. |
| --- | --- |

(iii)

the address of the website used for that purpose and all information necessary to identify that website.

1a.
     
  On grounds of public or animal health, animal welfare or environmental protection, Members States shall be able to limit or condition, or both, the sale at a distance on the internet to the public on their territory of veterinary medicinal products or of other prescription veterinary medicinal products for food producing animals.

2.   In addition to the information requirements set out in Article 6 of the Directive 2000/31/EC of the European Parliament and of the Council (29), websites offering veterinary medicinal products shall contain at least:

2.   In addition to the information requirements set out in Article 6 of the Directive 2000/31/EC of the European Parliament and of the Council (29)

  and Article 6 of Directive 2011/83/EU of the European Parliament and of the Council

   (29a), websites offering veterinary medicinal products shall contain at least:

| (a) | the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established; |
| --- | --- |

(a)

the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;

| (a) | the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established; |
| --- | --- |

(a)

the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;

| (b) | a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5; |
| --- | --- |

(b)

a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5;

| (b) | a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5; |
| --- | --- |

(b)

a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5;

| (c) | the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5. |
| --- | --- |

(c)

the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5.

| (c) | the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5. |
| --- | --- |

(c)

the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5.

3.   A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering veterinary medicinal products for sale at a distance to the public is established. The logo shall be clearly displayed on websites offering veterinary medicinal products for sale at a distance.

3.   A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering veterinary medicinal products for sale at a distance to the public is established. The logo shall be clearly displayed on websites offering veterinary medicinal products for sale at a distance.

4.   The Commission shall adopt the design of the common logo by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

4.   The Commission shall adopt the design of the common logo by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

5.   Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information:

5.   Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information:

| (a) | information on its national legislation applicable to the offering of veterinary medicinal products for sale at a distance
  to the public by means of information society services,
  including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products; |
| --- | --- |

(a)

information on its national legislation applicable to the offering of veterinary medicinal products for sale at a distance
  to the public by means of information society services,
  including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;

| (a) | information on its national legislation applicable to the offering of veterinary medicinal products for sale at a distance
  on the internet
  , including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products; |
| --- | --- |

(a)

information on its national legislation applicable to the offering of veterinary medicinal products for sale at a distance
  on the internet
  , including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;

| (b) | information on the common logo; |
| --- | --- |

(b)

information on the common logo;

| (b) | information on the common logo; |
| --- | --- |

(b)

information on the common logo;

| (c) | a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public
  by means of information society services
  in accordance with paragraph 1 as well as the website addresses of those retailers. |
| --- | --- |

(c)

a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public
  by means of information society services
  in accordance with paragraph 1 as well as the website addresses of those retailers.

| (c) | a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public
  on the internet
  in accordance with paragraph 1 as well as the website addresses of those retailers
  ; and also a hyperlink to the website of the Agency set up in accordance with paragraph 6; |
| --- | --- |

(c)

a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public
  on the internet
  in accordance with paragraph 1 as well as the website addresses of those retailers
  ; and also a hyperlink to the website of the Agency set up in accordance with paragraph 6;

| (ca) | information on applicable procedures for the safe disposal of medicinal products, specifying the public or private body responsible at national or local level for the disposal of veterinary medicine residues and the collection points for disposal free of charge; |
| --- | --- |

(ca)

information on applicable procedures for the safe disposal of medicinal products, specifying the public or private body responsible at national or local level for the disposal of veterinary medicine residues and the collection points for disposal free of charge;

| (cb) | hyperlinks to the web pages of the bodies responsible in Member States for listing authorised national retailers. |
| --- | --- |

(cb)

hyperlinks to the web pages of the bodies responsible in Member States for listing authorised national retailers.

The websites set up by Member States shall contain a hyperlink to the website of the Agency set up in accordance with paragraph 6.

6.   The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public
  by means of information society services
  in the Member State concerned.

6.   The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public
  on the internet
  in the Member State concerned.
  The Agency’s website shall be linked to the web pages of the appropriate Member State bodies which list authorised retailers in Member States.

7.
     
  Members States may impose conditions, justified on grounds of public health protection, for the retail on their territory of medicinal products offered for sale at a distance to the public by means of information society services.

7a.
     
  Member States shall take the measures necessary to ensure that persons other than those referred to in paragraph 1 offering veterinary medicinal products for sale at a distance to the public on the internet and operating on their territory are subject to effective, proportionate, and dissuasive penalties in case of abuse or illegal practice, or the failure to act according to their professional code of conduct.

7b.
     
  No later than (six) months after the date of application of this Regulation, the Commission shall adopt guidelines supporting the Member States in the development of a harmonized system of digital prescription across the Union, including measures for controlling cross-border veterinary prescriptions.

7c.
     
  On the basis of the guidelines referred to in paragraph 7b, Member States shall be encouraged to develop a system of digital prescription at national level, to include measures for the delivery and control of prescriptions. Member States shall also be encouraged to set up a system to facilitate the e-submission of prescriptions by means of a national database, directly linked to all pharmacies (both shop and internet ones), national competent authorities and veterinarians.

Amendment 231

Proposal for a regulation

Article 109 — title

| Text proposed by the Commission | Amendment |
| --- | --- |
| Retail of anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic
  veterinary medicinal products | Retail
  only
  of
  medicinal products which are subject to prescription, or active substances, with
  anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal,
  immunological
  or psychotropic
  properties |

Text proposed by the Commission

Amendment

Retail of anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic
  veterinary medicinal products

Retail
  only
  of
  medicinal products which are subject to prescription, or active substances, with
  anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal,
  immunological
  or psychotropic
  properties

Amendment 232

Proposal for a regulation

Article 109 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Only manufacturers, wholesale distributors and retailers authorised
  specifically
  to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties. | 1.   Only manufacturers, wholesale distributors and retailers authorised to do so in accordance with applicable national law shall be allowed to supply and purchase
  prescription only
  veterinary medicinal products which have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal
  , immunological
  or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
  In the case of non-food producing animals (i.e. companion and small animals) all retailers, ranging from supermarkets, pet stores, to traditional and online (veterinary) pharmacies, shall be allowed to sell anti-parasitic and anti-inflammatory products, without the need to be specifically authorised to do so. |

Text proposed by the Commission

Amendment

1.   Only manufacturers, wholesale distributors and retailers authorised
  specifically
  to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.

1.   Only manufacturers, wholesale distributors and retailers authorised to do so in accordance with applicable national law shall be allowed to supply and purchase
  prescription only
  veterinary medicinal products which have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal
  , immunological
  or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
  In the case of non-food producing animals (i.e. companion and small animals) all retailers, ranging from supermarkets, pet stores, to traditional and online (veterinary) pharmacies, shall be allowed to sell anti-parasitic and anti-inflammatory products, without the need to be specifically authorised to do so.

Amendment 233

Proposal for a regulation

Article 109 — paragraph 3 — subparagraph 1 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction: | 3.   Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction
  of prescription for veterinary medicinal products
  : |

Text proposed by the Commission

Amendment

3.   Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction:

3.   Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction
  of prescription for veterinary medicinal products
  :

Amendment 234

Proposal for a regulation

Article 109 — paragraph 3 — subparagraph 1 — point d

| Text proposed by the Commission | Amendment |
| --- | --- |
| (d) | name and address of the supplier in the event of purchase
  , or of the recipient in the event of sale
  . |

Text proposed by the Commission

Amendment

(d)

name and address of the supplier in the event of purchase
  , or of the recipient in the event of sale
  .

| (d) | name and address of the supplier in the event of purchase. |
| --- | --- |

(d)

name and address of the supplier in the event of purchase.

Amendment 235

Proposal for a regulation

Article 110

| Text proposed by the Commission | Amendment |
| --- | --- |
| Veterinary prescriptions | Veterinary prescriptions |
| 1.   A veterinary prescription shall contain at least the following elements (‘minimum requirements’): | 1.   A veterinary prescription shall contain at least the following elements (‘minimum requirements’): |
| (a) | identification of the animal under treatment; |

Text proposed by the Commission

Amendment

Veterinary prescriptions

Veterinary prescriptions

1.   A veterinary prescription shall contain at least the following elements (‘minimum requirements’):

1.   A veterinary prescription shall contain at least the following elements (‘minimum requirements’):

(a)

identification of the animal under treatment;

| (a) | identification of the animal
  or class of animal
  under treatment
  and the condition which is being treated; |
| --- | --- |

(a)

identification of the animal
  or class of animal
  under treatment
  and the condition which is being treated;

| (b) | full name and contact details of the animal owner or keeper; |
| --- | --- |

(b)

full name and contact details of the animal owner or keeper;

| (b) | full name and contact details of the animal owner or keeper; |
| --- | --- |

(b)

full name and contact details of the animal owner or keeper;

| (c) | issue date; |
| --- | --- |

(c)

issue date;

| (c) | issue date; |
| --- | --- |

(c)

issue date;

| (d) | full name and contact details, qualifications and professional membership number of the person writing the prescription; |
| --- | --- |

(d)

full name and contact details, qualifications and professional membership number of the person writing the prescription;

| (d) | full name and contact details, qualifications and professional membership number of the person writing the prescription; |
| --- | --- |

(d)

full name and contact details, qualifications and professional membership number of the person writing the prescription;

| (e) | signature or an equivalent electronic form of identification of the person
  writing
  the prescription; |
| --- | --- |

(e)

signature or an equivalent electronic form of identification of the person
  writing
  the prescription;

| (e) | signature or an equivalent electronic form of identification of the person
  issuing
  the prescription; |
| --- | --- |

(e)

signature or an equivalent electronic form of identification of the person
  issuing
  the prescription;

| (f) | name of the prescribed product; |
| --- | --- |

(f)

name of the prescribed product;

| (f) | name of the prescribed product
  and the active substance(s); |
| --- | --- |

(f)

name of the prescribed product
  and the active substance(s);

| (g) | pharmaceutical form (tablet, solution, etc.); |
| --- | --- |

(g)

pharmaceutical form (tablet, solution, etc.);

| (g) | pharmaceutical form (tablet, solution, etc.); |
| --- | --- |

(g)

pharmaceutical form (tablet, solution, etc.);

| (h) | quantity; |
| --- | --- |

(h)

quantity;

| (h) | quantity
  and in cases where the treatment has to be repeated, it shall also contain the number of times it can be repeated; |
| --- | --- |

(h)

quantity
  and in cases where the treatment has to be repeated, it shall also contain the number of times it can be repeated;

| (i) | strength; |
| --- | --- |

(i)

strength;

| (i) | strength; |
| --- | --- |

(i)

strength;

| (j) | dosage regimen; |
| --- | --- |

(j)

dosage regimen;

| (j) | dosage regimen; |
| --- | --- |

(j)

dosage regimen;

| (k) | withdrawal period if relevant; |
| --- | --- |

(k)

withdrawal period if relevant;

| (k) | withdrawal period if relevant; |
| --- | --- |

(k)

withdrawal period if relevant;

| (l) | any necessary warnings; |
| --- | --- |

(l)

any necessary warnings;

| (l) | any necessary warnings
  and restrictions, including, where relevant, the risks entailed by imprudent use of antimicrobials; |
| --- | --- |

(l)

any necessary warnings
  and restrictions, including, where relevant, the risks entailed by imprudent use of antimicrobials;

| (m) | if a product is prescribed for a condition not mentioned in the marketing authorisation for that product, a statement to that effect. |
| --- | --- |

(m)

if a product is prescribed for a condition not mentioned in the marketing authorisation for that product, a statement to that effect.

| (m) | if a product is prescribed for a condition not mentioned in the marketing authorisation for that product, a statement to that effect; |
| --- | --- |

(m)

if a product is prescribed for a condition not mentioned in the marketing authorisation for that product, a statement to that effect;

| (ma) | period of validity of prescription. |
| --- | --- |

(ma)

period of validity of prescription.

2.   A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law.

2.   A veterinary prescription shall only be issued by a 
  veterinarian or other
  person qualified to do so in accordance with applicable national law
  , following a proper assessment of the health status of the animal concerned
  .

2a.
     
  A veterinary prescription of a veterinary medicinal product which has anabolic, anti-inflammatory, anti-infectious (other than anthelmintic), anti-cancer, hormonal or psychotropic properties or substances shall only be issued by a veterinarian after a clinical examination and diagnosis.

3.   Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned.

3.   Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned.
  The maximum quantity of veterinary medicinal products supplied at one time shall not, however, exceed one month's treatment. For chronic diseases and for periodic treatments the maximum quantity shall not exceed three month's treatment.

4.   Veterinary prescriptions shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.

4.   Veterinary prescriptions
  issued by a veterinarian
  shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.

Those provisions shall not apply to prescriptions issued under the exceptional circumstances set out in Articles 115 and 116. Those Member States that recognise prescriptions in their national systems issued by any person other than a veterinarian shall immediately notify the Commission, which shall forward such information to all Member States.

Amendment 236

Proposal for a regulation

Article 110 — paragraph 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4a.
     
  The removal of regulatory and administrative barriers to such recognition shall not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription. |

Text proposed by the Commission

Amendment

4a.
     
  The removal of regulatory and administrative barriers to such recognition shall not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.

Amendment 237

Proposal for a regulation

Article 111 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation. | 1.   Veterinary medicinal products shall be used
  responsibly
  in accordance
  with the principle of good animal husbandry and
  with the terms of the marketing authorisation
  or registration when no marketing authorisation is required. |

Text proposed by the Commission

Amendment

1.   Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation.

1.   Veterinary medicinal products shall be used
  responsibly
  in accordance
  with the principle of good animal husbandry and
  with the terms of the marketing authorisation
  or registration when no marketing authorisation is required.

Amendment 238

Proposal for a regulation

Article 111 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  Antimicrobial veterinary medicines shall not under any circumstances serve to improve performance or compensate for poor animal husbandry. Routine prophylactic use of antimicrobials is therefore prohibited. Prophylactic use of antimicrobial veterinary medicines shall only be permitted on single animals and when fully justified by a veterinarian in exceptional indications, of which a list shall be drafted by the Agency. |
| | Metaphylactic use of antimicrobial veterinary medicines shall be restricted to use in clinicall-ill animals and to those single animals that are identified as being at a high risk of contamination, to prevent further spread of the disease in the group. Where such products are to be used for non-routine metaphylaxis, owners and keepers of food-producing animals shall ensure that they have a health plan specifying appropriate non-medical measures to reduce the need to resort to metaphylactic use in the future. Moreover, they shall be required to comply with the following measures: |
| | (i) | using good healthy breeding stock with suitable genetic diversity; |

Text proposed by the Commission

Amendment

2a.
     
  Antimicrobial veterinary medicines shall not under any circumstances serve to improve performance or compensate for poor animal husbandry. Routine prophylactic use of antimicrobials is therefore prohibited. Prophylactic use of antimicrobial veterinary medicines shall only be permitted on single animals and when fully justified by a veterinarian in exceptional indications, of which a list shall be drafted by the Agency.

Metaphylactic use of antimicrobial veterinary medicines shall be restricted to use in clinicall-ill animals and to those single animals that are identified as being at a high risk of contamination, to prevent further spread of the disease in the group. Where such products are to be used for non-routine metaphylaxis, owners and keepers of food-producing animals shall ensure that they have a health plan specifying appropriate non-medical measures to reduce the need to resort to metaphylactic use in the future. Moreover, they shall be required to comply with the following measures:

(i)

using good healthy breeding stock with suitable genetic diversity;

| (ii) | conditions that respect the behavioural needs of the species, including social interactions/hierarchies; |
| --- | --- |

(ii)

conditions that respect the behavioural needs of the species, including social interactions/hierarchies;

| (iii) | stocking densities that do not increase risk of disease transmission; |
| --- | --- |

(iii)

stocking densities that do not increase risk of disease transmission;

| (iv) | isolation of sick animals away from the rest of the group; |
| --- | --- |

(iv)

isolation of sick animals away from the rest of the group;

| (v) | for chickens and smaller animals, subdivision of flocks into smaller, physically separated groups; |
| --- | --- |

(v)

for chickens and smaller animals, subdivision of flocks into smaller, physically separated groups;

| (vi) | implementation of existing animal welfare rules already in cross compliance under the Common Agricultural Policy's horizontal Regulation (EU) nr. 1306/2013, Annex II, SMRs 11, 12, 13. |
| --- | --- |

(vi)

implementation of existing animal welfare rules already in cross compliance under the Common Agricultural Policy's horizontal Regulation (EU) nr. 1306/2013, Annex II, SMRs 11, 12, 13.

(Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23) Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33), Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28))

Amendment 239

Proposal for a regulation

Article 111 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 111a |
| | Supply and use of antimicrobials |
| | 1.
     
  Member States may restrict or prohibit the supply or use, or both, of certain antimicrobials in animals on their territory if either of the following conditions is fulfilled: |
| | (a) | the antimicrobials are critically important for use in humans; or |

Text proposed by the Commission

Amendment

Article 111a

Supply and use of antimicrobials

1.
     
  Member States may restrict or prohibit the supply or use, or both, of certain antimicrobials in animals on their territory if either of the following conditions is fulfilled:

(a)

the antimicrobials are critically important for use in humans; or

| (b) | the administration of antimicrobials to animals is contradictory to the implementation of a national policy on prudent use of antimicrobials and that the policy is in line with the precautionary principle. |
| --- | --- |

(b)

the administration of antimicrobials to animals is contradictory to the implementation of a national policy on prudent use of antimicrobials and that the policy is in line with the precautionary principle.

2.
     
  Before adopting measures referred to in paragraph 1, the Member State shall ensure that relevant stakeholders have been consulted.

3.
     
  Measures adopted by Member States on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of protection of animal and public health.

4.
     
  A Member State adopting a measure on the basis of paragraph 1 shall inform the Commission thereof.

Amendment 240

Proposal for a regulation

Article 112 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Owners or, where the animals are not kept by the owners, keepers of food-producing animals shall keep records of the veterinary medicinal products they use and, if applicable, a copy of the veterinary prescription. | 1.   Owners or, where the animals are not kept by the owners, keepers of food-producing animals shall keep records of the
  veterinarian-prescribed
  veterinary medicinal products
  and veterinary medicinal products with a withdrawal period higher than nil
  they use and, if applicable, a copy of the veterinary prescription. |

Text proposed by the Commission

Amendment

1.   Owners or, where the animals are not kept by the owners, keepers of food-producing animals shall keep records of the veterinary medicinal products they use and, if applicable, a copy of the veterinary prescription.

1.   Owners or, where the animals are not kept by the owners, keepers of food-producing animals shall keep records of the
  veterinarian-prescribed
  veterinary medicinal products
  and veterinary medicinal products with a withdrawal period higher than nil
  they use and, if applicable, a copy of the veterinary prescription.

Amendment 241

Proposal for a regulation

Article 112 — paragraph 2 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | date of administering the veterinary medicinal product to the animal; |

Text proposed by the Commission

Amendment

(a)

date of administering the veterinary medicinal product to the animal;

| (a) | date of administering the veterinary medicinal product to the animal
  and the disease treated
  ; |
| --- | --- |

(a)

date of administering the veterinary medicinal product to the animal
  and the disease treated
  ;

Amendment 242

Proposal for a regulation

Article 112 — paragraph 2 — point d

| Text proposed by the Commission | Amendment |
| --- | --- |
| (d) | name and address of the supplier; |

Text proposed by the Commission

Amendment

(d)

name and address of the supplier;

| (d) | name and address of the supplier
  and, if applicable, a copy of the delivery note
  ; |
| --- | --- |

(d)

name and address of the supplier
  and, if applicable, a copy of the delivery note
  ;

Amendment 243

Proposal for a regulation

Article 112 — paragraph 2 — point e

| Text proposed by the Commission | Amendment |
| --- | --- |
| (e) | identification of the animals treated; |

Text proposed by the Commission

Amendment

(e)

identification of the animals treated;

| (e) | identification of the animals treated
  and the diagnosis of the disease treated
  ; |
| --- | --- |

(e)

identification of the animals treated
  and the diagnosis of the disease treated
  ;

Amendment 244

Proposal for a regulation

Article 112 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  Particulars already contained in the prescription or in a delivery note shall not need to be recorded again if a clear reference can be made to the corresponding prescription and delivery note. |

Text proposed by the Commission

Amendment

2a.
     
  Particulars already contained in the prescription or in a delivery note shall not need to be recorded again if a clear reference can be made to the corresponding prescription and delivery note.

Amendment 245

Proposal for a regulation

Article 112 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 112a |
| | Examination of therapy frequency |
| | 1.
     
  The national competent authority shall identify on the basis of the numbers determined under Article 112, for each half year, the average number of treatments with antibacterial effective substances and the treatment frequency following a standard European key, based on the particular business and the particular type of animals kept, taking into account the type of use. |
| | 2.
     
  The competent national authority shall inform the farmer in accordance with paragraph 1 about the biannual therapy frequency for the particular species of animals held by him in consideration of their type of use. |
| | 3.
     
  The information collected under paragraph 1 by the national competent authority are evaluated by the Commission and compared throughout the Union. |
| | 4.
     
  Member States may request data beyond. |

Text proposed by the Commission

Amendment

Article 112a

Examination of therapy frequency

1.
     
  The national competent authority shall identify on the basis of the numbers determined under Article 112, for each half year, the average number of treatments with antibacterial effective substances and the treatment frequency following a standard European key, based on the particular business and the particular type of animals kept, taking into account the type of use.

2.
     
  The competent national authority shall inform the farmer in accordance with paragraph 1 about the biannual therapy frequency for the particular species of animals held by him in consideration of their type of use.

3.
     
  The information collected under paragraph 1 by the national competent authority are evaluated by the Commission and compared throughout the Union.

4.
     
  Member States may request data beyond.

Amendment 246

Proposal for a regulation

Article 112 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 112b |
| | Reduction of therapy approaches based on antibacterial substances |
| | 1.
     
  In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry shall: |
| | (a) | determine, respectively, two months after the disclosure of the key figures in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence; |

Text proposed by the Commission

Amendment

Article 112b

Reduction of therapy approaches based on antibacterial substances

1.
     
  In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry shall:

(a)

determine, respectively, two months after the disclosure of the key figures in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence;

| (b) | take immediate record of the results of the assessment under point 1. |
| --- | --- |

(b)

take immediate record of the results of the assessment under point 1.

2.
     
  In a case where the operational, biannual therapy prevalence of the animal husbandman with respect to his business lies above the biannual average, the animal husbandman under consultation of a veterinarian has to assess the reasons that may have led to exceeding the average, and how the treatment of his cattle with pharmaceuticals containing antibacterial substances may be decreased.

If the assessment of the animal husbandman comes to the result that a therapy by means of the concerned pharmaceuticals may be reduced, the husbandman shall take all necessary steps in order to accomplish the reduction. The husbandman shall consider the wellbeing of his cattle and guarantee the required medical care.

3.
     
  Member States may determine measures extending beyond the above mentioned requirements.

Amendment 247

Proposal for a regulation

Article 115 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in
  particular to avoid causing unacceptable suffering
  , exceptionally treat the animal concerned with the following: | 1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in
  the interest of animal health and welfare
  , exceptionally treat the animal concerned with the following,
  in descending order of preference
  : |
| (a) | a
  medicinal product: |

Text proposed by the Commission

Amendment

1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in
  particular to avoid causing unacceptable suffering
  , exceptionally treat the animal concerned with the following:

1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in
  the interest of animal health and welfare
  , exceptionally treat the animal concerned with the following,
  in descending order of preference
  :

(a)

a
  medicinal product:

| (a) | any veterinary
  medicinal product
  authorised under this Regulation with the exception of antimicrobial products used as routine prophylactic measure, unless specifically authorised by the Committee for Medicinal Products for Veterinary Use; |
| --- | --- |

(a)

any veterinary
  medicinal product
  authorised under this Regulation with the exception of antimicrobial products used as routine prophylactic measure, unless specifically authorised by the Committee for Medicinal Products for Veterinary Use;

| (i) | a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another animal species, or for another condition in the same species; |
| --- | --- |

(i)

a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another animal species, or for another condition in the same species;

| (ii) | a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another species, for the same condition or for another condition; |
| --- | --- |

(ii)

a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another species, for the same condition or for another condition;

| (iii) | a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council

   (30)

  or Regulation (EC) No 726/2004; |
| --- | --- |

(iii)

a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council

   (30)

  or Regulation (EC) No 726/2004;

| (b) | if there is no product as referred to in point (a),
  a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation. |
| --- | --- |

(b)

if there is no product as referred to in point (a),
  a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.

| (b) | if there is no product as referred to in point (a): |
| --- | --- |

(b)

if there is no product as referred to in point (a):

| | (i) | a medicinal product for human use authorised in the Member State concerned or another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council

   (30)

  or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed subject to the issuing of a prescription by a veterinarian and the approval by the veterinary authority responsible for monitoring the work of the veterinarian in question; |
| --- | --- | --- |

(i)

a medicinal product for human use authorised in the Member State concerned or another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council

   (30)

  or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed subject to the issuing of a prescription by a veterinarian and the approval by the veterinary authority responsible for monitoring the work of the veterinarian in question;

| (ii) | a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national law. |
| --- | --- |

(ii)

a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national law.

Amendment 303

Proposal for a regulation

Article 115 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1a.
     
  By way of derogation from paragraph 1, homeopathic medicinal products may be administered to non-food producing animals. |

Text proposed by the Commission

Amendment

1a.
     
  By way of derogation from paragraph 1, homeopathic medicinal products may be administered to non-food producing animals.

Amendment 249

Proposal for a regulation

Article 116 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in
  particular to avoid causing unacceptable suffering
  , exceptionally treat the animal concerned with
  any of
  the following: | 1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in
  the interest of animal health and welfare
  , exceptionally treat the animal concerned with the following
  , in descending order of preference
  : |
| (a) | a
  veterinary medicinal product authorised under this Regulation
  in the Member State concerned for use with another food-producing animal species, or for another condition in the same species
  ; |

Text proposed by the Commission

Amendment

1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in
  particular to avoid causing unacceptable suffering
  , exceptionally treat the animal concerned with
  any of
  the following:

1.   By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in
  the interest of animal health and welfare
  , exceptionally treat the animal concerned with the following
  , in descending order of preference
  :

(a)

a
  veterinary medicinal product authorised under this Regulation
  in the Member State concerned for use with another food-producing animal species, or for another condition in the same species
  ;

| (a) | any
  veterinary medicinal product authorised under this Regulation
  with the exception of antimicrobial products used prophylactically in an individual or a group where there is no diagnosis of disease in any of the animals; |
| --- | --- |

(a)

any
  veterinary medicinal product authorised under this Regulation
  with the exception of antimicrobial products used prophylactically in an individual or a group where there is no diagnosis of disease in any of the animals;

| (b) | a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another food-producing species for the same condition or for another condition; |
| --- | --- |

(b)

a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another food-producing species for the same condition or for another condition;

| (ba) | if there is no product as referred to in point (a): |
| --- | --- |

(ba)

if there is no product as referred to in point (a):

| (c) | a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or |
| --- | --- |

(c)

a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or

| (d) | if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation. |
| --- | --- |

(d)

if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.

| (i) | a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may be employed subject to the issuing of a prescription by a veterinarian and the approval by the veterinary authority responsible for monitoring the work of the veterinarian in question and treatment with a veterinary medicinal product as referred to in point (a) or point (ba) is not possible; or |
| --- | --- |

(i)

a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may be employed subject to the issuing of a prescription by a veterinarian and the approval by the veterinary authority responsible for monitoring the work of the veterinarian in question and treatment with a veterinary medicinal product as referred to in point (a) or point (ba) is not possible; or

| (ii) | a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription issued by a person authorised to do so under national law. |
| --- | --- |

(ii)

a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription issued by a person authorised to do so under national law.

Amendment 251

Proposal for a regulation

Article 116 — paragraph 2 — point b a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ba) | veterinary medicinal products authorised under this Regulation in another Member State for use in the same aquatic species or in another food-producing aquatic species for the condition in question or for another condition. |

Text proposed by the Commission

Amendment

(ba)

veterinary medicinal products authorised under this Regulation in another Member State for use in the same aquatic species or in another food-producing aquatic species for the condition in question or for another condition.

Amendment 252

Proposal for a regulation

Article 116 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   By way of derogation from paragraph 2, and until an implementing act referred to in paragraph 4 is established, if there is no product as referred to in subparagraphs (a) and (b) of paragraph 2, a veterinarian may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing animals of an aquatic species on a particular holding with: | 3.   By way of derogation from paragraph 2, and until an implementing act referred to in paragraph 4 is established, if there is no product as referred to in subparagraphs (a) and (b) of paragraph 2, a veterinarian may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing animals of an aquatic species on a particular holding with: |
| (a) | a veterinary medicinal product authorised under this Regulation in the Member State concerned or in another Member State for use with a food-producing non-aquatic species; |

Text proposed by the Commission

Amendment

3.   By way of derogation from paragraph 2, and until an implementing act referred to in paragraph 4 is established, if there is no product as referred to in subparagraphs (a) and (b) of paragraph 2, a veterinarian may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing animals of an aquatic species on a particular holding with:

3.   By way of derogation from paragraph 2, and until an implementing act referred to in paragraph 4 is established, if there is no product as referred to in subparagraphs (a) and (b) of paragraph 2, a veterinarian may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing animals of an aquatic species on a particular holding with:

(a)

a veterinary medicinal product authorised under this Regulation in the Member State concerned or in another Member State for use with a food-producing non-aquatic species;

| (a) | a veterinary medicinal product authorised under this Regulation in the Member State concerned or in another Member State for use with a food-producing non-aquatic species;
  or |
| --- | --- |

(a)

a veterinary medicinal product authorised under this Regulation in the Member State concerned or in another Member State for use with a food-producing non-aquatic species;
  or

| (b) | a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004. |
| --- | --- |

(b)

a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004.

| (b) | if there is no product as referred to in point (a),
  a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004. |
| --- | --- |

(b)

if there is no product as referred to in point (a),
  a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004.

Amendment 304

Proposal for a regulation

Article 116 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  By way of derogation from paragraphs 1 to 3, homeopathic medicinal products may be administered to treat food-producing animals under the responsibility of the veterinarian provided that they contain only active ingredients listed in Table 1 of the Annex to Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set. |

Text proposed by the Commission

Amendment

3a.
     
  By way of derogation from paragraphs 1 to 3, homeopathic medicinal products may be administered to treat food-producing animals under the responsibility of the veterinarian provided that they contain only active ingredients listed in Table 1 of the Annex to Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.

Amendment 255

Proposal for a regulation

Article 116 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6.   Pharmacologically active substances included in the medicinal product used in accordance with paragraph 1 shall be listed in Table 1 of the Annex to Regulation (EU) No 37/2010. The veterinarian shall specify an appropriate withdrawal period in accordance with Article 117. | 6.   Pharmacologically active substances included in the medicinal product used in accordance with paragraph 1
  and paragraph 3(b)
  shall be listed in Table 1 of the Annex to Regulation (EU) No 37/2010. The veterinarian shall specify an appropriate withdrawal period in accordance with Article 117. |

Text proposed by the Commission

Amendment

6.   Pharmacologically active substances included in the medicinal product used in accordance with paragraph 1 shall be listed in Table 1 of the Annex to Regulation (EU) No 37/2010. The veterinarian shall specify an appropriate withdrawal period in accordance with Article 117.

6.   Pharmacologically active substances included in the medicinal product used in accordance with paragraph 1
  and paragraph 3(b)
  shall be listed in Table 1 of the Annex to Regulation (EU) No 37/2010. The veterinarian shall specify an appropriate withdrawal period in accordance with Article 117.

Amendment 256

Proposal for a regulation

Article 117 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   
  With regard to
  homeopathic veterinary medicinal products
  the withdrawal period shall be established at zero days
  . | 4.   
  The withdrawal period shall be established at zero days for
  homeopathic veterinary medicinal products
  containing solely active substances listed in Table 1 of Regulation (EU) No 37/2010 with the classification ‘No maximum residue level (MRL) required’. |

Text proposed by the Commission

Amendment

4.   
  With regard to
  homeopathic veterinary medicinal products
  the withdrawal period shall be established at zero days
  .

4.   
  The withdrawal period shall be established at zero days for
  homeopathic veterinary medicinal products
  containing solely active substances listed in Table 1 of Regulation (EU) No 37/2010 with the classification ‘No maximum residue level (MRL) required’.

Amendment 257

Proposal for a regulation

Article 117 — paragraph 5 — subparagraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Data on the use of antibiotics outside the terms of authorisation shall be collected and mandatorily reported to national authorities in accordance with Article 54. |

Text proposed by the Commission

Amendment

Data on the use of antibiotics outside the terms of authorisation shall be collected and mandatorily reported to national authorities in accordance with Article 54.

Amendment 258

Proposal for a regulation

Article 118 — title

| Text proposed by the Commission | Amendment |
| --- | --- |
| Use of antimicrobial
  veterinary medicinal products
  for species or indications outside the terms of the marketing authorisation | Use of antimicrobial
  substances
  for species or indications outside the terms of the marketing authorisation |

Text proposed by the Commission

Amendment

Use of antimicrobial
  veterinary medicinal products
  for species or indications outside the terms of the marketing authorisation

Use of antimicrobial
  substances
  for species or indications outside the terms of the marketing authorisation

Amendment 259

Proposal for a regulation

Article 118 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health. | 1.   Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health.
  Articles 115 and 116 do not apply to critically important antimicrobials as referred to in Article 32(2). |

Text proposed by the Commission

Amendment

1.   Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health.

1.   Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health.
  Articles 115 and 116 do not apply to critically important antimicrobials as referred to in Article 32(2).

Amendment 260

Proposal for a regulation

Article 118 — paragraph 2 — subparagraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The Commission
  may
  , by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial
  medicinal products
  that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions. | 2.   The Commission
  shall
  , by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial
  substances or groups of substances
  that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions. |

Text proposed by the Commission

Amendment

2.   The Commission
  may
  , by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial
  medicinal products
  that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions.

2.   The Commission
  shall
  , by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial
  substances or groups of substances
  that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions.

Amendment 261

Proposal for a regulation

Article 118 — paragraph 2 — subparagraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The principles to be used to establish the list of antimicrobials to be restricted in veterinary medicine shall not interfere with or deter Member States from prohibiting the use of certain antimicrobials in some species if they deem it appropriate. |

Text proposed by the Commission

Amendment

The principles to be used to establish the list of antimicrobials to be restricted in veterinary medicine shall not interfere with or deter Member States from prohibiting the use of certain antimicrobials in some species if they deem it appropriate.

Amendment 262

Proposal for a regulation

Article 118 — paragraph 2 — subparagraph 2 — point a

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | risks to public health if the antimicrobial product is used in accordance with paragraph 1; |

Text proposed by the Commission

Amendment

(a)

risks to public health if the antimicrobial product is used in accordance with paragraph 1;

| (a) | risks to public health if the antimicrobial product is used in accordance with paragraph 1
  , including the risks involved in using antimicrobials critical to human health in food producing animals
  ; |
| --- | --- |

(a)

risks to public health if the antimicrobial product is used in accordance with paragraph 1
  , including the risks involved in using antimicrobials critical to human health in food producing animals
  ;

Amendment 263

Proposal for a regulation

Article 118 — paragraph 2 — subparagraph 2 — point c a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ca) | availability of other farming methods that could prevent the outbreak of the disease; |

Text proposed by the Commission

Amendment

(ca)

availability of other farming methods that could prevent the outbreak of the disease;

Amendment 264

Proposal for a regulation

Article 118 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2a.
     
  Third countries with laws that authorise the use of antimicrobial medicinal products on the list referred to in paragraph 2 under different conditions from those laid down in that paragraph may not appear on any of the lists of third countries provided for under Union law from which Member States are authorised to import farm or aquaculture animals or meat or products obtained from such animals. |

Text proposed by the Commission

Amendment

2a.
     
  Third countries with laws that authorise the use of antimicrobial medicinal products on the list referred to in paragraph 2 under different conditions from those laid down in that paragraph may not appear on any of the lists of third countries provided for under Union law from which Member States are authorised to import farm or aquaculture animals or meat or products obtained from such animals.

Amendment 265

Proposal for a regulation

Article 118 — paragraph 2 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2b.
     
  Member States shall also prohibit the importation from third countries on any of the lists referred to in paragraph 2a of: |
| | (a) | farm or aquaculture animals to which substances on the list referred to in paragraph 2 have been administered, unless those substances were administered in compliance with the conditions laid down in paragraph 1; |

Text proposed by the Commission

Amendment

2b.
     
  Member States shall also prohibit the importation from third countries on any of the lists referred to in paragraph 2a of:

(a)

farm or aquaculture animals to which substances on the list referred to in paragraph 2 have been administered, unless those substances were administered in compliance with the conditions laid down in paragraph 1;

| (b) | meat or products obtained from animals the importation of which is prohibited under point (a) of this paragraph. |
| --- | --- |

(b)

meat or products obtained from animals the importation of which is prohibited under point (a) of this paragraph.

Amendment 266

Proposal for a regulation

Article 119 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No.../.... of the European Parliament and the Council (31) a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product authorised in another Member State. | 2.   By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No.../.... of the European Parliament and the Council (31)

  or any critical health situation acknowledged by the Chief Veterinary Officer of the Member State
  a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product
  without a marketing authorisation in the Member State in question but which is
  authorised
  either
  in another Member State
  or in accordance with the laws of a third country, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use
  . |

Text proposed by the Commission

Amendment

2.   By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No.../.... of the European Parliament and the Council (31) a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product authorised in another Member State.

2.   By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No.../.... of the European Parliament and the Council (31)

  or any critical health situation acknowledged by the Chief Veterinary Officer of the Member State
  a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product
  without a marketing authorisation in the Member State in question but which is
  authorised
  either
  in another Member State
  or in accordance with the laws of a third country, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use
  .

Amendment 267

Proposal for a regulation

Article 122 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Within two years of entry into force of this Regulation, the Commission shall develop, through delegated acts, a harmonised system for collecting these types of products and waste materials at Union level. |

Text proposed by the Commission

Amendment

Within two years of entry into force of this Regulation, the Commission shall develop, through delegated acts, a harmonised system for collecting these types of products and waste materials at Union level.

Amendment 268

Proposal for a regulation

Article 123 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1a.
     
  Member States may provide for additional conditions in terms of advertising of veterinary medicinal products to protect public and animal health, animal welfare and the environment including conditions in terms of comparative and misleading advertising or unfair commercial practices. |

Text proposed by the Commission

Amendment

1a.
     
  Member States may provide for additional conditions in terms of advertising of veterinary medicinal products to protect public and animal health, animal welfare and the environment including conditions in terms of comparative and misleading advertising or unfair commercial practices.

Amendment 269

Proposal for a regulation

Article 124 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The prohibition
  laid down
  in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products. | 2.   The prohibition
  set out
  in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products. |

Text proposed by the Commission

Amendment

2.   The prohibition
  laid down
  in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products.

2.   The prohibition
  set out
  in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products.

Amendment 270

Proposal for a regulation

Article 125 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products regularly, on a risk-basis, in order to verify that the requirements as set out in this Regulation are complied with. | 1.   Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products
  as well as animals and foodstuff
  regularly, on a risk-basis, in order to verify that the requirements as set out in this Regulation are complied with. |

Text proposed by the Commission

Amendment

1.   Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products regularly, on a risk-basis, in order to verify that the requirements as set out in this Regulation are complied with.

1.   Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products
  as well as animals and foodstuff
  regularly, on a risk-basis, in order to verify that the requirements as set out in this Regulation are complied with.

Amendment 271

Proposal for a regulation

Article 125 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1a.
     
  The Commission shall ensure a harmonised approach to inspections and controls of veterinary medicines throughout the Union. |

Text proposed by the Commission

Amendment

1a.
     
  The Commission shall ensure a harmonised approach to inspections and controls of veterinary medicines throughout the Union.

Amendment 272

Proposal for a regulation

Article 125 — paragraph 1 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1b.
     
  To combat fraud, the competent authorities shall establish a plan for spot checks on veterinary practices and herds to verify that medicinal products held comply with quality standards. |

Text proposed by the Commission

Amendment

1b.
     
  To combat fraud, the competent authorities shall establish a plan for spot checks on veterinary practices and herds to verify that medicinal products held comply with quality standards.

Amendment 273

Proposal for a regulation

Article 125 — paragraph 4 — subparagraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| If necessary, the
  inspections
  may
  be carried out unannounced. | All
  inspections
  shall
  be carried out unannounced. |

Text proposed by the Commission

Amendment

If necessary, the
  inspections
  may
  be carried out unannounced.

All
  inspections
  shall
  be carried out unannounced.

Amendment 274

Proposal for a regulation

Article 125 — paragraph 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4a.
     
  Inspections may also be carried out on the premises of manufacturers of active substances used as starting materials for veterinary medicinal products where there are grounds for suspecting non-compliance with good manufacturing practices. |

Text proposed by the Commission

Amendment

4a.
     
  Inspections may also be carried out on the premises of manufacturers of active substances used as starting materials for veterinary medicinal products where there are grounds for suspecting non-compliance with good manufacturing practices.

Amendment 275

Proposal for a regulation

Article 125 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6.   Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities. | 6.   Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities.
  A summary of the inspection results shall be made publicly available. |

Text proposed by the Commission

Amendment

6.   Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities.

6.   Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities.
  A summary of the inspection results shall be made publicly available.

Amendment 276

Proposal for a regulation

Article 128 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a.
     
  The Agency and the Commission shall ensure a harmonised approach to veterinary medicine inspections. |

Text proposed by the Commission

Amendment

3a.
     
  The Agency and the Commission shall ensure a harmonised approach to veterinary medicine inspections.

Amendment 277

Proposal for a regulation

Article 132 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 132a |
| | Suspending and withdrawing wholesale distribution authorisations |
| | In cases of non-compliance with the requirements laid down in Articles 104, 105 and 106, the competent authority may: |
| | (a) | suspend the wholesale distribution of the veterinary medicinal products; |

Text proposed by the Commission

Amendment

Article 132a

Suspending and withdrawing wholesale distribution authorisations

In cases of non-compliance with the requirements laid down in Articles 104, 105 and 106, the competent authority may:

(a)

suspend the wholesale distribution of the veterinary medicinal products;

| (b) | suspend the authorisation for wholesale distribution of a category of veterinary medicinal products; |
| --- | --- |

(b)

suspend the authorisation for wholesale distribution of a category of veterinary medicinal products;

| (c) | withdraw the authorisation for wholesale distribution of a category, or all categories, of veterinary medicinal products. |
| --- | --- |

(c)

withdraw the authorisation for wholesale distribution of a category, or all categories, of veterinary medicinal products.

Amendment 279

Proposal for a regulation

Article 136 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Member States shall designate the competent authorities to carry out tasks under this Regulation. | 1.   Member States shall designate the competent authorities to carry out tasks under this Regulation.
  The competent authorities shall, inter alia, be responsible for providing the scientific expertise for assessment of all applications under this Regulation. |

Text proposed by the Commission

Amendment

1.   Member States shall designate the competent authorities to carry out tasks under this Regulation.

1.   Member States shall designate the competent authorities to carry out tasks under this Regulation.
  The competent authorities shall, inter alia, be responsible for providing the scientific expertise for assessment of all applications under this Regulation.

Amendment 280

Proposal for a regulation

Article 136 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1a.
     
  The management of funds intended for activities connected with requirements provided under this Regulation, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee the independence of these authorities. |

Text proposed by the Commission

Amendment

1a.
     
  The management of funds intended for activities connected with requirements provided under this Regulation, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee the independence of these authorities.

Amendment 281

Proposal for a regulation

Article 136 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other, particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations, for the certificates of good manufacturing practice or for marketing authorisations. | 2.   The competent authorities shall cooperate with each other
  and other concerned authorities
  in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other
  and other concerned authorities
  , particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations, for the certificates of good manufacturing practice or for marketing authorisations. |

Text proposed by the Commission

Amendment

2.   The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other, particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations, for the certificates of good manufacturing practice or for marketing authorisations.

2.   The competent authorities shall cooperate with each other
  and other concerned authorities
  in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other
  and other concerned authorities
  , particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations, for the certificates of good manufacturing practice or for marketing authorisations.

Amendment 305

Proposal for a regulation

Article 140 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1a.
     
  All members, alternate members and accompanying experts shall provide a publicly accessible declaration of interest. |

Text proposed by the Commission

Amendment

1a.
     
  All members, alternate members and accompanying experts shall provide a publicly accessible declaration of interest.

Amendment 282

Proposal for a regulation

Article 140 — paragraph 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| 7.   The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. | 7.   The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
  The co-opted members may act as rapporteurs. |

Text proposed by the Commission

Amendment

7.   The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.

7.   The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
  The co-opted members may act as rapporteurs.

Amendment 283

Proposal for a regulation

Article 141 — paragraph 1 — point h a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ha) | tackle the contribution of farming practices to the development of antimicrobial resistance, by building on the existing action plans of the Commission and Member States, specifically by developing and implementing strategies to:








  — | reduce overall use, |

Text proposed by the Commission

Amendment

(ha)

tackle the contribution of farming practices to the development of antimicrobial resistance, by building on the existing action plans of the Commission and Member States, specifically by developing and implementing strategies to:

—

reduce overall use,

| — | reduce the use of antimicrobials that are critically important for human use, and |
| --- | --- |

—

reduce the use of antimicrobials that are critically important for human use, and

| — | end routine prophylactic use. |
| --- | --- |

—

end routine prophylactic use.

Amendment 284

Proposal for a regulation

Article 144 — paragraph 1 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | examine questions concerning pharmacovigilance of veterinary medicinal products authorised in Member States; |

Text proposed by the Commission

Amendment

(b)

examine questions concerning pharmacovigilance of veterinary medicinal products authorised in Member States;

deleted

Amendment 285

Proposal for a regulation

Annex 2 — part 1 — point 1.1 — paragraph 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| Experiments on animals
  other than clinical trials
  shall be conducted in accordance with Directive 2010/63/EU. | Member States shall ensure that all
  experiments on animals shall be conducted in accordance with Directive 2010/63/EU.
  As specified in Directive 2010/63/EU, it shall be necessary to replace, reduce or refine testing on vertebrate animals. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. |

Text proposed by the Commission

Amendment

Experiments on animals
  other than clinical trials
  shall be conducted in accordance with Directive 2010/63/EU.

Member States shall ensure that all
  experiments on animals shall be conducted in accordance with Directive 2010/63/EU.
  As specified in Directive 2010/63/EU, it shall be necessary to replace, reduce or refine testing on vertebrate animals. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved.

Amendment 286

Proposal for a regulation

Annex 2 — part 1 — point 1.3 — subpoint 1.3.1 — paragraph 1 — point e

| Text proposed by the Commission | Amendment |
| --- | --- |
| (e) | the potential risks relating to the development of antimicrobial resistance. |

Text proposed by the Commission

Amendment

(e)

the potential risks relating to the development of antimicrobial resistance.

| (e) | the potential risks relating to the development of antimicrobial resistance
  during production and use
  . |
| --- | --- |

(e)

the potential risks relating to the development of antimicrobial resistance
  during production and use
  .

Amendment 287

Proposal for a regulation

Annex 2 — part 1 — point 1.3 — subpoint 1.3.1 — paragraph 7 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| This assessment shall normally be conducted in two phases. The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items: | This assessment shall normally be conducted in two phases.
  All available data of sufficient reliability and relevance shall be considered, including information gained during the drug discovery process.
  The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items: |

Text proposed by the Commission

Amendment

This assessment shall normally be conducted in two phases. The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:

This assessment shall normally be conducted in two phases.
  All available data of sufficient reliability and relevance shall be considered, including information gained during the drug discovery process.
  The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:

Amendment 288

Proposal for a regulation

Annex 2 — part 1 — point 1.3 — subpoint 1.3.1 — paragraph 8

| Text proposed by the Commission | Amendment |
| --- | --- |
| In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration. | In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance
  , and taking into account the pharmacological effect of the product as well as any relevant side effects
  . The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration. |

Text proposed by the Commission

Amendment

In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration.

In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance
  , and taking into account the pharmacological effect of the product as well as any relevant side effects
  . The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration.

Amendment 289

Proposal for a regulation

Annex 2 — part 1 — point 1.3 — subpoint 1.3.1 — paragraph 8 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The environmental risk assessment shall be updated when new information becomes available that would change the estimation of the risk. |

Text proposed by the Commission

Amendment

The environmental risk assessment shall be updated when new information becomes available that would change the estimation of the risk.

---

(1)  The matter was referred back to the committee responsible for reconsideration pursuant to Rule 61(2), second subparagraph (A8-0046/2016).

(15)  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

(15)  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

(17)  Communication from the Commission on the precautionary principle, COM(2000)0001 (final).

(17)  Communication from the Commission on the precautionary principle, COM(2000)0001 (final).

(1a)  
  Regulation (EÚ) .../... of the European Parliament and the Council of ... on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (OJ L ...) [2014/0255(COD)].

(1a)  
  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

(*1)  
  2014/0255(COD).

(22)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

(22)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

(28)  
  Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).

(29)  Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).

(29)  Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).

(29a)  
  Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).

(30)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(30)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(31)  Regulation of the European Parliament and the Council of..... on animal health (OJ L ......).

(31)  Regulation of the European Parliament and the Council of..... on animal health (OJ L ......).

---

| 9.2.2018 | EN | Official Journal of the European Union | C 50/280 |
| --- | --- | --- | --- |

9.2.2018

EN

Official Journal of the European Union

C 50/280

---

P8_TA(2016)0088

Authorisation and supervision of veterinary medicinal products ***I

Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (COM(2014)0557 — C8-0142/2014 — 2014/0256(COD)) (1)

(Ordinary legislative procedure: first reading)

(2018/C 050/27)

Amendment 1

Proposal for a regulation

Recital 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| (1) | Directive 2001/82/EC of the European Parliament and of the Council (5) and Regulation (EC) 726/2004 of the European Parliament and of the Council (6) constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No [...] of the European Parliament and of the Council (7) laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted. |

Text proposed by the Commission

Amendment

(1)

Directive 2001/82/EC of the European Parliament and of the Council (5) and Regulation (EC) 726/2004 of the European Parliament and of the Council (6) constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No [...] of the European Parliament and of the Council (7) laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted.

| (1) | Directive 2001/82/EC of the European Parliament and of the Council (5) and Regulation (EC)
  No
  726/2004 of the European Parliament and of the Council (6) constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No [...] of the European Parliament and of the Council (7) laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted
  , with a view to harmonisation of the laws of the Member States
  . |
| --- | --- |

(1)

Directive 2001/82/EC of the European Parliament and of the Council (5) and Regulation (EC)
  No
  726/2004 of the European Parliament and of the Council (6) constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No [...] of the European Parliament and of the Council (7) laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted
  , with a view to harmonisation of the laws of the Member States
  .

Amendment 2

Proposal for a regulation

Recital 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| (4) | As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex to technical and scientific progress, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection. |

Text proposed by the Commission

Amendment

(4)

As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex to technical and scientific progress, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.

| (4) | As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex
  with regard
  to technical and scientific progress
  so as to facilitate the placing on the market of new medicinal products
  , determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection. |
| --- | --- |

(4)

As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex
  with regard
  to technical and scientific progress
  so as to facilitate the placing on the market of new medicinal products
  , determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.

Amendment 3

Proposal for a regulation

Recital 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| (6) | In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). |

Text proposed by the Commission

Amendment

(6)

In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (2).

| (6) | In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human
  and veterinary
  use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (3). |
| --- | --- |

(6)

In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human
  and veterinary
  use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (3).

Amendment 4

Proposal for a regulation

Recital 6 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6a) | Advances in alternative testing require the creation of a regulatory framework capable of adapting to new developments in this field, including for example the recognition and evaluation of modeling and simulation technologies. |

Text proposed by the Commission

Amendment

(6a)

Advances in alternative testing require the creation of a regulatory framework capable of adapting to new developments in this field, including for example the recognition and evaluation of modeling and simulation technologies.

Amendment 5

Proposal for a regulation

Recital 6 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6b) | Animal testing currently plays a key regulatory and scientific role in the development of medicines, and in relation to the replacement, reduction or refinement of animal testing is subject to Directive 2010/63/EU. |

Text proposed by the Commission

Amendment

(6b)

Animal testing currently plays a key regulatory and scientific role in the development of medicines, and in relation to the replacement, reduction or refinement of animal testing is subject to Directive 2010/63/EU.

Amendment 6

Proposal for a regulation

Recital 6 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6c) | In the interest of public health, authorisation decisions adopted under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy. |

Text proposed by the Commission

Amendment

(6c)

In the interest of public health, authorisation decisions adopted under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy.

Amendment 7

Proposal for a regulation

Recital 6 d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6d) | Provision should be made for the quality, safety and efficacy criteria laid down in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Union and it should be possible to assess the risk-benefit balance of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate. |

Text proposed by the Commission

Amendment

(6d)

Provision should be made for the quality, safety and efficacy criteria laid down in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Union and it should be possible to assess the risk-benefit balance of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate.

Amendment 8

Proposal for a regulation

Recital 6 e (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6e) | Member States have developed an evaluation of the comparative efficacy of medicinal products aimed at positioning a new medicinal product with respect to those that already exist in the same therapeutic class. Similarly, the Council, in its conclusions on medicinal products and public health, adopted on 29 June 2000, emphasised the importance of identifying medicinal products that presented an added therapeutic value. That evaluation should be conducted in the context of the marketing authorisation. |

Text proposed by the Commission

Amendment

(6e)

Member States have developed an evaluation of the comparative efficacy of medicinal products aimed at positioning a new medicinal product with respect to those that already exist in the same therapeutic class. Similarly, the Council, in its conclusions on medicinal products and public health, adopted on 29 June 2000, emphasised the importance of identifying medicinal products that presented an added therapeutic value. That evaluation should be conducted in the context of the marketing authorisation.

Amendment 9

Proposal for a regulation

Article 1 — point 2 a (new)

Regulation (EC) No 726/2004

Article 1 — paragraph 2

| Present text | Amendment |
| --- | --- |
| | (2a) | In Article 1, the second paragraph is replaced by the following: |

Present text

Amendment

(2a)

The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies.

‘The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions
  , provided that Member States take into due consideration the reference comparative evaluation of human medicinal product as referred to in Article 9(4).
  In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies.’

Amendment 10

Amendment 10

Proposal for a regulation

Proposal for a regulation

Article 1 — point 3

Article 1 — point 3

Regulation (EC) No 726/2004

Article 2 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation. | The definitions laid down in Article 1 of Directive 2001/83/EC
  and
  ,
  as appropriate, in Article 4 of Regulation (EU) .../... of the European Parliament and of the Council

   (1a) shall apply for the purposes of this Regulation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation.

The definitions laid down in Article 1 of Directive 2001/83/EC
  and
  ,
  as appropriate, in Article 4 of Regulation (EU) .../... of the European Parliament and of the Council

   (1a) shall apply for the purposes of this Regulation.

and

as appropriate, in Article 4 of Regulation (EU) .../... of the European Parliament and of the Council

1a

Amendment 11

Amendment 11

Proposal for a regulation

Proposal for a regulation

Article 1 — point 4 — point a

Article 1 — point 4 — point a

Regulation (EC) No 726/2004

Article 3 — paragraph 2 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (a) | in
  paragraph 2,
  point (b)
  is replaced by the following: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

in
  paragraph 2,
  point (b)
  is replaced by the following:

in

point (b)

| (a) | paragraph 2 is replaced by the following: |
| --- | --- |

(a)

paragraph 2 is replaced by the following:

| | ‘2.   
  Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with this Regulation, if: |
| --- | --- |

‘2.   
  Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with this Regulation, if:

Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with this Regulation, if:

| | (a) | the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union; or |
| --- | --- | --- |

(a)

(a)

the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union; or

the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union; or

| | ‘(b) | the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level.’ |
| --- | --- | --- |

‘(b)

the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level.’

| | (b) | the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level.’ |
| --- | --- | --- |

(b)

the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level.’

Amendment 12

Amendment 12

Proposal for a regulation

Proposal for a regulation

Article 1 — point 5 a (new)

Article 1 — point 5 a (new)

Regulation (EC) No 726/2004

Article 6 — paragraphs 4 a and 4 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (5a) | In Article 6, the following paragraphs are added:



  ‘4a.
     
  The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU.




  4b.
     
  The Agency shall develop a framework for the regulatory acceptance of alternative models and shall take into consideration the opportunities presented by these new concepts which aim at providing for more predictive medicines. These concepts may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways.’ |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(5a)

(5a)

In Article 6, the following paragraphs are added:

‘4a.
     
  The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU.

‘4a.

The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU.

4b.
     
  The Agency shall develop a framework for the regulatory acceptance of alternative models and shall take into consideration the opportunities presented by these new concepts which aim at providing for more predictive medicines. These concepts may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways.’

4b.

The Agency shall develop a framework for the regulatory acceptance of alternative models and shall take into consideration the opportunities presented by these new concepts which aim at providing for more predictive medicines. These concepts may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways.’

Amendment 13

Amendment 13

Proposal for a regulation

Proposal for a regulation

Article 1 — point 5 b (new)

Article 1 — point 5 b (new)

Regulation (EC) No 726/2004

Article 9 — paragraph 4 — point d a (new)

| Present text | Amendment |
| --- | --- |
| | (5b) | In Article 9(4), the following point is inserted:









  ‘(da) | the comparative evaluation of the human medicinal product;
  ’ |

Present text

Present text

Amendment

Amendment

(5b)

(5b)

In Article 9(4), the following point is inserted:

‘(da)

‘(da)

the comparative evaluation of the human medicinal product;
  ’

the comparative evaluation of the human medicinal product;

Amendment 14

Amendment 14

Proposal for a regulation

Proposal for a regulation

Article 1 — point 10 a (new)

Article 1 — point 10 a (new)

Regulation (EC) No 726/2004

Article 55 — paragraph 2

| Present text | Amendment |
| --- | --- |
| | (10a) | In Article 55, the second paragraph is replaced by the following: |

Present text

Present text

Amendment

Amendment

(10a)

(10a)

In Article 55, the second paragraph is replaced by the following:

The Agency shall be responsible for coordinating the
  existing
  scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.

existing

‘The Agency shall be responsible for coordinating the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products
  for human use, as provided for in this Regulation, and for veterinary use, as provided for in Regulation (EU) .../...

   (*1)

  .
  ’

Amendment 15

Amendment 15

Proposal for a regulation

Proposal for a regulation

Article 1 — point 10 b (new)

Article 1 — point 10 b (new)

Regulation (EC) No 726/2004

Article 56 — paragraph 2 — subparagraph 1

| Present text | Amendment |
| --- | --- |
| | (10b) | In Article 56(2), the first subparagraph is replaced by the following: |

Present text

Present text

Amendment

Amendment

(10b)

(10b)

In Article 56(2), the first subparagraph is replaced by the following:

2.   The committees referred to in paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in
  Articles
  5 and
  30
  .

Articles

30

‘2.   The committees referred to in paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in
  Article
  5
  of this Regulation
  and
  in Article 141(1) of Regulation (EU) .../...

   (*2)

  .
  ’

Amendment 16

Amendment 16

Proposal for a regulation

Proposal for a regulation

Article 1 — point 10 c (new)

Article 1 — point 10 c (new)

Regulation (EC) No 726/2004

Article 57 — paragraph 1 — subparagraph 1

| Present text | Amendment |
| --- | --- |
| | (10c) | In Article 57(1), the first subparagraph is replaced by the following: |

Present text

Present text

Amendment

Amendment

(10c)

(10c)

In Article 57(1), the first subparagraph is replaced by the following:

1.   The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety
  and
  efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.

and

‘1.   The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety, efficacy
  and comparative assessment
  of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.’

Amendment 17

Amendment 17

Proposal for a regulation

Proposal for a regulation

Article 1 — point 10 d (new)

Article 1 — point 10 d (new)

Regulation (EC) No 726/2004

Article 57 — paragraph 1 — subparagraph 2 — point t a (new)

| Present text | Amendment |
| --- | --- |
| | (10d) | In the second subparagraph of Article 57(1), the following point is added:









  ‘(ta) | cooperating with the Health Technology Assessment Network, with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment and reduce disparities in patients’ access to health technologies
  .’ |

Present text

Present text

Amendment

Amendment

(10d)

(10d)

In the second subparagraph of Article 57(1), the following point is added:

‘(ta)

‘(ta)

cooperating with the Health Technology Assessment Network, with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment and reduce disparities in patients’ access to health technologies
  .’

cooperating with the Health Technology Assessment Network, with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment and reduce disparities in patients’ access to health technologies

Amendment 18

Amendment 18

Proposal for a regulation

Proposal for a regulation

Article 1 — point 10 e (new)

Article 1 — point 10 e (new)

Regulation (EC) No 726/2004

Article 57 — paragraph 1 — subparagraph 2 — point t b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (10e) | In the second subparagraph of Article 57(1), the following point is added:









  ‘(tb) | in cooperation with EFSA and ECDC annually publishing a report on the use of antimicrobials for human and veterinary medicine as well as the current situation on the antimicrobial resistance in the Union.’ |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(10e)

(10e)

In the second subparagraph of Article 57(1), the following point is added:

‘(tb)

‘(tb)

in cooperation with EFSA and ECDC annually publishing a report on the use of antimicrobials for human and veterinary medicine as well as the current situation on the antimicrobial resistance in the Union.’

in cooperation with EFSA and ECDC annually publishing a report on the use of antimicrobials for human and veterinary medicine as well as the current situation on the antimicrobial resistance in the Union.’

Amendment 19

Amendment 19

Proposal for a regulation

Proposal for a regulation

Article 1 — point 11

Article 1 — point 11

Regulation (EC) No 726/2004

Article 57 — paragraph 2 — subparagraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product authorised in the Union. | 2.   The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product
  for human use
  authorised in the Union. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product authorised in the Union.

2.   The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product
  for human use
  authorised in the Union.

for human use

Amendment 20

Amendment 20

Proposal for a regulation

Proposal for a regulation

Article 1 — point 13

Article 1 — point 13

Regulation (EC) No 726/2004

Article 61 — paragraph 1 — subparagraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human. | 1.   Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human
  Use
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human.

1.   Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human
  Use
  .

Use

Amendment 21

Amendment 21

Proposal for a regulation

Proposal for a regulation

Article 1 — point 13 a (new)

Article 1 — point 13 a (new)

Regulation (EC) No 726/2004

Article 62 — paragraph 2

| Present text | Amendment |
| --- | --- |
| | (13a) | Article 62(2) is replaced by the following: |

Present text

Present text

Amendment

Amendment

(13a)

(13a)

Article 62(2) is replaced by the following:

2.   Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products
  for human use
  who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.

for human use

‘2.   Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.

The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and other experts appointed
  directly
  by the Agency. The list shall be updated.

directly

The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and
  any
  other experts appointed by the Agency
  or the Commission
  . The list shall be updated.’

any

or the Commission

Amendment 22

Amendment 22

Proposal for a regulation

Proposal for a regulation

Article 1 — point 14

Article 1 — point 14

Regulation (EC) No 726/2004

Article 62

| Text proposed by the Commission | Amendment |
| --- | --- |
| (14) | in
  Article 62
  (3), the second subparagraph is deleted
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(14)

in
  Article 62
  (3), the second subparagraph is deleted
  ;

in

(3), the second subparagraph is deleted

| (14) | Article 62
  is amended as follows:










  (a) | in paragraph 1, the third subparagraph is replaced by the following:


  ‘
  When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) of this Regulation and in Article 40(3) of Regulation (EU) .../...

   (*3)

  are met.
  ’; |
| --- | --- | --- |

(14)

Article 62
  is amended as follows:

is amended as follows:

(a)

(a)

in paragraph 1, the third subparagraph is replaced by the following:

in paragraph 1, the third subparagraph is replaced by the following:

‘
  When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) of this Regulation and in Article 40(3) of Regulation (EU) .../...

   (*3)

  are met.
  ’;

When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) of this Regulation and in Article 40(3) of Regulation (EU) .../...

*3

are met.

| (b) | in paragraph 1, the fourth subparagraph is replaced by the following:


  ‘
  The substance of the opinion shall be included in the assessment report published in accordance with Article 13(3) of this Regulation and Article 40(11) of Regulation (EU) .../...

   (*3)

  .
  ’; |
| --- | --- |

(b)

(b)

in paragraph 1, the fourth subparagraph is replaced by the following:

in paragraph 1, the fourth subparagraph is replaced by the following:

‘
  The substance of the opinion shall be included in the assessment report published in accordance with Article 13(3) of this Regulation and Article 40(11) of Regulation (EU) .../...

   (*3)

  .
  ’;

The substance of the opinion shall be included in the assessment report published in accordance with Article 13(3) of this Regulation and Article 40(11) of Regulation (EU) .../...

*3

.

Amendment 23

Amendment 23

Proposal for a regulation

Proposal for a regulation

Article 1 — point 14 a (new)

Article 1 — point 14 a (new)

Regulation (EC) No 726/2004

Article 64 — paragraph 1

| Present text | Amendment |
| --- | --- |
| | (14a) | Article 64(1) is replaced by the following: |

Present text

Present text

Amendment

Amendment

(14a)

(14a)

Article 64(1) is replaced by the following:

1.   The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post.

‘1.   The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once
  by the Management Board, in consultation with the Commission
  . The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post.’

Amendment 24

Amendment 24

Proposal for a regulation

Proposal for a regulation

Article 1 — point 14 b (new)

Article 1 — point 14 b (new)

Regulation (EC) No 726/2004

Article 66 — points a and j

| Present text | Amendment |
| --- | --- |
| | (14b) | Article 66 is amended as follows: |

Present text

Present text

Amendment

Amendment

(14b)

(14b)

Article 66 is amended as follows:

| (a) | point (a) is replaced by the following: |
| --- | --- |

(a)

(a)

point (a) is replaced by the following:

point (a) is replaced by the following:

| (a) | adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use
  and the Committee for Medicinal Products for Veterinary Use
  (Article 61); |
| --- | --- |

(a)

adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use
  and the Committee for Medicinal Products for Veterinary Use
  (Article 61);

and the Committee for Medicinal Products for Veterinary Use

| | ‘(a) | adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use (Article 61
  of this Regulation
  )
  and the Committee for Medicinal Products for Veterinary Use (Article 140 of Regulation (EU) .../...

   (*4)

  );
  ’; |
| --- | --- | --- |

‘(a)

adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use (Article 61
  of this Regulation
  )
  and the Committee for Medicinal Products for Veterinary Use (Article 140 of Regulation (EU) .../...

   (*4)

  );
  ’;

of this Regulation

and the Committee for Medicinal Products for Veterinary Use (Article 140 of Regulation (EU) .../...

*4

);

| (b) | point (j) is deleted. |
| --- | --- |

(b)

(b)

point (j) is deleted.

point (j) is deleted.

Amendment 25

Amendment 25

Proposal for a regulation

Proposal for a regulation

Article 1 — point 15

Article 1 — point 15

Regulation (EC) No 726/2004

Article 67 — paragraph 3 — subparagraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| (15) | the first subparagraph of
  Article 67(3) is replaced by the following: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(15)

the first subparagraph of
  Article 67(3) is replaced by the following:

the first subparagraph of

| (15) | Article 67(3) is replaced by the following: |
| --- | --- |

(15)

Article 67(3) is replaced by the following:

‘The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107 g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agency.’

‘The Agency’s revenue shall consist of:

| (a) | a contribution from the Union; |
| --- | --- |

(a)

(a)

a contribution from the Union;

| (b) | a contribution from any European third country with which the Union has concluded agreements; |
| --- | --- |

(b)

(b)

a contribution from any European third country with which the Union has concluded agreements;

a contribution from any European third country with which the Union has concluded agreements;

| (c) | the
  fees paid by undertakings for obtaining and maintaining Union marketing authorisations
  for human and veterinary medicinal products
  and for other services provided by the Agency,
  as provided for in this Regulation and in Regulation (EU) .../...

   (*5)

  ,
  or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107 g, 107k and 107q of Directive 2001/83/EC; |
| --- | --- |

(c)

(c)

the
  fees paid by undertakings for obtaining and maintaining Union marketing authorisations
  for human and veterinary medicinal products
  and for other services provided by the Agency,
  as provided for in this Regulation and in Regulation (EU) .../...

   (*5)

  ,
  or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107 g, 107k and 107q of Directive 2001/83/EC;

the

for human and veterinary medicinal products

as provided for in this Regulation and in Regulation (EU) .../...

*5

,

| (d) | charges for
  any
  other services provided by the Agency
  ; and |
| --- | --- |

(d)

(d)

charges for
  any
  other services provided by the Agency
  ; and

any

; and

| (e) | other sources of income, including any ad-hoc grants within the scope of Title VI of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council

   (1a)

  . |
| --- | --- |

(e)

(e)

other sources of income, including any ad-hoc grants within the scope of Title VI of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council

   (1a)

  .

other sources of income, including any ad-hoc grants within the scope of Title VI of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council

1a

.

The European Parliament and the Council (“the budgetary authority”) shall re-examine, when necessary, the level of the Union contribution, referred to in point (a) of the first subparagraph, on the basis of an evaluation of needs and by taking account of the level of fees.
  ’

The European Parliament and the Council (“the budgetary authority”) shall re-examine, when necessary, the level of the Union contribution, referred to in point (a) of the first subparagraph, on the basis of an evaluation of needs and by taking account of the level of fees.

Amendment 26

Amendment 26

Proposal for a regulation

Proposal for a regulation

Article 1 — point 15 a (new)

Article 1 — point 15 a (new)

Regulation (EC) No 726/2004

Article 67 — paragraph 3 — subparagraph 1 a (new)

| Present text | Amendment |
| --- | --- |
| | (15a) | In Article 67(3), the following subparagraph is inserted after the first subparagraph:



  ‘In order to safeguard fluctuations in fee revenue, any positive budget outturn of a financial year (N) shall be set aside as assigned revenue and serve as a reserve in the event that actual fee revenue be below budgeted appropriations. The total amount of such a safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year
  .’ |

Present text

Present text

Amendment

Amendment

(15a)

(15a)

In Article 67(3), the following subparagraph is inserted after the first subparagraph:

‘In order to safeguard fluctuations in fee revenue, any positive budget outturn of a financial year (N) shall be set aside as assigned revenue and serve as a reserve in the event that actual fee revenue be below budgeted appropriations. The total amount of such a safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year
  .’

‘In order to safeguard fluctuations in fee revenue, any positive budget outturn of a financial year (N) shall be set aside as assigned revenue and serve as a reserve in the event that actual fee revenue be below budgeted appropriations. The total amount of such a safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year

Amendment 27

Amendment 27

Proposal for a regulation

Proposal for a regulation

Article 1 — point 15 b (new)

Article 1 — point 15 b (new)

Regulation (EC) No 726/2004

Article 67 — paragraph 6 — subparagraph 1 a (new)

| Present text | Amendment |
| --- | --- |
| | (15b) | In Article 67(6), the following subparagraph is added:



  ‘The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget
  .’ |

Present text

Present text

Amendment

Amendment

(15b)

(15b)

In Article 67(6), the following subparagraph is added:

‘The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget
  .’

‘The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget

Amendment 28

Amendment 28

Proposal for a regulation

Proposal for a regulation

Article 1 — point 15 c (new)

Article 1 — point 15 c (new)

Regulation (EC) No 726/2004

Article 67 — paragraph 8

| Present text | Amendment |
| --- | --- |
| | (15c) | Article 67(8) is replaced by the following: |

Present text

Present text

Amendment

Amendment

(15c)

(15c)

Article 67(8) is replaced by the following:

8.   On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.

‘8.   On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan
  concerning the staff financed by the Union budget
  and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.’

Amendment 29

Amendment 29

Proposal for a regulation

Proposal for a regulation

Article 1 — point 15 d (new)

Article 1 — point 15 d (new)

Regulation (EC) No 726/2004

Article 67 — paragraph 9 — subparagraph 2

| Present text | Amendment |
| --- | --- |
| | (15d) | In Article 67(9), the second subparagraph is replaced by the following: |

Present text

Present text

Amendment

Amendment

(15d)

(15d)

In Article 67(9), the second subparagraph is replaced by the following:

The budgetary authority shall adopt the establishment plan for the Agency.

‘The budgetary authority shall adopt the establishment plan
  for the staff financed by the Union budget
  for the Agency.’

Amendment 30

Amendment 30

Proposal for a regulation

Proposal for a regulation

Article 1 — point 15 e (new)

Article 1 — point 15 e (new)

Regulation (EC) No 726/2004

Article 68

| Present Text | Amendment |
| --- | --- |
| | (15e) | Article 68 is replaced by the following: |

Present Text

Present Text

Amendment

Amendment

(15e)

(15e)

Article 68 is replaced by the following:

1.   The Executive Director shall implement the budget of the Agency.

‘1.   The Executive Director shall implement the budget of the Agency.

2.   By 1 March
  at
  the
  latest
  following
  each
  financial year, the Agency's accounting officer shall
  communicate
  the provisional accounts to the Commission's accounting officer
  together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation applicable to the general budget of the European Communities(19) (hereinafter referred to as the ‘general Financial Regulation’).

at

latest

each

communicate

together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation applicable to the general budget of the European Communities(19) (hereinafter referred to as the ‘general Financial Regulation’).

2.   By 1 March
  of
  the following financial year, the Agency's accounting officer shall
  send
  the provisional accounts to the Commission's Accounting Officer
  and to the Court of Auditors.

of

send

and to the Court of Auditors.

3.   By 31 March
  at
  the
  latest
  following
  each
  financial year, the
  Commission's accounting officer
  shall
  submit the Agency's provisional accounts to the Court of Auditors, together with a
  report on the budgetary and financial management
  for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded
  to the European Parliament
  and
  the Council.

at

latest

each

Commission's accounting officer

submit the Agency's provisional accounts to the Court of Auditors, together with a

for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded

and

3.   By 31 March
  of
  the following financial year, the
  Executive Director
  shall
  send the
  report on the budgetary and financial management to the European Parliament,
  the Commission,
  the Council
  and the Court of Auditors
  .

of

Executive Director

send the

the Commission,

and the Court of Auditors

4.   On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article
  129
  of the
  general
  Financial Regulation
  , the Executive Director
  shall draw up the Agency's final accounts
  under his own responsibility
  and submit them to the Management Board for an opinion.

129

general

, the Executive Director

under his own responsibility

4.   
  By 31 March of the following financial year, the Commission's accounting officer shall send the Agency's provisional accounts, consolidated with the Commission's provisional accounts, to the Court of Auditors.

By 31 March of the following financial year, the Commission's accounting officer shall send the Agency's provisional accounts, consolidated with the Commission's provisional accounts, to the Court of Auditors.

On receipt of the Court of Auditors' observations on the Agency's provisional accounts pursuant to Article
  148
  of the Financial Regulation
  applicable to the general budget of the Union, the accounting officer
  shall draw up the Agency's final accounts and
  the Executive Director shall
  submit them to the Management Board for an opinion.

148

applicable to the general budget of the Union, the accounting officer

the Executive Director shall

5.   The Management Board
  of the Agency
  shall deliver an opinion on the Agency's final accounts.

of the Agency

5.   The Management Board shall deliver an opinion on the Agency's final accounts.

6.   The
  Executive Director
  shall, by 1 July
  at the latest
  following each financial year,
  forward
  the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion.

Executive Director

at the latest

forward

6.   The
  accounting officer
  shall, by 1 July following each financial year,
  send
  the final accounts to the European Parliament, the Council,
  the accounting officer of
  the Commission and the Court of Auditors, together with the Management Board's opinion.

accounting officer

send

the accounting officer of

7.   The final accounts shall be published.

7.   The final accounts shall be published
  in the Official Journal of the European Union by 15 November of the following year.

in the Official Journal of the European Union by 15 November of the following year.

8.   The
  Agency's
  Executive Director shall send the Court of Auditors a reply to its observations by 30 September
  at the latest. He shall also send this reply to the Management Board
  .

Agency's

at the latest. He shall also send this reply to the Management Board

8.   The Executive Director shall send
  to
  the Court of Auditors a reply to its observations by 30 September.

to

9.   The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question,
  as laid down in Article 146(3) of the general
  Financial Regulation.

as laid down in Article 146(3) of the general

9.   The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question,
  in accordance with Article 165(3) of the
  Financial Regulation
  applicable to the general budget of the Union.

in accordance with Article 165(3) of the

applicable to the general budget of the Union.

10.   
  The European Parliament
  , on a recommendation from the Council
  acting by a qualified majority,
  shall, before
  30 April
  of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.

The European Parliament

acting by a qualified majority,

30 April

10.   On a recommendation from the Council
  , the European Parliament
  shall, before
  15 May
  of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.

, the European Parliament

15 May

11.   The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They
  may
  not depart from Commission
  Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(20),
  unless specifically required for the Agency's operation and with the Commission's prior consent.

may

Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(20),

11.   The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They
  shall
  not depart from Commission
  Delegated Regulation (EU) No 1271/2013
  unless specifically required for the Agency's operation and with the Commission's prior consent.’

shall

Delegated Regulation (EU) No 1271/2013

Amendment 31

Amendment 31

Proposal for a regulation

Proposal for a regulation

Article 1 — point 16

Article 1 — point 16

Regulation (EC) No 726/2004

Article 70

| Text proposed by the Commission | Amendment |
| --- | --- |
| (16) | Article 70 is replaced by the following: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(16)

(16)

Article 70 is replaced by the following:

deleted

deleted

‘Article 70

‘Article 70

1.
     
  The Commission shall, on the basis of the principles set out in paragraph 2, adopt implementing acts in accordance with the procedure laid down in Article 87(2) specifying:

1.

The Commission shall, on the basis of the principles set out in paragraph 2, adopt implementing acts in accordance with the procedure laid down in Article 87(2) specifying:

| (a) | the structure and the level of the fees and charges referred to in Article 67(3); |
| --- | --- |

(a)

(a)

the structure and the level of the fees and charges referred to in Article 67(3);

the structure and the level of the fees and charges referred to in Article 67(3);

| (b) | the services for which charges may be collected; |
| --- | --- |

(b)

(b)

the services for which charges may be collected;

the services for which charges may be collected;

| (c) | the conditions under which small and medium-sized enterprises may pay reduced fees, defer payment of fees or receive administrative assistance; |
| --- | --- |

(c)

(c)

the conditions under which small and medium-sized enterprises may pay reduced fees, defer payment of fees or receive administrative assistance;

the conditions under which small and medium-sized enterprises may pay reduced fees, defer payment of fees or receive administrative assistance;

| (d) | the rules defining the remuneration for work carried out by the member of the relevant committee or the coordination group who acts as a rapporteur; and |
| --- | --- |

(d)

(d)

the rules defining the remuneration for work carried out by the member of the relevant committee or the coordination group who acts as a rapporteur; and

the rules defining the remuneration for work carried out by the member of the relevant committee or the coordination group who acts as a rapporteur; and

| (e) | the conditions for payment and remuneration. |
| --- | --- |

(e)

(e)

the conditions for payment and remuneration.

the conditions for payment and remuneration.

The fees shall be set at such a level as to avoid a deficit or a significant accumulation of surplus in the budget of the Agency and be revised when this is not the case.

The fees shall be set at such a level as to avoid a deficit or a significant accumulation of surplus in the budget of the Agency and be revised when this is not the case.

2.
     
  When adopting the implementing acts referred to in paragraph 1, the Commission shall take the following into account:

2.

When adopting the implementing acts referred to in paragraph 1, the Commission shall take the following into account:

| (a) | fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered and shall not exceed what is necessary to cover the costs; |
| --- | --- |

(a)

(a)

fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered and shall not exceed what is necessary to cover the costs;

fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered and shall not exceed what is necessary to cover the costs;

| (b) | the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities; |
| --- | --- |

(b)

(b)

the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities;

the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities;

| (c) | the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases; |
| --- | --- |

(c)

(c)

the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;

the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;

| (d) | on public health grounds the fee may be totally or partially waived for a particular category of medicinal products; |
| --- | --- |

(d)

(d)

on public health grounds the fee may be totally or partially waived for a particular category of medicinal products;

on public health grounds the fee may be totally or partially waived for a particular category of medicinal products;

| (e) | the structure and amount of fees shall take into account whether information has been submitted jointly or separately; |
| --- | --- |

(e)

(e)

the structure and amount of fees shall take into account whether information has been submitted jointly or separately;

the structure and amount of fees shall take into account whether information has been submitted jointly or separately;

| (f) | under exceptional and duly justified circumstances and upon acceptance by the Agency, the whole fee or part of it may be waived; |
| --- | --- |

(f)

(f)

under exceptional and duly justified circumstances and upon acceptance by the Agency, the whole fee or part of it may be waived;

under exceptional and duly justified circumstances and upon acceptance by the Agency, the whole fee or part of it may be waived;

| (g) | the remuneration for the work of the rapporteur shall be paid in principle to the national competent authority employing the rapporteur or, where the rapporteur is not employed by the national competent authority, the Member State that nominated him; |
| --- | --- |

(g)

(g)

the remuneration for the work of the rapporteur shall be paid in principle to the national competent authority employing the rapporteur or, where the rapporteur is not employed by the national competent authority, the Member State that nominated him;

the remuneration for the work of the rapporteur shall be paid in principle to the national competent authority employing the rapporteur or, where the rapporteur is not employed by the national competent authority, the Member State that nominated him;

| (h) | the time of payment for the fees and charges shall be fixed taking due account of the time limits under the provisions of this Regulation and Regulation (EU) No [...]’; |
| --- | --- |

(h)

(h)

the time of payment for the fees and charges shall be fixed taking due account of the time limits under the provisions of this Regulation and Regulation (EU) No [...]’;

the time of payment for the fees and charges shall be fixed taking due account of the time limits under the provisions of this Regulation and Regulation (EU) No [...]’;

Amendment 32

Amendment 32

Proposal for a regulation

Proposal for a regulation

Article 1 — point 16 a (new)

Article 1 — point 16 a (new)

Regulation (EC) No 726/2004

Article 70 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (16a) | The following Article is inserted:

  ‘
  Article 70a




  With regard to the level and the structure of the fees referred to in Article 67(3) of this Regulation, Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 shall be applicable until an amendment of Regulation (EC) No 297/95 or any other relevant provisions on fees are adopted and become applicable.
  ’ |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(16a)

(16a)

The following Article is inserted:

‘
  Article 70a

Article 70a

With regard to the level and the structure of the fees referred to in Article 67(3) of this Regulation, Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 shall be applicable until an amendment of Regulation (EC) No 297/95 or any other relevant provisions on fees are adopted and become applicable.
  ’

With regard to the level and the structure of the fees referred to in Article 67(3) of this Regulation, Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 shall be applicable until an amendment of Regulation (EC) No 297/95 or any other relevant provisions on fees are adopted and become applicable.

Amendment 33

Amendment 33

Proposal for a regulation

Proposal for a regulation

Article 1 — point 16 b (new)

Article 1 — point 16 b (new)

Regulation (EC) No 726/2004

Article 82 — paragraph 3

| Present text | Amendment |
| --- | --- |
| | (16b) | Article 82(3) is replaced by the following: |

Present text

Present text

Amendment

Amendment

(16b)

(16b)

Article 82(3) is replaced by the following:

3.   Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4)
  and in points (a) to (e) of Article 34(4)
  , this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.

and in points (a) to (e) of Article 34(4)

| | ‘3.   Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.’ |
| --- | --- |

‘3.   Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.’

Amendment 34

Amendment 34

Proposal for a regulation

Proposal for a regulation

Article 1 — point 18

Article 1 — point 18

Regulation (EC) No 726/2004

Article 86

| Text proposed by the Commission | Amendment |
| --- | --- |
| At least every
  ten
  years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation,
  and
  in Chapter 4 of Title III of Directive 2001/83/EC. | At least every
  five
  years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter 4 of Title III of Directive 2001/83/EC
  and in Regulation (EU) .../...

   (*6)

  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

At least every
  ten
  years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation,
  and
  in Chapter 4 of Title III of Directive 2001/83/EC.

ten

and

At least every
  five
  years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter 4 of Title III of Directive 2001/83/EC
  and in Regulation (EU) .../...

   (*6)

  .

five

and in Regulation (EU) .../...

*6

.

Amendment 35

Amendment 35

Proposal for a regulation

Proposal for a regulation

Article 1 — point 20

Article 1 — point 20

Regulation (EC) No 726/2004

Article 87b — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for
  an indeterminate
  period of
  time
  from the date of entry into force of this Regulation. | 2.   The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for
  a
  period of
  five years
  from the date of entry into force of this Regulation.
  The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for
  an indeterminate
  period of
  time
  from the date of entry into force of this Regulation.

an indeterminate

time

2.   The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for
  a
  period of
  five years
  from the date of entry into force of this Regulation.
  The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

a

five years

The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

---

(1)  The matter was referred back to the committee responsible for reconsideration pursuant to Rule 61(2), second subparagraph (A8-0035/2016).

1

(5)  Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

5

(6)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

6

(7)  Regulation ... of the European Parliament and of the Council of ... ... ... on veterinary medicinal products (OJ L ..., ... ... ..., p. ...).

7

(5)  Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

5

(6)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

6

(7)  Regulation ... of the European Parliament and of the Council of ... ... ... on veterinary medicinal products (OJ L ..., ... ... ..., p. ...).

7

(2)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

2

(3)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

3

(1a)  
  Regulation (EU) .../... of the European Parliament and of the Council of ... on veterinary medicinal products (OJ L ...) [2014/0257(COD)].

1a

Regulation (EU) .../... of the European Parliament and of the Council of ... on veterinary medicinal products (OJ L ...) [2014/0257(COD)].

(*1)  
  2014/0257(COD).

*1

2014/0257(COD).

(*2)  
  2014/0257(COD).

*2

2014/0257(COD).

(*3)  
  2014/0257(COD).

*3

2014/0257(COD).

(*4)  
  2014/0257(COD).

*4

2014/0257(COD).

(*5)  
  2014/0257(COD).

*5

2014/0257(COD).

(1a)  
  Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).

1a

Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).

(*6)  
  2014/0257(COD).

*6

2014/0257(COD).

---