# C_2018050EN.01028001.xml

| 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

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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)

1

(Ordinary legislative procedure: first reading)

(2018/C 050/27)

Amendment 1

Amendment 1

Proposal for a regulation

Proposal for a regulation

Recital 1

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

Text proposed by the Commission

Amendment

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.

5

6

7

| (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
  .

5

No

6

7

, with a view to harmonisation of the laws of the Member States

Amendment 2

Amendment 2

Proposal for a regulation

Proposal for a regulation

Recital 4

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

Text proposed by the Commission

Amendment

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.

with regard

so as to facilitate the placing on the market of new medicinal products

Amendment 3

Amendment 3

Proposal for a regulation

Proposal for a regulation

Recital 6

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

Text proposed by the Commission

Amendment

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).

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).

and veterinary

3

Amendment 4

Amendment 4

Proposal for a regulation

Proposal for a regulation

Recital 6 a (new)

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

Text proposed by the Commission

Amendment

Amendment

(6a)

(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.

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

Amendment 5

Proposal for a regulation

Proposal for a regulation

Recital 6 b (new)

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

Text proposed by the Commission

Amendment

Amendment

(6b)

(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.

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

Amendment 6

Proposal for a regulation

Proposal for a regulation

Recital 6 c (new)

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

Text proposed by the Commission

Amendment

Amendment

(6c)

(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.

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

Amendment 7

Proposal for a regulation

Proposal for a regulation

Recital 6 d (new)

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

Text proposed by the Commission

Amendment

Amendment

(6d)

(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.

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

Amendment 8

Proposal for a regulation

Proposal for a regulation

Recital 6 e (new)

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

Text proposed by the Commission

Amendment

Amendment

(6e)

(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.

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

Amendment 9

Proposal for a regulation

Proposal for a regulation

Article 1 — point 2 a (new)

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

Present text

Amendment

Amendment

(2a)

(2a)

In Article 1, the second paragraph is replaced by the following:

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).

---