ddrg/super_eurlex huggingface dataset:
2.

Point 15q (Directive 2001/83/EC of the European Parliament and of the Council) shall be amended as follows: (i) The following indent is added: ‘— 32010 L 0084: Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 74), as corrected by OJ L 21, 25.1.2011, p. 8 and OJ L 276, 21.10.2011, p. 63.’ (ii) The adaptation text is replaced by the following: ‘The provisions of the Directive shall, for the purposes of this Agreement, be read with the following adaptations: (a) Liechtenstein shall not be obliged to participate in the decentralised procedure (DCP) and in the mutual recognition procedure (MRP) and shall, therefore, not be obliged to issue the corresponding marketing authorisations. Instead, Austrian marketing authorisations within the DCP and the MRP shall be valid for Liechtenstein upon request of a marketing authorisation applicant. (b) The EFTA States may initiate the urgent Union procedure pursuant to Section 4 of Chapter 3 of Title IX of the Directive. (c) With respect to Title IX, the obligations of Liechtenstein will be executed by Austria. Liechtenstein will however, as far as applicable to Liechtenstein: — operate a pharmacovigilance system in accordance with Article 101(1); — perform a regular audit of its pharmacovigilance system in accordance with Article 101(2); — designate a competent authority for the performance of its pharmacovigilance tasks in accordance with Article 101(3), — take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the national competent authority in accordance with Article 102(a); — facilitate patient reporting through the provision of alternative reporting formats in addition to web-based formats in accordance with Article 102(b); — impose an obligation on a marketing authorisation holder to operate a risk management system, as referred to in Article 104(3)(c), if there are concerns about the risks affecting the risk-benefit balance of an authorised medicinal product in accordance with Article 104a(2). For the imposition of such obligation Liechtenstein will base itself on a corresponding decision of the Austrian authorities; — set up and maintain a national medicines web-portal which shall be linked to the European medicines web-portal in accordance with Article 106; — record all suspected adverse reactions that occur in its territory which are brought to its attention from healthcare professionals and patients and ensure that reports of such reactions may be submitted by means of the national medicines web-portals or by other means in accordance with Article 107a(1), and — submit reports in accordance with Article 107a(4). (d) The following subparagraph shall be added to Article 107c(5): “Swiss marketing authorisation for a medicinal product taking effect in Liechtenstein by virtue of Liechtenstein law on the basis of the Customs Union between the Principality of Liechtenstein and the Swiss Confederation shall not be considered as a first authorisation to place a product on the market for the purposes of this paragraph.” ’
EN Official Journal of the European Union L 92/14

DECISION OF THE EEA JOINT COMMITTEE

No 188/2013

of 8 November 2013

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Regulation (EU) No 244/2013 of 19 March 2013 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Tricalcium phosphate (E 341 (iii)) in nutrient preparations intended for use in foods for infants and young children (1) is to be incorporated into the EEA Agreement.

(2) Commission Regulation (EU) No 256/2013 of 20 March 2013 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Sodium ascorbate (E 301) in vitamin D preparations intended for use in foods for infants and young children (2) is to be incorporated into the EEA Agreement.

(3) This Decision concerns legislation regarding foodstuffs. Legislation regarding foodstuffs shall not apply to Liechtenstein as long as the application of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein, as specified in the introduction to Chapter XII of Annex II to the EEA Agreement. This Decision is therefore not to apply to Liechtenstein.

(4) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following indents are added in point 54zzzzr (Regulation (EC) No 1333/2008 of the European Parliament and of the Council) of Chapter XII of Annex II to the EEA Agreement:

‘— 32013 R 0244: Commission Regulation (EU) No 244/2013 of 19 March 2013 (OJ L 77, 20.3.2013, p. 3),

— 32013 R 0256: Commission Regulation (EU) No 256/2013 of 20 March 2013 (OJ L 79, 21.3.2013, p. 24).’

Article 2

The texts of Regulations (EU) No 244/2013 and (EU) No 256/2013 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 9 November 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (3).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 8 November 2013. For the EEA Joint Committee The President Thórir IBSEN

(1) OJ L 77, 20.3.2013, p. 3.

(2) OJ L 79, 21.3.2013, p. 24.

(3) No constitutional requirements indicated.
EN Official Journal of the European Union L 92/32

DECISION OF THE EEA JOINT COMMITTEE

No 206/2013

of 8 November 2013

amending Annex XV (State Aid) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Council Regulation (EC) No 1540/98 (1), which is incorporated into the EEA Agreement, expired on 31 December 2003 and consequently the reference thereto should be deleted from the EEA Agreement.

(2) Council Regulation (EC) No 1177/2002 (2), which is incorporated into the EEA Agreement, expired on 31 March 2005, following the extension of its validity by Council Regulation (EC) No 502/2004 (3), and consequently the reference thereto should be deleted from the EEA Agreement.

(3) Commission Decision No 2496/96/ECSC (4), which is incorporated into the EEA Agreement, expired on 22 July 2002 and consequently the reference thereto should be deleted from the EEA Agreement.

(4) Annex XV to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The text of points 1aa (Commission Decision No 2496/96/ECSC), 1b (Council Regulation (EC) No 1540/98) and 1ca (Council Regulation (EC) No 1177/2002) of Annex XV to the EEA Agreement is deleted.

Article 2

This Decision shall enter into force on 9 November 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (5).

Article 3

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 8 November 2013. For the EEA Joint Committee The President Thórir IBSEN

(1) OJ L 202, 18.7.1998, p. 1.

(2) OJ L 172, 2.7.2002, p. 1.

(3) OJ L 81, 19.3.2004, p. 6.

(4) OJ L 338, 28.12.1996, p. 42.

(5) No constitutional requirements indicated.
EN Official Journal of the European Union L 154/21

DECISION OF THE EEA JOINT COMMITTEE

No 224/2013

of 13 December 2013

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area ‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Directive 2013/27/EU of 17 May 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include chlorfenapyr as an active substance in Annex I thereto (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following indent is added in point 12n (Directive 98/8/EC of the European Parliament and of the Council) of Chapter XV of Annex II to the EEA Agreement:

‘— 32013 L 0027: Commission Directive 2013/27/EU of 17 May 2013 (OJ L 135, 22.5.2013, p. 10).’

Article 2

The text of Directive 2013/27/EU in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 14 December 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 13 December 2013. For the EEA Joint Committee The President Thórir IBSEN

(1) OJ L 135, 22.5.2013, p. 10.

(2) No constitutional requirements indicated.
EN Official Journal of the European Union L 154/24

DECISION OF THE EEA JOINT COMMITTEE

No 226/2013

of 13 December 2013

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Directive 2012/4/EU of 22 February 2012 amending Directive 2008/43/EC setting up, pursuant to Council Directive 93/15/EEC, a system for the identification and traceability of explosives for civil uses (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following is added in point 5 (Commission Directive 2008/43/EC) of Chapter XXIX of Annex II to the EEA Agreement:

‘, as amended by:

— 32012 L 0004: Commission Directive 2012/4/EU of 22 February 2012 (OJ L 50, 23.2.2012, p. 18).’

Article 2

The texts of Directive 2012/4/EU in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 14 December 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 13 December 2013. For the EEA Joint Committee The President Thórir IBSEN

(1) OJ L 50, 23.2.2012, p. 18.

(2) Constitutional requirements indicated.
EN Official Journal of the European Union L 58/15

DECISION OF THE EEA JOINT COMMITTEE

No 162/2013

of 8 October 2013

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following point is inserted after point 15qa (Commission Implementing Decision 2013/51/EU) of Chapter XIII of Annex II to the EEA Agreement:

‘15qb. 32012 D 0715: Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (OJ L 325, 23.11.2012, p. 15).’

Article 2

The texts of Implementing Decision 2012/715/EU in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 9 October 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 8 October 2013. For the EEA Joint Committee The President Thórir IBSEN

(1) OJ L 325, 23.11.2012, p. 15.

(2) No constitutional requirements indicated.
EN Official Journal of the European Union L 154/38

DECISION OF THE EEA JOINT COMMITTEE

No 235/2013

of 13 December 2013

amending Annex XIII (Transport) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) No 657/2013 of 10 July 2013 amending Implementing Regulation (EU) No 1079/2012 laying down requirements for voice channels spacing for the single European sky (1) is to be incorporated into the EEA Agreement.

(2) Annex XIII to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following is added in point 66we (Commission Implementing Regulation (EU) No 1079/2012) of Annex XIII to the EEA Agreement:

‘, as amended by:

— 32013 R 0657: Commission Implementing Regulation (EU) No 657/2013 of 10 July 2013 (OJ L 190, 11.7.2013, p. 37).’

Article 2

The text of Implementing Regulation (EU) No 657/2013 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 14 December 2013, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2), or on the day of the entry into force of Decision of the EEA Joint Committee No 233/2013 of 13 December 2013 (3), whichever is the later.

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 13 December 2013. For the EEA Joint Committee The President Thórir IBSEN

(1) OJ L 190, 11.7.2013, p. 37.

(2) No constitutional requirements indicated.

(3) See page 36 of this Official Journal.
EN Official Journal of the European Union L 211/1

DECISION OF THE EEA JOINT COMMITTEE

No 1/2014

of 14 February 2014

amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Decision 2013/261/EU of 3 June 2013 authorising a laboratory in Ukraine to carry out serological tests to monitor the effectiveness of rabies vaccines (1) is to be incorporated into the EEA Agreement.

(2) This Decision concerns legislation regarding live animals other than fish and aquaculture animals. Legislation concerning these matters shall not apply to Iceland, as specified in paragraph 2 of the Introductory Part of Chapter I of Annex I to the EEA Agreement. This Decision is therefore not to apply to Iceland.

(3) This Decision concerns legislation regarding veterinary matters. Legislation regarding veterinary matters shall not apply to Liechtenstein as long as the application of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein, as specified in the sectoral adaptations to Annex I to the EEA Agreement. This Decision is therefore not to apply to Liechtenstein.

(4) Annex I to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following point is inserted after point 97 (Commission Implementing Decision 2011/396/EU) in Part 4.2 of Chapter I of Annex I to the EEA Agreement:

‘98. 32013 D 0261: Commission Implementing Decision 2013/261/EU of 3 June 2013 authorising a laboratory in Ukraine to carry out serological tests to monitor the effectiveness of rabies vaccines (OJ L 152, 5.6.2013, p. 50). This act shall not apply to Iceland.’

Article 2

The text of Implementing Decision 2013/261/EU in the Norwegian language, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 15 February 2014, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 14 February 2014. For the EEA Joint Committee The President Gianluca GRIPPA

(1) OJ L 152, 5.6.2013, p. 50.

(2) No constitutional requirements indicated.
EN Official Journal of the European Union L 310/37

DECISION OF THE EEA JOINT COMMITTEE

No 84/2014

of 16 May 2014

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Decision 2013/121/EU of 7 March 2013 on the safety requirements to be met by European standards for certain seats for children pursuant to Directive 2001/95/EC of the European Parliament and of the Council on general product safety (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following point is inserted after point 3r (Commission Decision 2011/477/EU) of Chapter XIX of Annex II to the EEA Agreement:

‘3s. 32013 D 0121: Commission Decision 2013/121/EU of 7 March 2013 on the safety requirements to be met by European standards for certain seats for children pursuant to Directive 2001/95/EC of the European Parliament and of the Council on general product safety (OJ L 65, 8.3.2013, p. 23).’

Article 2

The texts of Decision 2013/121/EU in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 17 May 2014, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 16 May 2014. For the EEA Joint Committee The President Gianluca GRIPPA

(1) OJ L 65, 8.3.2013, p. 23.

(2) No constitutional requirements indicated.
EN Official Journal of the European Union L 256/40

DECISION OF THE EEA JOINT COMMITTEE

No 61/2014

of 10 April 2014

amending Annex XX (Environment) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Regulation (EU) No 206/2014 of 4 March 2014 amending Regulation (EU) No 601/2012 as regards global warming potentials for non-CO2 greenhouse gases (1) is to be incorporated into the EEA Agreement.

(2) Annex XX to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following is added in point 21apg (Commission Regulation (EU) No 601/2012) of Annex XX to the EEA Agreement:

‘, as amended by:

— 32014 R 0206: Commission Regulation (EU) No 206/2014 of 4 March 2014 (OJ L 65, 5.3.2014, p. 27).’.

Article 2

The text of Regulation (EU) No 206/2014 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 11 April 2014, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 10 April 2014. For the EEA Joint Committee The President Gianluca GRIPPA

(1) OJ L 65, 5.3.2014, p. 27.

(2) No constitutional requirements indicated.
EN Official Journal of the European Union L 310/34

DECISION OF THE EEA JOINT COMMITTEE

No 81/2014

of 16 May 2014

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) No 1235/2013 of 2 December 2013 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance diclazuril (1) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following indent is added in point 13 (Commission Regulation (EU) No 37/2010) of Chapter XIII of Annex II to the EEA Agreement:

‘— 32013 R 1235: Commission Implementing Regulation (EU) No 1235/2013 of 2 December 2013 (OJ L 322, 3.12.2013, p. 21).’

Article 2

The texts of Implementing Regulation (EU) No 1235/2013 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 17 May 2014, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (2).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 16 May 2014. For the EEA Joint Committee The President Gianluca GRIPPA

(1) OJ L 322, 3.12.2013, p. 21.

(2) No constitutional requirements indicated.