EN Official Journal of the European Union L 105/15

COUNCIL DECISION (EU) 2017/715

of 27 March 2017

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement (Paediatric Regulation)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.

(2) Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement.

(3) Regulation (EC) No 1901/2006 of the European Parliament and of the Council (3) is to be incorporated into the EEA Agreement.

(4) Regulation (EC) No 1902/2006 of the European Parliament and of the Council (4) is to be incorporated into the EEA Agreement.

(5) Regulation (EC) No 469/2009 of the European Parliament and of the Council (5) is to be incorporated into the EEA Agreement.

(6) Commission Regulation (EU) No 488/2012 (6) is to be incorporated into the EEA Agreement.

(7) Regulation (EC) No 469/2009 repeals Council Regulation (EEC) No 1768/92 (7), which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.

(8) Commission Regulation (EC) No 658/2007 (8) lays down rules concerning the application of financial penalties to the holders of marketing authorisations granted under Regulation (EC) No 726/2004. Once the Commission has granted a marketing authorisation, the EFTA States should simultaneously take corresponding decisions within 30 days from the grant. Due to the special circumstances, namely, that the Commission grants marketing authorisations, that the infringements affect the Union and its interests, and the complex and technical nature of the infringement procedures, the EFTA Surveillance Authority should cooperate closely with the Commission and await the Commission's assessment and proposal for action before taking a decision regarding the application of financial penalties to the holders of marketing authorisations established in an EFTA State.

(9) Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement should therefore be amended accordingly.

(10) The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted, on behalf of the Union within the EEA Joint Committee, on the proposed amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 27 March 2017. For the Council The President C. ABELA

(1) OJ L 305, 30.11.1994, p. 6.

(2) OJ L 1, 3.1.1994, p. 3.

(3) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).

(4) Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation (EC) No 1901/2006 on medicinal products for paediatric use (OJ L 378, 27.12.2006, p. 20).

(5) Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).

(6) Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Commission Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 150, 9.6.2012, p. 68).

(7) OJ L 182, 2.7.1992, p. 1.

(8) Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10).