Considerations on COM(2017)13 - EU position concerning an amendment to Annexes II and XVII to the EEA Agreement (Paediatric Regulation)

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dossier COM(2017)13 - EU position concerning an amendment to Annexes II and XVII to the EEA Agreement (Paediatric Regulation).
document COM(2017)13 EN
date March 27, 2017
 
table>(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Regulation (EEC) No 1768/92 (7), which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.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,