Attachment

THE EEA JOINT COMMITTEE,

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

Whereas:

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^f1 is to be incorporated into the EEA Agreement.

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^f2 is to be incorporated into the EEA Agreement.

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 (Codified version)^f3 is to be incorporated into the EEA Agreement.

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^f4, as corrected by OJ L 338, 12.12.2012, p. 44, is to be incorporated into the EEA Agreement.

Regulation (EC) No 469/2009 repeals Council Regulation (EEC) No 1768/92^f5, which has been incorporated into the EEA Agreement and which is therefore to be repealed under the EEA Agreement.

Commission Regulation (EC) No 658/2007 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, notably 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 financial penalties to the holders of marketing authorisations established in an EFTA State.

Annexes II and XVII to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION: