Decision of the EEA Joint Committee No 129/2009 of 4 December 2009 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
Date: 2009-12-04
Institutions: EEA Joint Committee
Subjects: European Medicines Agency, drug surveillance, economic sanctions, infringement procedure (EU), market approval, medicinal product, veterinary drug




L_2010062EN.01001801.xml










11.3.2010   


EN


Official Journal of the European Union


L 62/18








            DECISION OF THE EEA JOINT COMMITTEE
         
No 129/2009
of 4 December 2009
         
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, as amended by the Protocol adjusting the Agreement on the European Economic Area, hereinafter referred to as ‘the Agreement’, and in particular Article 98 thereof,

Whereas:







(1)


Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 62/2009 of 29 May 2009 (1).












(2)


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 (2) is to be incorporated into the Agreement,





HAS DECIDED AS FOLLOWS:



Article 1
The following point shall be inserted after point 15zi (Commission Regulation (EC) No 1234/2008) of Chapter XIII of Annex II to the Agreement:






‘15zj.



32007 R 0658: 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).
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
The right to impose financial penalties on the holders of marketing authorisations in accordance with Article 84(3) of Regulation (EC) No 726/2004 shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by that EFTA State based on a proposal of the European Commission.’
                        






Article 2
The text of Regulation (EC) No 658/2007 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 5 December 2009, provided that all the notifications under Article 103(1) of the Agreement have been made to the EEA Joint Committee (*1), or on the date of entry into force of Decision of the EEA Joint Committee No 61/2009 of 29 May 2009, 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, 4 December 2009.


For the EEA Joint Committee


The President

Oda Helen SLETNES
            





(1)  
            OJ L 232, 3.9.2009, p. 18.

(2)  
            OJ L 155, 15.6.2007, p. 10.

(*1)  Constitutional requirements indicated.