CELEX: 22015D2130
Language: en
Date: 2014-12-12 00:00:00
Title: Decision of the EEA Joint Committee No 263/2014 of 12 December 2014 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2015/2130]

26.11.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 311/13
            
         DECISION OF THE EEA JOINT COMMITTEE
   No 263/2014
   of 12 December 2014
   amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2015/2130]
   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 Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required (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 15qb (Commission Implementing Decision 2012/715/EU) of Chapter XIII of Annex II to the EEA Agreement:
   
               ‘15qc.
            
            
               
                  32014 R 0357: Commission Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required (OJ L 107, 10.4.2014, p. 1).’
            
         Article 2
   The text of Delegated Regulation (EU) No 357/2014 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 13 December 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, 12 December 2014.
      
         
            For the EEA Joint Committee
         
         
            The President
         
         Kurt JÄGER
      
   
   
      (1)  OJ L 107, 10.4.2014, p. 1.
   
      (2)  No constitutional requirements indicated.