CELEX: 22013D0161
Language: en
Date: 2013-10-08 00:00:00
Title: Decision of the EEA Joint Committee No 161/2013 of 8 October 2013 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

27.2.2014   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 58/14
            
         
      DECISION OF THE EEA JOINT COMMITTEE
   
   No 161/2013
   of 8 October 2013
   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 (‘the EEA Agreement’), and in particular Article 98 thereof,
   Whereas:
   
               (1)
            
            
               Commission Implementing Decision 2013/51/EU of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council (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 15q (Directive 2001/83/EC of the European Parliament and of the Council) of Chapter XIII of Annex II to the EEA Agreement:
   
               ‘15qa.
            
            
               
                  32013 D 0051: Commission Implementing Decision 2013/51/EU of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council (OJ L 21, 24.1.2013, p. 36).’
            
         Article 2
   The text of Implementing Decision 2013/51/EU 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 9 October 2013, 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, 8 October 2013.
      
         
            For the EEA Joint Committee
         
         
            The President
         
         Thórir IBSEN
         
      
   
   
      (1)  OJ L 21, 24.1.2013, p. 36.
   
      (2)  No constitutional requirements indicated.