CELEX: 22020D0065
Language: en
Date: 2018-03-23 00:00:00
Title: Decision of the EEA Joint Committee No 48/2018 of 23 March 2018 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2020/65]

30.1.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 26/26
               
            
         DECISION OF THE EEA JOINT COMMITTEE
         No 48/2018
         of 23 March 2018
         amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2020/65]
         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 Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (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 is inserted after point 15qd (Commission Delegated Regulation (EU) No 1252/2014) of Chapter XIII of Annex II to the EEA Agreement:
            
                        ‘15qe.
                     
                     
                        
                           32017 L 1572: Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 238, 16.9.2017, p. 44).
                        The provisions of the Directive shall, for the purposes of this Agreement, be read with the following adaptation:
                        
                                     
                                 
                                 
                                    The inspections in Liechtenstein shall be performed by the Swiss inspectorate on behalf of Liechtenstein on the basis of the agreement between Swissmedic and Amt für Gesundheit (Verwaltungsvereinbarung betreffend Inspektionen).’
                                 
                              
                  
         
            Article 2
            The text of Directive (EU) 2017/1572 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 24 March 2018, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).
         
         
            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, 23 March 2018.
            
               
                  For the EEA Joint Committee
               
               
                  The President
               
               Claude MAERTEN
            
         
         
            (1)  OJ L 238, 16.9.2017, p. 44.
         
            (*1)  Constitutional requirements indicated.