CELEX: 22021D1505
Language: en
Date: 2018-12-05 00:00:00
Title: Decision of the EEA Joint Committee No 238/2018 of 5 December 2018 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2021/1505]

23.9.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 337/30
               
            
         DECISION OF THE EEA JOINT COMMITTEE No 238/2018
         of 5 December 2018
         amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2021/1505]
         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 Regulation (EU) 2018/781 of 29 May 2018 amending Regulation (EC) No 847/2000 as regards the definition of the concept ‘similar medicinal product’ (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 added in point 15n (Commission Regulation (EC) No 847/2000) of Chapter XIII of Annex II to the EEA Agreement:
            ‘, as amended by:
            
                        —
                     
                     
                        
                           32018 R 0781: Commission Regulation (EU) 2018/781 of 29 May 2018 (OJ L 132, 30.5.2018, p. 1).’
                     
                  
         
            Article 2
            The text of Commission Regulation (EU) 2018/781 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 6 December 2018, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*).
         
         
            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, 5 December 2018.
            
               
                  For the EEA Joint Committee
               
               
                  The President
               
               Oda Helen SLETNES
            
            
               
                  The Secretaries
               
               
                  To the EEA Joint Committee
               
               Hege M. HOFF
               Mikołaj KARŁOWSKI
            
         
         
            (1)  OJ L 132, 30.5.2018, p. 1.
         
            (*)  No constitutional requirements indicated.