CELEX: 32013D0262
Language: en
Date: 2013-06-04 00:00:00
Title: 2013/262/EU: Commission Implementing Decision of 4 June 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union  Text with EEA relevance

5.6.2013   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 152/52
            
         COMMISSION IMPLEMENTING DECISION
   of 4 June 2013
   amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union
   (Text with EEA relevance)
   (2013/262/EU)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (1), and in particular Article 111b(1) thereof,
   Whereas:
   
               (1)
            
            
               In accordance with Article 111b(1) of Directive 2001/83/EC a third country may request the Commission to assess whether its regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health.
            
         
               (2)
            
            
               Japan requested, by letter dated 6 December 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. The equivalence assessment by the Commission confirmed that the requirements of that Article were fulfilled.
            
         
               (3)
            
            
               Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (2) should be amended accordingly,
            
         HAS ADOPTED THIS DECISION:
   Article 1
   The Annex to Implementing Decision 2012/715/EU is replaced by the text set out in the Annex to this Decision.
   Article 2
   This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   
      Done at Brussels, 4 June 2013.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 311, 28.11.2001, p. 67.
   
      (2)  OJ L 325, 23.11.2012, p. 15.
   
      ANNEX
      
         
            ‘ANNEX
            
                        Third country
                     
                     
                        Remarks
                     
                  
                        Australia
                     
                     
                         
                     
                  
                        Japan
                     
                     
                         
                     
                  
                        Switzerland’