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
Date: 2013-06-04
Institutions: European Commission
Subjects: Australia, Japan, Switzerland, health control, import (EU), medicinal product, public health








L_2013152EN.01005201.xml










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’