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, and in particular Article 111b(1) thereof,
OJ L 311, 28.11.2001, p. 67.
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 should be amended accordingly,
OJ L 325, 23.11.2012, p. 15.
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
ANNEX

‘ANNEX
Third country	Remarks
Australia	
Japan	
Switzerland	’