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,

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’ | * * *