# Commission Implementing Decision (EU) 2015/1057Show full title

Commission Implementing Decision (EU) 2015/1057 of 1 July 2015 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)         

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U.K.

# Commission Implementing Decision (EU) 2015/1057                     

# of 1 July 2015

# 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)

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)Israel requested, by letter dated 9 May 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. The                              equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled. In exercising this                              equivalence assessment, account was taken of the agreement on conformity assessment and acceptance of industrial products(2), as referred to in Article 51(2) of that Directive, between Israel and the Union.

(3)Brazil requested, by letter dated 4 October 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC.                              On the basis of a review of relevant documentation and two on-site reviews, and taking due account of the action plan proposed                              by Brazil on 12 March 2015, the equivalence assessment by the Commission concluded that the requirements of that Article were                              fulfilled.

(4)Commission Implementing Decision 2012/715/EU(3) should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

# Article 1U.K.

The Annex to Implementing Decision 2012/715/EU is replaced by the text set out in the Annex to this Decision.

# Article 2U.K.

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, 1 July 2015.

*For the Commission*                            

*The President*                            

Jean-Claude Juncker                            

## ANNEXU.K.

### “‘ANNEX

#### **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**

1

OJ L 311, 28.11.2001, p. 67.                           

2

Council Decision 2013/1/EU of 20 November 2012 on the conclusion of a Protocol to the Euro-Mediterranean Agreement establishing                              an association between the European Communities and their Member States, of the one part, and the State of Israel, of the                              other part, on Conformity Assessment and Acceptance of Industrial Products (CAA) (OJ L 1, 4.1.2013, p. 1).                           

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 (OJ L 325, 23.11.2012, p. 15).