# 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)

EU Decision 2013/262 · adopted 4 June 2013

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)

## Introductory text

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,
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,
HAS ADOPTED THIS DECISION:

## 1 

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

## 2 

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

## Signature

Done at Brussels, 4 June 2013.
For the Commission
The President
José Manuel Barroso

## 

ANNEX
Third country
Remarks
Australia
Japan
Switzerland

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Source: https://www.legislation.gov.uk/eudn/2013/262 (the official version)
Page: https://openlegislation.uk/eu-decision-2013-262
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.