2012D0715 — EN — 15.05.2013 — 001.001
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
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COMMISSION IMPLEMENTING DECISION 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 (Text with EEA relevance) (OJ L 325, 23.11.2012, p.15) |
Amended by:
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Official Journal |
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No |
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L 113 |
22 |
25.4.2013 |
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COMMISSION IMPLEMENTING DECISION
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
(Text with EEA relevance)
(2012/715/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. |
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(2) |
Switzerland requested, by letter dated 4 April 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. In exercising this equivalence assessment, account was taken of the agreement on mutual recognition ( 2 ) as referred to in Article 51(2) of that Directive between Switzerland and the Union, |
HAS ADOPTED THIS DECISION:
Article 1
The list of third countries referred to in Article 111b(1) of Directive 2001/83/EC is 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.
ANNEX
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Third country |
Remarks |
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Australia |
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Switzerland |
( 1 ) OJ L 311, 28.11.2001, p. 67.
( 2 ) OJ L 114, 30.4.2002, p. 369.