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Document 02012D0715-20190604
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02012D0715 — EN — 04.06.2019 — 004.001
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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 |
page |
date |
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COMMISSION IMPLEMENTING DECISION 2013/196/EU of 24 April 2013 |
L 113 |
22 |
25.4.2013 |
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L 152 |
52 |
5.6.2013 |
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COMMISSION IMPLEMENTING DECISION 2013/301/EU of 11 June 2013 |
L 169 |
71 |
21.6.2013 |
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COMMISSION IMPLEMENTING DECISION (EU) 2015/1057 Text with EEA relevance of 1 July 2015 |
L 171 |
23 |
2.7.2015 |
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COMMISSION IMPLEMENTING DECISION (EU) 2019/769 Text with EEA relevance of 14 May 2019 |
L 126 |
70 |
15.5.2019 |
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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)
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
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
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Third country |
Remarks |
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Australia |
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Brazil |
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Israel (1) |
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Japan |
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Republic of Korea |
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Switzerland |
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United States of America |
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(1) Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank. |
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