EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 32013D0262
2013/262/EU: 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: 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: 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
OJ L 152, 5.6.2013, p. 52–53
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Special edition in Croatian: Chapter 15 Volume 027 P. 139 - 140
In force
- Date of document:
- 04/06/2013
- Date of effect:
- 25/06/2013; Entry into force Date pub. +20 See Art 2
- Date of end of validity:
- No end date
- Author:
- European Commission
- Responsible body:
- Directorate-General for Health and Food Safety
- Form:
- Implementing decision
- Additional information:
- EEA relevance
- Treaty:
- Treaty on the Functioning of the European Union
- Legal basis:
-
- 32001L0083 - A111TRP1
- Link
- Link
- Link
- Select all documents mentioning this document No data available in the table
- Modifies:
-
Relation Act Comment Subdivision concerned From To Modifies 32012D0715 Replacement annex 25/06/2013 - Link
- EUROVOC descriptor:
- Subject matter:
- Directory code:
|
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’ |
|
