Legalize2012/715/EU: 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
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 exported to the Union and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union
| Third country | Remarks |
|---|---|
| Australia | |
| Brazil | |
| Canada | |
| Israel [^E0002] | |
| Japan | |
| South Korea | |
| Switzerland | |
| Taiwan [^E0003] | |
| United States |
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.
This Decision should not be interpreted as reflecting any official position of the European Union with regard to the legal status of Taiwan.
[^E0001]: (*1) This Decision should not be interpreted as reflecting any official position of the European Union with regard to the legal status of Taiwan.
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