02012D0715 — EN — 04.06.2019 — 004.001

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Amended by:

▼B

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.

▼M5

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