Commission Implementing Decision (EU) 2019/769
of 14 May 2019
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)
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 use1, and in particular Article 111b(1) thereof,
Whereas:
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.
The Republic of Korea requested, by letter dated 22 January 2015, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. On the basis of a review of relevant documentation and two on-site reviews, and taking due account of the action plan proposed by the Korean competent authorities, the Ministry of Food and Drug Safety, on 12 February 2019, the equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled.
Commission Implementing Decision 2012/715/EU2 should be amended accordingly,
HAS ADOPTED THIS DECISION: