Commission Implementing Decision (EU) 2015/1057 of 1 July 2015 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)
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/decision/2015/1057@2015-07-01/en
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, 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) Israel requested, by letter dated 9 May 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. The equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled. In exercising this equivalence assessment, account was taken of the agreement on conformity assessment and acceptance of industrial products, as referred to in Article 51(2) of that Directive, between Israel and the Union.
(3) Brazil requested, by letter dated 4 October 2012, 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 Brazil on 12 March 2015, the equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled.
(4) Commission Implementing Decision 2012/715/EU should therefore 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, 1 July 2015. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX
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
Third country Remarks Australia Brazil Israel Japan Switzerland United States of America