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.

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.

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 Council2 should be amended accordingly,