Report from the Commission. Annual report (2012-2013) on the application of Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines

This is the eighth annual report foreseen under Article 11 of Regulation (EC) No 953/2003, which is designed to prevent parallel trade in discounted medicines intended for the least developed countries. This report covers the period from 1 January 2012 to 31 December 2013.

As in previous reporting periods, the volume of sales of registered tiered priced medicines has further declined in 2012 and 2013, with a historic low sales volume in 2012. This is explained by the fact that currently fourteen licenses have been granted by the applicant for the manufacture and supply of medicines for the treatment of HIV/AIDS (ARVs), as opposed to nine in 2011.

This report is mainly based on the information received from the applicant under Article 11(1) of the Regulation.

• Primary Source

EUR-Lex: COM(2014)737: Follow the progress of this report through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2014:737:FIN

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