Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions – Amendment of the financial statement accompanying Regulation (EC) No 297/95

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, set up the European Medicines Agency (EMA). Article 67(3) of this regulation establishes that the revenue of the Agency shall consist of a contribution from the European Union, and the fees paid by the undertaking for obtaining and maintaining a Community marketing authorisation and for other services provided by the Agency.

Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the EMA sets out the different types of fees payable for services provided, including the possibility for waivers and reductions of certain fees. For neither the establishment of Regulation (EC) No 297/95 nor its amendments in 1998, 2003 and 2005 the corresponding financial statements (if applicable) provided for the human resource element required to handle fee-related applications.

The Budgetary Authority agreed to additional staff for fee-related activities in 2010. For 2011 and 2012 no additional fee-financed staffing was provided; the additional posts agreed for 2012 correspond to the implementation of the new pharmacovigilance activities only. In DB2013 the Commission agreed on an increase of the EMA establishment plan with 21 additional posts, to be financed by fees from the industry. With this Communication, the Commission wants to address the justification of this increase.

EUR-Lex: COM(2012)543: Follow the progress of this document through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2012:543:FIN

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