Commission Regulation (EU) No 301/2011

of 28 March 2011

amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products1, and in particular Article 12 thereof,

Whereas:

(1)
According to Article 67(3) of 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 Agency2, the revenue of the European Medicines Agency (hereinafter ‘the Agency’) consists of a contribution from the Union and fees paid by undertakings to the Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.
(2)

Article 12 of Regulation (EC) No 297/95 requires that the fees of the Agency be updated each year by reference to the inflation rate.

(3)

Those fees should therefore be updated by reference to the inflation rate of 2010. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 2,1 % in 2010.

(4)

For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.

(5)

Regulation (EC) No 297/95 should therefore be amended accordingly.

(6)

For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2011.

(7)

Pursuant to Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2011. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,

HAS ADOPTED THIS REGULATION: