Commission Regulation (EC) No 249/2009 of 23 March 2009 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
Commission Regulation (EC) No 249/2009of 23 March 2009amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rateTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,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 ProductsOJ L 35, 15.2.1995, p. 1., and in particular Article 12 thereof,Whereas:(1)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 AgencyOJ L 136, 30.4.2004, p. 1., stipulates that the revenue of the European Medicines Agency (hereinafter the Agency) shall consist of a contribution from the Community 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 lays down that the Commission shall review the fees of the Agency by reference to the inflation rate and update them, with effect from 1 April of each year.(3)Those fees should therefore be updated by reference to the inflation rate of 2008. The inflation rate in the Community, as published by the Statistical Office of the European Communities (Eurostat), was 3,7 % in 2008.(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 for legal certainty this Regulation should not apply to valid applications which are pending on 1 April 2009.(7)Pursuant to Article 12 of Regulation (EC) No 297/95 the update has to be made with effect from 1 April 2009. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,HAS ADOPTED THIS REGULATION: