Commission Regulation (EC) No 312/2008 of 3 April 2008 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 312/2008of 3 April 2008amending 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. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, 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. Regulation as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 10.12.2007, p. 121)., 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.(3)Since 2005, the fees of the Agency have not been adjusted to the inflation rate. It is therefore necessary to review those fees by reference to the inflation rate in the Community in the years 2006 and 2007.(4)The inflation rate in the Community, as published by the Statistical Office of the European Communities (Eurostat), was 2,2 % in 2006 and 2,3 % in 2007.(5)For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.(6)Regulation (EC) No 297/95 should therefore be amended accordingly.(7)For reasons for legal certainty this Regulation should not apply to valid applications which are pending on 1 April 2008.(8)Pursuant to Article 12 of Regulation (EC) No 297/95 the update has to be made with effect from 1 April 2008, it is therefore appropriate that this Regulation enter into force as a matter of urgency and apply from that date,HAS ADOPTED THIS REGULATION: