Commission Regulation (EU) 2022/510 of 29 March 2022 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2022 (Text with EEA relevance)
Commission Regulation (EU) 2022/510of 29 March 2022amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2022(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 ProductsOJ L 35, 15.2.1995, p. 1., and in particular Article 12, fifth subparagraph, thereof,Whereas:(1)In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the CouncilRegulation (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 (OJ L 136, 30.4.2004, p. 1)., the revenue of the European Medicines Agency consists of a contribution from the Union and fees paid by undertakings to that Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.(2)Those fees should be updated by reference to the inflation rate of 2020 and 2021. The inflation rate in the Union, as published by the Statistical Office of the European UnionEurostat, euroindicators 11/2022, published on 20 January 2022, was 0,3 % in 2020 and 5,3 % in 2021.(3)For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.(4)Regulation (EC) No 297/95 should therefore be amended accordingly.(5)For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2022.(6)In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2022. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,HAS ADOPTED THIS REGULATION: