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:
Article 1Regulation (EC) No 297/95 is amended as follows:(1)Article 3 is amended as follows:(a)paragraph 1 is amended as follows:(i)point (a) is amended as follows:in the first subparagraph, "EUR 296500" is replaced by "EUR 313200",in the second subparagraph, "EUR 29800" is replaced by "EUR 31500",in the third subparagraph, "EUR 7400" is replaced by "EUR 7800";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 115100" is replaced by "EUR 121500",in the second subparagraph, "EUR 191700" is replaced by "EUR 202500",in the third subparagraph, "11500" is replaced by "EUR 12100",in the fourth subparagraph, "EUR 7400" is replaced by "EUR 7800";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 89000" is replaced by "EUR 94000",in the second subparagraph, "EUR 22400 to EUR 66800" is replaced by "EUR 23700 to EUR 70600",in the third subparagraph, "EUR 7400" is replaced by "EUR 7800";(b)paragraph 2 is amended as follows:(i)point (a), first subparagraph is amended as follows:"EUR 3300" is replaced by "EUR 3500","EUR 7400" is replaced by "EUR 7800";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 89000" is replaced by "EUR 94000",in the second subparagraph, "EUR 22400 to EUR 66800" is replaced by "EUR 23700 to EUR 70600";(c)in paragraph 3, "EUR 14600" is replaced by "EUR 15400";(d)in paragraph 4, first subparagraph, "EUR 22400" is replaced by "EUR 23700";(e)in paragraph 5, "EUR 7400" is replaced by "EUR 7800";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 106300" is replaced by "EUR 112200";(ii)in the second subparagraph, "EUR 26400 to EUR 79700" is replaced by "EUR 27900 to EUR 84100";(2)in Article 4, first subparagraph, "EUR 73800" is replaced by "EUR 77900";(3)Article 5 is amended as follows:(a)paragraph 1 is amended as follows:(i)point (a) is amended as follows:in the first subparagraph, "EUR 148400" is replaced by "EUR 156700",in the second subparagraph, "EUR 14600" is replaced by "EUR 15400",in the third subparagraph, "EUR 7400" is replaced by "EUR 7800",the fourth subparagraph is amended as follows:"EUR 73800" is replaced by "EUR 77900","EUR 7400" is replaced by "EUR 7800";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 73800" is replaced by "EUR 77900",in the second subparagraph, "EUR 125300" is replaced by "EUR 132400",in the third subparagraph, "EUR 14600" is replaced by "EUR 15400",in the fourth subparagraph, "EUR 7400" is replaced by "EUR 7800",the fifth subparagraph is amended as follows:"EUR 37100" is replaced by "EUR 39200","EUR 7400" is replaced by "EUR 7800";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 37100" is replaced by "EUR 39200",in the second subparagraph, "EUR 9200 to EUR 27900" is replaced by "EUR 9700 to EUR 29500",in the third subparagraph, "EUR 7400" is replaced by "EUR 7800";(b)paragraph 2 is amended as follows:(i)point (a), first subparagraph, is amended as follows:"EUR 3300" is replaced by "EUR 3500","EUR 7400" is replaced by "EUR 7800";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 44400" is replaced by "EUR 46900",in the second subparagraph, "EUR 11200 to EUR 33500" is replaced by "EUR 11800 to EUR 35400",in the third subparagraph, "EUR 7400" is replaced by "EUR 7800";(c)in paragraph 3, "EUR 7400" is replaced by "EUR 7800";(d)in paragraph 4, first subparagraph, "EUR 22400" is replaced by "EUR 23700";(e)in paragraph 5, "EUR 7400" is replaced by "EUR 7800";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 35600" is replaced by "EUR 37600";(ii)in the second subparagraph, "EUR 8700 to EUR 26400" is replaced by "EUR 9200 to EUR 27900";(4)in Article 6, first subparagraph, "EUR 44400" is replaced by "EUR 46900";(5)Article 7 is amended as follows:(a)in the first paragraph, "EUR 73800" is replaced by "EUR 77900";(b)in the second paragraph, "EUR 22400" is replaced by "EUR 23700";(6)Article 8 is amended as follows:(a)paragraph 1 is amended as follows:(i)in the second subparagraph, "EUR 89000" is replaced by "EUR 94000";(ii)in the third subparagraph, "EUR 44400" is replaced by "EUR 46900";(iii)in the fourth subparagraph, "EUR 22400 to EUR 66800" is replaced by "EUR 23700 to EUR 70600";(iv)in the fifth subparagraph, "EUR 11200 to EUR 33500" is replaced by "EUR 11800 to EUR 35400";(b)paragraph 2 is amended as follows:(i)in the second subparagraph, "EUR 296500" is replaced by "EUR 313200";(ii)in the third subparagraph, "EUR 148400" is replaced by "EUR 156700";(iii)in the fifth subparagraph, "EUR 3300 to EUR 255500" is replaced by "EUR 3500 to EUR 269900";(iv)in the sixth subparagraph, "EUR 3300 to EUR 127900" is replaced by "EUR 3500 to EUR 135100";(c)in paragraph 3, first subparagraph, "EUR 7400" is replaced by "EUR 7800".Article 2This Regulation shall not apply to valid applications pending on 1 April 2022.Article 3This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.It shall apply from 1 April 2022.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 29 March 2022.For the CommissionThe PresidentUrsula von der Leyen