Commission Regulation (EU) 2023/699 of 29 March 2023 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 2023 (Text with EEA relevance)
Commission Regulation (EU) 2023/699of 29 March 2023amending 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 2023(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 paragraph, 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 2022. The inflation rate in the Union, as published by the Statistical Office of the European Unionhttps://ec.europa.eu/eurostat/documents/2995521/15725179/2-18012023-AP-EN.pdf/e301db8f-984c-27e2-1245-199a89f37bca, was 10,4% in 2022.(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 2023.(6)In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2023. 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 313200" is replaced by "EUR 345800";in the second subparagraph, "EUR 31500" is replaced by "EUR 34800";in the third subparagraph, "EUR 7800" is replaced by "EUR 8600";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 121500" is replaced by "EUR 134100";in the second subparagraph, "EUR 202500" is replaced by "EUR 223600";in the third subparagraph, "12100" is replaced by "EUR 13400";in the fourth subparagraph, "EUR 7800" is replaced by "EUR 8600";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 94000" is replaced by "EUR 103800";in the second subparagraph, "EUR 23700 to EUR 70600" is replaced by "EUR 26200 to EUR 77900";in the third subparagraph, "EUR 7800" is replaced by "EUR 8600";(b)paragraph 2 is amended as follows:(i)in point (a), the first subparagraph is amended as follows:"EUR 3500" is replaced by "EUR 3900";"EUR 7800" is replaced by "EUR 8600";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 94000" is replaced by "EUR 103800";in the second subparagraph, "EUR 23700 to EUR 70600" is replaced by "EUR 26200 to EUR 77900";(c)in paragraph 3, "EUR 15400" is replaced by "EUR 17000";(d)in paragraph 4, first subparagraph, "EUR 23700" is replaced by "EUR 26200";(e)in paragraph 5, "EUR 7800" is replaced by "EUR 8600";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 112200" is replaced by "EUR 123900";(ii)in the second subparagraph, " EUR 27900 to EUR 84100" is replaced by "EUR 30800 to EUR 92800";(2)in Article 4, first paragraph, "EUR 77900" is replaced by "EUR 86000";(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 156700" is replaced by "EUR 173000";in the second subparagraph, "EUR 15400" is replaced by "EUR 17000";in the third subparagraph, "EUR 7800" is replaced by "EUR 8600";the fourth subparagraph is amended as follows:"EUR 77900" is replaced by "EUR 86000";"EUR 7800" is replaced by "EUR 8600";(ii)point (b) is amended as follows :in the first subparagraph, "EUR 77900" is replaced by "EUR 86000";in the second subparagraph, "EUR 132400" is replaced by "EUR 146200";in the third subparagraph, "EUR 15400" is replaced by "EUR 17000";in the fourth subparagraph, "EUR 7800" is replaced by "EUR 8600";the fifth subparagraph is amended as follows:"EUR 39200" is replaced by "EUR 43300";"EUR 7800" is replaced by "EUR 8600";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 39200" is replaced by "EUR 43300";in the second subparagraph, " EUR 9700 to EUR 29500" is replaced by "EUR 10700 to EUR 32600";in the third subparagraph, "EUR 7800" is replaced by "EUR 8600";(b)paragraph 2 is amended as follows:(i)in point (a), the first subparagraph is amended as follows:"EUR 3500" is replaced by "EUR 3900";"EUR 7800" is replaced by "EUR 8600";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 46900" is replaced by "EUR 51800";in the second subparagraph, "EUR 11800 to EUR 35400" is replaced by "EUR 13000 to EUR 39100";in the third subparagraph, "EUR 7800" is replaced by "EUR 8600";(c)in paragraph 3, "EUR 7800" is replaced by "EUR 8600";(d)in paragraph 4, first subparagraph, "EUR 23700" is replaced by "EUR 26200";(e)in paragraph 5, "EUR 7800" is replaced by "EUR 8600";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 37600" is replaced by "EUR 41500";(ii)in the second subparagraph, "EUR 9200 to EUR 27900" is replaced by "EUR 10200 to EUR 30800";(4)in Article 6, first paragraph, "EUR 46900" is replaced by "EUR 51800";(5)Article 7 is amended as follows:(a)in the first paragraph, "EUR 77900" is replaced by "EUR 86000";(b)in the second paragraph, "EUR 23700" is replaced by "EUR 26200";(6)Article 8 is amended as follows:(a)paragraph 1 is amended as follows:(i)in the second subparagraph, "EUR 94000" is replaced by "EUR 103800";(ii)in the third subparagraph, "EUR 46900" is replaced by "EUR 51800";(iii)in the fourth subparagraph, "EUR 23700 to EUR 70600" is replaced by "EUR 26200 to EUR 77900";(iv)in the fifth subparagraph, "EUR 11800 to EUR 35400" is replaced by "EUR 13000 to EUR 39100";(b)paragraph 2 is amended as follows:(i)in the second subparagraph, "EUR 313200" is replaced by "EUR 345800";(ii)in the third subparagraph, "EUR 156700" is replaced by "EUR 173000";(iii)in the fifth subparagraph, "EUR 3500 to EUR 269900" is replaced by "EUR 3900 to EUR 298000";(iv)in the sixth subparagraph, "EUR 3500 to EUR 135100" is replaced by "EUR 3900 to EUR 149200";(c)in paragraph 3, first subparagraph, "EUR 7800" is replaced by "EUR 8600".Article 2This Regulation shall not apply to valid applications pending on 1 April 2023.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 2023.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 29 March 2023.For the CommissionThe PresidentUrsula von der Leyen