Commission Regulation (EU) 2020/422 of 19 March 2020 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 2020 (Text with EEA relevance)
Commission Regulation (EU) 2020/422of 19 March 2020amending 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 2020(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 the fifth paragraph of Article 12 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 2019. The inflation rate in the Union, as published by the Statistical Office of the European Unionhttps://ec.europa.eu/eurostat/documents/2995521/10159211/2-17012020-AP-EN.pdf, was 1,6 % in 2019.(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 2020.(6)In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2020. 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 291800" is replaced by "EUR 296500";in the second subparagraph, "EUR 29300" is replaced by "EUR 29800";in the third subparagraph, "EUR 7300" is replaced by "EUR 7400";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 113300" is replaced by "EUR 115100";in the second subparagraph, "EUR 188700" is replaced by "EUR 191700";in the third subparagraph, "EUR 11300" is replaced by "EUR 11500";in the fourth subparagraph, "EUR 7300" is replaced by "EUR 7400";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 87600" is replaced by "EUR 89000";in the second subparagraph, "EUR 22000 to EUR 65700" is replaced by "EUR 22400 to EUR 66800";in the third subparagraph, "EUR 7300" is replaced by "EUR 7400";(b)paragraph 2 is amended as follows:(i)the first subparagraph of point (a) is amended as follows:"EUR 3200" is replaced by "EUR 3300";"EUR 7300" is replaced by "EUR 7400";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 87600" is replaced by "EUR 89000";in the second subparagraph, "EUR 22000 to EUR 65700" is replaced by "EUR 22400 to EUR 66800";(c)in paragraph 3, "EUR 14400" is replaced by "EUR 14600";(d)in the first subparagraph of paragraph 4, "EUR 22000" is replaced by "EUR 22400";(e)in paragraph 5, "EUR 7300" is replaced by "EUR 7400";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 104600" is replaced by "EUR 106300";(ii)in the second subparagraph, "EUR 26000 to EUR 78400" is replaced by "EUR 26400 to EUR 79700";(2)in the first paragraph of Article 4, "EUR 72600" is replaced by "EUR 73800";(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 146100" is replaced by "EUR 148400";in the second subparagraph, "EUR 14400" is replaced by "EUR 14600";in the third subparagraph, "EUR 7300" is replaced by "EUR 7400";the fourth subparagraph is amended as follows:"EUR 72600" is replaced by "EUR 73800";"EUR 7300" is replaced by "EUR 7400";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 72600" is replaced by "EUR 73800";in the second subparagraph, "EUR 123300" is replaced by "EUR 125300";in the third subparagraph, "EUR 14400" is replaced by "EUR 14600";in the fourth subparagraph, "EUR 7300" is replaced by "EUR 7400";the fifth subparagraph is amended as follows:"EUR 36500" is replaced by "EUR 37100";"EUR 7300" is replaced by "EUR 7400";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 36500" is replaced by "EUR 37100";in the second subparagraph, "EUR 9100 to EUR 27500" is replaced by "EUR 9200 to EUR 27900";in the third subparagraph, "EUR 7300" is replaced by "EUR 7400";(b)paragraph 2 is amended as follows:(i)the first subparagraph of point (a) is amended as follows:"EUR 3200" is replaced by "EUR 3300";"EUR 7300" is replaced by "EUR 7400";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 43700" is replaced by "EUR 44400";in the second subparagraph, "EUR 11000 to EUR 33000" is replaced by "EUR 11200 to EUR 33500";in the third subparagraph, "EUR 7300" is replaced by "EUR 7400";(c)in paragraph 3, "EUR 7300" is replaced by "EUR 7400";(d)in the first subparagraph of paragraph 4, "EUR 22000" is replaced by "EUR 22400";(e)in paragraph 5, "EUR 7300" is replaced by "EUR 7400";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 35000" is replaced by "EUR 35600";(ii)in the second subparagraph, "EUR 8600 to EUR 26000" is replaced by "EUR 8700 to EUR 26400";(4)in the first paragraph of Article 6, "EUR 43700" is replaced by "EUR 44400";(5)Article 7 is amended as follows:(a)in the first paragraph, "EUR 72600" is replaced by "EUR 73800";(b)in the second paragraph, "EUR 22000" is replaced by "EUR 22400";(6)Article 8 is amended as follows:(a)paragraph 1 is amended as follows:(i)in the second subparagraph, "EUR 87600" is replaced by "EUR 89000";(ii)in the third subparagraph, "EUR 43700" is replaced by "EUR 44400";(iii)in the fourth subparagraph, "EUR 22000 to EUR 65700" is replaced by "EUR 22400 to EUR 66800";(iv)in the fifth subparagraph, "EUR 11000 to EUR 33000" is replaced by "EUR 11200 to EUR 33500";(b)paragraph 2 is amended as follows:(i)in the second subparagraph, "EUR 291800" is replaced by "EUR 296500";(ii)in the third subparagraph, "EUR 146100" is replaced by "EUR 148400";(iii)in the fifth subparagraph, "EUR 3200 to EUR 251500" is replaced by "EUR 3300 to EUR 255500";(iv)in the sixth subparagraph, "EUR 3200 to EUR 125900" is replaced by "EUR 3300 to EUR 127900";(c)in the first subparagraph of paragraph 3, "EUR 7300" is replaced by "EUR 7400".Article 2This Regulation shall not apply to valid applications pending on 1 April 2020.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 2020.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 19 March 2020.For the CommissionThe PresidentUrsula von der Leyen