Commission Regulation (EU) 2018/471 of 21 March 2018 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 2018 (Text with EEA relevance. )
Commission Regulation (EU) 2018/471of 21 March 2018amending 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 2018(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 the 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 2017. The inflation rate in the Union, as made available by the Statistical Office of the European Union, was 1,7 % in 2017.(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 2018.(6)In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2018. 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 282100" is replaced by "EUR 286900",in the second subparagraph, "EUR 28300" is replaced by "EUR 28800",in the third subparagraph, "EUR 7100" is replaced by "EUR 7200";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 109500" is replaced by "EUR 111400",in the second subparagraph, "EUR 182400" is replaced by "EUR 185500",in the third subparagraph, "EUR 10900" is replaced by "EUR 11100",in the fourth subparagraph, "EUR 7100" is replaced by "EUR 7200";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 84700" is replaced by "EUR 86100",in the second subparagraph, "EUR 21200 to EUR 63500" is replaced by "EUR 21600 to EUR 64600",in the third subparagraph, "EUR 7100" is replaced by "EUR 7200";(b)paragraph 2 is amended as follows:(i)in the first subparagraph of point (a), "EUR 3000" is replaced by "EUR 3100"and "EUR 7100" is replaced by "EUR 7200";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 84700" is replaced by "EUR 86100",in the second subparagraph, "EUR 21200 to EUR 63500" is replaced by "EUR 21600 to EUR 64600";(c)in paragraph 3, "EUR 14000" is replaced by "EUR 14200";(d)in the first subparagraph of paragraph 4, "EUR 21200" is replaced by "EUR 21600";(e)in paragraph 5, "EUR 7100" is replaced by "EUR 7200";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 101200" is replaced by "EUR 102900";(ii)in the second subparagraph, "EUR 25200 to EUR 75800" is replaced by "EUR 25600 to EUR 77100";(2)in the first paragraph of Article 4, "EUR 70200" is replaced by "EUR 71400";(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 141300" is replaced by "EUR 143700",in the second subparagraph, "EUR 14000" is replaced by "EUR 14200",in the third subparagraph, "EUR 7100" is replaced by "EUR 7200",in the fourth subparagraph, "EUR 70200" is replaced by "EUR 71400" and "EUR 7100" is replaced by "EUR 7200";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 70200" is replaced by "EUR 71400",in the second subparagraph, "EUR 119200" is replaced by "EUR 121200",in the third subparagraph, "EUR 14000" is replaced by "EUR 14200",in the fourth subparagraph, "EUR 7100" is replaced by "EUR 7200",in the fifth subparagraph, "EUR 35300" is replaced by "EUR 35900" and "EUR 7100" is replaced by "EUR 7200";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 35300" is replaced by "EUR 35900",in the second subparagraph, "EUR 8800 to EUR 26500" is replaced by "EUR 8900 to EUR 27000",in the third subparagraph, "EUR 7100" is replaced by "EUR 7200";(b)paragraph 2 is amended as follows:(i)in the first subparagraph of point (a), "EUR 3000" is replaced by "EUR 3100" and "EUR 7100" is replaced by "EUR 7200";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 42300" is replaced by "EUR 43000",in the second subparagraph, "EUR 10600 to EUR 31900" is replaced by "EUR 10800 to EUR 32400",in the third subparagraph, "EUR 7100" is replaced by "EUR 7200";(c)in paragraph 3, "EUR 7100" is replaced by "EUR 7200";(d)in the first subparagraph of paragraph 4, "EUR 21200" is replaced by "EUR 21600";(e)in paragraph 5, "EUR 7100" is replaced by "EUR 7200";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 33800" is replaced by "EUR 34400";(ii)in the second subparagraph, "EUR 8400 to EUR 25200" is replaced by "EUR 8500 to EUR 25600";(4)in the first paragraph of Article 6, "EUR 42300" is replaced by "EUR 43000";(5)Article 7 is amended as follows:(a)in the first paragraph, "EUR 70200" is replaced by "EUR 71400";(b)in the second paragraph, "EUR 21200" is replaced by "EUR 21600";(6)Article 8 is amended as follows:(a)paragraph 1 is amended as follows:(i)in the second subparagraph, "EUR 84700" is replaced by "EUR 86100";(ii)in the third subparagraph, "EUR 42300" is replaced by "EUR 43000";(iii)in the fourth subparagraph, "EUR 21200 to EUR 63500" is replaced by "EUR 21600 to EUR 64600";(iv)in the fifth subparagraph, "EUR 10600 to EUR 31900" is replaced by "EUR 10800 to EUR 32400";(b)paragraph 2 is amended as follows:(i)in the second subparagraph, "EUR 282100" is replaced by "EUR 286900";(ii)in the third subparagraph, "EUR 141300" is replaced by "EUR 143700";(iii)in the fifth subparagraph, "EUR 3000 to EUR 243200" is replaced by "EUR 3100 to EUR 247300";(iv)in the sixth subparagraph, "EUR 3000 to EUR 121700" is replaced by "EUR 3100 to EUR 123800";(c)in the first subparagraph of paragraph 3, "EUR 7100" is replaced by "EUR 7200".Article 2This Regulation shall not apply to valid applications pending on 1 April 2018.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 2018.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 21 March 2018.For the CommissionThe PresidentJean-Claude Juncker