Commission Regulation (EU) 2017/612 of 30 March 2017 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 2017 (Text with EEA relevance. )
Commission Regulation (EU) 2017/612of 30 March 2017amending 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 2017(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 to it by undertakings. 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 2016. The inflation rate in the Union, as published by the Statistical Office of the European Union, was 1,2 % in 2016.(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 2017.(6)In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2017. 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 278800" is replaced by "EUR 282100",in the second subparagraph, "EUR 28000" is replaced by "EUR 28300",in the third subparagraph, "EUR 7000" is replaced by "EUR 7100",(ii)point (b) is amended as follows:in the first subparagraph, "EUR 108200" is replaced by "EUR 109500",in the second subparagraph, "EUR 180200" is replaced by "EUR 182400",in the third subparagraph, "EUR 10800" is replaced by "EUR 10900",in the fourth subparagraph, "EUR 7000" is replaced by "EUR 7100",(iii)point (c) is amended as follows:in the first subparagraph, "EUR 83700" is replaced by "EUR 84700",in the second subparagraph, "EUR 20900 to EUR 62700" is replaced by "EUR 21200 to EUR 63500",in the third subparagraph, "EUR 7000" is replaced by "EUR 7100";(b)paragraph 2 is amended as follows:(i)in the first subparagraph of point (a) "EUR 7000" is replaced by "EUR 7100",(ii)point (b) is amended as follows:in the first subparagraph, "EUR 83700" is replaced by "EUR 84700",in the second subparagraph, "EUR 20900 to EUR 62700" is replaced by "EUR 21200 to EUR 63500";(c)in paragraph 3, "EUR 13800" is replaced by "EUR 14000";(d)in paragraph 4, "EUR 20900" is replaced by "EUR 21200";(e)in paragraph 5, "EUR 7000" is replaced by "EUR 7100";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 100000" is replaced by "EUR 101200",(ii)in the second subparagraph, "EUR 24900 to EUR 74900" is replaced by "EUR 25200 to EUR 75800";(2)in the first paragraph of Article 4, "EUR 69400" is replaced by "EUR 70200";(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 139600" is replaced by "EUR 141300",in the second subparagraph, "EUR 13800" is replaced by "EUR 14000",in the third subparagraph, "EUR 7000" is replaced by "EUR 7100",the fourth subparagraph is amended as follows:"EUR 69400" is replaced by "EUR 70200","EUR 7000" is replaced by "EUR 7100";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 69400" is replaced by "EUR 70200",in the second subparagraph, "EUR 117800" is replaced by "EUR 119200",in the third subparagraph, "EUR 13800" is replaced by "EUR 14000",in the fourth subparagraph, "EUR 7000" is replaced by "EUR 7100",the fifth subparagraph is amended as follows:"EUR 34900" is replaced by "EUR 35300","EUR 7000" is replaced by "EUR 7100";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 34900" is replaced by "EUR 35300",in the second subparagraph, "EUR 8700 to EUR 26200" is replaced by "EUR 8800 to EUR 26500",in the third subparagraph, "EUR 7000" is replaced by "EUR 7100";(b)paragraph 2 is amended as follows:(i)in the first subparagraph of point (a), "EUR 7000" is replaced by "EUR 7100";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 41800" is replaced by "EUR 42300",in the second subparagraph, "EUR 10500 to EUR 31500" is replaced by "EUR 10600 to EUR 31900",in the third subparagraph, "EUR 7000" is replaced by "EUR 7100";(c)in paragraph 3, "EUR 7000" is replaced by "EUR 7100";(d)in paragraph 4, "EUR 20900" is replaced by "EUR 21200";(e)in paragraph 5, "EUR 7000" is replaced by "EUR 7100";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 33400" is replaced by "EUR 33800",(ii)in the second subparagraph, "EUR 8300 to EUR 24900" is replaced by "EUR 8400 to EUR 25200";(4)in the first paragraph of Article 6, "EUR 41800" is replaced by "EUR 42300";(5)Article 7 is amended as follows:(a)in the first paragraph, "EUR 69400" is replaced by "EUR 70200",(b)in the second paragraph, "EUR 20900" is replaced by "EUR 21200";(6)Article 8 is amended as follows:(a)paragraph 1 is amended as follows:(i)in the second subparagraph, "EUR 83700" is replaced by "EUR 84700",(ii)in the third subparagraph, "EUR 41800" is replaced by "EUR 42300",(iii)in the fourth subparagraph, "EUR 20900 to EUR 62700" is replaced by "EUR 21200 to EUR 63500",(iv)in the fifth subparagraph, "EUR 10500 to EUR 31500" is replaced by "EUR 10600 to EUR 31900";(b)paragraph 2 is amended as follows:(i)in the second subparagraph, "EUR 278800" is replaced by "EUR 282100",(ii)in the third subparagraph, "EUR 139600" is replaced by "EUR 141300",(iii)in the fifth subparagraph, "EUR 3000 to EUR 240300" is replaced by "EUR 3000 to EUR 243200",(iv)in the sixth subparagraph, "EUR 3000 to EUR 120300" is replaced by "EUR 3000 to EUR 121700";(c)in the first subparagraph of paragraph 3, "EUR 7000" is replaced by "EUR 7100".Article 2This Regulation shall not apply to valid applications pending on 1 April 2017.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 2017.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 30 March 2017.For the CommissionThe PresidentJean-Claude Juncker