Commission Regulation (EU) No 301/2011 of 28 March 2011 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate Text with EEA relevance
Commission Regulation (EU) No 301/2011of 28 March 2011amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate(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 thereof,Whereas:(1)According to Article 67(3) of Regulation (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 AgencyOJ L 136, 30.4.2004, p. 1., the revenue of the European Medicines Agency (hereinafter "the 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)Article 12 of Regulation (EC) No 297/95 requires that the fees of the Agency be updated each year by reference to the inflation rate.(3)Those fees should therefore be updated by reference to the inflation rate of 2010. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 2,1 % in 2010.(4)For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.(5)Regulation (EC) No 297/95 should therefore be amended accordingly.(6)For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2011.(7)Pursuant to Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2011. 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 254100" is replaced by "EUR 259400",in the second subparagraph, "EUR 25500" is replaced by "EUR 26000",in the third subparagraph, "EUR 6400" is replaced by "EUR 6500";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 98600" is replaced by "EUR 100700",in the second subparagraph, "EUR 164200" is replaced by "EUR 167600",in the third subparagraph, "EUR 9800" is replaced by "EUR 10000",in the fourth subparagraph, "EUR 6400" is replaced by "EUR 6500";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 76300" is replaced by "EUR 77900",in the second subparagraph, "EUR 19100 to EUR 57200" is replaced by "EUR 19500 to EUR 58400",in the third subparagraph, "EUR 6400" is replaced by "EUR 6500";(b)paragraph 2 is amended as follows:(i)the first subparagraph of point (a) is amended as follows:"EUR 2700" is replaced by "EUR 2800","EUR 6400" is replaced by "EUR 6500";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 76300" is replaced by "EUR 77900",in the second subparagraph, "EUR 19100 to EUR 57200" is replaced by "EUR 19500 to EUR 58400";(c)in paragraph 3, "EUR 12600" is replaced by "EUR 12900";(d)in paragraph 4, "EUR 19100" is replaced by "EUR 19500";(e)in paragraph 5, "EUR 6400" is replaced by "EUR 6500";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 91100" is replaced by "EUR 93000";(ii)in the second subparagraph, "EUR 22700 to EUR 68300" is replaced by "EUR 23200 to EUR 69700";(2)in Article 4, "EUR 63400" is replaced by "EUR 64700";(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 127100" is replaced by "EUR 129800",in the second subparagraph, "EUR 12600" is replaced by "EUR 12900",in the third subparagraph, "EUR 6400" is replaced by "EUR 6500",the fourth subparagraph is amended as follows:"EUR 63400" is replaced by "EUR 64700","EUR 6400" is replaced by "EUR 6500";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 63400" is replaced by "EUR 64700",in the second subparagraph, "EUR 107400" is replaced by "EUR 109700",in the third subparagraph,"EUR 12600" is replaced by "EUR 12900",in the fourth subparagraph, "EUR 6400" is replaced by "EUR 6500",the fifth subparagraph is amended as follows:"EUR 31700" is replaced by "EUR 32400","EUR 6400" is replaced by "EUR 6500";(iii)point (c) is amended as follows:in the first subparagraph, "EUR 31700" is replaced by "EUR 32400",in the second subparagraph, "EUR 7900 to EUR 23700" is replaced by "EUR 8100 to EUR 24200",in the third subparagraph, "EUR 6400" is replaced by "EUR 6500";(b)paragraph 2 is amended as follows:(i)in point (a) is amended as follows:"EUR 2700" is replaced by "EUR 2800","EUR 6400" is replaced by "EUR 6500";(ii)point (b) is amended as follows:in the first subparagraph, "EUR 38100" is replaced by "EUR 38900",in the second subparagraph, "EUR 9500 to EUR 28600" is replaced by "EUR 9700 to EUR 29200",in the third subparagraph, "EUR 6400" is replaced by "EUR 6500";(c)in paragraph 3, "EUR 6400" is replaced by "EUR 6500";(d)in paragraph 4, "EUR 19100" is replaced by "EUR 19500";(e)in paragraph 5, "EUR 6400" is replaced by "EUR 6500";(f)paragraph 6 is amended as follows:(i)in the first subparagraph, "EUR 30400" is replaced by "EUR 31000";(ii)in the second subparagraph, "EUR 7600 to EUR 22700" is replaced by "EUR 7800 to EUR 23200";(4)in Article 6, "EUR 38100" is replaced by "EUR 38900";(5)Article 7 is amended as follows:(a)in the first paragraph, "EUR 63400" is replaced by "EUR 64700";(b)in the second paragraph, "EUR 19100" is replaced by "EUR 19500";(6)Article 8 is amended as follows:(a)paragraph 1 is amended as follows:(i)in the second subparagraph, "EUR 76300" is replaced by "EUR 77900";(ii)in the third subparagraph, "EUR 38100" is replaced by "EUR 38900";(iii)in the fourth subparagraph, " EUR 19100 to EUR 57200" is replaced by "EUR 19500 to EUR 58400";(iv)in the fifth subparagraph, "EUR 9500 to EUR 28600" is replaced by "EUR 9700 to EUR 29200";(b)paragraph 2 is amended as follows:(i)in the second subparagraph, "EUR 254100" is replaced by "EUR 259400";(ii)in the third subparagraph, "EUR 127100" is replaced by "EUR 129800";(iii)in the fifth subparagraph, "EUR 2700 to EUR 219000" is replaced by "EUR 2800 to EUR 223600";(iv)in the sixth subparagraph, "EUR 2700 to EUR 109600" is replaced by "EUR 2800 to EUR 111900";(c)in paragraph 3, "EUR 6400" is replaced by "EUR 6500".Article 2This Regulation shall not apply to valid applications pending on 1 April 2011.Article 3This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.It shall apply from 1 April 2011.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 28 March 2011.For the CommissionThe PresidentJosé Manuel Barroso