Commission Regulation (EU) 2015/490 of 23 March 2015 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)
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/regulation/2015/490@2015-03-23/en
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 Products, 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 Council, 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) Those fees should be updated by reference to the inflation rate of 2014. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was — 0,1 % in 2014.
(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 2015.
(6) In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2015. 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 1
Regulation (EC) No 297/95 is amended as follows:
(1) Article 3 is amended as follows:
(a) paragraph 1 is amended as follows:
(i) in point (a) in the first subparagraph, EUR 278500 is replaced by EUR 278200;
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 108100 is replaced by EUR 108000,
in the second subparagraph, EUR 180000 is replaced by EUR 179800;
(iii) point (c) is amended as follows:
in the first subparagraph, EUR 83600 is replaced by EUR 83500,
in the second subparagraph, EUR 20900 to EUR 62700 is replaced by EUR 20900 to EUR 62600;
(b) in paragraph 2, point (b) is amended as follows:
(i) in the first subparagraph, EUR 83600 is replaced by EUR 83500;
(ii) in the second subparagraph, EUR 20900 to EUR 62700 is replaced by EUR 20900 to EUR 62600;
(c) paragraph 6 is amended as follows:
(i) in the first subparagraph, EUR 99900 is replaced by EUR 99800;
(ii) in the second subparagraph, EUR 24900 to EUR 74900 is replaced by EUR 24900 to EUR 74800;
(2) in Article 4, EUR 69400 is replaced by EUR 69300;
(3) in Article 5, paragraph 1 is amended as follows:
(a) point (a) is amended as follows:
(i) in the first subparagraph, EUR 139400 is replaced by EUR 139300;
(ii) in the fourth subparagraph, EUR 69400 is replaced by EUR 69300;
(b) point (b) is amended as follows:
(i) in the first subparagraph, EUR 69400 is replaced by EUR 69300;
(ii) in the second subparagraph, EUR 117700 is replaced by EUR 117600;
(4) in Article 7, in the first paragraph, EUR 69400 is replaced by EUR 69300;
(5) Article 8 is amended as follows:
(a) paragraph 1 is amended as follows:
(i) in the second subparagraph, EUR 83600 is replaced by EUR 83500;
(ii) in the fourth subparagraph, EUR 20900 to EUR 62700 is replaced by EUR 20900 to EUR 62600;
(b) paragraph 2 is amended as follows:
(i) in the second subparagraph, EUR 278500 is replaced by EUR 278200;
(ii) in the third subparagraph, EUR 139400 is replaced by EUR 139300;
(iii) in the fifth subparagraph, EUR 3000 to EUR 240000 is replaced by EUR 3000 to EUR 239800;
(iv) in the sixth subparagraph, EUR 3000 to EUR 120200 is replaced by EUR 3000 to EUR 120100.
Article 2
This Regulation shall not apply to valid applications pending on 1 April 2015.
Article 3
This 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 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 23 March 2015. For the Commission The President Jean-Claude Juncker