Commission Regulation (EU) No 273/2012 of 27 March 2012 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)
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Address https://gelex.eu/eli/EU/regulation/2012/273@2012-03-27/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 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 Agency, 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 2011. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 3,1 % in 2011.
(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 2012.
(6) Pursuant to Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2012. 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) point (a) is amended as follows:
in the first subparagraph, EUR 259400 is replaced by EUR 267400,
in the second subparagraph, EUR 26000 is replaced by EUR 26800,
in the third subparagraph, EUR 6500 is replaced by EUR 6700;
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 100700 is replaced by EUR 103800,
in the second subparagraph, EUR 167600 is replaced by EUR 172800,
in the third subparagraph, EUR 10000 is replaced by EUR 10300,
in the fourth subparagraph, EUR 6500 is replaced by EUR 6700;
(iii) point (c) is amended as follows:
in the first subparagraph, EUR 77900 is replaced by EUR 80300,
in the second subparagraph, EUR 19500 to EUR 58400 is replaced by EUR 20100 to EUR 60200,
in the third subparagraph, EUR 6500 is replaced by EUR 6700;
(b) paragraph 2 is amended as follows:
(i) the first subparagraph of point (a) is amended as follows:
EUR 2800 is replaced by EUR 2900,
EUR 6500 is replaced by EUR 6700;
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 77900 is replaced by EUR 80300,
in the second subparagraph, EUR 19500 to EUR 58400 is replaced by EUR 20100 to EUR 60200;
(c) in paragraph 3, EUR 12900 is replaced by EUR 13300;
(d) in paragraph 4, EUR 19500 is replaced by EUR 20100;
(e) in paragraph 5, EUR 6500 is replaced by EUR 6700;
(f) paragraph 6 is amended as follows:
(i) in the first subparagraph, EUR 93000 is replaced by EUR 95900;
(ii) in the second subparagraph, EUR 23200 to EUR 69700 is replaced by EUR 23900 to EUR 71900;
(2) in Article 4, EUR 64700 is replaced by EUR 66700;
(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 129800 is replaced by EUR 133800,
in the second subparagraph, EUR 12900 is replaced by EUR 13300,
in the third subparagraph, EUR 6500 is replaced by EUR 6700,
the fourth subparagraph is amended as follows:
EUR 64700 is replaced by EUR 66700,
EUR 6500 is replaced by EUR 6700;
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 64700 is replaced by EUR 66700,
in the second subparagraph, EUR 109700 is replaced by EUR 113100,
in the third subparagraph, EUR 12900 is replaced by EUR 13300,
in the fourth subparagraph, EUR 6500 is replaced by EUR 6700,
the fifth subparagraph is amended as follows:
EUR 32400 is replaced by EUR 33400,
EUR 6500 is replaced by EUR 6700;
(iii) point (c) is amended as follows:
in the first subparagraph, EUR 32400 is replaced by EUR 33400,
in the second subparagraph, EUR 8100 to EUR 24200 is replaced by EUR 8400 to EUR 25000,
in the third subparagraph, EUR 6500 is replaced by EUR 6700;
(b) paragraph 2 is amended as follows:
(i) point (a) is amended as follows:
EUR 2800 is replaced by EUR 2900,
EUR 6500 is replaced by EUR 6700;
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 38900 is replaced by EUR 40100,
in the second subparagraph, EUR 9700 to EUR 29200 is replaced by EUR 10000 to EUR 30100,
in the third subparagraph, EUR 6500 is replaced by EUR 6700;
(c) in paragraph 3, EUR 6500 is replaced by EUR 6700;
(d) in paragraph 4, EUR 19500 is replaced by EUR 20100;
(e) in paragraph 5, EUR 6500 is replaced by EUR 6700;
(f) paragraph 6 is amended as follows:
(i) in the first subparagraph, EUR 31000 is replaced by EUR 32000;
(ii) in the second subparagraph, EUR 7800 to EUR 23200 is replaced by EUR 8000 to EUR 23900;
(4) in Article 6, EUR 38900 is replaced by EUR 40100;
(5) Article 7 is amended as follows:
(a) in the first paragraph, EUR 64700 is replaced by EUR 66700;
(b) in the second paragraph, EUR 19500 is replaced by EUR 20100;
(6) Article 8 is amended as follows:
(a) paragraph 1 is amended as follows:
(i) in the second subparagraph, EUR 77900 is replaced by EUR 80300;
(ii) in the third subparagraph, EUR 38900 is replaced by EUR 40100;
(iii) in the fourth subparagraph, EUR 19500 to EUR 58400 is replaced by EUR 20100 to EUR 60200;
(iv) in the fifth subparagraph, EUR 9700 to EUR 29200 is replaced by EUR 10000 to EUR 30100;
(b) paragraph 2 is amended as follows:
(i) in the second subparagraph, EUR 259400 is replaced by EUR 267400;
(ii) in the third subparagraph, EUR 129800 is replaced by EUR 133800;
(iii) in the fifth subparagraph, EUR 2800 to EUR 223600 is replaced by EUR 2900 to EUR 230500;
(iv) in the sixth subparagraph, EUR 2800 to EUR 111900 is replaced by EUR 2900 to EUR 115400;
(c) in paragraph 3, EUR 6500 is replaced by EUR 6700.
Article 2
This Regulation shall not apply to valid applications pending on 1 April 2012.
Article 3
This 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 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 March 2012. For the Commission The President José Manuel Barroso
Versions
Cited by
- Council Decision of 9 July 2013 on the position to be adopted, on behalf of the European Union, in the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (2013/455/EU) Decision · Grade B
Commission Regulation (EU) No 273/2012 of 27 March 2012 (OJ L 90, 28.3.2012, p. 11) and