Commission Regulation (EU) No 272/2014 of 17 March 2014 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/2014/272@2014-03-17/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 2013. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 1,5 % in 2013.
(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 2014.
(6) In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2014. 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 274400 is replaced by EUR 278500,
in the second subparagraph, EUR 27500 is replaced by EUR 27900,
in the third subparagraph, EUR 6900 is replaced by EUR 7000.
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 106500 is replaced by EUR 108100,
in the second subparagraph, EUR 177300 is replaced by EUR 180000,
in the third subparagraph, EUR 10600 is replaced by EUR 10800,
in the fourth subparagraph, EUR 6900 is replaced by EUR 7000.
(iii) point (c) is amended as follows:
in the first subparagraph, EUR 82400 is replaced by EUR 83600,
in the second subparagraph, EUR 20600 to EUR 61800 is replaced by EUR 20900 to EUR 62700,
in the third subparagraph, EUR 6900 is replaced by EUR 7000.
(b) paragraph 2 is amended as follows:
(i) the first subparagraph of point (a) is amended as follows:
EUR 6900 is replaced by EUR 7000.
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 82400 is replaced by EUR 83600,
in the second subparagraph, EUR 20600 to EUR 61800 is replaced by EUR 20900 to EUR 62700.
(c) in paragraph 3, EUR 13600 is replaced by EUR 13800.
(d) in paragraph 4, EUR 20600 is replaced by EUR 20900.
(e) in paragraph 5, EUR 6900 is replaced by EUR 7000.
(f) paragraph 6 is amended as follows:
(i) in the first subparagraph, EUR 98400 is replaced by EUR 99900,
(ii) in the second subparagraph, EUR 24500 to EUR 73800 is replaced by EUR 24900 to EUR 74900.
(2) in Article 4, EUR 68400 is replaced by EUR 69400.
(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 137300 is replaced by EUR 139400,
in the second subparagraph, EUR 13600 is replaced by EUR 13800,
in the third subparagraph, EUR 6900 is replaced by EUR 7000,
the fourth subparagraph is amended as follows:
EUR 68400 is replaced by EUR 69400,
EUR 6900 is replaced by EUR 7000.
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 68400 is replaced by EUR 69400,
in the second subparagraph, EUR 116000 is replaced by EUR 117700,
in the third subparagraph, EUR 13600 is replaced by EUR 13800,
in the fourth subparagraph, EUR 6900 is replaced by EUR 7000,
the fifth subparagraph is amended as follows:
EUR 34300 is replaced by EUR 34800,
EUR 6900 is replaced by EUR 7000.
(iii) point (c) is amended as follows:
in the first subparagraph, EUR 34300 is replaced by EUR 34800,
in the second subparagraph, EUR 8600 to EUR 25700 is replaced by EUR 8700 to EUR 26100,
in the third subparagraph, EUR 6900 is replaced by EUR 7000.
(b) paragraph 2 is amended as follows:
(i) point (a) is amended as follows:
EUR 6900 is replaced by EUR 7000.
(ii) point (b) is amended as follows:
in the first subparagraph, EUR 41100 is replaced by EUR 41700,
in the second subparagraph, EUR 10300 to EUR 30900 is replaced by EUR 10500 to EUR 31400,
in the third subparagraph, EUR 6900 is replaced by EUR 7000.
(c) in paragraph 3, EUR 6900 is replaced by EUR 7000.
(d) in paragraph 4, EUR 20600 is replaced by EUR 20900.
(e) in paragraph 5, EUR 6900 is replaced by EUR 7000.
(f) paragraph 6 is amended as follows:
(i) in the first subparagraph, EUR 32800 is replaced by EUR 33300;
(ii) in the second subparagraph, EUR 8200 to EUR 24500 is replaced by EUR 8300 to EUR 24900.
(4) in Article 6, EUR 41100 is replaced by EUR 41700.
(5) Article 7 is amended as follows:
(a) in the first paragraph, EUR 68400 is replaced by EUR 69400,
(b) in the second paragraph, EUR 20600 is replaced by EUR 20900.
(6) Article 8 is amended as follows:
(a) paragraph 1 is amended as follows:
(i) in the second subparagraph, EUR 82400 is replaced by EUR 83600,
(ii) in the third subparagraph, EUR 41100 is replaced by EUR 41700,
(iii) in the fourth subparagraph, EUR 20600 to EUR 61800 is replaced by EUR 20900 to EUR 62700,
(iv) in the fifth subparagraph, EUR 10300 to EUR 30900 is replaced by EUR 10500 to EUR 31400.
(b) paragraph 2 is amended as follows:
(i) in the second subparagraph, EUR 274400 is replaced by EUR 278500,
(ii) in the third subparagraph, EUR 137300 is replaced by EUR 139400,
(iii) in the fifth subparagraph, EUR 3000 to EUR 236500 is replaced by EUR 3000 to EUR 240000,
(iv) in the sixth subparagraph, EUR 3000 to EUR 118400 is replaced by EUR 3000 to EUR 120200.
(c) in paragraph 3, EUR 6900 is replaced by EUR 7000.
Article 2
This Regulation shall not apply to valid applications pending on 1 April 2014.
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 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 March 2014. For the Commission The President José Manuel Barroso