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Document 32014R0272
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
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
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
OJ L 79, 18.3.2014, p. 37–39
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
18.3.2014 |
EN |
Official Journal of the European Union |
L 79/37 |
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)
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 (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 Council (2), 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:
|
(2) |
in Article 4, ‘EUR 68 400’ is replaced by ‘EUR 69 400’. |
(3) |
article 5 is amended as follows:
|
(4) |
in Article 6, ‘EUR 41 100’ is replaced by ‘EUR 41 700’. |
(5) |
Article 7 is amended as follows:
|
(6) |
Article 8 is amended as follows:
|
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
(2) 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 (OJ L 136, 30.4.2004, p. 1).