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Document 32013R0220
Commission Regulation (EU) No 220/2013 of 13 March 2013 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 220/2013 of 13 March 2013 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 220/2013 of 13 March 2013 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 70, 14.3.2013, p. 1–3
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) This document has been published in a special edition(s)
(HR)
In force
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Modifies | 31995R0297 | Amendment | article 3.1 point A) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.2 L3 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.3 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.1 L3 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.2 point B) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.1 L2 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.2 L2 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 7 L1 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.1 point A) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.2 point B) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 6 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.2 point A) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.1 point C) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.1 point C) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 4 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.3 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.1 L4 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.6 L1 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.1 point B) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.4 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.6 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.1 point B) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.4 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.5 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 7 L2 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.1 L5 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.2 L5 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.2 L6 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.5 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 5.6 L2 | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 3.2 point A) | 01/04/2013 | |
Modifies | 31995R0297 | Amendment | article 8.3 | 01/04/2013 |
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Implicitly repealed by | 32024R0568 | 01/01/2025 |
14.3.2013 |
EN |
Official Journal of the European Union |
L 70/1 |
COMMISSION REGULATION (EU) No 220/2013
of 13 March 2013
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 Article 12(5) thereof,
Whereas:
(1) |
In accordance with 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 (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 2012. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 2,6 % in 2012. |
(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 2013. |
(6) |
In accordance with Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2013. 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 66 700’ is replaced by ‘EUR 68 400’; |
(3) |
Article 5 is amended as follows:
|
(4) |
In Article 6, ‘EUR 40 100’ is replaced by ‘EUR 41 100’; |
(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 2013.
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 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 March 2013.
For the Commission
The President
José Manuel BARROSO