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Document 32010R0261
Commission Regulation (EU) No 261/2010 of 25 March 2010 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
Commission Regulation (EU) No 261/2010 of 25 March 2010 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
Commission Regulation (EU) No 261/2010 of 25 March 2010 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
OJ L 80, 26.3.2010, p. 36–39
(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 | 01/01/2010 | |
Modifies | 31995R0297 | Amendment | article 8.2 L2 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.6 L1 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 6 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.4 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.1 L2 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.1 L4 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.1 L3 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.2 PT B) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.2 PT A) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 4 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 7.1 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.1 PT B) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.4 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.2 PT A) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.3 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.5 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.1 L5 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.2 L5 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.2 L6 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.1 PT B) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.6 L1 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.1 PT A) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.1 PT C) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.2 PT B) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 8.2 L 3 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.1 PT A) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.5 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 7.2 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.3 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.6 L2 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.1 PT C) | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 3.3 | 01/04/2010 | |
Modifies | 31995R0297 | Amendment | article 5.6 L2 | 01/04/2010 |
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Implicitly repealed by | 32024R0568 | 01/01/2025 |
26.3.2010 |
EN |
Official Journal of the European Union |
L 80/36 |
COMMISSION REGULATION (EU) No 261/2010
of 25 March 2010
amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
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 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 (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) |
Article 12 of Regulation (EC) No 297/95 requires that the fees of the Agency be updated each year by reference to the inflation rate. |
(3) |
Those fees should therefore be updated by reference to the inflation rate of 2009. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 1 % in 2009. |
(4) |
For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100. |
(5) |
Regulation (EC) No 297/95 should therefore be amended accordingly. |
(6) |
For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2010. |
(7) |
Pursuant to Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2010. 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 62 800’ is replaced by ‘EUR 63 400’. |
3. |
Article 5 is amended as follows:
|
4. |
In Article 6, ‘EUR 37 700’ is replaced by ‘EUR 38 100’. |
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 2010.
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 2010.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 March 2010.
For the Commission
The President
José Manuel BARROSO