Commission Regulation (EC) No 249/2009

of 23 March 2009

amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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) 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], stipulates that the revenue of the European Medicines Agency (hereinafter the Agency) shall consist of a contribution from the Community 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 lays down that the Commission shall review the fees of the Agency by reference to the inflation rate and update them, with effect from 1 April of each year.

(3) Those fees should therefore be updated by reference to the inflation rate of 2008. The inflation rate in the Community, as published by the Statistical Office of the European Communities (Eurostat), was 3,7 % in 2008.

(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 for legal certainty this Regulation should not apply to valid applications which are pending on 1 April 2009.

(7) Pursuant to Article 12 of Regulation (EC) No 297/95 the update has to be made with effect from 1 April 2009. 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 242600" is replaced by "EUR 251600",

- in the second subparagraph, "EUR 24300" is replaced by "EUR 25200",

- in the third subparagraph, "EUR 6100" is replaced by "EUR 6300";

(ii) point (b) is amended as follows:

- in the first subparagraph, "EUR 94100" is replaced by "EUR 97600",

- in the second subparagraph, "EUR 156800" is replaced by "EUR 162600",

- in the third subparagraph, "EUR 9400" is replaced by "EUR 9700",

- in the fourth subparagraph, "EUR 6100" is replaced by "EUR 6300";

(iii) point (c) is amended as follows:

- in the first subparagraph, "EUR 72800" is replaced by "EUR 75500",

- in the second subparagraph, "EUR 18200 to EUR 54600" is replaced by "EUR 18900 to EUR 56600",

- in the third subparagraph, "EUR 6100" is replaced by "EUR 6300";

(b) paragraph 2 is amended as follows:

(i) the first subparagraph of point (a) is amended as follows:

- "EUR 2600" is replaced by "EUR 2700",

- "EUR 6100" is replaced by "EUR 6300";

(ii) point (b) is amended as follows:

- in the first subparagraph, "EUR 72800" is replaced by "EUR 75500",

- in the second subparagraph, "EUR 18200 to EUR 54600" is replaced by "EUR 18900 to EUR 56600";

(c) in paragraph 3, "EUR 12100" is replaced by "EUR 12500";

(d) in paragraph 4, "EUR 18200" is replaced by "EUR 18900";

(e) in paragraph 5, "EUR 6100" is replaced by "EUR 6300";

(f) paragraph 6 is amended as follows:

(i) in the first subparagraph, "EUR 87000" is replaced by "EUR 90200";

(ii) in the second subparagraph, "EUR 21700 to EUR 65200" is replaced by "EUR 22500 to EUR 67600".

2. in Article 4, "EUR 60600" is replaced by "EUR 62800".

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 121300" is replaced by "EUR 125800",

- in the second subparagraph, "EUR 12100" is replaced by "EUR 12500",

- in the third subparagraph, "EUR 6100" is replaced by "EUR 6300",

- the fourth subparagraph is amended as follows:

- "EUR 60600" is replaced by "EUR 62800"

- "EUR 6100" is replaced by "EUR 6300";

(ii) point (b) is amended as follows:

- in the first subparagraph, "EUR 60600" is replaced by "EUR 62800",

- in the second subparagraph, "EUR 102500" is replaced by "EUR 106300",

- in the third subparagraph, "EUR 12100" is replaced by "EUR 12500",

- in the fourth subparagraph, "EUR 6100" is replaced by "EUR 6300",

- the fifth subparagraph is amended as follows:

- "EUR 30300" is replaced by "EUR 31400"

- "EUR 6100" is replaced by "EUR 6300";

(iii) point (c) is amended as follows:

- in the first subparagraph, "EUR 30300" is replaced by "EUR 31400",

- in the second subparagraph "EUR 7500 to EUR 22700" is replaced by "EUR 7800 to EUR 23500",

- in the third subparagraph, "EUR 6100" is replaced by "EUR 6300",

(b) Paragraph 2 is amended as follows:

(i) in point (a) "EUR 2600" is replaced by "EUR 2700" and "EUR 6100" is replaced by "EUR 6300";

(ii) point (b) is amended as follows:

- in the first subparagraph, "EUR 36400" is replaced by "EUR 37700",

- in the second subparagraph, "EUR 9100 to EUR 27300" is replaced by "EUR 9400 to EUR 28300",

- in the third subparagraph, "EUR 6100" is replaced by "EUR 6300";

(c) in paragraph 3, "EUR 6100" is replaced by "EUR 6300";

(d) in paragraph 4, "EUR 18200" is replaced by "EUR 18900";

(e) in paragraph 5, "EUR 6100" is replaced by "EUR 6300";

(f) paragraph 6 is amended as follows:

(i) in the first subparagraph, "EUR 29000" is replaced by "EUR 30100";

(ii) in the second subparagraph "EUR 7200 to EUR 21700" is replaced by "EUR 7500 to EUR 22500";

4. in Article 6, "EUR 36400" is replaced by "EUR 37700";

5. Article 7 is amended as follows:

(a) in the first paragraph, "EUR 60600" is replaced by "EUR 62800";

(b) in the second paragraph, "EUR 18200" is replaced by "EUR 18900";

6. Article 8 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) in the second subparagraph, "EUR 72800" is replaced by "EUR 75500";

(ii) in the third subparagraph, "EUR 36400" is replaced by "EUR 37700";

(iii) in the fourth subparagraph, "EUR 18200 to EUR 54600" is replaced by "EUR 18900 to EUR 56600";

(iv) in the fifth subparagraph, "EUR 9100 to EUR 27300" is replaced by "EUR 9400 to EUR 28300";

(b) paragraph 2 is amended as follows:

(i) in the second subparagraph, "EUR 242600" is replaced by "EUR 251600";

(ii) in the third subparagraph, "EUR 121300" is replaced by "EUR 125800";

(iii) in the fifth subparagraph, "EUR 2600 to EUR 209100" is replaced by "EUR 2700 to EUR 216800";

(iv) in the sixth subparagraph, "EUR 104600" is replaced by "EUR 108500";

(c) in paragraph 3, "EUR 6100" is replaced by "EUR 6300".

Article 2

This Regulation shall not apply to valid applications pending on 1 April 2009.

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 2009.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 March 2009.

For the Commission

Günter Verheugen

Vice-President

[1] OJ L 35, 15.2.1995, p. 1.

[2] OJ L 136, 30.4.2004, p. 1.

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