Commission Regulation (EC) No 312/2008

of 3 April 2008

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.

(3) Since 2005, the fees of the Agency have not been adjusted to the inflation rate. It is therefore necessary to review those fees by reference to the inflation rate in the Community in the years 2006 and 2007.

(4) The inflation rate in the Community, as published by the Statistical Office of the European Communities (Eurostat), was 2,2 % in 2006 and 2,3 % in 2007.

(5) For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.

(6) Regulation (EC) No 297/95 should therefore be amended accordingly.

(7) For reasons for legal certainty this Regulation should not apply to valid applications which are pending on 1 April 2008.

(8) Pursuant to Article 12 of Regulation (EC) No 297/95 the update has to be made with effect from 1 April 2008, it is therefore appropriate that this Regulation enter into force as a matter of urgency and apply 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 232000" is replaced by "EUR 242600",

- in the second subparagraph, "EUR 23200" is replaced by "EUR 24300",

- in the third subparagraph, "EUR 5800" is replaced by "EUR 6100";

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

- in the first subparagraph, "EUR 90000" is replaced by "EUR 94100",

- in the second subparagraph, "EUR 150000" is replaced by "EUR 156800",

- in the third subparagraph, "EUR 9000" is replaced by "EUR 9400",

- in the fourth subparagraph, "EUR 5800" is replaced by "EUR 6100";

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

- in the first subparagraph, "EUR 69600" is replaced by "EUR 72800",

- in the second subparagraph, "EUR 17400 to EUR 52200" is replaced by "EUR 18200 to EUR 54600",

- in the third subparagraph, "EUR 5800" is replaced by "EUR 6100".

(b) Paragraph 2 is amended as follows:

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

- "EUR 2500" is replaced by "EUR 2600",

- "EUR 5800" is replaced by "EUR 6100";

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

- in the first subparagraph, "EUR 69600" is replaced by "EUR 72800",

- in the second subparagraph, "EUR 17400 to EUR 52200" is replaced by "EUR 18200 to EUR 54600".

(c) In paragraph 3, "EUR 11600" is replaced by "EUR 12100".

(d) In paragraph 4, "EUR 17400" is replaced by "EUR 18200".

(e) In paragraph 5, "EUR 5800" is replaced by "EUR 6100".

(f) Paragraph 6 is amended as follows:

(i) in the first subparagraph, "EUR 83200" is replaced by "EUR 87000";

(ii) in the second subparagraph, "EUR 20800 to EUR 62400" is replaced by "EUR 21700 to EUR 65200".

2. In Article 4, "EUR 58000" is replaced by "EUR 60600".

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 116000" is replaced by "EUR 121300",

- in the second subparagraph, "EUR 11600" is replaced by "EUR 12100",

- in the third subparagraph, "EUR 5800" is replaced by "EUR 6100",

- the fourth subparagraph is amended as follows:

- "EUR 58000" is replaced by "EUR 60600",

- "EUR 5800" is replaced by "EUR 6100";

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

- in the first subparagraph, "EUR 58000" is replaced by "EUR 60600",

- in the second subparagraph, "EUR 98000" is replaced by "EUR 102500",

- in the third subparagraph, "EUR 11600" is replaced by "EUR 12100",

- in the fourth subparagraph, "EUR 5800" is replaced by "EUR 6100",

- the fifth subparagraph is amended as follows:

- "EUR 29000" is replaced by "EUR 30300",

- "EUR 5800" is replaced by "EUR 6100";

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

- in the first subparagraph, "EUR 29000" is replaced by "EUR 30300",

- in the second subparagraph "EUR 7200 to EUR 21700" is replaced by "EUR 7500 to EUR 22700",

- in the third subparagraph, "EUR 5800" is replaced by "EUR 6100".

(b) Paragraph 2 is amended as follows:

(i) in point (a) "EUR 2500" is replaced by "EUR 2600" and "EUR 5800" is replaced by "EUR 6100";

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

- in the first subparagraph, "EUR 34800" is replaced by "EUR 36400",

- in the second subparagraph, "EUR 8700 to EUR 26100" is replaced by "EUR 9100 to EUR 27300",

- in the third subparagraph, "EUR 5800" is replaced by "EUR 6100".

(c) In paragraph 3, "EUR 5800" is replaced by "EUR 6100".

(d) In paragraph 4, "EUR 17400" is replaced by "EUR 18200".

(e) In paragraph 5, "EUR 5800" is replaced by "EUR 6100".

(f) Paragraph 6 is amended as follows:

(i) in the first subparagraph, "EUR 27700" is replaced by "EUR 29000";

(ii) in the second subparagraph "EUR 6900 to EUR 20800" is replaced by "EUR 7200 to EUR 21700".

4. In Article 6, "EUR 34800" is replaced by "EUR 36400".

5. Article 7 is amended as follows:

(a) in the first paragraph, "EUR 58000" is replaced by "EUR 60600";

(b) in the second paragraph, "EUR 17400" is replaced by "EUR 18200".

6. Article 8 is amended as follows:

(a) Paragraph 1 is amended as follows:

(i) in the second subparagraph, "EUR 69600" is replaced by "EUR 72800";

(ii) in the third subparagraph, "EUR 34800" is replaced by "EUR 36400";

(iii) in the fourth subparagraph, "EUR 17400 to EUR 52200" is replaced by "EUR 18200 to EUR 54600";

(iv) in the fifth subparagraph, "EUR 8700 to EUR 26100" is replaced by "EUR 9100 to EUR 27300".

(b) Paragraph 2 is amended as follows:

(i) in the second subparagraph, "EUR 232000" is replaced by "EUR 242600";

(ii) in the third subparagraph, "EUR 116000" is replaced by "EUR 121300";

(iii) in the fifth subparagraph, "EUR 2500 to EUR 200000" is replaced by "EUR 2600 to EUR 209100";

(iv) in the sixth subparagraph, "EUR 100000" is replaced by "EUR 104600".

(c) In paragraph 3, "EUR 5800" is replaced by "EUR 6100".

Article 2

This Regulation shall not apply to valid applications pending at 1 April 2008.

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 2008.

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

Done at Brussels, 3 April 2008.

For the Commission

Günter Verheugen

Vice-President

[1] OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).

[2] OJ L 136, 30.4.2004, p. 1. Regulation as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 10.12.2007, p. 121).

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