委员会条例(EU) No 261/2010，就欧洲药品局对通货膨胀率而进行的费用调整，修订理事会条例(EC) No 297/95

技术法规类型：欧盟Eurlex法规 来源：tbtmap

EURLEX ID：32010R0261

OJ编号：OJ L 80, 26.3.2010, p. 36-39

中文标题：委员会条例(EU) No 261/2010，就欧洲药品局对通货膨胀率而进行的费用调整，修订理事会条例(EC) No 297/95

原文标题：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

分类：13.30.15_医药产品

文件类型：二级立法 Regulation|条例

生效日期：2010-03-27

废止日期：2058-12-31

法规全文：查看欧盟官方文件

EUR-Lex - 32010R0261 - EN
?

32010R0261


Title and reference

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)

?BG?CS?DA?DE?EL?EN?ES?ET?FI?FR?HU?IT?LT?LV?MT?NL?PL?PT?RO?SK?SL?SV

Text

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Dates

    of document: 25/03/2010
    of effect: 27/03/2010; Entry into force Date pub. + 1 See Art 3
    of effect: 01/04/2010; Implementation See Art 3
    end of validity: 99/99/9999

Classifications

Miscellaneous information

  • Author:
    European Commission
  • Form:
    Regulation

Relationship between documents

  • Treaty:
    Treaty on the Functioning of the European Union
  • Legal basis:
    31995R0297 -A12
  • Select all documents based on this document
  • Amendment to:
    31995R0297 Amendment Amendment Article 3 from 01/01/2010
    31995R0297 Amendment Amendment Article 3.1 PT A) from 01/04/2010
    31995R0297 Amendment Amendment Article 3.1 PT B) from 01/04/2010
    31995R0297 Amendment Amendment Article 3.1 PT C) from 01/04/2010
    31995R0297 Amendment Amendment Article 3.2 PT A) from 01/04/2010
    31995R0297 Amendment Amendment Article 3.2 PT B) from 01/04/2010
    31995R0297 Amendment Amendment Article 3.3 from 01/04/2010
    31995R0297 Amendment Amendment Article 3.4 from 01/04/2010
    31995R0297 Amendment Amendment Article 3.5 from 01/04/2010
    31995R0297 Amendment Amendment Article 3.6 L1 from 01/04/2010
    31995R0297 Amendment Amendment Article 3.6 L2 from 01/04/2010
    31995R0297 Amendment Amendment Article 4 from 01/04/2010
    31995R0297 Amendment Amendment Article 5.1 PT A) from 01/04/2010
    31995R0297 Amendment Amendment Article 5.1 PT B) from 01/04/2010
    31995R0297 Amendment Amendment Article 5.1 PT C) from 01/04/2010
    31995R0297 Amendment Amendment Article 5.2 PT A) from 01/04/2010
    31995R0297 Amendment Amendment Article 5.2 PT B) from 01/04/2010
    31995R0297 Amendment Amendment Article 5.3 from 01/04/2010
    31995R0297 Amendment Amendment Article 5.4 from 01/04/2010
    31995R0297 Amendment Amendment Article 5.5 from 01/04/2010
    31995R0297 Amendment Amendment Article 5.6 L1 from 01/04/2010
    31995R0297 Amendment Amendment Article 5.6 L2 from 01/04/2010
    31995R0297 Amendment Amendment Article 6 from 01/04/2010
    31995R0297 Amendment Amendment Article 7.1 from 01/04/2010
    31995R0297 Amendment Amendment Article 7.2 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.1 L2 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.1 L3 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.1 L4 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.1 L5 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.2 L2 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.2 L 3 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.2 L5 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.2 L6 from 01/04/2010
    31995R0297 Amendment Amendment Article 8.3 from 01/04/2010
  • Instruments cited:
    32004R0726
  • Select all documents mentioning this document

Text

Bilingual display: BG CS DA DE EL EN ES ET FI FR HU IT LT LV MT NL PL PT RO SK SL SV

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:

(a) Paragraph 1 is amended as follows:

(i) point (a) is amended as follows:

- in the first subparagraph, "EUR 251600" is replaced by "EUR 254100",

- in the second subparagraph, "EUR 25200" is replaced by "EUR 25500",

- in the third subparagraph, "EUR 6300" is replaced by "EUR 6400",

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

- in the first subparagraph, "EUR 97600" is replaced by "EUR 98600",

- in the second subparagraph, "EUR 162600" is replaced by "EUR 164200",

- in the third subparagraph, "EUR 9700" is replaced by "EUR 9800",

- in the fourth subparagraph, "EUR 6300" is replaced by "EUR 6400",

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

- in the first subparagraph, "EUR 75500" is replaced by "EUR 76300",

- in the second subparagraph, "EUR 18900 to EUR 56600" is replaced by "EUR 19100 to EUR 57200",

- in the third subparagraph, "EUR 6300" is replaced by "EUR 6400",

(b) Paragraph 2 is amended as follows:

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

- "EUR 6300" is replaced by "EUR 6400",

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

- in the first subparagraph, "EUR 75500" is replaced by "EUR 76300",

- in the second subparagraph, "EUR 18900 to EUR 56600" is replaced by "EUR 19100 to EUR 57200",

(c) In paragraph 3, "EUR 12500" is replaced by "EUR 12600".

(d) In paragraph 4, "EUR 18900" is replaced by "EUR 19100".

(e) In paragraph 5, "EUR 6300" is replaced by "EUR 6400".

(f) Paragraph 6 is amended as follows:

(i) in the first subparagraph, "EUR 90200" is replaced by "EUR 91100";

(ii) in the second subparagraph, "EUR 22500 to EUR 67600" is replaced by "EUR 22700 to EUR 68300".

2. In Article 4, "EUR 62800" is replaced by "EUR 63400".

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 125800" is replaced by "EUR 127100",

- in the second subparagraph, "EUR 12500" is replaced by "EUR 12600",

- in the third subparagraph, "EUR 6300" is replaced by "EUR 6400",

- the fourth subparagraph is amended as follows:

- "EUR 62800" is replaced by "EUR 63400",

- "EUR 6300" is replaced by "EUR 6400",

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

- in the first subparagraph, "EUR 62800" is replaced by "EUR 63400",

- in the second subparagraph, "EUR 106300" is replaced by "EUR 107400",

- in the third subparagraph, "EUR 12500" is replaced by "EUR 12600",

- in the fourth subparagraph, "EUR 6300" is replaced by "EUR 6400",

- the fifth subparagraph is amended as follows:

- "EUR 31400" is replaced by "EUR 31700",

- "EUR 6300" is replaced by "EUR 6400",

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

- in the first subparagraph, "EUR 31400" is replaced by "EUR 31700",

- in the second subparagraph, "EUR 7800 to EUR 23500" is replaced by "EUR 7900 to EUR 23700",

- in the third subparagraph, "EUR 6300" is replaced by "EUR 6400",

(b) Paragraph 2 is amended as follows:

(i) in point (a), "EUR 6300" is replaced by "EUR 6400";

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

- in the first subparagraph, "EUR 37700" is replaced by "EUR 38100",

- in the second subparagraph, "EUR 9400 to EUR 28300" is replaced by "EUR 9500 to EUR 28600",

- in the third subparagraph, "EUR 6300" is replaced by "EUR 6400",

(c) In paragraph 3, "EUR 6300" is replaced by "EUR 6400".

(d) In paragraph 4, "EUR 18900" is replaced by "EUR 19100".

(e) In paragraph 5, "EUR 6300" is replaced by "EUR 6400".

(f) Paragraph 6 is amended as follows:

(i) in the first subparagraph, "EUR 30100" is replaced by "EUR 30400";

(ii) in the second subparagraph, "EUR 7500 to EUR 22500" is replaced by "EUR 7600 to EUR 22700".

4. In Article 6, "EUR 37700" is replaced by "EUR 38100".

5. Article 7 is amended as follows:

(a) in the first paragraph, "EUR 62800" is replaced by "EUR 63400";

(b) in the second paragraph, "EUR 18900" is replaced by "EUR 19100".

6. Article 8 is amended as follows:

(a) Paragraph 1 is amended as follows:

(i) in the second subparagraph, "EUR 75500" is replaced by "EUR 76300";

(ii) in the third subparagraph, "EUR 37700" is replaced by "EUR 38100";

(iii) in the fourth subparagraph, "EUR 18900 to EUR 56600" is replaced by "EUR 19100 to EUR 57200";

(iv) in the fifth subparagraph, "EUR 9400 to EUR 28300" is replaced by "EUR 9500 to EUR 28600".

(b) Paragraph 2 is amended as follows:

(i) in the second subparagraph, "EUR 251600" is replaced by "EUR 254100";

(ii) in the third subparagraph, "EUR 125800" is replaced by "EUR 127100";

(iii) in the fifth subparagraph, "EUR 2700 to EUR 216800" is replaced by "EUR 2700 to EUR 219000";

(iv) in the sixth subparagraph, "EUR 108500" is replaced by "EUR 109600".

(c) In paragraph 3, "EUR 6300" is replaced by "EUR 6400".

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

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

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

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