{
  "url": "https://openlegislation.uk/eu-regulation-2009-249/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2009-249/introduction.json",
  "legislation": "eur/2009/249",
  "legislation_title": "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",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2009-249",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EC) No 249/2009\nof 23 March 2009\namending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate\nTHE COMMISSION OF THE EUROPEAN COMMUNITIES,\nHaving regard to the Treaty establishing the European Community,\nHaving 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, and in particular Article 12 thereof,\nWhereas:\n(1)\nArticle 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, 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.\n(2)\nArticle 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.\n(3)\nThose 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.\n(4)\nFor the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.\n(5)\nRegulation (EC) No 297/95 should therefore be amended accordingly.\n(6)\nFor reasons for legal certainty this Regulation should not apply to valid applications which are pending on 1 April 2009.\n(7)\nPursuant 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,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 35, 15.2.1995, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 136, 30.4.2004, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2009/249/introduction",
    "retrieved_at": "2026-11-01T14:51:35.729247+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}