{
  "url": "https://openlegislation.uk/eu-regulation-2008-312/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-312/introduction.json",
  "legislation": "eur/2008/312",
  "legislation_title": "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",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-312",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EC) No 312/2008\nof 3 April 2008\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.\n(3)\nSince 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.\n(4)\nThe 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.\n(5)\nFor the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.\n(6)\nRegulation (EC) No 297/95 should therefore be amended accordingly.\n(7)\nFor reasons for legal certainty this Regulation should not apply to valid applications which are pending on 1 April 2008.\n(8)\nPursuant 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,\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. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "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)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2008/312/introduction",
    "retrieved_at": "2026-11-01T14:52:20.283940+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."
}