{
  "url": "https://openlegislation.uk/eu-regulation-1995-297/article-12",
  "json_url": "https://openlegislation.uk/eu-regulation-1995-297/article-12.json",
  "legislation": "eur/1995/297",
  "legislation_title": "Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products",
  "legislation_url": "https://openlegislation.uk/eu-regulation-1995-297",
  "path": "article/12",
  "kind": "article",
  "number": "12",
  "heading": "Amendment",
  "text": "Any amendment to this Regulation shall be adopted by the Council acting by a qualified majority after consulting the European Parliament, on a proposal from the Commission.\nHowever, amendments to the amounts of the fees established by this Regulation shall be adopted in accordance with the procedure laid down in Article 87(2) of Regulation (EC) No 726/2004, with exception of the updating provided for in the fifth paragraph of this Article.\nBy 24 November 2010, the Commission shall present a report on its implementation to the Council, this report shall contain an analysis of the need for including a dispute settlement procedure into this Regulation.\nAny review of the fees shall be based on an evaluation of the Agency’s costs and on the basis of the related costs of the services provided for by the Member States. Those costs shall be calculated in accordance with generally accepted international costing methods, which shall be adopted in accordance with Article 11(2).\nWith effect from 1 April of each year, the Commission shall review the fees by reference to the inflation rate as published in the Official Journal of the European Union and update them.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Inserted by Council Regulation (EC) No 2743/98 of 14 December 1998."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Substituted by Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency."
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Inserted by Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/1995/297/article/12",
    "retrieved_at": "2026-11-01T14:59:48.109940+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."
}