{
  "url": "https://openlegislation.uk/eu-regulation-1995-297/article-4",
  "json_url": "https://openlegislation.uk/eu-regulation-1995-297/article-4.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/4",
  "kind": "article",
  "number": "4",
  "heading": "Medicinal products for human use covered by the procedures laid down in Directive 2001/83/EC",
  "text": "Referral fee\nA referral fee of EUR 73 800 shall apply where the procedures laid down in Article 30(1) and Article 31 of Directive 2001/83/EC are initiated by the applicant of a marketing authorisation or the holder of an existing marketing authorisation.\nWhere more than one applicant of marketing authorisations or holder of existing marketing authorisations are concerned by the procedures referred to in the first subparagraph, the applicants or holders may be grouped for the purpose of the payment of one single referral fee. If however, the same procedure concerns more than ten different applicants or holders, the fee shall be charged by the application of the abovementioned referral fee.",
  "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": "Substituted by Commission Regulation (EU) 2020/422 of 19 March 2020 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020 (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/1995/297/article/4",
    "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."
}