{
  "url": "https://openlegislation.uk/eu-regulation-2000-141/article-2",
  "json_url": "https://openlegislation.uk/eu-regulation-2000-141/article-2.json",
  "legislation": "eur/2000/141",
  "legislation_title": "Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2000-141",
  "path": "article/2",
  "kind": "article",
  "number": "2",
  "heading": "Definitions",
  "text": "For the purposes of this Regulation:\n(a)‘medicinal product’ means a medicinal product for human use, as defined in Article 2 of Directive 65/65/EEC;\n(b)‘orphan medicinal product’ means a medicinal product designated as such under the terms and conditions of this Regulation;\n(c)‘sponsor’ means any legal or natural person, established in the Community, seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product;\n(d)‘Agency’ means the European Agency for the Evaluation of Medicinal Products.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(f) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2000/141/article/2",
    "retrieved_at": "2026-11-01T14:57:33.227512+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."
}