{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-321",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-321.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/321",
  "kind": "regulation",
  "number": "321",
  "heading": "Specified publications",
  "text": "(1) In this regulation “specified publication” means any of the following—\n(a) the European Pharmacopoeia;\n(b) the British Pharmacopoeia;\n(c) the Cumulative List of Recommended International Nonproprietary Names;\n(d) a compendium prepared and published under regulation 317; or\n(e) a list of names prepared and published under regulation 318.\n(2) Paragraph (3) applies if an authorisation refers to a specified publication, but not to a particular edition of the publication.\n(3) Where this paragraph applies, in order to determine whether anything done at a time when the authorisation is in force is done in accordance with the authorisation, the reference to a specified publication is to be construed as a reference to the edition of the specified publication in force at that time, unless the authorisation expressly provides otherwise.\n(4) In paragraph (3) the reference to the edition of a specified publication in force at a particular time is a reference to the edition of that publication in force, under whatever title, at that time.\n(5) In this regulation “authorisation” means any of the following—\n(a) a manufacturer's licence;\n(b) a wholesale dealer's licence;\n(c) a UK marketing authorisation;\n(ca) ...\n(d) an Article 126a authorisation;\n(e) a certificate of registration; or\n(f) a traditional herbal registration.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in reg. 321(5)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 218(a); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 321(5)(ca) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 127"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/321",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}