{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-36",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-36.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/36",
  "kind": "regulation",
  "number": "36",
  "heading": "Conditions for manufacturer's licence",
  "text": "(1) Regulations 37 to 41 apply to the holder of a manufacturer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products).\n(2) Those provisions are regulations 37(3), 38, 39(6)(a) and (8) , 40 and 41.\n(3) The requirements of Part 1 of Schedule 6 apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.\n(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in reg. 36(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 10"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 36(4)-(7) 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), 14"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/36",
    "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."
}