{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-41",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-41.json",
  "legislation": "uksi/2004/1031",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
  "path": "regulation/41",
  "kind": "regulation",
  "number": "41",
  "heading": "Application and effect of manufacturing authorisation",
  "text": "A manufacturing authorisation shall apply only in relation to—\n(a) the descriptions of investigational medicinal products;\n(b) the manufacturing, assembling or importation operations; ...\n(bb) in the case of an authorisation relating to the inactivation of viral or non-conventional agents, the manufacturing process; and\n(c) except in the case of an MM investigational medicinal product or a POC investigational medicinal product, the premises,\nspecified in the application made pursuant to regulation 38 and in respect of which the authorisation is granted.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in reg. 41(b) omitted (29.8.2006) by virtue of The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 21(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 41(bb) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 21(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 41(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 44"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/41",
    "retrieved_at": "2026-10-29T05:28:03.775386+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."
}