{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-6/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-6/paragraph-3.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": "schedule/6/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": null,
  "text": "A statement of the manufacturing, assembling or importation operations to which the authorisation is to relate, including a statement whether they include one or more of the following—\n(a) the manufacture of investigational medicinal products , including specifically MM investigational medicinal products or POC investigational medicinal products;\n(b) the assembly of investigational medicinal products , including specifically MM investigational medicinal products or POC investigational medicinal products; or\n(c) the importation of investigational medicinal products except for MM investigational medicinal products and POC investigational medicinal products.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 6 para. 3(a) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 51(3)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 6 para. 3(b) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 51(3)(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 6 para. 3(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), 51(3)(c)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/6/paragraph/3",
    "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."
}