{
  "url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-regulations-2024/regulation-31",
  "json_url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-regulations-2024/regulation-31.json",
  "legislation": "ukdsi/2024/9780348267167",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024",
  "legislation_url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-regulations-2024",
  "path": "regulation/31",
  "kind": "regulation",
  "number": "31",
  "heading": "Insertion of new Part 6A",
  "text": "After Part 6, insert—\n“Part 6A\nNON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS\nNon-investigational medicinal and non-medicinal products\n45A (1) A non-investigational medicinal product shall be manufactured or assembled in accordance with the principles and guidelines for good manufacturing practice which apply under these Regulations or the 2012 Regulations.\n(2) A product which is not a medicinal product but which is used or to be used in a clinical trial, as described in the protocol, must—\n(a) comply with safety standards applicable to that product; and\n(b) be listed in the investigational medicinal product dossier with information about its properties, labelling, manufacture and safety controls, appropriate to the product.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348267167/regulation/31",
    "retrieved_at": "2026-10-30T14:39:55.019280+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."
}