{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-44A",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-44A.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/44A",
  "kind": "regulation",
  "number": "44A",
  "heading": "Variation of MM (IMP) master file",
  "text": "Subject to regulation 45(5), the holder of a manufacturing authorisation (MM) may amend the information in the MM (IMP) master file provided in accordance with paragraph 10(a), (c) and (h) to (k) of Schedule 6 and paragraph 14E(a) of Schedule 7 without applying to the licensing authority for a variation under regulation 44.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 44A, 44B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 46"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/44A",
    "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."
}