{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-42",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-42.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/42",
  "kind": "regulation",
  "number": "42",
  "heading": "Obligations of manufacturing authorisation holder",
  "text": "The holder of a manufacturing authorisation shall—\n(a) comply with the principles and guidelines of good manufacturing practice;\n(b) comply with the provisions referred to in regulation 40(3);\n(c) allow the licensing authority access to his premises at any reasonable time; and\n(d) put and keep in place arrangements which enable the qualified person to carry out his duties, including placing at his disposal all the necessary facilities.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 42 substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 22"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/42",
    "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."
}