{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-12",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-12.json",
  "legislation": "uksi/2025/538",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025",
  "path": "regulation/12",
  "kind": "regulation",
  "number": "12",
  "heading": "Amendment to regulation 12",
  "text": "(1) Regulation 12 (requirement for authorisation and ethics committee opinion) is amended as follows.\n(2) In paragraph (2)—\n(a) in sub-paragraph (a), for “subject” substitute “participant”;\n(b) in sub-paragraph (b), for “subjects” substitute “participants”.\n(3) For paragraph (3) substitute—\n“(3) The conditions referred to in paragraphs (1) and (2) are—\n(a) an ethics committee has given a favourable opinion in relation to the clinical trial; and\n(b) the clinical trial has been authorised by the licensing authority,\nin accordance with these Regulations.”.\n(4) Omit paragraph (4).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 12 in force at 28.4.2026, see reg. 1(2)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 12(3) was amended by S.I. 2006/1928."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2025/538/regulation/12",
    "retrieved_at": "2026-10-28T21:16:31.731081+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."
}