{
  "url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-regulations-2024/regulation-4",
  "json_url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-regulations-2024/regulation-4.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/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Amendment to regulation 3",
  "text": "(1) Regulation 3 (sponsor of a clinical trial) is amended as follows.\n(2) In paragraphs (4) and (5)—\n(a) for “request for authorisation”, in both places where it occurs, substitute “request for approval”;\n(b) for “regulation 17”, in both places where it occurs, substitute “regulation 16”.\n(3) In paragraph (6)—\n(a) for “authorised by the licensing authority” substitute “approved”;\n(b) for “, 19 or 20” substitute “or 18A”;\n(c) for “substantial amendment” substitute “modification of an important detail as defined in Part 3”;\n(d) for “authorisation” substitute “approval”;\n(e) for “regulations 24 to 26” substitute “regulation 22”.\n(4) In paragraph (7)—\n(a) in sub-paragraph (a), omit “, except regulation 15”;\n(b) in sub-paragraph (b), omit “Parts 2 to 4 of”;\n(c) in sub-paragraph (c), omit “, in so far as it relates to decisions of the licensing authority under Part 3”.\n(5) In paragraph (10)—\n(a) in sub-paragraph (a), for “regulations 15 and 28(1)” substitute “regulation 28(1)”;\n(b) in sub-paragraph (c), omit “, and Part 1 of Schedule 3”.",
  "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/4",
    "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."
}