{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-9",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-9.json",
  "legislation": "uksi/2006/1928",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006",
  "path": "regulation/9",
  "kind": "regulation",
  "number": "9",
  "heading": "Amendment of regulation 15 of the principal Regulations",
  "text": "In regulation 15 of the principal Regulations (ethics committee opinion), in paragraph (5)—\n(a) in sub-paragraph (b), for “paragraph 2” substitute “paragraph 10”;\n(b) in sub-paragraph (e), after “investigator’s brochure” insert “ or, where the investigational medicinal product has a marketing authorization and the product is to be used in accordance with the terms of that authorization, the summary of product characteristics relating to that product”; and\n(c) in sub-paragraph (h)—\n(i) after “include” insert “ minors or”, and\n(ii) for “Part 5” substitute “Part 4 or Part 5 respectively”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2006/1928/regulation/9",
    "retrieved_at": "2026-10-29T04:25:32.359836+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."
}