{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-29",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-29.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/29",
  "kind": "regulation",
  "number": "29",
  "heading": "Conduct of trial in accordance with clinical trial authorisation etc.",
  "text": "Subject to regulation 30, no person shall conduct a clinical trial otherwise than in accordance with—\n(a) the protocol relating to that trial, as may be modified from time to time in accordance with regulations 20 to 22C;\n(b) the terms of—\n(i) the request for authorisation to conduct that trial,\n(ii) the application for an ethics committee opinion in relation to that trial, and\n(iii) any particulars or documents, other than the protocol, accompanying that request or that application,\nas may be modified from time to time in accordance with regulations 20 to 22C; and\n(c) any conditions imposed ... under regulation 18(3), 18B(3), 22A(4), 22C(3) or Schedule 5.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in reg. 29(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 29(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Word in reg. 29(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(a)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 29(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(b)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 29(c) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(3)(a)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in reg. 29(c) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(3)(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/29",
    "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."
}