{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-29A",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-29A.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/29A",
  "kind": "regulation",
  "number": "29A",
  "heading": "Notification of serious breaches",
  "text": "(1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of—\n(a) the conditions and principles of good clinical practice in connection with that trial; or\n(b) the protocol relating to that trial, as modified from time to time in accordance with regulations 20 to 22C,\nwithin 7 days of becoming aware of that breach.\n(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree—\n(a) the safety or physical or mental integrity of the participants of the trial; or\n(b) the scientific value of the trial.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 29A inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 16"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in reg. 29A(1)(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 19(2)(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 29A(1)(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 19(2)(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Word in reg. 29A(2)(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 19(3)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/29A",
    "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."
}