{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-16",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-16.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/16",
  "kind": "regulation",
  "number": "16",
  "heading": "Insertion of regulation 29A of the principal Regulations",
  "text": "After regulation 29 of the principal Regulations (conduct of trial in accordance with clinical trial authorisation etc.), insert the following regulation—\n“Notification of serious breaches\n29A (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 amended from time to time in accordance with regulations 22 to 25,\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 subjects of the trial; or\n(b) the scientific value of the trial.”.",
  "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/16",
    "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."
}