{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-21",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-21.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/21",
  "kind": "regulation",
  "number": "21",
  "heading": "Modifications by the licensing authority or the ethics committee",
  "text": "(1) The appropriate authority may require the sponsor to make modifications to a clinical trial approval if it appears to the authority to be necessary to ensure—\n(a) the safety or scientific validity of the clinical trial; or\n(b) that the conditions and principles of good clinical practice are satisfied or adhered to in relation to the clinical trial.\n(2) Where the appropriate authority proposes a modification in accordance with paragraph (1), that authority must, at least 7 days before the date on which it is proposed that the modification should take effect, serve a notice on the sponsor stating their proposal and the reasons for it.\n(3) If, within the period of 7 days beginning with the date on which notice is served in accordance with paragraph (2), the sponsor makes representations in writing to the appropriate authority, that authority—\n(a) must take those representations into account before deciding whether to require the sponsor to make the modification; and\n(b) may delay the date the proposed modification is to take effect, in order to allow time for them to consider those representations.\n(4) In this regulation, the “appropriate authority” means either or both of the following—\n(a) the licensing authority;\n(b) the ethics committee.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 14-26 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 14"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/21",
    "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."
}