{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-22C",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-22C.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/22C",
  "kind": "regulation",
  "number": "22C",
  "heading": "Approval procedure for amended requests regarding substantial modifications",
  "text": "(1) An amended modification request must be reviewed by the appropriate authority, which, for the purposes of this regulation, is either or both of the following—\n(a) the licensing authority, if the request for further information relates to the licensing authority’s decision;\n(b) the ethics committee, if the request for further information relates to the ethics committee opinion.\n(2) The appropriate authority must notify the sponsor of its decision or its opinion, or both its decision and opinion.\n(3) A notice under paragraph (2) must—\n(a) be in writing; and\n(b) state that the appropriate authority—\n(i) approves the amended request,\n(ii) approves the amended request, subject to conditions specified in the notice, or\n(iii) does not approve the amended request, setting out the grounds for this decision.\n(4) The appropriate authority must take all reasonable steps to ensure that the notice is given within the period of 10 days beginning with the date of receipt of an amended modification request.\n(5) If a notice is given in accordance with paragraph (3)(b)(ii)—\n(a) the notice must specify whether the conditions relate to either or both of the following—\n(i) the licensing authority’s decision;\n(ii) the ethics committee opinion;\n(b) the modification is to be treated as approved only if the conditions specified in the notice are satisfied.\n(6) The modification request is to be treated as rejected and the authorities may not consider any further amendments to that request if—\n(a) the authorities give written notice to the sponsor in accordance with regulation 22A(4)(b)(iii) and—\n(i) the notice does not contain a request for further information in accordance with regulation 22B(1), or\n(ii) the sponsor does not submit an amended request in accordance with regulation 22B(2); or\n(b) the sponsor has submitted an amended request in accordance with regulation 22B(3), but the appropriate authority gives written notice to the sponsor in accordance with paragraph (3)(b)(iii).",
  "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/22C",
    "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."
}