{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-4/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-4/paragraph-1.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": "schedule/4/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": null,
  "text": "(1) Subject to the following sub-paragraphs, where the United Kingdom Ethics Committee Authority (“the Authority”) receive a notice pursuant to regulation 24(3) that a sponsor wishes to appeal against an ethics committee opinion which is not favourable, the Authority shall, subject to sub-paragraph (2)—\n(a) direct that the application for that opinion may be considered by another ethics committee specified in the direction; ...\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(2) ... The Authority may refuse to give a direction ... pursuant to sub-paragraph (1) where it considers that the grounds for appealing against the opinion are unfounded.\n(3) Where the Authority refuse to give a direction ... pursuant to sub-paragraph (1), the Authority shall send a notice to the sponsor setting out their reasons for refusal.\n(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 4 para. 1(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(a)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in Sch. 4 para. 1(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(a)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sch. 4 para. 1(1)(b) and word omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(a)(iii)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Sch. 4 para. 1(2) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(b)(i)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in Sch. 4 para. 1(2) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(b)(ii)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in Sch. 4 para. 1(3) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(c)(i)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Word in Sch. 4 para. 1(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(c)(ii)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Sch. 4 para. 1(4) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(2)(d)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/4/paragraph/1",
    "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."
}