{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-12",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-12.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/12",
  "kind": "regulation",
  "number": "12",
  "heading": "Requirement for authorisation and ethics committee opinion",
  "text": "(1) No person shall—\n(a) start a clinical trial or cause a clinical trial to be started; or\n(b) conduct a clinical trial,\nunless the conditions specified in paragraph (3) are satisfied.\n(2) No person shall—\n(a) recruit an individual to be a participant in a trial;\n(b) issue an advertisement for the purpose of recruiting individuals to be participants in a trial,\nunless the condition specified in paragraph (3)(a) has been satisfied.\n(3) The conditions referred to in paragraphs (1) and (2) are—\n(a) an ethics committee has given a favourable opinion in relation to the clinical trial; and\n(b) the clinical trial has been authorised by the licensing authority,\nin accordance with these Regulations.\n(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in reg. 12(2)(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 12(2)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in reg. 12(2)(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 12(2)(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 12(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 12(3)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 12(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), 12(4)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/12",
    "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."
}