{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-14/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-14/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/14/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "Interpretation",
  "text": "(1) In this Schedule—\n“end of trial date” is the date of the conclusion of the trial that is specified in the protocol of a clinical trial and which, in the case of a clinical trial conducted in other countries as well as the United Kingdom, is the end of the date of the trial in all the participating countries;\n“the new rules” means these Regulations as in force on and after the relevant day;\n“new rules clinical trial” means a clinical trial which is not an old rules clinical trial;\n“old committee” means an ethics committee recognised under the old rules that has been abolished or has ceased to operate as an ethics committee for the purposes of these Regulations;\n“the old rules” means these Regulations as in force immediately before the relevant day;\n“old rules clinical trial” is to be construed in accordance with paragraph 2(1)(a);\n“the relevant day” means the day on which this Schedule comes into force.\n(2) Where, by virtue of this Schedule, the old rules continue to apply, regulation 2 of the old rules applies to the interpretation of the old rules, except in so far as it is necessary for regulation 2 of the new rules to apply to their interpretation in order to give effect to a provision of this Schedule (for example, because a new committee is performing functions of an old committee).\n(3) For purposes of this Schedule, “sponsor”, in the context of the old rules, has the meaning given in regulation 3 of the old rules.\n(4) Regulation 53 of the new rules applies to both the new rules and the old rules.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 14 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 45"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/14/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."
}