{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-14/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-14/paragraph-2.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/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Application of the old rules to the authorisation etc of existing clinical trials",
  "text": "(1) If a request for authorisation to conduct a clinical trial has been received by the licensing authority before the relevant day, or an application for an ethics committee opinion in relation to a clinical trial has been received before the relevant day, Part 3 of the old rules including its related Schedules, rather than Part 3 of the new rules including its related Schedules, applies in respect of—\n(a) that trial (an “old rules clinical trial”), including—\n(i) the authorisation of that trial and any amended requests for authorisation,\n(ii) the giving of an ethics committee opinion in relation to that trial, or a review or appeal relating to such an opinion, and\n(iii) information sharing and the publication of information; and\n(b) the supply of any investigational medicinal product for a purpose related to that trial,\nsubject to the following sub-paragraphs.\n(2) An ethics committee established under regulation 6(1) of the new rules (“a new committee”) may, with the agreement of the Authority, take over and perform any function under the old rules of an ethics committee recognised under the old rules.\n(3) Where a new committee performs functions of an ethics committee under the old rules pursuant to this Schedule, the new committee may, with the agreement of the Authority, regulate its proceedings and business in relation to old rules clinical trials in a manner that is consistent, subject to any necessary modifications, with how it regulates its proceedings and business in relation to new rules clinical trials, provided that there is no detriment to—\n(a) the sponsor of an old rules clinical trial; or\n(b) achieving the outcome of performing the functions of an old committee under the old rules.\n(4) Any recognition of an ethics committee under regulation 7 of the old rules may, with the agreement of the Authority, continue in effect notwithstanding the repeal of regulation 7, but—\n(a) solely for the purposes of that committee performing the functions under the old rules of an ethics committee, and Part 2 of the old rules and its related Schedules continue to apply for that purpose; and\n(b) subject to any conditions or limitations imposed by the Authority.\n(5) In a case where the licensing authority or ethics committee receives a valid notice of amendment to a clinical trials authorisation from a sponsor before the relevant day, Part 3 of the old rules including its related Schedules, rather than Part 3 of the new rules including its related Schedules, applies in respect of that notice of amendment, including—\n(a) the giving of a written notice by the licensing authority, and the review of any amended notice of amendment or any appeal relating to such written notice; and\n(b) the giving of an opinion by an ethics committee, and the review of any amended notice of amendment,\nbut no notice of amendment received on or after the relevant day pursuant to the old rules is to be treated as valid.\n(6) In a case where the licensing authority serves a notice on a sponsor pursuant to regulation 23 of the old rules before the relevant day, the old rules continue to apply for the purposes of the consideration of representations relating to, and any making of an amendment as a consequence of, that notice.\n(7) As regards the modifications to an old rules clinical trial authorisation on and after the relevant day, except in a case to which sub-paragraph (5) or (6) applies, that modification (including a modification that would have been an amendment by the sponsor under regulation 24 of the old rules) is to be made in accordance with and subject to the requirements of the new rules.\n(8) Regulation 25 of the new rules applies to old rules clinical trials as it does to new rules clinical trials (including automatic deferrals in regulation 25(10)), except that—\n(a) it does not apply to an old rules clinical trial that has an end of trial date that is before the relevant day; and\n(b) in the case of an old rules trial that has been approved but its end of trial date is on or after the relevant day—\n(i) where, before the relevant day the first individual has not yet been recruited to be a participant in that trial, regulation 25(1) applies as if the reference to approval of the trial were a reference to the relevant day,\n(ii) where, before the relevant day the first individual has been recruited to be a participant in that trial, regulation 25(1) applies as if the reference to approval of the trial were a reference to the relevant day and sub-paragraph (a) were omitted, and\n(iii) regulation 25(2)(b) does not apply.",
  "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/2",
    "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."
}