{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-15",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-15.json",
  "legislation": "uksi/2019/744",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019",
  "path": "regulation/15",
  "kind": "regulation",
  "number": "15",
  "heading": "Amendment of regulation 34 (clinical trials conducted in third countries)",
  "text": "(1) In the heading of regulation 34, for “third countries” substitute “ countries other than the United Kingdom ”.\n(2) In regulation 34—\n(a) for “a third country” substitute “ another country ”; and\n(b) for the words “entered into” to the end, substitute—\n“reported as soon as possible to the licensing authority, and in any event—\n(a) in the case of a reaction that is fatal or life-threatening, within 7 days beginning with the day after the sponsor was first aware of the reaction; or\n(b) in any other case, within 15 days beginning with the day after the sponsor is first aware of the reaction.”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/744/regulation/15",
    "retrieved_at": "2026-10-28T22:42:33.457024+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."
}