{
  "url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-16",
  "json_url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-16.json",
  "legislation": "ukdsi/2019/9780111179116",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019",
  "path": "regulation/16",
  "kind": "regulation",
  "number": "16",
  "heading": "Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report)",
  "text": "(1) Regulation 35 is amended as follows.\n(2) In paragraph (2)(b), for “EEA State” substitute “any country”.\n(3) In paragraph (3)—\n(a) for “an EEA State” substitute “a country”; and\n(b) for sub-paragraphs (a) and (b), substitute—\n“(a) the date on which the trial was authorised by a regulatory body responsible for authorising clinical trials in that country; or\n(b) where the clinical trial was conducted in a country without a formal authorisation process, a date designated by the sponsor that is linked to the commencement of the first clinical trial.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111179116/regulation/16",
    "retrieved_at": "2026-10-30T15:01:33.158857+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."
}