{
  "url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-8",
  "json_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-8.json",
  "legislation": "ukdsi/2019/9780111189092",
  "legislation_title": "The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019",
  "path": "schedule/1/paragraph/8",
  "kind": "paragraph",
  "number": "8",
  "heading": "Amendment of regulation 139 (amendment of regulation 177 of the 2012 Regulations – application of Part 11 (pharmacovigilance) and interpretation)",
  "text": "For regulation 139(6), substitute—\n“(6) In paragraph (5)—\n(a) for “Schedule 33” substitute “Schedules 33 and 33A”;\n(b) in paragraph (c) of the definition of “relevant post-authorisation safety study”, omit “and”;\n(c) after that definition, insert—\n““signal” means information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and”; and\n(d) omit the definitions of “co-ordination group”, “Eudravigilance database”, “Implementing Regulation” and “relevant competent authorities”.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111189092/schedule/1/paragraph/8",
    "retrieved_at": "2026-10-30T14:59:28.001075+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."
}