{
  "url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-4",
  "json_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-4.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/4",
  "kind": "paragraph",
  "number": "4",
  "heading": "Amendment of regulation 47 (amendment of regulation 48 of the 2012 Regulations – application of Part 5)",
  "text": "In regulation 47(2)—\n(a) in sub-paragraph (a), in the inserted definition of “EU reference medicinal product”, after “paragraph (b)” insert “or (c)”; and\n(b) in sub-paragraph (d), in the substituted definition of “reference medicinal product”—\n(i) omit the “or” at the end of paragraph (a); and\n(ii) at the end of paragraph (b) insert—\n“; or\n(c) in relation to which an EU marketing authorisation had ceased to be in force before exit day for reasons not relating to safety, quality or efficacy.”.",
  "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/4",
    "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."
}