{
  "url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-6",
  "json_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-6.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/6",
  "kind": "paragraph",
  "number": "6",
  "heading": "Amendment of regulation 58 (amendment of regulation 53 of the 2012 Regulations - applications relating to similar biological medicinal products)",
  "text": "(1) Regulation 58 is amended as follows.\n(2) In paragraph (3), for substituted paragraph (2)(a) of regulation 53 of the 2012 Regulations, substitute—\n“(a) may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to a reference medicinal product which is or has been authorised for not less than eight years—\n(i) under regulation 49(1)(a) (subject to paragraphs (2) and (3) of regulation 51), or\n(ii) if the reference medicinal product is an EU reference medicinal product, under Regulation (EC) No 726/2004; but”.\n(3) For paragraph (4)(a), substitute—\n“(a) for “Regulation 51(2)” substitute “Paragraphs (2) to (14) of regulation 51”; and”.",
  "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/6",
    "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."
}