{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-46",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-46.json",
  "legislation": "ukdsi/2020/9780348213980",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020",
  "path": "schedule/2/paragraph/46",
  "kind": "paragraph",
  "number": "46",
  "heading": null,
  "text": "In regulation 63 (amendment of Schedule 11 (advice and representations))—\n(a) for paragraph (2)(c) substitute—\n“(c) for sub-paragraph (2) substitute—\n“(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”;”;\n(b) for paragraph (4) substitute—\n“(4) In paragraph 14(a) (application of Part 2), after “veterinary medicinal products” insert “or paragraph 1 of Schedule 10A”.”;\n(c) for paragraph (7) substitute—\n“(7) For paragraph 17 substitute—\n“17. In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”.”;\n(d) for paragraph (8)(b)(ii) substitute—\n“(ii) for sub-paragraph (2) substitute—\n“(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”; and”;\n(e) for paragraph (9) substitute—\n“(9) In Part 4 (exceptions to Schedule) omit paragraphs 31, 34, 35, 37 and 38.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/46",
    "retrieved_at": "2026-10-30T14:48:26.477695+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."
}