{
  "url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-137",
  "json_url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-137.json",
  "legislation": "uksi/2024/832",
  "legislation_title": "The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024",
  "path": "regulation/137",
  "kind": "regulation",
  "number": "137",
  "heading": "Amendment to Schedule 8",
  "text": "In Schedule 8 (material to accompany an application for a UK marketing authorisation)—\n(a) in paragraph 18—\n(i) omit sub-paragraph (a);\n(ii) in sub-paragraph (b), omit “in the case of a medicinal product for sale or supply in Great Britain,”;\n(b) in paragraph 23—\n(i) in sub-paragraph (a), for “medicinal product for sale or supply in Northern Ireland” substitute “UKMA(NI) or a UKMA(UK)(Category 2)”;\n(ii) in sub-paragraph (b), for “medicinal product for sale or supply in Great Britain” substitute “UKMA(GB) or a UKMA(UK)(Category 1)”;\n(c) in paragraph 25A, omit “for sale or supply in Great Britain”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 137 in force at 1.1.2025, see reg. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Paragraphs 18 and 23 were substituted by, and paragraph 25A was inserted by, S.I. 2019/755 as amended by S.I. 2020/1488."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2024/832/regulation/137",
    "retrieved_at": "2026-10-28T21:27:38.976848+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."
}