{
  "url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-25",
  "json_url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-25.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/25",
  "kind": "regulation",
  "number": "25",
  "heading": "Amendment to regulation 48",
  "text": "(1) Regulation 48 (application of Part) is amended as follows.\n(2) In paragraph (2)—\n(a) omit the definition of “EU reference medicinal product”;\n(b) in the definition of “excluded reference product”, in paragraph (c), for “53A(1)” substitute “53B(1)”;\n(c) in the definition of “generic medicinal product”—\n(i) in paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;\n(ii) in paragraph (b), in the opening words, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”;\n(d) in the definition of “reference medicinal product”—\n(i) omit paragraph (b);\n(ii) in paragraph (c)—\n(aa) at the end of sub-paragraph (i), for “; or” substitute a comma;\n(bb) omit sub-paragraph (ii).\n(3) In paragraph (7), for “51A(1) and (6)” substitute “51B(1) and (6)”.\n(4) Omit paragraphs (8) and (9).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 25 in force at 1.1.2025, see reg. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "The definition was inserted by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "The definition was inserted by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "The definition was substituted by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "The definition was substituted by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "Paragraphs (7), (8) and (9) were inserted by S.I. 2019/775 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/25",
    "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."
}