{
  "url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-7",
  "json_url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-7.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/7",
  "kind": "regulation",
  "number": "7",
  "heading": "Amendment to regulation 8",
  "text": "In regulation 8 (general interpretation)—\n(a) in paragraph (1)—\n(i) omit the definition of “advanced therapy medicinal product”;\n(ii) in the definition of “Annex I to the 2001 Directive”, after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;\n(iii) omit the definition of “Commission Regulation 2016/161”;\n(iv) in the definition of “conditional marketing authorisation”, for “UKMA (GB)” substitute “UKMA(UK)(Category 1)”;\n(v) omit the definition of “healthcare institution”;\n(vi) in the definition of “marketing authorisation”, omit paragraph (b) and the “or” which precedes it;\n(vii) in the definition of “name”, omit paragraph (b) (but not the “and” which follows it);\n(viii) in the definition of “pharmacovigilance system”, omit “, EU marketing authorisation”;\n(ix) in the definition of “pharmacovigilance system master file”, omit “, EU marketing authorisation”;\n(x) in the definition of “post-authorisation safety study”, omit “, EU marketing authorisation”;\n(xi) omit the definition of “Regulation (EC) No 1394/2007”;\n(xii) in the definition of “UK marketing authorisation”, in paragraph (a), after “authorisation” insert “, within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2),”;\n(xiii) after the definition of “UK marketing authorisation”, insert—\n““UKMA(UK)(Category 1)” means a marketing authorisation of the description in regulation 49(1ZB);\n“UKMA(UK)(Category 2)” means a marketing authorisation of the description in regulation 49(1ZC);”;\n(xiv) in the definition of “under the unfettered access route”, in paragraph (a), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”;\n(b) in paragraph (9), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 7 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. 2019/62 and S.R. 2019 No. 10."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "The definition was inserted by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "The definition was inserted by S.I. 2019/62 and S.R. 2019 No. 10."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "The definition was amended by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "The definition was amended by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "The definition was substituted by S.I. 2019/775 as amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "Paragraph (9) was 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/7",
    "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."
}