{
  "url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-51",
  "json_url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-51.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/51",
  "kind": "regulation",
  "number": "51",
  "heading": "Amendment to regulation 61",
  "text": "In regulation 61 (conditions of UK marketing authorisation: new obligations post-authorisation)—\n(a) in paragraph (4)(b), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;\n(b) in paragraph (6), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”;\n(c) in paragraph (6A), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;\n(d) for paragraph (7), substitute—\n“(7) The obligation under paragraph (5) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive while taking account of the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.”;\n(e) omit paragraph (7A);\n(f) in paragraph (13), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 51 in force at 1.1.2025, see reg. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Relevant amendments to regulation 61 were made 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/51",
    "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."
}