{
  "url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-56",
  "json_url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-56.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/56",
  "kind": "regulation",
  "number": "56",
  "heading": "Amendment to regulation 68",
  "text": "In regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)—\n(a) in paragraph (7)—\n(i) for sub-paragraph (a) substitute—\n“(a) Northern Ireland, in the case of a UKMA(UK)(Category 2) granted under the unfettered access route, and”;\n(ii) for sub-paragraph (b) substitute—\n“(b) the United Kingdom or an EEA State, in any other case,”;\n(b) after paragraph (11G) insert—\n“(11H) Condition Q is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(UK)(Category 1).\n(11I) Condition R is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(GB) and separate UKMA(NI).\n(A12) Where Condition R is met, and the licence holder requests the cancellation of, or fails to renew, either the UKMA(GB) or UKMA(NI) that result from a variation being made under paragraph 11I, the licensing authority may revoke the corresponding UKMA(NI) or UKMA(GB) that results from that variation.”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 56 in force at 1.1.2025, see reg. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 68 was amended by S.I. 2013/1855, 2014/1878 and 2019/775 (including that instrument 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/56",
    "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."
}