{
  "url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-82",
  "json_url": "https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-82.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/82",
  "kind": "regulation",
  "number": "82",
  "heading": "Amendment to regulation 191",
  "text": "In regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)—\n(a) in paragraph (1)—\n(i) after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”;\n(ii) after “UKMA(GB”) insert “or a UKMA(UK)(Category 1)”;\n(b) in paragraph (4A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;\n(c) in paragraph (7)—\n(i) after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”;\n(ii) after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;\n(d) in paragraph (8A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;\n(e) in paragraph (10)—\n(i) in sub-paragraph (b)(i), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;\n(ii) in sub-paragraph (b)(ii)—\n(aa) after “a UKMA(GB)” insert “or a “UKMA(UK)(Category 1)”;\n(bb) for “Great Britain”, in both places, substitute “the United Kingdom”;\n(iii) in sub-paragraph (c)—\n(aa) in paragraph (i), in the opening words, for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;\n(bb) in paragraph (ii), for the opening words substitute—\n“in relation to a product authorised under a UKMA(GB) or a UKMA(UK)(Category 1), the product has been placed on the market in the United Kingdom”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 82 in force at 1.1.2025, see reg. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 191 was amended by S.I. 2019/775 including as that instrument was amended by S.I. 2020/1488."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2024/832/regulation/82",
    "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."
}