{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-24",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-24.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/12A/paragraph/24",
  "kind": "paragraph",
  "number": "24",
  "heading": "Updates of the risk management plan",
  "text": "(1) Subject to sub-paragraph (2), where the holder updates a risk management plan, it must submit the updated risk management plan to the licensing authority.\n(2) If the licensing authority agrees, the holder may submit only the modules concerned by the update.\n(3) If necessary, the holder must provide the licensing authority with an updated summary of the risk management plan.\n(4) Each submission of the risk management plan must—\n(a) have a distinct version number; and\n(b) be dated.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/24",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}