{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-22",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-22.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/22",
  "kind": "paragraph",
  "number": "22",
  "heading": "Content of the risk management plan",
  "text": "(1) The risk management plan established by the holder must contain the following elements—\n(a) an identification or characterisation of the safety profile of the medicinal product concerned;\n(b) an indication of how to characterise further the safety profile of the medicinal product(s) concerned;\n(c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those measures; and\n(d) a documentation of post-authorisation obligations that have been imposed as a condition of the UKMA(GB) or the UKMA(UK)(Category 1).\n(2) Medicinal products may, where appropriate be subject to the same risk management plan if they—\n(a) contain the same active substance; and\n(b) belong to the same holder.\n(3) Where a risk management plan refers to post-authorisation studies—\n(a) it must indicate whether those studies are initiated, managed or financed by the holder voluntarily, or pursuant to obligations imposed by the licensing authority or an equivalent authority to the licensing authority in another country; and\n(b) all post-authorisation obligations must be listed in the summary of the risk management plan referred to in paragraph 23, together with a timeframe for meeting those obligations.",
  "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)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 12A para. 22(1)(d) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(d) (with reg. 1(2))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/22",
    "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."
}