{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-25",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-25.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/25",
  "kind": "paragraph",
  "number": "25",
  "heading": "Format of the risk management plan",
  "text": "The risk management plan must be in the following format—\n(a) Part I: product overview;\n(b) Part II: safety specification consisting of—\n(i) Module SI: epidemiology of each indication and each target population,\n(ii) Module SII: non-clinical part of the safety specification,\n(iii) Module SIII: clinical trial exposure,\n(iv) Module SIV: populations not studied in clinical trials,\n(v) Module SV: post-authorisation experience,\n(vi) Module SVI: additional EU requirements for the safety specification,\n(vii) Module SVII: identified and potential risks, and\n(viii) Module SVIII: summary of the safety concerns;\n(c) Part III: pharmacovigilance plan, including post-authorisation safety studies;\n(d) Part IV: plans for post-authorisation efficacy studies;\n(e) Part V: risk minimisation measures, including evaluation of the effectiveness of risk minimisation activities;\n(f) Part VI: summary of the risk management plan; and\n(g) Part VII: annexes.",
  "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/25",
    "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."
}