{
  "url": "https://openlegislation.uk/eu-regulation-2012-520/article-31",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-520/article-31.json",
  "legislation": "eur/2012/520",
  "legislation_title": "Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-520",
  "path": "article/31",
  "kind": "article",
  "number": "31",
  "heading": "Summary of the risk management plan",
  "text": "1. The summary of the risk management plan to be made publicly available in accordance with point (c) of Article 106 of Directive 2001/83/EC and Article 26(1)(c) of Regulation (EC) No 726/2004 shall include key elements of the risk management plan with a specific focus on risk minimisation activities and, with regard to the safety specification of the medicinal product concerned, important information on potential and identified risks as well as missing information.\n2. Where a risk management plan concerns more than one medicinal product, a separate summary of the risk management plan shall be provided for each medicinal product.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/520/article/31",
    "retrieved_at": "2026-11-01T14:49:23.286977+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."
}