{
  "url": "https://openlegislation.uk/eu-regulation-2012-520/article-3",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-520/article-3.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/3",
  "kind": "article",
  "number": "3",
  "heading": "Content of the Annex to the pharmacovigilance system master file",
  "text": "The pharmacovigilance system master file shall have an Annex containing the following documents:\n(1)a list of medicinal products covered by the pharmacovigilance system master file, including the name of the medicinal product, the international non-proprietary name (INN) of the active substance(s), and the Member State(s) in which the authorisation is valid;\n(2)a list of written policies and procedures for the purpose of complying with Article 11(1);\n(3)the list of subcontracts referred to in Article 6(2);\n(4)a list of the tasks that have been delegated by the qualified person for pharmacovigilance;\n(5)a list of all scheduled and completed audits;\n(6)where applicable, a list of the performance indicators referred to in Article 9;\n(7)where applicable, a list of other pharmacovigilance system master files held by the same marketing authorisation holder;\n(8)a logbook containing the information referred to in Article 5(4).",
  "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/3",
    "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."
}