{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-3",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-3.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/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Content of the Annex to the pharmacovigilance system master file",
  "text": "The pharmacovigilance system master file must have an Annex containing the following documents—\n(a) a list of medicinal products covered by the pharmacovigilance system master file, including the name of each medicinal product, the international non-proprietary name (INN) of each active substance and the countries other than the United Kingdom in which the products covered are authorised to be marketed;\n(b) a list of written policies and procedures for the purpose of complying with Part 11 of these Regulations;\n(c) the list of any sub-contracts falling within paragraph 6(1);\n(d) a list of the tasks that have been delegated by the qualified person for pharmacovigilance;\n(e) a list of all scheduled and completed audits;\n(f) where applicable, a list of the performance indicators that support the quality system for pharmacovigilance specified in paragraph 2(e);\n(g) where applicable, a list of other pharmacovigilance system master files held by the same holder; and\n(h) a logbook containing a record of any alteration of the content of the pharmacovigilance system master file made within the preceding 5 year period, except any alteration of the content that is specified in of paragraph 2(a)(ii) to (iv) or this paragraph.",
  "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/3",
    "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."
}