{
  "url": "https://openlegislation.uk/eu-regulation-2012-520/article-6",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-520/article-6.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/6",
  "kind": "article",
  "number": "6",
  "heading": "Subcontracting",
  "text": "1. The marketing authorisation holder may subcontract certain activities of the pharmacovigilance system to third parties. It shall nevertheless retain full responsibility for the completeness and accuracy of the pharmacovigilance system master file.\n2. The marketing authorisation holder shall draw up a list of its existing subcontracts between it and the third parties referred to in paragraph 1, specifying the product(s) and territory(ies) concerned.",
  "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/6",
    "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."
}