{
  "url": "https://openlegislation.uk/eu-regulation-2012-520/article-15",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-520/article-15.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/15",
  "kind": "article",
  "number": "15",
  "heading": "Compliance management",
  "text": "1. The national competent authorities and the Agency shall establish specific procedures and processes in order to achieve all of the following objectives:\n(a) ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted;\n(b) ensuring the assessment of pharmacovigilance data and its processing within the timelines provided by Directive 2001/83/EC and Regulation (EC) No 726/2004;\n(c) ensuring independence in the performance of pharmacovigilance activities;\n(d) ensuring effective communication among national competent authorities and between the national competent authorities and the Agency as well as with patients, healthcare professionals, marketing authorisation holders and the general public;\n(e) guaranteeing that the national competent authorities and the Agency inform each other and the Commission of their intention to make announcements relating to the safety of a medicinal product authorised in several Member States or an active substance contained in such a medicinal product in accordance with Article 106a of Directive 2001/83/EC;\n(f) conducting inspections, including pre-authorisation inspections.\n2. In addition to the procedures referred to in paragraph 1, national competent authorities shall establish procedures for collecting and recording all suspected adverse reactions that occur in their territory.\n3. The Agency shall establish procedures for the monitoring of medical literature in accordance with Article 27 of Regulation (EC) No 726/2004.",
  "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/15",
    "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."
}