{
  "url": "https://openlegislation.uk/eu-regulation-2012-520",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-520.json",
  "id": "eur/2012/520",
  "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)",
  "short_title": "Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation…",
  "long_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)",
  "citation": "EU Regulation No 520/2012",
  "type": "eur",
  "year": "2012",
  "number": "520",
  "version": "current",
  "date": "2012-06-19",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/I",
      "kind": "chapter",
      "number": "I",
      "heading": "Pharmacovigilance system master file",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Structure of the pharmacovigilance system master file",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Content of the pharmacovigilance system master file",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Content of the Annex to the pharmacovigilance system master file",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Maintenance",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Form of the documents contained in the pharmacovigilance system master file",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Subcontracting",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/7",
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      "number": "7",
      "heading": "Availability and location of the pharmacovigilance system master file",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "Minimum requirements for the quality systems for the performance of pharmacovigilance activities",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
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      "parent": "chapter/II"
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      "heading": "Performance indicators",
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      "heading": "Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders",
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      "status": null,
      "parent": "chapter/II"
    },
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      "path": "article/10",
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      "heading": "Management of human resources",
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      "status": null,
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    },
    {
      "path": "article/11",
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      "heading": "Compliance management",
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      "status": null,
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    {
      "path": "article/12",
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      "heading": "Record management and data retention",
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    {
      "path": "article/13",
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      "heading": "Audit",
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    },
    {
      "path": "chapter/II/section/3",
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      "heading": "Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/14",
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      "heading": "Management of human resources",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II/section/3"
    },
    {
      "path": "article/15",
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      "heading": "Compliance management",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/16",
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      "heading": "Record management and data retention",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/17",
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      "heading": "Audit",
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      "status": null,
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    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "Minimum requirements for the monitoring of data in the Eudravigilance database",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/18",
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      "heading": "General requirements",
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      "status": null,
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    {
      "path": "article/19",
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      "number": "19",
      "heading": "Identification of changed risks and new risks",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
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    {
      "path": "article/20",
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      "heading": "Methodology for determining the evidentiary value of a signal",
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      "extent": "E+W+S+N.I.",
      "status": null,
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    {
      "path": "article/21",
      "kind": "article",
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      "heading": "Signal management process",
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      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Worksharing for signal management",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/23",
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      "number": "23",
      "heading": "Signal detection support",
      "url": "https://openlegislation.uk/eu-regulation-2012-520/article-23",
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      "status": null,
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    {
      "path": "article/24",
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      "heading": "Signal detection audit trail",
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      "status": null,
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    {
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      "heading": "Use of terminology, formats and standards",
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    {
      "path": "chapter/V",
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      "heading": "Transmission of reports of suspected adverse reactions",
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      "status": null,
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    {
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      "heading": "Individual case safety reports",
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      "heading": "Format of electronic transmission of suspected adverse reactions",
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      "heading": "Risk management plans",
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      "heading": "Summary of the risk management plan",
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      "heading": "Updates of the risk management plan",
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      "path": "signature",
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