{
  "node_id": "eu-pharmacovigilance-directive-2010-84-eu",
  "title": "Directive 2010/84/EU of the European Parliament and of the Council of 19 January 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2026-04-21",
  "bluf": "This directive establishes a robust pharmacovigilance system for medicinal products in the EU, mandating marketing authorization holders (MAHs) to monitor, report, and manage adverse drug reactions…",
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    "_note": "Full crosswalk values included in vault response"
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  "dependencies": [
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    "ich-q10-pharmaceutical-quality-system-2008",
    "fda-21-cfr-part-314-nda-new-drug-application"
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  "primary_citations_count": 5,
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  "citation_preview": [
    "Directive 2010/84/EU, Article 5 - Appointment of the Qualified Person for Pharmacovigilance",
    "Directive 2001/83/EC, Article 107c - Risk Management Systems and Periodic Safety Update Reports"
  ]
}