{
  "node_id": "eu-pharmacovigilance-regulation-1235-2010-psur",
  "title": "Commission Regulation (EU) No 1235/2010 of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004, Regulation (EC) No 1394/2007, Directive 2001/83/EC and Directive 2001/82/EC",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2026-04-20",
  "bluf": "This regulation requires marketing authorisation holders to submit periodic safety update reports (PSURs) to the European Medicines Agency, as outlined in Article 28a of Directive 2001/83/EC. It applies to all medicinal products for human use authorised in the European Union.",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "nist_framework",
      "iso_standard",
      "industry_mapping",
      "ai_overlay_2026"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "ich-gcp-e6-r3-2023",
    "iso-13485-qms"
  ],
  "primary_citations_count": 5
}