What Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC requires
This Implementing Regulation amends the pharmacovigilance performance rules in Regulation (EU) No 520/2012: it limits Pharmacovigilance System Master File deviation documentation to major or critical deviations, strengthens audit and…
This is a preview. The full record adds the complete summary, 10 workflow steps, 9 schema fields and 7 primary citations. Start a free trial or see pricing.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/eli/reg_impl/2025/1466/oj/eng
SHA-256 integrity: 64ddf2d15e58fa276e80fa8c2d7bcac7453a9b3d4ff35c7e2d615bba9c41e88f
Primary Citations — 7 traced to source
- Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities
- Major or critical deviations from the pharmacovigilance procedures, their impact and their management shall be documented
+ 5 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/eu-pharmacovigilance-implementing-regulation-2025-1466.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-pharmacovigilance-implementing-regulation-2025-1466.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-pharmacovigilance-implementing-regulation-2025-1466
- Back to registry: Browse all 10,102 compliance nodes