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 inspection duties over subcontractors and third parties, clarifies signal validation timelines and EudraVigilance monitoring, updates the ISO IDMP electronic standards and requires DOIs for literature references, and applies from 12 February 2026.
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
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- 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
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