The new 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 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council, brings crucial pharmacovigilance changes for MAH.
While most are effective from February 12, 2026, key shifts for EudraVigilance and signal validation begin August 12, 2025.