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 Sets out, among other things, the content of the pharmacovigilance system master file. To avoid unnecessary administrative burden for applicants and competent authorities, only significant deviations from the pharmacovigilance procedures, their impact and their management should be documented in the pharmacovigilance system master file until resolved. https://eur-lex.europa.eu/eli/reg_impl/2025/1466/oj/eng