EMA posts new Q&A on pharmacovigilance implementing rules
This article was originally published in SRA
Executive Summary
The European Medicines Agency has issued an updated question and answer document on pharmacovigilance requirements for human drugs (EudraLex Volume 9A)1,2. The revised document (version 5.4), issued on 29 March, is applicable to all stakeholders exchanging individual case safety reports electronically within the European Economic Area.