EMA Rolls Out Monthly Time Slots To Stagger Registration To Revamped EudraVigilance Database
Executive Summary
The European Medicines Agency has drawn up a list of approximately 3,000 marketing authorization holders that need to be registered to the modernized pharmacovigilance database by November. The agency will tackle the list in alphabetical order, undertaking around 600 registrations per month starting June 1. Companies that fail to apply within the designated monthly slot will be put at the end of the queue, which may delay their access to the database.