Announcement of changes in EU pharmacovigilance legislation

Announcement of changes in EU pharmacovigilance legislation

Europe In December 2024, a draft version of an amendment to the European legislation for pharmacovigilance activities (Implementing Regulation EU No. 520/2012) has been published by the European Commission. Public feedback was collected until the 15th of January 2025....
Update on the pharmacovigilance system for Luxembourg

Update on the pharmacovigilance system for Luxembourg

Luxembourg There has been an update on: New instructions for the preparation and submission of additional risk minimisation material (aRMM) for evaluation and approval in Luxembourg: update contact detail adverse event reportingupdate address to send the printed...

New and improved version of Eudravigilance

EMA On 22 November 2017, a new and improved version of EudraVigilance will be launched by the European Medicines Agency (EMA). Users of this system, including marketing authorization holders and sponsors of clinical trials, should prepare themselves to ensure that...