Bioequivalence and Bioavailability Forum

Dear Mr Compliance,

You should report suspected side effects and SAE to either the national medicines regulatory authority in the European Union or the pharmaceutical company that holds the marketing authorisation for the medicine. These reports are then transmitted electronically to EudraVigilance.

How to report AE/SAE to Eudravigilance, see here

The Agency, on behalf of European Member States, is responsible for the development, maintenance and coordination of EudraVigilance.

Pharmaceutical companies that hold the marketing authorisation for a medicine in the European Economic Area (EEA) are also legally required to submit to EudraVigilance all reports of suspected unexpected adverse reactions that are serious and that occurred in a third country (non-EEA) where they hold a marketing authorisation.