To marketing authorisation holders and their representatives in Iceland: The European Medicines Agency improves and updates the database for adverse reactions, EudraVigilance

14.6.2017

The European Medicines Agency (EMA) will improve and update EudraVigilance, the database for collection and administration of adverse reaction reports for pharmaceutical companies and competent authorities. It is important that marketing authorisation holders and representatives become familiar with technical functionalities in time. New EudraVigilance will be launched on 22 November 2017.

EMA has confirmed that tests for the new and enhanced adverse reactions database EudraVigilance are accomplished and that the system fulfils all technical requirements. New and enhanced EudraVigilance database will therefore be launched on 22 November 2017.

It is important that marketing authorisation holders and representatives become familiar with technical functionalities of the new system and ensure that their information systems are adapted to the new database and the international agreed layout for adverse reactions reports. EMA offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance.

Further reading on the green light for new EudraVigilance system on the EMA's website.

Further reading on the change management of EudraVigilance on the EMA´s website.

Further reading on the training courses on the new EudraVigilance system on the EMA´s website.