CHANGES TO EUDRAVIGILANCE REGISTRATION AND MANAGEMENT FROM 26 JULY 2018

On 26 July 2018, the European Medicines Agency (EMA) integrated the services of EudraVigilance (human) with EMA’s Account Management portal icon and Organisation Management Service (OMS).

Pharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the EEA need to register with EudraVigilance for the electronic data interchange of pharmacovigilance information. The registration process is a prerequisite for electronic reporting.