EudraVigilance Veterinary - Registration

The registration process is necessary to identify the partners of the European Medicines Agency in the European Economic Area (EEA) for the secure electronic transmission of Adverse Event Reports (AERs). Only registered partners are permitted to exchange safety or acknowledgement messages through the EudraVigilance Veterinary Gateway and Database Management System (DBMS). Pharmaceutical Companies and National Competent Authorities can register on this website for the purpose of the secure electronic transmission of AERs and to become part of the EudraVigilance Veterinary user community. It is recommended to download and read the Guidance for registration with EudraVigilance Veterinary document.

On 26 November 2019, the European Medicines Agency (EMA) integrated the services of EudraVigilance (veterinary) with EMA's Account Management portal and Organisations Management Service (OMS). All users, including organisations, need an active EMA account created through the EMA Account Management portal.

EudraVigilance Veterinary has two different environments:

Test Environment (XCOMP) is for the testing of electronic transmission of AERs.

 Production Environment is for the regular electronic transmission of AERs.

Please refer to the following documents for more information about the EudraVigilance Veterinary registration process:

The required registration forms are here:

UPDATE: Registering organisations in EVVET External Test (XCOMP) environment and managing the account via the EMA's Account Management portal

To sign into the EV VET XCOMP environment, MAHs and NCAs should use the same single sign-on credentials as for the EMA Account Management portal and other EMA applications. These are the same login details used to access the production environment.

Registration of an organisation in the production environment automatically creates an EV VET XCOMP profile. This enables MAHs and NCAs to use the same self-service process to manage access and maintain accurate data on their organisation.

For more information, see Eudravigilance EV VET XCOMP communication to stakeholders.

For guidance on how to access XCOMP, users should consult section 7. of the EudraVigilance VET Registration Manual.

Users can access the XCOMP environment by clicking on the link below:

EV VET XCOMP Restricted Area

IT vendors and third-party service providers

IT vendors and third-party service providers who offer software solutions and services related to electronic reporting can register as gateway organisations with the EudraVigilance VET XCOMP environment for testing purposes.

IT vendors and third-party service providers should register with the EudraVigilance VET XCOMP environment via the EMA Account Management system. Registration allows users to submit test files to the XCOMP environment via a gateway connection only; no access to the EVWEB application will be possible.

For detailed instructions on how to register with XCOMP as a vendor, see:

Vendor Registration in the Eudravigilance Veterinary external compliance testing environment (XCOMP)