Guidance for Marketing Authorisation Holders on Electronic Reporting via EudraVigilance

Electronic reporting of suspected adverse reactions through EudraVigilance is mandatory for marketing authorisation holders. EudraVigilance Veterinary (EVVet) allows for the rapid and secure exchange of adverse reactions between Competent Authorities, the European Medicines Agency and marketing authorisation holder s. Three different routes have been set-up to allow for the electronic distribution of safety information by the marketing authorisation holder:

1. Gateway (registration required)

• Preferred option for organisations where large volumes of data are exported 
• Marketing authorisation holder s work on a day-to-day basis with their local system for the data input which is then securely distributed over the gateway to EVVet system

2. EVWEB (registration required)

• Direct and secure access to EVVet over the internet 
• User is supplied with a username and password to open a web application that allows on-line data entry

3. Simplified Electronic Reporting Form (no registration required)

• May be used by marketing authorisation holder s with limited experience in reporting adverse events using EVWEB 
• On-line form that allows user to create report using standard terminology 
• Completed form is sent as an email attachment to the competent authority which then uploads the attachment directly into the EVVet central database

Additional guidance for marketing authorisation holder s on the various registration options, reporting, transmission options and tutorials are available from the EudraVigilance Veterinary website.