How MAHs can report adverse events

Essential guidance for Marketing Authorisation Holders (MAHs) on reporting adverse reactions to the EU database EudraVigilance Veterinary (EVVet). Discover the three reporting routes and processes.

Reporting suspected adverse events to the EU pharmacovigilance database

EudraVigilance Veterinary (EVVet) is the European data-processing network and database management system designed for the rapid and secure exchange of reports on suspected adverse events relating to veterinary medicines. Reporting to EVVet is mandatory for marketing authorisation holders (MAHs) in compliance with EU legislation. There are 3 distinct routes for submitting reports to EVVet:

Gateway (registration with the EMA is required)

• Preferred option for MAHs exporting large volumes of data.
• MAHs utilise their local system for daily data input, which is then securely transmitted via the Gateway to EVVet.

EVWEB (registration with the EMA required)

• Provides direct and secure access to EVVet over the internet.
• User receive a username and password to access a web application for on-line data entry.

Simplified Electronic Reporting Form (no registration required)

• Suitable for MAHs with limited reporting experience.
• An on-line form allows user to create reports using standardised terminology.
• The completed form is emailed to the HPRA or other EU competent authority, which then uploads the attachment directly to EVVet.

Additional guidance on the transmission options and tutorials are available on the EudraVigilance website.