EudraVigilance Veterinary

EudraVigilance is the data-processing network and database for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.

EudraVigilance Veterinary (EVVet) is one of the systems that supports the implementation of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), specifically its provisions on the Union Pharmacovigilance Database.

The functionalities for veterinary pharmacovigilance referred to in the Regulation are implemented as follows:

• Recording of suspected adverse event reports (AERs): EVWeb
• Signal detection and data analysis: EVVet DWH
• Signal management and inspections outcomes: IRIS

Log into EudraVigilance Veterinary

Registered users can log into the following environments:

•    EVWeb: allows the sending and receiving of safety and acknowledgement messages via the web user interface.
•    Data Warehouse (EVVet DWH): query tool to access EVVet data in the Data Warehouse.
•    EVWeb test environment: allows the sending and receiving of safety and acknowledgement messages in the test environment
•    IRIS: for signal management and inspections outcomes

How to register

Guidance is available on how to register to access Eudravigilance Veterinary, for staff of national competent authorities and marketing authorisation holders:

EudraVigilance veterinary - Registration manual

Reference Number: Revision 5

User guidance

The user guide for Eudravigilance Veterinary helps marketing authorisation holders and national competent authorities with using the database via the web interface, EVWeb. 

Separate guidance is available on how to access suspected adverse reaction reports via the data warehouse.

For general questions, for example those relating to the implementation of the Veterinary Medicines Regulation, please use our webform on Send a question to the European Medicines Agency.

For technical support, including reporting bugs, please contact the EMA Service Desk (ServiceNow).

 

EVVET - EVWEB user manual

Reference Number: Version 1.8

EVVET – Data warehouse user manual

Reference Number: EMA/53385/2022 Version 3.0

EVVET - Procedures to be followed in case of prolonged system failure

Reference Number: EMA/131441/2010

Guidance on using VICH standard format for reporting adverse events

The system uses the pharmacovigilance reporting standards developed by theInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), which replace the data format described in the Guideline on data elements (DEG). However, both standards may be used for a transition period - EMA will provide more information shortly. 

Marketing authorisation holders and national competent authorities need to be able to read messages in VICH format to comply with their pharmcovigilance obligations once the enhanced system is live. If they cannot adapt their systems on time, they should build and use a suitable conversion tool. 

The implementation guide on reporting adverse events in the VICH format was finalised after a public consultation.

It contains guidance for marketing authorisation holders and national competent authorities on the technical requirements and process for transmitting adverse event reports electronically to the enhanced EVVet system. 

The guide complements relevant VICH guidelines. It should be read in conjunction with VICH GL42 and GL35, and the VICH 'step-by step document', which are available on VICH's website.

Mapping documents comparing the currently used 'DEG' and the VICH standard terms and data fields are available below.

EU VICH adverse event report implementation guide

Adopted Reference Number: EMA/186368/202 Legal effective date: 28/01/2022

Draft EU VICH adverse event report implementation guide

Draft: consultation closed Consultation dates: 04/06/2021 to 04/08/2021 Reference Number: EMA/186368/2021 Summary:

This document aims to support stakeholders in the implementation of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC1 (‘the Regulation’), by providing guidance on the technical specifications and the process of transmission of adverse event reports (AERs). It is targeted at all stakeholders responsible for submitting AERs electronically to the Union Pharmacovigilance Database.

VICH schema

Annex 1 - Field level specification

Draft Reference Number: Version 2.7

Annex 1 - XML file examples

Annex 2 - EVVET3 Business rules

Standard term lists mapping from Data Elements Guideline (DEG) standard to VICH standard

Field-by-field mapping from Data Elements Guideline (DEG) standard to VICH standard

For more information on implementing the Regulation, see Veterinary Medicines Regulation.

Guidance on using DEG standard format for reporting adverse events

Guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of veterinary pharmacovigilance information is available in the Guideline on data elements (DEG) below. 

From 28 January 2022, the data format described in the DEG is replaced by the VICH standard format described above, but both standards may be used for a transition period - EMA will provide more information shortly. 

Guideline on data elements for the electronic submission of adverse reaction reports related to veterinary medicinal products authorised in the european economic area (EEA) including message and transmission specificatio...

Adopted Reference Number: EMA/CVMP/65/2003 Version 2.2.2

• Eudravigilance veterinary XML schema definition (XSD)

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA)

EudraVigilance Veterinary uses VeDDRA terminology for the reporting of suspected adverse events in animals and humans. EMA publishes the standard list of clinical terms used, including current and obsolete terms.

EMA's Committee for Veterinary Medicinal Products (CVMP) revises VeDDRA every year, considering the comments received during the consultation, as outlined in:

• Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list

The next revision will take place in 2026.

Please submit any comments on the VeDDRA list before 14 February 2026 to [e-mail] using:

• Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)

For the VeDDRA list and associated documents, see:

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products - Rev.16

Adopted Reference Number: EMA/CVMP/PhVWP/10418/2009 Rev.16 Legal effective date: 01/10/2025

Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products

Adopted Reference Number: EMA/148106/2025

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025

Adopted Reference Number: EMA/CVMP/PhVWP/118833/2025 Rev.2 Corr.

Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes

Adopted Reference Number: EMA/CVMP/PhVWP/360871/2010 Rev.9

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms

Adopted Reference Number: EMA/158818/2025 Rev.16 Corr.

Guidance on the use of VeDDRA terminology is also available:

Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.17

Adopted Reference Number: EMA/CVMP/PhVWP/288284/2007 Rev.17 Corr.1 Legal effective date: 01/10/2025

DEG list of species and breeds

The species referred to in the 'Guideline on data elements for the electronic submission of adverse reaction reports related to veterinary medicinal products authorised in the EEA including message and transmission specifications' (DEG) can be found below.

• List of species and breeds for electronic reporting of suspected adverse reactions in veterinary pharmacovigilance
• List of species and breeds for electronic reporting of suspected adverse reactions in veterinary pharmacovigilance

DEG additional controlled terminology

The Guideline on data elements for the electronic submission of adverse reaction reports related to veterinary medicinal products authorised in the european economic area (EEA) including message and transmission specificatio... specifies which data fields require controlled terminology. The guideline below defines acceptable values for some of those data fields.

• List on additional controlled terminology for electronic submission of reports on adverse reactions to veterinary medicinal products

Webinars and training activities

• Union Pharmacovigilance Database: follow up webinar on signal detection, evaluation and yearly reporting - 19/01/2022
• Union Pharmacovigilance Database: follow up webinar on collection and recording of suspected adverse events for veterinary medicinal products - 18/01/2022
• Webinar on veterinary pharmacovigilance (PhV) inspections and systems, their quality management systems and PhV system master files: Introduction and principles - 8/12/2021
• Union Pharmacovigilance Database: webinar on signal detection and analysis- 23-24/11/2021
• Union Pharmacovigilance Database: webinar on adverse event collection and recording - 10/11/2021

Release of data

EMA publishes data from EVVet in the European database for suspected adverse drug reaction reports

The EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reactions reports.