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

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

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

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.

Marketing authorisation holders with questions not addressed by the guidance may email vetchange.programme@ema.europa.eu. 

EMA launched an enhanced EVVet system on 28 January 2022 to adapt to the Veterinary Medicines Regulation (Regulation (EU) 2019/6), which forms part of the 'Union Pharmacovigilance Database'.

The system uses the pharmacovigilance reporting standards developed by the Veterinary International Conference on Harmonization (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. They can submit reports using the current data format for at least six months after go-live.

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.

For more information on implementing the Regulation, see Veterinary Medicinal Products Regulation.

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. 

• Eudravigilance veterinary XML schema definition (XSD)

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

The VeDDRA subgroup of EMA's Committee for Veterinary Medicinal Products (CVMP) usually revises the lists at its annual meetings.

For the lists of clinical terms, current and obsolete, see:

Guidance on the use of VeDDRA terminology is also available:

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 EEA including message and transmission specifications specifies which data fields require controlled terminology. The guideline below defines acceptable values for some of those data fields.

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

• 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

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.