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:
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.
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).
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.
For more information on implementing the Regulation, see Veterinary Medicines 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 uses VeDDRA terminology for the reporting of suspected adverse events 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.
The next revision will take place in 2024.
Please submit any comments on the lists before 1 March 2024 to veddracomments@ema.europa.eu using the Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
For the lists of clinical terms, current and obsolete, see:
Guidance on the use of VeDDRA terminology is also available:
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.
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.
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.