EudraVigilance Veterinary
Table of contents
- Log into EudraVigilance Veterinary
- How to register
- User guidance
- Guidance on using VICH standard format for reporting adverse events
- Guidance on using DEG standard format for reporting adverse events
- Veterinary Dictionary for Drug Regulatory Activities (VeDDRA)
- Webinars and training activities
- Release of data
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.
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).
-
List item
EVVET - EVWEB user manual (PDF/8.29 MB) (updated)
First published: 28/01/2022
Last updated: 24/11/2023
Version 1.7 -
List item
EVVET – Data warehouse user manual (PDF/4.83 MB)
First published: 28/01/2022
Last updated: 07/09/2023
EMA/53385/2022 Version 2.0 -
List item
EVVET - Procedures to be followed in case of prolonged system failure (PDF/311.69 KB)
First published: 28/01/2022
EMA/131441/2010
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.
-
List item
EU VICH adverse event report implementation guide (PDF/1.2 MB)
Adopted
First published: 23/11/2021
Legal effective date: 28/01/2022
EMA/186368/202 -
List item
Draft EU VICH adverse event report implementation guide (PDF/612.36 KB)
Draft: consultation closed
First published: 04/06/2021
Consultation dates: 04/06/2021 to 04/08/2021
EMA/186368/2021 -
List item
VICH schema (ZIP/375.53 KB)
First published: 23/11/2021 -
List item
Annex 1 - Field level specification (PDF/824.32 KB)
Draft
First published: 04/06/2021
Last updated: 23/11/2021
Version 2.7 -
List item
Annex 1 - XML file examples (ZIP/89.74 KB)
First published: 04/06/2021
Last updated: 23/11/2021 -
List item
Annex 2 - EVVET3 Business rules (XLS/160.5 KB)
First published: 04/06/2021
Last updated: 01/06/2022 -
List item
Form for submission of comments on scientific guidelines (DOC/232 KB)
First published: 05/02/2010
Last updated: 10/05/2019 -
List item
Standard term lists mapping from Data Elements Guideline (DEG) standard to VICH standard (XLS/724.5 KB)
First published: 30/09/2021
Last updated: 13/06/2022 -
List item
Field-by-field mapping from Data Elements Guideline (DEG) standard to VICH standard (XLSX/68.33 KB)
First published: 30/09/2021
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 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
submission template
For the lists of clinical terms, current and obsolete, see:
-
List item
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 (PDF/149.15 KB)
Adopted
First published: 22/07/2009
Last updated: 29/09/2023
Legal effective date: 01/10/2021
EMA/CVMP/PhVWP/10418/2009 Rev.14 corr. -
List item
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 (PDF/291.72 KB)
Adopted
First published: 19/07/2010
Last updated: 23/06/2023
EMA/CVMP/PhVWP/218994/2023 -
List item
Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes (XLSX/106.74 KB)
Adopted
First published: 19/07/2010
Last updated: 23/06/2023
EMA/CVMP/PhVWP/360871/2010-Rev.7 -
List item
Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms (XLSX/3.61 MB)
Adopted
First published: 02/10/2014
Last updated: 29/09/2023
Legal effective date: 01/10/2021
EMA/502060/2014 Rev.14 -
List item
Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products (XLSX/195.43 KB)
First published: 05/07/2023
Last updated: 29/09/2023
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.
- 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.