EudraVigilance Veterinary

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EudraVigilance is the data-processing network and database management system 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 the system for the exchange, processing and evaluation of suspected adverse reaction reports (SARs) related to veterinary medicines authorised in the EEA. 

The latest EVVet Status Report can be found below:

Access to EudraVigilance Veterinary data

Stakeholders including marketing authorisation holders, regulatory authorities, academia and healthcare professionals can access data held in the EudraVigilance Veterinary database, based on EMA's EudraVigilance access policy. The policy is designed to provide as much information as possible while meeting data protection obligations.

Electronic submission of adverse reaction reports

Guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of veterinary pharmacovigilance information can be found below:

Controlled terminology for electronic reporting

Adverse events reports must contain standard vocabulary to allow systematic coding and analysis of adverse events. Controlled terminology is available for the various data elements in an electronic report. 

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA)

EudraVigilance Veterinary uses VeDDRA terminology for the reporting of suspected adverse reactions in animals and humans. Below are the lists of clinical terms, current and obsolete.

The lists are revised at the annual meeting of the VeDDRA sub-group. Any comments on the lists should be submitted to veddra@ema.europa.eu using the submission template which can be found in the following document:

Lists of clinical terms, current and obsolete :

Guidance on the use of VeDDRA terminology is also available:

List of species and breeds

The VeDDRA species list referred to in Volume 9B and 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' is frequently updated and can be found below.

Any comments on the list should be submitted to veddra@ema.europa.eu

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.

Data surveillance

The Agency has published a recommendation for regulators on the methodology to be used for the analysis of adverse event data using the EVVet data analysis system. 

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