EudraVigilance Veterinary

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.

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.

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. EMA publishes the lists of clinical terms used, including current and obsolete ones.

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

The next revision will take place in 2021.

Please submit any comments on the lists before 1 March 2021 to veddra@ema.europa.eu using the Microsoft Office document iconsubmission template which can be found in the following document:

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

    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 PDF iconGuideline 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.

    Recommendation on data surveillance

    In May 2018, EMA revised its recommendation on the methodology for the analysis of adverse event data using the EVVet data analysis system, which provides guidance on efficient detection and evaluation of potential safety issues in veterinary medicines in the EEA, for the benefit of animal and public health.

    The revised recommendation integrates processes for signal detection based on EVVet data and the evaluation of periodic safety update reports, allowing national competent authorities to identify the need for regulatory action on suspected adverse reactions with centrally authorised veterinary medicines earlier and more effectively:

    Implementation of the recommendation is voluntary for marketing authorisation holders.

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