Updated 4 December 2025:
'Veterinary signal assessment report template' section
A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation.
Safety signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature.
Eudravigilance veterinary is an important source of information on suspected adverse reactions and signals with veterinary medicines in the European Union (EU).
Marketing authorisation holders must continuously monitor the data on their medicines in Eudravigilance veterinary and inform EMA and the national competent authorities of validated signals detected in the database.
Guidance for marketing authorisation holders is available in the module on signal management of the guidelines on the veterinary good pharmacovigilance practices (VGVP).
The legal basis is Article 81 of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).
Marketing authorisation holders should report the outcomes of their signal management activities on an annual basis.
The recommended due dates for submitting these annual statements via EMA's IRIS platform for all veterinary medicines is available below.
More information on submitting annual statements is available in the VGVP guideline module on signal management.
Marketing authorisation holders should use the template below to provide their assessment of all signals detected and validated in the Union Pharmacovigilance database (EudraVigilance Veterinary(EVV)) or from any other sources, including the MAH’s own database.
This includes:
The template has been revised in order to provide MAHs with detailed guidance on the information required for signal submissions and to ensure a consistent approach for all types of validated signals.
Some of the main changes implemented refer to the inclusion of a standardised overview of signals (e.g. in terms of the VeDDRA terms linked to the submitted signal, the type of signal: in initial or follow-up), a more comprehensive guidance on what information should be included in each section of the assessment report template, reference to mandatory dates for analysis, EVV queries and to the creation of standardised statements for the outcome of the assessment, available in the conclusion section.
The template should be filled in considering also the guidance provided in the current version of the Veterinary Union Pharmacovigilance Database - Best Practice Guide, which was also recently updated to include practical advice in relation to the signal management process and its management through the EMA digital systems IRIS and EudraVigilance Veterinary Data Warehouse.
EMA and national competent authorities in EU Member States may carry out targeted signal management procedure for a given veterinary medicine or a group of veterinary medicines.
They can start a targeted signal management procedure at any time. The legal basis is Article 81(3) of Regulation (EU) 2019/6.
EMA publishes information on targeted signal management procedures initiated by EMA or national competent authorities below.
| Procedure | Targeted Signal Management for VMPs with ATCvet code QN03AA02 (Phenobarbital) |
| Status | Ongoing |
| Procedure start date | April 2024 |
| Description |
National competent authorities have identified an increase in adverse event reporting for veterinary medicinal products under ATCvet code QN03AA02 (phenobarbital). The objective of the targeted signal management (TSM) procedure is to collect data, knowledge and comments from all involved marketing authorisation holders (MAHs) and coordinate and perform any further analysis necessary to determine if amendments to the product information is needed regarding any of the above-described signals. |
| Advice for veterinarians |
Veterinarians should promptly report any adverse events observed to the relevant national competent authority or to the marketing authorisation holder or its local representative (where applicable). They should provide the complete vaccination history and overview of the veterinary medicinal products used in the reacting animals, where possible. |
| Procedure | Anaphylactic reactions in cattle following the use of injectable veterinary medicinal products |
| Status | Closed |
| Procedure start date | March 2023 |
| Procedure end date | December 2024 |
| Outcome |
Between 2020 and 2022, it was observed a notable increase of adverse event reports (AERs) in cattle involving anaphylactic reactions following the use of injectable veterinary medicinal products (pharmaceuticals and vaccines). Since 2023, the number of these reactions has decreased and appears to have stabilised in the EU. Based on the information evaluated to date, and following the implementation of mitigation measures (communication towards veterinarians and changes in manufacturing processes of the main vaccines involved), this targeted signal management procedure can now be closed. However, adverse events will continue to be closely monitored by all competent authorities and the marketing authorisation holders. Should the need arise, additional mitigation measures and communication activities can be considered in the future. |
| Advice for veterinarians | Veterinarians are reminded to continue reporting any observed side effects, including anaphylactic reactions. |