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 report their assessment of validated safety signals that require regulatory action, such as updating the product information.
If needed, they can also use the template to report signals that they refute or propose close monitoring for after conducting a thorough assessment.
Marketing authorisation holders should promptly inform EMA of any changes to the contact details of their qualified person responsible for pharmacovigilance (QPPV), to ensure that they do not miss important updates from EMA.
Further information on how to submit the report is available in the document.
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. |