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 | Anaphylactic reactions in cattle following the use of injectable veterinary medicinal products |
| Status | Ongoing |
| Procedure start date | March 2023 |
| Description | National competent authorities have identified a significant increase of adverse event reporting of anaphylactic reactions in cattle in 2020, 2021, and 2022. Reports of adverse events were related to the use of injectable veterinary medicinal products (pharmaceuticals and vaccines). Most of the reported cases occurred in France, Spain, Italy, and Belgium. The root cause has not yet been established and the objective is to allow an in-depth investigation of the adverse events focused on the potential sensitisation of animals from e.g., specific vaccinations which may explain the apparent regional occurrence. |
| Advice for veterinarians | Veterinarians should promptly report any adverse events observed to the relevant national competent authority or the marketing authorisation holder. They should provide the complete vaccination history and overview of the veterinary medicinal products used in the reacting animals, where possible. |