2025 is the year when the new process for signal management is being fully embedded, following a pilot phase of testing and some experimentation which started with Regulation (EU) No. 2019/6 that became applicable in 2022. The final process is centered around work sharing between EU Member States for the assessment of signals and annual statements submitted by marketing authorisation holders. Following this model, all EU Member States contribute to pharmacovigilance activities for the medicinal products under their responsibility, based on the type of authorisation.
We have some additional focus areas, such as finalising the EudraVigilance Veterinary (EVVet) best practice guide for industry, which will offer support supplementing the existing VGVP modules, to facilitate high quality submissions of adverse events and signals.
We look forward to launching a Veterinary Medicines Safety Day in April, targeting all stakeholders involved in pharmacovigilance activities and putting under the spotlight the importance of reporting adverse events. Finally, we also aim to update two key VGVP modules: on signal management and on communication.
We are looking forward to continued collaboration with the network and our stakeholders in 2025!
Camelia Mihaescu
Head of Veterinary Pharmacovigilance Service
