Monitoring and risk management
Veterinary medicinal products continue to be monitored and evaluated once they have been authorised. Even if therapy is performed with greatest care, the occurrence of adverse drug reactions cannot always be avoided.
The English website on Veterinary medicines is under construction. Please refer to the German website in case desired information cannot be found here.
An overview
Pharmacovigilance
The BVL employs a pharmacovigilance system to ensure animal health, consumer and environmental safety in the context of the use of veterinary medicinal products.
PSMF and pharmacovigilance inspections
The PSMF (Pharmacovigilance System Master File) describes the pharmacovigilance system of a marketing authorisation, exemption or registration holder. To check compliance with legal requirements, the BVL carries out pharmacovigilance inspections.
Signal management
A central instrument in the continuous monitoring of the quality, safety and efficacy of veterinary medicinal products is signal management.
Adverse event (AE) following the use of a veterinary medicinal product
The collection and evaluation of adverse event reports is an important tool for monitoring the quality, efficacy and safety of veterinary medicinal products.
National pharmacovigilance centres
The pharmacovigilance centres support the BVL in raising awareness and imparting knowledge in the field of pharmacovigilance as well as by actively recording adverse event reports.
Post-Marketing Surveillance Studies
In addition to the recording of spontaneous adverse events following the use of veterinary medicinal products, marketing authorisation holders can be requested to carry out Post-Marketing Surveillance Studies.
Risk communication
Risk communication is the exchange of information about possible risks. The BVL ensures the flow of information between veterinarians, consumers, scientists and companies at national and European level.
Risk management
The BVL evaluates and implements suitable prevention and control options and strategic alternatives to minimise risks associated with the use of veterinary medicinal products.
Veterinary Medicinal Product Dispensing Volume Register
Pharmaceutical companies and wholesalers report their annual sales figures of antibiotics to a register for recording dispensing quantities. The BVL evaluates this data in order to better understand correlations in the development of resistance and