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.

Reports of adverse events following the use of veterinary medicinal products are to be reported electronically to EMA. Different options are available for this purpose.

Representatives of the marketing authorisation holder and co-distributors may also have certain obligations with regard to the recording and forwarding of adverse event reports following the use of the veterinary medicinal products they distribute.