The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) contains new legal provisions on veterinary pharmacovigilance. These aim to focus on continuous signal management based on adverse event data in the ‘Union Pharmacovigilance Database’ and cover pharmacovigilance inspections and the maintenance of pharmacovigilance master files. To assist marketing authorization holders in fulfilling their pharmacovigilance obligations, the […]
