Veterinary Pharmacovigilance System and the New Regulatory Framework
On 28/01/2022, the new Regulation (EU) 2019/6 on veterinary medicinal products and Commission Implementing Regulation (EU) 2021/1281, laying down rules for application as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products entered into force.
As a result, Directive 2001/82/EC and Regulation (EC) No 1. 764/2004, which have constituted the EU regulatory framework for the marketing, manufacture, import, export, supply, distribution, pharmacovigilance, supervision and use of veterinary medicinal products, have been repealed. Veterinary pharmacovigilance (VP) shall exercise functions regarding the safety and efficacy of authorised veterinary medicinal products (VMPs) to ensure the ongoing assessment of the benefit-risk balance (B/R). This new regulation shall establish high standards of quality, safety and efficacy of veterinary medicinal products related to the protection of public health, animal health and the environment…
