The Veterinary Pharmacovigilance System established by EU Regulation (EU) 2019/6 mandates Marketing Authorization Holders (MAHs) to establish and maintain a pharmacovigilance system for the management of adverse events related to their veterinary medicinal products. A crucial component of this system is the Pharmacovigilance System Master File (PSMF), which describes the details of the pharmacovigilance system. The PSMF focuses on the Quality Management System (QMS) supporting pharmacovigilance processes and activities, including standard operating procedures, subcontracted tasks, adverse event and signal management, risk management, communication, training, documentation management, performance monitoring, change control, auditing, and corrective actions. An effective and comprehensive PSMF ensures compliance with regulations and facilitates successful audits by the MAH and supervision by the Qualified Person for Pharmacovigilance (QPPV). Ensuring a compliant PSMF minimizes potential issues during Competent Authority Inspections.
In January 2022, the EU Reg. 2019/6 Marketing Authorization Holders (MAH) was adopted in order to fulfil veterinary pharmacovigilance responsibilities. Based on this regulation, manufacturers must establish and maintain a system, known as a pharmacovigilance system, for the management of suspected adverse events concerning their authorized veterinary medicinal products, in order to guarantee the safety of their products for animal health.