Welcome to Asphalion’s Pharmacovigilance Month! In March, we’re focusing on essential pharmacovigilance topics, and today we explore navigating veterinary pharmacovigilance inspections. These inspections ensure Marketing Authorization Holders (MAHs) comply with regulations for the safety and efficacy of veterinary medicinal products.
Regulatory Framework
Inspections are governed by Regulation (EU) 2019/6, Commission Implementing Regulation (EU) 2021/1281, and the Veterinary Good Pharmacovigilance Practices (VGVP) module, essential for maintaining high standards of animal health.
Inspection Process Overview
- Notification – MAHs receive details about the inspection, requiring a prompt response to confirm personnel and submit documents.
- Agenda – MAHs receive a timeline and focus areas, allowing them to prepare presentations and identify participating personnel.
- Inspection – Inspectors review systems, processes, and documents, examining adverse event reporting, risk monitoring, and compliance.
- Initial Report and CAPA Plan – An initial report highlights findings requiring a Corrective and Preventive Action (CAPA) plan.
- Final Report and Completion – Implementation of the CAPA plan is verified, concluding the inspection once all corrective actions are taken.
Asphalion is committed to guiding you through these processes, ensuring you are well-prepared for veterinary pharmacovigilance inspections. Stay tuned for more insights this month.
Check out our detailed infographic for a comprehensive overview of navigating veterinary pharmacovigilance inspections!
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