Best practices for maintaining a veterinary pharmacovigilance quality system under Regulation (EU) 2019/6

Pharmacovigilance quality system is an essential part of maintaining compliance throughout the lifecycle of veterinary medicinal products. Beyond meeting regulatory requirements, an effective quality management system helps ensure that pharmacovigilance activities are performed consistently, responsibilities are clear and processes remain inspection-ready at any time.

Under Regulation (EU) 2019/6, marketing authorisation holders are responsible for establishing and maintaining an appropriate pharmacovigilance system. This means taking an active and structured approach to quality management, rather than reacting only when issues arise.

This article outlines the key elements of a veterinary pharmacovigilance quality system and highlights practical considerations for maintaining compliance, inspection readiness and effective oversight. For a more detailed discussion, see our webinar EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system.

What are the key elements of a veterinary pharmacovigilance quality system?

A veterinary pharmacovigilance quality system should cover all activities and processes necessary to ensure that pharmacovigilance obligations are fulfilled appropriately.

In practice, this includes:

• Pharmacovigilance System Master File (PSMF)
• written procedures and work instructions
• roles and responsibilities
• training management
• documentation and record keeping
• deviation management and CAPA processes
• QPPV oversight of all PV activities, including outsourced ones
• continuous improvement of processes

These elements are quite well known, but the real challenge is making sure they actually work together in day-to-day operations – not just on paper.

Why are documentation and procedures essential for the quality system?

PSMF provides an overview of the pharmacovigilance system and documents how pharmacovigilance activities are organised. It should accurately reflect actual practices and remain up to date throughout the lifecycle of the product. Maintaining a well-structured and current PSMF helps demonstrate compliance and facilitates inspections. Keeping the PSMF up to date is therefore not just a formal task – it is a good way to check that your system is still aligned with reality.

The same applies to written procedures, often referred as Standard Operating Procedures (SOPs) or Work Instructions (WIs). These are the foundation of a functioning quality system. They help ensure that activities are performed consistently and that responsibilities are clearly assigned. Procedures should describe how pharmacovigilance activities are conducted and should be reviewed regularly to ensure that they remain aligned with current requirements and working practices.

How can effective oversight support compliance?

The Qualified Person Responsible for Pharmacovigilance (QPPV) should have sufficient visibility of pharmacovigilance activities, regardless of whether they are performed internally or by external partners. Many companies rely on external service providers for selected pharmacovigilance activities. However, outsourcing activities does not transfer regulatory responsibility. QPPV should be able to assess whether the system is functioning as intended, identify potential risks, and support timely implementation of any necessary improvements. Effective oversight helps ensure that important pharmacovigilance information is communicated appropriately and that regulatory obligations continue to be met.

Clearly defined pharmacovigilance agreements, effective communication and appropriate oversight mechanisms are essential to maintaining control of the pharmacovigilance system.

Deviation management and corrective and preventive actions (CAPAs) are also important tools for maintaining and improving quality. Deviations should be documented, investigated and assessed to determine the root cause. Appropriate corrective and preventive actions help prevent recurrence of the issue and support continuous development. Deviations and CAPAs are often associated with problems and mistakes, but they should be seen as valuable tools for process improvement. Usually deviations provide an opportunity to learn, identify weaknesses, and strengthen the quality system.

How can inspection readiness be maintained?

Inspection readiness should not be viewed as a separate activity performed only before an inspection. Instead, it should be part of everyday pharmacovigilance operations.

Maintaining up-to-date documentation, training records and procedures helps ensure that the pharmacovigilance system remains inspection-ready at all times. Regular internal reviews and audits can also help identify opportunities for improvement and support compliance.

Regulatory expectations and practical requirements continue to evolve, making it essential to regularly monitor applicable legislation, guidance, and industry best practices. Maintaining compliance is not only about keeping procedures and documentation up to date, but also about critically evaluating whether existing processes remain fit for their purpose. Where gaps or emerging risks are identified, processes should be adapted and improved accordingly. Taking a proactive approach to continuous improvement helps ensure that the pharmacovigilance system evolves alongside regulatory expectations and operational needs.

A strong quality system brings consistency to everyday work. When processes are clear and followed in practice, inspection readiness becomes a natural outcome rather than a last-minute effort.

Maintaining a robust veterinary pharmacovigilance quality system requires a proactive approach

An effective pharmacovigilance quality system relies on clear procedures, accurate documentation and ongoing oversight of all PV activities. Taking a proactive approach to quality management helps support compliance, inspection readiness and continuous improvement throughout the lifecycle of veterinary medicinal products.

Medfiles provides comprehensive veterinary pharmacovigilance services, ranging from full pharmacovigilance system setup and maintenance (including QPPV service) to adverse event processing, signal management, literature screening and local pharmacovigilance activities. Our experts also support PSMF maintenance, pharmacovigilance agreements, audits, training and quality management activities, helping marketing authorisation holders maintain a robust and compliant pharmacovigilance system.

Author: Saana Lamminjoki, M.Sc. Tox., Safety Manager

Saana joined Medfiles Pharmacovigilance team in May 2021 and since then has been working with both human and veterinary PV activities in the EU and UK.

Saana is responsible for operational leading of veterinary pharmacovigilance activities. Her day-to-day responsibilities for veterinary products include project management, monitoring of published scientific literature, signal detection and management, risk management and evaluation and processing of adverse event reports. Saana is also actively involved in the maintenance of the Pharmacovigilance System Master File (PSMF) and the Quality Management System related to PV, ensuring that all veterinary SOPs and processes are compliant.

See also:

• Upcoming revision of the VGVP Signal Management Module: What will change in practice
• Meet our people: Veterinarian brings valuable expertise to vet pharmacovigilance
• Veterinary QPPV ensures compliance with EU Regulation 2019/6
• How veterinary adverse event cases are managed in the EU/EEA and UK
• What to know about veterinary signal management
• Veterinary Medicines Regulation (EU) 2019/6: An overview from a pharmacovigilance perspective
• Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines
• Meet Medfiles’ dedicated animal health team – experts in CMC, regulatory affairs, pharmacovigilance and animal feed