The Veterinary Medicines Regulation (Regulation (EU) 2019/6) has modernised the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) and has become applicable on 28 January 2022 — ensuring full veterinary pharmacovigilance compliance across all post-authorisation obligations
Since 28 January 2022, Regulation (EU) 2019/6 has introduced stronger obligations across the EU veterinary medicines sector. The regulation not only modernises authorisation, manufacture, import, export, supply, distribution, control and use of veterinary medicinal products, but places veterinary pharmacovigilance at the heart of regulatory compliance. Authorities now require that marketing-authorisation holders continuously monitor safety via signal management, maintain a detailed Pharmacovigilance System Master File (PSMF), and ensure oversight through a Qualified Person for Pharmacovigilance (QPPV), underpinned by a robust quality management system.
Veterinary pharmacovigilance involves continuous safety monitoring throughout the product’s lifecycle — collecting, recording and evaluating every veterinary adverse event, ensuring accurate documentation and timely reporting to regulatory authorities.
These activities must follow the veterinary adverse reporting guideline, which defines how suspected events should be documented, assessed, and submitted to the competent authorities.
Regulatory authorities now expect well-documented pharmacovigilance strategies covering all post-authorization responsibilities. Companies that do not fully implement Good Pharmacovigilance Practice (VGVP), fail to maintain the Pharmacovigilance System Master File (PSMF), or lack 24/7 oversight via a Qualified Person for Pharmacovigilance (QPPV), risk non-conformances, inspections, delays, or even legal penalties. Without clear procedures for collecting and reporting suspected adverse events, or signal management and oversight of quality management systems, the potential for serious regulatory actions increases under Regulation (EU) 2019/6. Competent authorities may issue corrective and preventive action requests, impose fines, or take other enforcement measures to ensure compliance. This highlights the importance of veterinary pharmacovigilance for companies placing veterinary medicinal products on the market, as continuous safety monitoring helps detect risks early and maintain regulatory compliance throughout the product lifecycle.
At Billev Pharma East, we bring the regulatory insight, veterinary expertise, and system-driven approach required to ensure that your veterinary pharmacovigilance is not only compliant but also efficient, responsive, and sustainable.
We help you meet the VGVP guidelines and Implementing Regulation (EU) 2021/1281 by establishing robust quality management systems, maintaining an up-to-date PSMF, ensuring round-the-clock oversight via a QPPV, and integrating continuous signal management.
Strong QPPV and veterinary pharmacovigilance oversight is essential for maintaining regulatory compliance, supervising safety monitoring activities, and ensuring that pharmacovigilance obligations are fulfilled throughout the lifecycle of veterinary medicinal products.
We help you meet the VGVP guidelines and Implementing Regulation (EU) 2021/1281 by establishing robust quality management systems, maintaining an up-to-date PSMF, ensuring round-the-clock oversight via a QPPV, and integrating continuous signal management.
These processes are essential for effective veterinary risk management, enabling organisations to identify safety signals early, assess potential risks, and maintain a favourable benefit-risk balance for veterinary medicinal products.
With our support, your organization can confidently navigate inspections, mitigate risk, and uphold the highest safety standards throughout the lifecycle of your veterinary medicinal products.
We are also experts in the United Kingdom’s evolving veterinary pharmacovigilance framework. Following the entry into force of The Veterinary Medicines (Amendment etc.) Regulations 2024 on 17 May 2024, the UK introduced significant updates to its Veterinary Medicines Regulations 2013, including new requirements for adverse event reporting, signal management, labelling, distribution (GDP), and marketing authorisation variations.
With our dedicated support, your veterinary pharmacovigilance framework becomes a strategic asset, ensuring regulatory compliance, protecting animal health, and safeguarding your reputation.
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
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