With Regulation (EU) 2019/6 having been in force since January 2022, it’s an opportune time to reflect on the impact this regulation has had on the veterinary medicinal products (VMPs) industry and how companies like ours have managed the compliance landscape.
The general aims of the regulation were to improve the functioning of the internal market for veterinary medicines, reduce the administrative burden on companies and EU regulatory authorities, increase the availability of veterinary medicinal products, stimulate innovation of new and existing medicines and strengthen the EU response to fight antimicrobial resistance. It also introduced robust pharmacovigilance requirements to ensure the safety and efficacy of VMPs. The aim was to ensure a high level of public and animal health, while also promoting innovation and enhancing the competitiveness of the veterinary pharmaceutical sector.
What changed in veterinary pharmacovigilance?
Regulation (EU) 2019/6 changed the pharmacovigilance and safety landscape in the veterinary field by introducing stricter requirements and many new technological tools. Key elements included the establishment of centralised databases such as the Union Pharmacovigilance Database (Eudravigilance Veterinary) and the Union Product Database (UPD), which have changed the adverse event reporting and product information management across the EU. Additionally, the introduction of IRIS, new online platform for handling product related scientific and regulatory procedures, affected on the signal management activities.
Pharmacovigilance System Master File
The Regulation also requires the maintenance of a Pharmacovigilance System Master File (PSMF) and the implementation of robust quality management systems to ensure comprehensive monitoring and documentation of pharmacovigilance activities. It is clear that the adoption and streamlining of new databases has been gradual, but their use is now having a positive impact. The requirements for reporting adverse events have been tightened with more detailed reporting obligations. With the elimination of periodic and expedited reporting, all adverse event reports must now be submitted within 30 calendar days. This applies to any suspected adverse events. Combined with the third country reporting requirement, this has increased the number of AE submissions to the EVV. Consequently, the importance of robust and efficient databases in AE processing has become a priority. However, the new Regulation has also simplified certain aspects of processing, as causality assessments are no longer required at the level of individual case reports. Instead, assessments can now be managed as larger entities within the broader context of signal management activities.
Shift from periodic to continuous safety monitoring
Before the implementation of Regulation (EU) 2019/6, Periodic Safety Update Reports (PSURs) were the primary tool for monitoring the safety of VMPs. Submitted at regular intervals, PSURs provided a comprehensive overview of the safety data collected since the previous reporting period. While these reports were essential for assessing the ongoing safety of products, they were often retrospective, relying on data accumulated over a set period. The current regulation mandates continuous signal detection activities, requiring MAHs to actively monitor and evaluate safety data as it becomes available. This shift from periodic to continuous monitoring has significantly changed the way safety signals are detected and managed.
Statistical tools for signal management
One of the key advancements in the area of signal management has been the use of statistical analysis tools within the EVV Data Warehouse. The query tool allows statistical algorithms to be applied to vast amounts of safety data, helping us to identify patterns or trends that may indicate emerging safety concerns. By systematically analysing this data, signals that may not be apparent through traditional review methods can be detected, ensuring a more comprehensive approach to veterinary medicinal product safety.
Transition to PSMF and collaboration between PV and QA teams
The previous Detailed Description of the Pharmacovigilance System (DDPS) has been replaced by a more comprehensive document, the PSMF, which initially required significant effort from all companies to implement, as it involved thoroughly documenting all processes related to the pharmacovigilance system in a specific way and ensuring that the PSMF accurately reflected current practices.
Maintaining the PSMF is an ongoing responsibility that requires regular updates to capture any changes in procedures or roles. While the primary objective of these continuous updates is to ensure ongoing compliance, they also enable us to quickly adapt our processes to meet any new regulatory requirements as they arise. As the legislation clearly highlights quality assurance and quality management systems as part of the pharmacovigilance system, constant collaboration between the PV and QA teams is essential. MAHs need to ensure that the Qualified Person for Pharmacovigilance (QPPV) has sufficient authority to influence the performance of the quality management system.
Free WEBINAR: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
In our webinar you will learn about the main changes and requirements brought about by the Veterinary Medicinal Products Regulation. In the webinar we will discuss variation management and the relationship between pharmacovigilance systems and the related quality measures.
Lessons learned and looking ahead
It’s clear that the Regulation has brought significant changes to the veterinary pharmacovigilance landscape. While the transition has not been without its challenges, it has also provided us with opportunities to improve our services and strengthen compliance.
By staying informed of the latest regulatory updates and maintaining a proactive approach to safety and compliance, we have been able to successfully navigate the changes brought about by Regulation (EU) 2019/6. While the legislation has provided a structured framework for action, much has also been learned through collaboration and practical experience over time with our veterinary pharmacovigilance team and our clients.
Looking ahead, we expect the regulatory landscape to continue to evolve, particularly as new technologies such as digital health gain traction also in the veterinary field. As developments continue, we remain committed to staying at the forefront of regulatory compliance and ensuring that our clients are well positioned to succeed in this changing environment.
If you lack in-house veterinary expertise or resources, Medfiles experts are ready to help. We provide timely, experienced veterinary regulatory support to help you manage the changes brought about by Regulation (EU) 2019/6. Whether your project is large or small, outsourcing to Medfiles ensures compliance and efficiency, getting your project to the finish line without delay.
P.S. You can also benefit from our feed and feed additive services, from product development to regulatory reviews, registrations and marketing, provided by our dedicated Feed Team.
Author: Saana Lamminjoki
Safety Manager
“I joined the Medfiles Pharmacovigilance Unit in 2021 and have since then been daily involved with veterinary pharmacovigilance activities. My master’s degree in general toxicology has given me a strong foundation for working with a wide range of safety tasks across the pharmaceutical industry. With our extensive experience of implementing the requirements of the current Regulation and the veterinary good pharmacovigilance practices into our everyday work, our team has gained a deep understanding of how to best integrate quality aspects in our pharmacovigilance activities.”
