Protecting animal health & beyond.
Veterinary Pharmacovigilance for all your VMPs.

What is Veterinary Pharmacovigilance?

Not just for animal health.

Veterinary Pharmacovigilance, is a vital discipline that focuses on the continuous monitoring, assessment, and enhancement of the safety of veterinary medicines. It addresses adverse events occurring in both animals and humans as a result of using these medications.

This field plays a crucial role in safeguarding public health, protecting animal welfare, and preserving the environment. Additionally, it encompasses the collection of data related to adverse events arising from off-label medication use and potential environmental concerns.

A holistic approach is essential, extending beyond companion animals and livestock to encompass the broader impact on human health, environmental factors, and the transmission of various infectious agents, such as viruses and particles.

Updated requirements.

Recent changes in European Union regulations, specifically (EU) 2109/6 and (EU) 2021/1281, have brought about significant transformations in the realm of Veterinary Medicinal Products (VMP). Notably, the European Medicines Agency (EMA) introduced the Veterinary Good Vigilance Practices (VGVP) guidelines on January 28th, 2022, marking a pivotal moment in this field.

Click for more information from the European Medicines Agency on VGVP,
and the Veterinary Medicinal Products Regulation.

Important benefits.

The VGVP guidelines are designed to achieve several key objectives:

  • Enhanced availability and accessibility, by ensuring that veterinarians, farmers, and pet owners have access to safe and high-quality medicines for the treatment and prevention of animal diseases.
  • Streamlined administrative processes, to reduce the administrative burden associated with pharmacovigilance activities.
  • Preserving antimicrobial efficacy, by Implementing rules that maintain the effectiveness of antimicrobial agents, including antibiotics, by adopting a ‘One Health’ approach that benefits both animal and public health.

The commonalities between VGVP & GVP.

VGVP mandates the establishment of a pharmacovigilance system that aligns with the stringent requirements of Good Vigilance Practice (GVP) designed for human medicines. This requires Marketing Authorization Holders (MAHs) to comply with various aspects, including the creation of a Pharmacovigilance System Master File (PSMF), reporting of Adverse Effect Reports (AERs) albeit with adjusted timelines, utilization of the veterinary EudraVigilance Veterinary database (EVVet), the Union Product Database (UPD), and the implementation of VeDDRA terminology coding, among other obligations.

Click for information on Pharmacovigilance and Cosmetovigilance.

Veterinary Pharmacovigilance services.

Why choose Aegisana for your Veterinary Pharmacovigilance requirements?

Experience and insight.

Our pharmacovigilance team boasts a wealth of experience in ensuring the compliance of Veterinary Medicinal Products (VMPs).

We have the knowledge and insight required to navigate the nuances and distinctions between GVP and VGVP guidelines, and the specialized aspects of Veterinary Pharmacovigilance, including continuous Signal Management, variations in Adverse Event Reporting, and the effective utilization of the European Medicines Agency’s (EMA) veterinary databases and systems.

Your success is our success.

Whatever your veterinary pharmacovigilance requirements are, our team is ready to provide you with the highest level of expertise, clear and effective communication, and unwavering reliability. We are dedicated to forging a robust and strategic partnership with you throughout the entire lifecycle of your VMP product portfolio.

Your success is our priority, and we are here to ensure it through our comprehensive approach to veterinary pharmacovigilance.