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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.

  • Regional Representative
  • Local Safety Officer
  • Local Case Management
  • Regulatory Intelligence
  • Veterinary Pharmacovigilance Training

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.

"Professional excellence from a great team highly experienced in different areas of the business such as pharmaceuticals, cosmetics, etc. and with extensive knowledge in the activities offered."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
"Aegisana not only meets, but exceeds the highest standards in Pharmacovigilance services, which is exactly what we have received. Their commitment to excellence is evident in every aspect of their work."
Alfonso Lomas Pharmacovigilance Activity Coordinator, Mana Pharma.
"Aegisana is an innovative, reliable company with which we have achieved 100% results. I would like to highlight their professionalism, availability, and efficiency, as well as their exceptional communication. We have a close relationship that creates real teamwork."
José Manuel de la Torre GarcíaQualified Person & Regulatory Affairs Manager, Tora Laboratories.
"Moving to Aegisana is a change that Qualix Pharma opted for years ago and they have more than met our expectations."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
“Aegisana’s technicians are highly trained experts, and their experience is invaluable for all our Pharmaceutical projects."
Alfonso Lomas Pharmacovigilance Activity Coordinator, Mana Pharma.
"We have been working with the team at Aegisana since its inception and it has been a great success. Pharmacovigilance is clearly a passion at Aegisana, and I cannot recommend a better partner to entrust your project requirements to. You are safe in their hands."
Sergio ArroyoLaboratory Director, Netpharmalab Consulting Services.
"In this sector, after years of experience, it is not easy to find a company that offers this type of service at such a high level, involving security, ease of management and communication, and optimization of work for the subcontracting company."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
“Working with Aegisana is super easy! They adapt to the needs and resources of our company 100%. They helped us update our PV department due to the change in legislation and the experience was fantastic."
Almudena Pradera DVM PhDChief Scientific Officer, EquiCord.
"A team very involved and responsible in every task developed and service provided. Excellent communication with quick advice and response."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
"The Aegisana team are experts in everything related to pharmacovigilance, giving us confidence and peace of mind. We work with them as a partner as if they were an internal company department."
Marta ManzanaresRegulatory Affairs, Quality Assurance & Pharmacovigilance Manager, Adamed.

Email us at

webinquiry@aegisana.com

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