The safety of veterinary medicinal products is a key part of responsible pharmaceutical practice. Adverse event monitoring is not limited to individual cases, but covers the safety evaluation of a medicinal product throughout its entire lifecycle. It affects animal welfare, food safety, and broader trust in the pharmaceutical sector.
Adverse event monitoring is not a separate requirement, but part of a wider system whose effectiveness is also reviewed through regulatory oversight.
What does adverse event monitoring mean for veterinary medicinal products?
Adverse events are harmful or unintended effects observed in connection with the use of a veterinary medicinal product. These may include unexpected symptoms in animals, reduced effectiveness, or other unforeseen reactions.
Importantly, adverse event monitoring also includes suspected events. Safety evaluation is based on multiple individual observations which together form an overall picture of how a product is used in real-life conditions.
Regulation and regulatory expectations guide monitoring
Adverse event monitoring for veterinary medicinal products is guided by EU-level requirements that emphasise the responsibility of the marketing authorisation holder to ensure product safety throughout its entire lifecycle. Regulation (EU) 2019/6 sets the regulatory framework for veterinary medicinal product safety, and the EMA’s Veterinary Good Pharmacovigilance Practices (VGVP) guidelines explain how adverse event monitoring and reporting should be carried out in practice. Responsibility does not end when a product is placed on the market, but continues as safety data are collected and evaluated during use.
At EU level, pharmacovigilance is coordinated centrally, while national authorities are responsible for receiving and processing adverse event reports. In Finland, this role is carried out by Fimea.
Responsibility remains even when tasks are outsourced
Although adverse event information can come from many different sources, overall responsibility for monitoring and reporting always remains with the marketing authorisation holder. Tasks can be shared or outsourced, but responsibility for compliance cannot be transferred.
In practice, this requires clear responsibilities, effective reporting processes, and good visibility into how adverse event data are collected, handled, and reported. The VGVP guidelines also note that adverse event information may come from several sources, such as healthcare professionals, animal owners, scientific literature, and digital or customer feedback channels. This highlights the need for consistent processes and clear overall responsibility.
Adverse event reporting in practice
An adverse event report should be submitted whenever a veterinary medicinal product is suspected of causing a harmful or unintended effect. The quality and timeliness of reports are important for the usefulness of safety data.
In practice, reporting challenges are rarely due to unwillingness to report. More often, they relate to unclear responsibilities, processes, or information flows. Statistics collected by Fimea show that adverse events related to veterinary medicinal products are reported regularly in Finland and from several sources, supporting the role of monitoring as part of routine regulatory oversight.
Why systematic processes matter
Without clear processes, adverse event data can easily become fragmented. This makes it harder to build a complete safety overview and to meet regulatory expectations. Systematic adverse event monitoring supports compliance and proactive risk management.
The VGVP guidelines also stress the importance of documentation and traceability, so that safety data can be reviewed and assessed later if needed.
When monitoring is built into everyday operations, it is not an extra administrative burden, but a natural part of high-quality and reliable pharmaceutical practice.
Medimo as a partner in pharmacovigilance
Medimo supports pharmaceutical companies in managing responsibilities, regulatory requirements, and practical implementation related to adverse event monitoring. Expert support helps ensure that processes are clear, controlled, and able to stand up to regulatory review.
