Keeping veterinary medicines safe in the European Union (EU), European Economic Area (EEA) and United Kingdom (UK) means staying alert to every possible adverse effect. After a product is approved, marketing authorisation holders (MAHs) don’t just step back – they actively monitor reports from veterinarians and animal owners, making sure any new risks are caught and addressed quickly.
Suspected AEs may involve any unfavourable and unintended observation in an animal following the administration of a veterinary medicinal product, regardless of whether a causal link is established. In addition, these include also cases of lack of expected efficacy, environmental incidents, suspected transmission of infectious agents, any harmful reactions in humans resulting from the administration or exposure to a veterinary medicinal product, and any unfavourable and unintended reaction in an animal to a medicinal product intended for human use.
Case management is more than just entering received information into safety database. It is structured process, that requires collection of information from veterinarians, animal owners, or distributors, assessment of the events, timely reporting to regulatory authorities, and ongoing trend analysis to detect potential safety signals. Effective case management is critical for maintaining both regulatory compliance and the safety of veterinary medicines.
Regulation in the EU/EEA and UK
In EU/EEA and UK, MAHs are required to report suspected adverse events for their veterinary medicinal products without delay and no later than 30 calendar days. However, a key difference lies in the systems used for submission. In the EU/EEA, reports are submitted to European Medicines Agency (EMA) via EudraVigilance Veterinary (EVVet), a centralised platform that enables monitoring of wide safety data and identifying emerging trends. In the UK, reports are submitted to the Veterinary Medicines Directorate (VMD) national pharmacovigilance database through VMD Adverse Event Reporting system. Northern Ireland follows EU legislation, but the adverse event reports need to be reported to VMD, as they are the national competent authority in the UK. Despite the use of different platforms, the reporting timelines and regulatory expectations are very much the same.
Regulation (EU) 2019/6 details the legal framework for veterinary pharmacovigilance in the EU/EEA, outlining the obligations of MAHs to maintain an active pharmacovigilance system. This system is overseen by a Qualified Person Responsible for Pharmacovigilance for Veterinary Medicinal Products (QPPV), who ensures that the company’s processes, documentation, and reporting meet regulatory standards. In the Great Britain, the Veterinary Medicines Regulations 2013 (as amended) define the corresponding obligations for MAHs operating under the VMD’s oversight. Companies must ensure that a QPPV or designated local contact is located in GB and registered with the VMD. For MAHs operating in both the EU/EEA and UK, these different legislative guidelines can mean maintenance of two parallel reporting structures while adhering to consistent timelines and quality standards in both.
Step-by-Step description of a Veterinary Adverse Event Case processing
1. Case receipt and triage
The case management process begins when a report is received, whether from a veterinarian, animal owner, product distributor, or through literature. Firstly, triage is performed, where the case is checked to confirm its validity. Minimum criteria required to create a valid case includes:
- an identifiable reporter
- sufficient animal details
- the product involved
- description of the event
If something is missing, the reporter shall be reached out for more information.
2. Data entry
Once the required minimum details are received, data entry is performed in a validated pharmacovigilance database, where it is documented using standardised terminology (Veterinary Dictionary for Drug Regulatory Activities, VeDDRA) and a narrative of chronological events.
3. Regulatory reporting and follow-up
Upon completed case processing, the case is submitted to the appropriate competent authority within the required 30-day reporting timeframe.
Often the initial report does not contain all necessary details for proper medical evaluation, and follow-up is useful to obtain additional clinical information, laboratory results, or clarification regarding circumstances of use. Veterinary expertise is important during the follow-up process, as it helps to ensure that the right questions are asked.
4. Signal management
AE reports describe the available information about the event, animal, and the product, but causality assessment for the individual case is not required to be performed separately.Instead, full evaluation of possible causal relationships is performed as part of signal management process. Cases are assessed to evaluate their clinical relevance and consider the likelihood of a causal relationship between the product and the reported events.
This evaluation takes into account
- species-specific considerations
- possible underlying health conditions
- concurrent treatments
- any other external factors that may influence the assessment, such as incorrect diagnosis or off-label use of the product
Pharmacovigilance experts continuously analyse safety data to identify emerging trends or potential signals, ensuring that any new safety issues are recognised early and processed accordingly. If any new trends are detected, these might lead to for example, updates to labelling, usage guidance, or broader risk management measures.
5. Documentation quality
Consistency in documentation practices, terminology, and assessment is essential for pharmacovigilance. Structured narratives, standardised coding, and logical clinical reasoning help in ensuring that safety information is interpretable by all relevant parties. Accurate data also supports the ongoing product safety evaluations.
Veterinary pharmacovigilance processes continue throughout the product lifecycle. Regular internal reviews and data analysis help ensure that the benefit–risk balance of the product remains favourable and that regulatory requirements are consistently met.
The Role of Veterinary Expertise
Veterinary expertise input is needed to be able to perform high-quality case processing and the further evaluation of the aggregated data. Clinical signs and reactions can vary widely between species, and interpreting these reactions often requires specialist knowledge. Veterinarians are also needed for evaluating complex cases, such as adverse events occurring alongside other treatments, environmental exposures, or boarder-level disease patterns. Their professional judgement ensures that causality assessments and regulatory reports are scientifically accurate.
Possible challenges MAHs are facing
For many MAHs, particularly those with large product portfolios or limited in-house pharmacovigilance resources, managing AE reports in full compliance can be challenging. AE processing requires ongoing monitoring of the sources as well as timely submission and follow-up. This work benefits greatly from veterinary knowledge, however, such expertise is not always available within case processing teams.
Case volumes can vary significantly over time, for example during product launches, changes in distribution, or seasonal fluctuations in use. Maintaining an internal team that can handle periods of high case volume without having excess capacity during quieter periods, can be challenging. Without adequate resources or veterinarian support, delays may occur or data consistency suffer, increasing the risk of non-compliance or regulatory observations.
We have previously written a blog post about benefits of outsourcing adverse event processing, which highlights the considerations that should be taken into account, if MAH is planning on outsourcing the case processing. Medfiles provides comprehensive VGVP-compliant pharmacovigilance services including adverse event processing and safety database services. We have in-house veterinarians, whose expertise is valuable to our veterinary clients. Together we ensure your product’s safety profile is comprehensively monitored and managed.
Author: Saana Lamminjoki, M.Sc. Tox., Safety Manager
Saana joined Medfiles Pharmacovigilance team in May 2021 and since then has been working with both human and veterinary PV activities in the EU and UK.
Saana is responsible for operational leading of veterinary pharmacovigilance activities. Her day-to-day responsibilities for veterinary products include project management, monitoring of published scientific literature, signal detection and management, risk management and evaluation and processing of adverse event reports. Saana is also actively involved in the maintenance of the Pharmacovigilance System Master File (PSMF) and the Quality Management System related to PV, ensuring that all veterinary SOPs and processes are compliant.
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.
See also:
- Upcoming revision of the VGVP Signal Management Module: What will change in practice
- What to know about veterinary signal management
- Best practices for maintaining a veterinary pharmacovigilance quality system
- Meet our people: Veterinarian brings valuable expertise to vet pharmacovigilance
- Veterinary QPPV ensures compliance with EU Regulation 2019/6
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines
- Meet Medfiles’ dedicated animal health team – experts in CMC, regulatory affairs, pharmacovigilance and animal feed
