RECORDREFERENCE OUTLINE

Veterinary Adverse Event Report

Veterinary adverse event report using the veterinary framework rather than human pharmacovigilance by analogy. Captures species, weight and actual administered dose without which a case cannot be assessed, the full event categories including suspected lack of expected efficacy and human exposure, clinical course, and causality with the method named. Maps to VICH GL24.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
VICH GL24
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

Pharmacovigilance for veterinary medicinal products has its own framework, its own event definitions, and a reporting population that includes both the treated animal and the humans exposed to the product. The common failure is applying human definitions by analogy, which quietly removes whole categories — suspected lack of expected efficacy, human exposure, environmental effects — from what the organisation treats as reportable at all.

What's Inside

✓Product and regime confirmation, establishing the authorisation and territory the reporting obligations actually attach to
✓Animal and exposure details — species, breed, weight, and the dose actually administered rather than prescribed
✓Event classification across the full veterinary category set, including suspected lack of expected efficacy
✓Human exposure recorded as its own category, with the route and the circumstances of that exposure
✓Clinical course, outcome, necropsy findings, and any dechallenge or rechallenge that was observed
✓Causality assessment with the method named, so a later reviewer can reproduce rather than accept the conclusion
✓Reporting timetable per authority, and the feed from closed cases into periodic safety review

How to Use It

1Do not apply human pharmacovigilance definitions by analogy; the categories genuinely differ, and so does what counts as reportable
2Capture species, weight and the actual administered dose — without them the case cannot be assessed across species at all
3Treat suspected lack of expected efficacy as a reportable event, not as a commercial complaint routed to the sales function
4Record human exposure to the product as its own case category, including accidental self-injection and routine handling exposure
5Name the causality method used rather than recording only a conclusion, because an unnamed method cannot be reviewed or repeated
6Feed every closed case into periodic review, since the signal lives in the series rather than in the individual report
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Product and Regime Confirmation
2Animal and Exposure Details
3Event Classification
4Clinical Course and Outcome
› Description of the event
5Causality and Reporting
REGULATORY CONTEXT

VICH GL24 sets the harmonised approach to the management of adverse event reports for veterinary medicinal products, including the event definitions, the categories used here, and the expectation that reports are assessed for causality. It does not decide whether a particular observation with your product is reportable in your territory, nor which national timetable governs — those determinations belong to the marketing authorisation holder. The report structure and the practitioner guidance are SPEQ synthesis.

MAPPED STANDARDS
VICH GL24
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