Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AERs)
The VICH guideline harmonising how spontaneous adverse event reports for marketed veterinary medicinal products are collected, documented, and exchanged between marketing authorisation holders and regulatory authorities. Adopted by the VICH Steering Committee in October 2007, it is implemented in the US as FDA CVM Guidance for Industry #117 and in the EU through the CVMP. Veterinary pharmacovigilance covers safety in treated animals and in the humans exposed to the products.
What this does not cover
stated in the document's own scope- Covers pharmacovigilance for marketed veterinary medicinal products; human-medicines pharmacovigilance follows the ICH E2 family and regional law.
- Manages spontaneous adverse event reports; the controlled terminology and the data elements for electronic submission are specified by VICH GL30 and GL42 respectively.
- A harmonisation guideline: the binding reporting obligations and timelines come from regional implementation — FDA CVM requirements in the US, Regulation (EU) 2019/6 in the EU.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
VICH GL24 is the harmonised guideline for managing pharmacovigilance adverse event reports on marketed veterinary medicinal products. Adopted by the VICH Steering Committee in October 2007, it standardises how spontaneous adverse event reports are identified, collected, documented, and exchanged between marketing authorisation holders and regulatory authorities across the VICH regions. Veterinary pharmacovigilance has a double object: safety and efficacy in the treated animals, and safety in the humans exposed to the products — so human exposure events are part of the reportable universe. GL24 is the management guideline of a family that includes GL30 (controlled list of terms) and GL42 (data elements for AER submission), which supply the terminology and data standards its processes assume.
Scope & applicability
Marketing authorisation holders and regulators managing spontaneous adverse event reports for authorised veterinary medicinal products in VICH regions. It works alongside GL30 (controlled list of terms) and GL42 (data elements for AER submission).
Legal basis & how it acquires force
A guideline of VICH — the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, the trilateral EU–Japan–US programme modelled on ICH. VICH guidelines bind through regional implementation: the FDA Center for Veterinary Medicine adopted GL24 as Guidance for Industry #117, and in the EU the CVMP implemented it (EMA/CVMP/VICH/547/2000) with legal effect from 31 December 2015; EU veterinary pharmacovigilance now operates under Regulation (EU) 2019/6.
Document structure
| Part | Covers |
|---|---|
| Introduction and scope | The purpose of harmonised AER management and the marketed veterinary products covered |
| Definitions and terminology | Harmonised terms for identifying and classifying possible adverse events, including human exposure |
| Roles of marketing authorisation holders and regulatory authorities | Who collects, documents, and exchanges adverse event reports, and their responsibilities |
| Management of adverse event reports | Collection, documentation, follow-up, and record-keeping for spontaneous AERs |
| Exchange of reports | The harmonised approach to transmitting AERs between authorisation holders and authorities |
Key requirements
- Collect and document spontaneous adverse event reports for marketed veterinary products, including human exposure events
- Apply harmonised terminology when identifying and classifying possible adverse events
- Exchange AERs between marketing authorisation holders and regulatory authorities using the harmonised approach
- Maintain follow-up and record-keeping supporting the reported cases
Implementation tips
- Implement GL24 together with GL30 and GL42 — the management guideline assumes the controlled terminology and data-element standards are in place
Revision notes
Adopted at the VICH Steering Committee in October 2007; the FDA CVM adoption is GFI #117, and in the EU the CVMP gave it legal effect from 31 December 2015 (EMA/CVMP/VICH/547/2000).
International alignment
GL24 is the veterinary counterpart of the human post-approval safety framework in ICH E2D(R1), built for a world where the patient is an animal and human exposure is itself an endpoint. It operates with VICH GL30 (controlled list of terms) and GL42 (data elements for AER submission), and regionally through FDA CVM GFI #117 in the US and the CVMP within the Regulation (EU) 2019/6 pharmacovigilance system in the EU.
VICH GL24: frequently asked questions
Quick answers to common questions about VICH GL24.
What is VICH GL24?
The VICH harmonised guideline on managing adverse event reports for marketed veterinary medicinal products — how spontaneous reports are identified, collected, documented, and exchanged between marketing authorisation holders and regulators. It was adopted by the VICH Steering Committee in October 2007.
How is GL24 implemented in the US and EU?
The FDA Center for Veterinary Medicine adopted it as Guidance for Industry #117. In the EU the CVMP implemented it under reference EMA/CVMP/VICH/547/2000 with legal effect from 31 December 2015, and EU veterinary pharmacovigilance now runs under Regulation (EU) 2019/6.
Does veterinary pharmacovigilance cover effects on people?
Yes. Its object is safety and efficacy in treated animals and safety in exposed humans — an owner or veterinarian exposed to a veterinary medicine is within the reportable universe, which is a structural difference from human pharmacovigilance.
How does GL24 relate to VICH GL30 and GL42?
GL24 defines the management process; GL30 supplies the controlled list of terms used to code veterinary adverse events; GL42 defines the data elements for submitting AERs electronically. The three are designed to be implemented together.