Design of studies to evaluate the safety and efficacy of fish vaccines - Scientific guideline

This document provides guidance regarding the conduct of studies to demonstrate the target animal safety and efficacy for immunological veterinary medicinal products intended for use in farmed finfish.

Keywords: Target animal safety, efficacy, finfish, immunological veterinary medicinal product (IVMP)

Current version

Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines - Revision 1

Adopted Reference Number: EMA/CVMP/IWP/314550/2010 Rev.1 Legal effective date: 14/07/2026

Document history

Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines

Adopted Reference Number: EMA/CVMP/IWP/314550/2010 Summary:

This document provides information on items to be considered in the design and conduct of studies to support the safety and efficacy of immunological veterinary medicinal products (IVMPs) in finfish.

Overview of comments received on 'Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines' (EMA/CVMP/IWP/314550/2010)

Reference Number: EMA/CVMP/IWP/897330/2011

Draft guideline on the design of studies to evaluate the safety and efficacy of fish vaccines

Draft: consultation closed Consultation dates: 30/03/2011 to 30/09/2011 Reference Number: EMA/CVMP/IWP/314550/2010