Design of studies to evaluate the safety and efficacy of fish vaccines - Scientific guideline
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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)
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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) (PDF/194.43 KB)
First published: 29/11/2011
Last updated: 29/11/2011
EMA/CVMP/IWP/897330/2011 -
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Draft guideline on the design of studies to evaluate the safety and efficacy of fish vaccines (PDF/148.54 KB)
Draft: consultation closed
First published: 30/03/2011
Last updated: 30/03/2011
Consultation dates: 30/03/2011 to 30/09/2011
EMA/CVMP/IWP/314550/2010