Demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish - Scientific guideline

This document provides guidance regarding the demonstration of efficacy and target animal safety for veterinary medicinal products intended for use in farmed finfish.

Keywords: Veterinary medicinal products, target animal safety, efficacy, farmed finfish.

Current version - effective from 28/01/2022

Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/459868/2008 Rev.1 Legal effective date: 28/01/2022

Document history

Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish

Adopted Reference Number: EMA/CVMP/EWP/459868/2008

Overview of comments received on 'Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish'

Reference Number: EMA/CVMP/EWP/324700/2010

Draft guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish

Draft: consultation closed Consultation dates: 14/10/2009 to 31/10/2010 Reference Number: EMA/CVMP/EWP/459868/2008-CONSULTATION

Concept paper on the revision of the guideline for the efficacy of veterinary medicinal products (pharmaceuticals) for use in farmed aquatic species

Reference Number: EMEA/CVMP/EWP/85954/2007

Superseded documents

Efficacy of veterinary medicinal products for use in farmed aquatic species

Adopted Reference Number: 7AE22a Volume 7 Legal effective date: 01/09/1994