Demonstration of palatability of veterinary medicinal products - Scientific guideline

This document provides recommendations regarding the design, conduct, and evaluation of studies for the demonstration of palatability of veterinary medicinal products intended for treatment of individual animals.

Keywords: Palatability, voluntary acceptance, oral dosage forms, veterinary medicinal products.

Current version - effective from 28/01/2022

Guideline on the demonstration of palatability of veterinary medicinal products - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/206024/2011 Rev.1 Legal effective date: 28/01/2022

Document history

Guideline on the demonstration of palatability of veterinary medicinal products

Adopted Reference Number: EMA/CVMP/EWP/206024/2011 Legal effective date: 01/02/2015 Summary:

The objective of this guideline is to specify requirements for the design, conduct, and evaluation of palatability studies for all oral dosage forms of pharmaceutical veterinary medicinal products (VMP) where palatability is claimed.

Overview of comments received on guideline on the demonstration of palatability of veterinary medicinal products

Reference Number: EMA/CVMP/EWP/391535/2013

Draft guideline on the demonstration of palatability of veterinary medicinal products

Draft: consultation closed Consultation dates: 16/11/2012 to 31/05/2013 Reference Number: EMA/CVMP/EWP/206024/2011-CONSULTATION Summary:

The objective of this guideline is to specify requirements for the design, conduct, and evaluation of palatability studies for all oral dosage forms of pharmaceutical veterinary medicinal products where palatability is claimed or regarded necessary as part of the efficacy evaluation.

Draft concept paper for a guideline on the demonstration of palatability of veterinary medicinal products

Draft: consultation closed Consultation dates: 09/11/2010 to 28/02/2011 Reference Number: EMA/CVMP/EWP/81987/2010 Summary:

In companion animals, oral medicines are often formulated to mask the bitterness of a substance and/or to improve the acceptance of e.g. tablets offered from the bowl/hand or mixed into the food in order to improve owner compliance. In relation to veterinary medicine products, this often results in an applicant submitting an application for a “palatability” claim, which should be demonstrated by appropriate data.