Quality aspects of single-dose veterinary spot-on products - Scientific guideline

This document addresses the factors that should be considered when developing veterinary single-dose spot-on products. It applies to pharmaceutical veterinary medicinal products presented as single-dose liquids, which are administered to the skin of individual animals.

Keywords: Spot-on, veterinary, single dose

Current effective version

Guideline on the quality aspects of single-dose veterinary spot-on products

Adopted Reference Number: EMA/CVMP/QWP/544461/2007-Rev.1 Legal effective date: 17/02/2023

Document history

Guideline on the quality aspects of single-dose veterinary spot-on products

Adopted Reference Number: EMEA/CVMP/QWP/ 544461/2007 Legal effective date: 28/02/2010

Overview of comments received on draft guideline on quality aspects of single-dose veterinary spot-on products

Reference Number: EMEA/CVMP/QWP/25621/2009

Draft guideline on the quality aspects of single-dose veterinary spot-on products

Draft: consultation closed Reference Number: EMEA/CVMP/QWP/544461/2007-CON.

Concept paper on the development of a guideline on the quality aspects of single-dose veterinary spot-on products

Reference Number: EMEA/CVMP/QWP/434665/2006