Draft concept paper for a guideline on user safety of topically administered products

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Document details

Download document Draft concept paper for a guideline on user safety of topically administered products
Reference number EMA/CVMP/SWP/92311/2014
Status draft: consultation open
First published 24/03/2014
Last updated 24/03/2014
Consultation start date 24/03/2014
Consultation end date 30/06/2014
Email address for submissions vet-guidelines@ema.europa.eu

Summary

This concept paper addresses the need for a specific user safety guideline for topically administered products. The CVMP adopted the revised general User Safety Guideline for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1) in March 2010. This document provides general guidance on how user risk assessment should be conducted and reported. It does not provide specific guidance on how exposure from topically administered products should be assessed.