Non-clinical local tolerance testing of medicinal products

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/SWP/2145/2000 Rev. 1
Published27/11/2015
Effective from01/05/2016
KeywordsNon-clinical, local tolerance testing, toxicity studies, sensitising potential, oral, ocular, cutaneous, transdermal, parenteral, rectal, vaginal
DescriptionThis document provides guidance on the non-clinical local tolerance testing of medicinal products for human use. It addresses the development and evaluation of medicinal products that will, or have the potential to, come into contact with different sites of the human body following normal clinical use, as well as after unintentional administration.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/05/2016


Published: 27/11/2015


Published: 30/04/2014


Published: 26/07/2011

First versionAdopted guidelineIn operation: 01/02/2001–01/05/2016


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