Draft guideline on non-clinical local tolerance testing of medicinal products

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Download document Draft guideline on non-clinical local tolerance testing of medicinal products
Reference number EMA/CHMP/SWP/2145/2000 Rev. 1
Status draft: consultation open
First published 30/04/2014
Last updated 30/04/2014
Consultation start date 30/04/2014
Consultation end date 31/07/2014
Email address for submissions swp-h@ema.europa.eu

Summary

Local tolerance testing is intended to support human exposure to a medicinal product (both active substance and excipient) at contact sites of the body following clinical use.