Quality of transdermal patches

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/QWP/608924/2014
Published16/12/2014
Effective from17/06/2015
KeywordsTransdermal patch, adhesives, dissolution, skin permeation
DescriptionThis document provides guidance on the general requirements concerning the development and quality of transdermal patches for systemic delivery. It covers both new marketing authorisation applications and variations. In addition, it provides specific guidance concerning the data requirements to support generic or abridged applications.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 17/06/2015–present


Published: 16/12/2014


Published: 14/08/2012

Superseded document

Concept paper


Adopted guideline

Published: 30/07/2010


In operation: 01/01/2000–16/06/2015


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