Quality of transdermal patches

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/QWP/608924/2014
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Superseded document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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