Quality of transdermal patches

Current effective version

PDF iconAdopted guideline

Reference number EMA/CHMP/QWP/608924/2014
Published 16/12/2014
Effective from 17/06/2015
Keywords Transdermal patch, adhesives, dissolution, skin permeation
Description This 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 17/06/2015–present


Published: 16/12/2014


Published: 14/08/2012

Superseded document

PDF iconConcept paper


PDF iconAdopted guideline

Published: 30/07/2010


In operation: 01/01/2000–16/06/2015

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