Quality of transdermal patches - Scientific guideline
Table of contents
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.
Keywords: Transdermal patch, adhesives, dissolution, skin permeation
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Guideline on quality of transdermal patches (PDF/241.59 KB)
Adopted
First published: 16/12/2014
Last updated: 16/12/2014
EMA/CHMP/QWP/608924/2014 -
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Overview of comments received on 'Draft guideline on quality of transdermal patches' (PDF/1.25 MB)
First published: 16/12/2014
Last updated: 16/12/2014
EMA/CHMP/QWP/608923/2014 -
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Draft guideline on quality of transdermal patches (PDF/241.26 KB)
Draft: consultation closed
First published: 14/09/2012
Last updated: 14/09/2012
Consultation dates: 15/09/2012 to 15/03/2013
EMA/CHMP/QWP/911254/2011 -
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Concept paper on the revision of the note for guidance on quality of modified release oral dosage forms and transdermal dosage forms: Section I (quality) - Superseded (PDF/94.71 KB)
Draft: consultation closed
First published: 30/07/2010
Last updated: 30/07/2010
Consultation dates: 24/06/2010 to 31/10/2010
EMA/CHMP/QWP/202350/2010 -
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Note for guidance on quality of modified release products: A: oral dosage formsB: transdermal dosage forms section I (quality) - Superseded (PDF/83.82 KB)
Adopted
First published: 29/07/1999
Last updated: 29/07/1999
Legal effective date: 01/01/2000
CPMP/QWP/604/96