Quality of transdermal patches - Scientific guideline

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

Current effective version

Guideline on quality of transdermal patches

Adopted Reference Number: EMA/CHMP/QWP/608924/2014 Summary:

This guideline addresses new marketing authorisation applications (including generic or abridged applications) and subsequent variation submissions for transdermal patches for systemic delivery.

Document history

Guideline on quality of transdermal patches

Adopted Reference Number: EMA/CHMP/QWP/608924/2014 Summary:

This guideline addresses new marketing authorisation applications (including generic or abridged applications) and subsequent variation submissions for transdermal patches for systemic delivery.

Overview of comments received on 'Draft guideline on quality of transdermal patches'

Reference Number: EMA/CHMP/QWP/608923/2014 Summary:

Interested parties (organisations or individuals) that commented on the draft document as released for consultation.

Draft guideline on quality of transdermal patches

Draft: consultation closed Consultation dates: 15/09/2012 to 15/03/2013 Reference Number: EMA/CHMP/QWP/911254/2011 Summary:

This guideline, together with the new guideline on quality of oral modified-release products, replaces the note for guidance on modified-release products: A: oral dosage forms B: transdermal dosage forms: part I (quality).

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note for guidance on quality of modified release oral dosage forms and transdermal dosage forms: Section I (quality) - Superseded

Draft: consultation closed Consultation dates: 24/06/2010 to 31/10/2010 Reference Number: EMA/CHMP/QWP/202350/2010

Note for guidance on quality of modified release products: A: oral dosage formsB: transdermal dosage forms section I (quality) - Superseded

Adopted Reference Number: CPMP/QWP/604/96 Legal effective date: 01/01/2000