Clinical requirements for locally applied, locally acting products containing known constituents

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCPMP/EWP/239/95
Effective from01/06/1996
KeywordsTherapeutic equivalence, gastrointestinal, locally applied and locally acting, pharmacokinetic, bioequivalence
DescriptionThis document defines requirements for the clinical development of locally applied, locally acting products with known active substance. It provides guidance on the information to be included in the dossier.

Document history

Revision 1

In progress

Draft guideline




Concept paper

Published: 04/04/2017


Deadline for comments: 30/09/2017


Published: 01/10/2013

First version

Current version

Adopted guidelineIn operation: 01/06/1996–present

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