Excipients in the dossier for application for marketing authorisation of a medicinal product

Current effective version

PDF iconRevision 2 - Adopted guideline

Reference number CHMP/QWP/396951/06
Published 19/06/2007
Effective from 01/01/2008
Keywords Excipients, human, novel excipient, antioxidant, preservative
Description This document describes the information that needs to be submitted about excipients in the context of applications for marketing authorisations or variations relating to an excipient in authorised medicinal products. It is applicable to all excipients in medicinal products for human use, including antioxidants and antimicrobial preservatives. This guideline replaces the PDF iconnote for guidance on inclusion of antioxidants and antimicrobal preservatives in medicinal products .

Document history

Revision 2
Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/01/2008–present


Published: 06/11/2006

Revision 1

PDF iconDraft guideline

Published: 20/02/2003
First version PDF iconAdopted guideline In operation: 01/08/1994–31/11/2007

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