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

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Current effective version

Revision 2 - Adopted guideline

Reference numberCHMP/QWP/396951/06
Published19/06/2007
Effective from01/01/2008
KeywordsExcipients, human, novel excipient, antioxidant, preservative
DescriptionThis 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 note for guidance on inclusion of antioxidants and antimicrobal preservatives in medicinal products.


Document history

Revision 2
Current version

Adopted guideline


Draft guideline

In operation: 01/01/2008–present


Published: 06/11/2006

Revision 1

Draft guideline

Published: 20/02/2003
First versionAdopted guidelineIn operation: 01/08/1994–31/11/2007


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