Excipients in the dossier for application for marketing authorisation of a medicinal product - Scientific guideline
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 note for guidance on inclusion of antioxidants and antimicrobal preservatives in medicinal products.
Keywords: Excipients, human, novel excipient, antioxidant, preservative
-
List item
Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product - Revision 2 (PDF/127.34 KB)
Adopted
First published: 19/06/2007
Last updated: 19/06/2007
Legal effective date: 01/01/2008
EMEA/CHMP/QWP/396951/2006 -
List item
Draft guideline on excipients in the dossier for application for marketing authorisation of a medicinal product - Revision 2 (PDF/80.36 KB)
Draft: consultation closed
First published: 06/11/2006
Last updated: 06/11/2006
EMEA/CHMP/QWP/396951/2006