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

Current effective version

Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product - Revision 2

AdoptedLegal effective date: 01/01/2008Reference Number: EMEA/CHMP/QWP/396951/2006

Document history - Revision 2

Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product - Revision 2

AdoptedLegal effective date: 01/01/2008Reference Number: EMEA/CHMP/QWP/396951/2006

Draft guideline on excipients in the dossier for application for marketing authorisation of a medicinal product - Revision 2

Draft: consultation closedReference Number: EMEA/CHMP/QWP/396951/2006

Document history - Revision 1

Note for guidance: Excipients in the dossier for application for marketing authorisation for veterinary medicinal products

AdoptedLegal effective date: 01/06/1999Reference Number: EMEA/CVMP/004/98 - FINAL

Document history - First version

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

AdoptedReference Number: 3AQ9A