This document offers best practice and guidance in the consideration of an excipient composition
profile. The excipient supplier may be a manufacturer or a distributor (or both). The Guide highlights
the factors to consider when assessing an excipient composition profile, particularly in the context of
Design Space and Quality by Design.
Eudralex Volume 3 Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product CHMP/QWP/396951/06
This guideline describes the information that needs to be submitted in relation to excipients including antioxidants and antimicrobial preservatives, in the context of applications for marketing authorisations or variations relating to an excipient in authorised medicinal products.
Eudralex Volume 3 VOLUME 3B Guidelines - Medicinal products for human use. Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use
This guideline is for use by competent authorities, applicants for a Marketing Authorisation and
Marketing Authorisation Holders. The Annex provides a list of the excipients which should be stated
on the labelling and outlines the information which should appear in the package leaflet, for these
excipients. This guideline does not apply to these substances when they are used as active substances.