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

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

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