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

We have adopted this International Scientific Guideline - EMEA/CHMP/QWP/396951/2006.

Last updated

4 June 2024

About this guideline

Overseas effective date: January 2008

Replaces: 3AQ9a and CPMP/CVMP/QWP/115/95

Categories: Quality | Excipients

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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