Guideline on the non-clinical documentation for mixed marketing authorisation applications

We have adopted this International Scientific Guideline: CPMP/SWP/799/95

Last updated

15 January 2025

About this guideline

Adopted by the TGA: 1 April 2006

Overseas effective date: 30 April 2006

Categories: Non-clinical | Non-clinical development

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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