International scientific guideline: Non-clinical documentation for mixed marketing authorisation applications

About this guideline

TGA adopted date: 1 April 2006

Overseas effective date: 1 April 2006

Categories: Nonclinical | General (nonclinical)

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For more information see International scientific guidelines adopted in Australia.

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.