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About this guideline
Overseas effective date: December 2009
Replaces: CPMP/ICH/286/95 Modification (adopted by TGA 17 December 2010)
Note: Please refer to ICH guideline M3 (R2) - questions and answers for further clarification of key issues.
Categories: ICH | Multidisciplinary
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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For more information see International scientific guidelines adopted in Australia.