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About this guideline
TGA adopted date: 15 Jul 2019
Overseas effective date: 1 Aug 2019
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence
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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.