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About this guideline
Overseas effective date: 1 Aug 2000
Categories: Clinical efficacy and safety | General (clinical) | Pharmacovigilance
Access this international scientific guideline
Further information
Published: TGA News October 2000
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.