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About this guideline
Overseas effective date: 1 August 2014
Categories: Clinical efficacy and safety | Genito-urinary system and sex hormones
Replaces: CPMP/EWP/18/01 (Adopted by TGA 4 February 2004)
Access this international scientific guideline
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.