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About this guideline
Adopted by the TGA: 13 March 2025
Overseas publication date: 18 October 2018
Replaces: Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95)
Categories: Clinical efficacy and safety | clinical pharmacology and pharmacokinetics
Clinical efficacy and safety | General
TGA annotations: Nil
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For more information see International scientific guidelines adopted in Australia.