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About this guideline
Overseas effective date: 25 May 2015
Replaces: CHMP/437/04 (adopted by TGA 15 June 2006)
Categories: Biological medicines | Drug substance | Comparability/biosimilarity | Multidisciplinary | Biosimilars | Overarching
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.