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About this guideline
Overseas effective date: 26 March 2010
Categories: Biological medicines | Drug substance | Comparability/biosimilarity | Multidisciplinary | Biosimilars | Other relevant guidelines
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.