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About this guideline
Adopted by the TGA: 8 June 2023
Overseas effective date: 1 January 2019
Replaces: EMEA/CHMP/BMWP/94528/2005
Note: this is a technical update to reflect current best practise with regard to implementation of 3Rs approaches and it is not intended as a full revision of guideline (only section 4 is affected) EMEA/CHMP/BMWP/94528/2005
Categories: Multidisciplinary | Biosimilars | Product-specific
TGA annotations: Nil
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For more information see International scientific guidelines adopted in Australia.