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About this guideline
Overseas effective date: 27 February 2001
Categories: Biologicals | Active substance | Manufacture, characterisation and control of the active substance
TGA Annotations: Nil
- 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.
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For more information see International scientific guidelines adopted in Australia.