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About this guideline
Overseas effective date: September 1999
Categories: ICH | Quality
Biologicals | Active substance
Biologicals | Finished product
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.