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About this guideline
Overseas effective date: April 1994
Replaces: III/3501/91 (adopted by TGA 1 January 1995)
Categories: Quality | Active substance
Clinical efficacy and safety | General
Non-clinical | toxicology | Specific types of products
Non-clinical) | development
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.