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About this guideline
Adopted by the TGA: 8 June 2023
Overseas effective date: 10 August 2017
Categories: Quality | Non-immunologicals | Specifications, analytical procedures and analytical validation
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.