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About this guideline
Provided for information: 1 August 2014
Categories: Quality | Quality of medicines Q and A - Introduction
TGA annotations:
Answers amended after 1 August 2014 are excluded until such time as they have been considered by TGA.
- 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.