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About this guideline
Adopted by the TGA: 13 March 2025
Overseas effective date: 28 July 2017
Categories: Pharmacovigilance | Safety
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.