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About this guideline
Overseas effective date: 15 January 2012
Replaces: EMEA/CHMP/EWP/435635/2008 concept paper on this topic (provided for information 1 May 2009)
Categories: Clinical efficacy and safety | Anti-infectives for systemic use
TGA annotations:
The Report of the Joint Expert Advisory Committee on Antibiotic Resistance (1999) accepted by the Commonwealth, also includes recommendations for assessment of the propensity for promoting resistance and cross-resistance.
- 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.