Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
About this guideline
Overseas effective date: 15 Sep 2014
Categories: Nonclinical | Pharmacokinetics
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TGA annotations
Guideline 3BS11a has been withdrawn, as explained in the above Question and Answer Guideline; however, the guidance contained within Guideline 3BS11a remains applicable in Australia, as in the EU, and has been incorporated into TGA Guidance 23: Nonclinical studies.
For more information see International scientific guidelines adopted in Australia.
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.