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About this guideline
Overseas effective date: 25 April 2014
Categories: Non-clinical | Pharmacokinetics
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Guideline 3BS11a has been withdrawn, as explained in the above Question and Answer Guideline; however, the guidance contained within Guideline 3BS11a remains applicable in Australia, as in the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.
- 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.
- All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.
For more information see International scientific guidelines adopted in Australia.