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About this guideline
Overseas effective date: 22 May 2002
Replaces: 3AQ3a
Categories: Quality | Manufacturing | Nonclinical | General (nonclinical)
Access this international scientific guideline
TGA annotations
Sponsors should note that the British Pharmacopoeia (BP 2014) states under Herbal Drugs (Ph Eur monograph 1433) that "the use of ethylene oxide for the decontamination of herbal products is prohibited".
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.