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Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products

We have adopted this International Scientific Guideline - CPMP/QWP/159/01; EMEA/CVMP/271/01

Last updated

About this guideline

Overseas effective date:  April 2001

Replaces: 3AQ3a

Categories:  Non-clinical | Toxicology | Immunotoxicity

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".

 

  • 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.

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