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About this guideline
Adopted by the TGA: 13 March 2025
Overseas effective date: 8 December 2022
Replaces: Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph "Substances for pharmaceutical use" and general chapter "Control of impurities in substances for pharmaceutical use" (CPMP/QWP/1529/04)
Categories: Quality | Impurities | Non-immunologicals
TGA annotations: Nil
- 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.