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Quality-working-party-questions-and-answers-on-api-mix
[PDF, 80.8 KB]
About this guideline
Adopted by the TGA: 13 March 2025
Overseas effective date: 21 April 2016
Categories: Quality | active substance
TGA annotations:
EMA filing procedures and CEP requirements are not applicable to submissions made to the TGA.
- 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.