Quality Working Party questions and answers on API mix

We have adopted this International Scientific Guideline- EMA/CHMP/CVMP/QWP/152772/2016

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.
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