Guideline on active substance master file procedure

We have adopted this International Scientific Guideline - CCHMP/QWP/227/02 Rev 3/Corr.

Last updated

3 June 2024

About this guideline

Adopted by the TGA: 25 May 2015

Overseas effective date: 1 October 2012

Replaces: CPMP/QWP/227/02 Rev 2 (adopted by TGA June 2013)

Categories: Quality | Active substance

TGA annotations

EU-specific procedural requirements stated in this Guideline do not apply 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.
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