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International scientific guideline: Guideline on stability testing for applications for variations to a marketing authorisation

EMA/CHMP/CVMP/QWP/441071/2011 Rev 2 adopted by the Therapeutic Goods Administration (TGA)

About this guideline

Overseas effective date: 25 May 2015

Categories: Quality | Stability

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TGA annotations

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

For more information see International scientific guidelines adopted 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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