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Guideline on stability testing for applications for variations to a marketing authorisation

We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/441071/2011 Rev. 2 

Last updated

About this guideline

Overseas effective date: 6 months after publication (published 21 March 2014)

Categories: Quality | Stability

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.
  • 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.

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