Guideline on stability testing for applications for ...

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 21 March 2014 EMA/CHMP/CVMP/QWP/441071/2011- Committee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on stability testing for applications for variations to a marketing authorisation Draft Agreed by CHMP / CVMP Quality Working Party June 2011 Adoption by CHMP for release for consultation June 2011 Adoption by CVMP for release for consultation July 2011 End of consultation (deadline for comments) 31 January 2012 Agreed by QWP December 2013 Adoption by CHMP February 2014 Adoption by CVMP January 2014 Date for coming into effect 6 months after publication This Guideline replaces Guideline on stability testing for applications for variations to a marketing authorisation previous version (CPMP/QWP/576/96 Rev 1, EMEA/CVMP/373/04).

This guideline provides guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation. The guideline provides general guidance on stability testing for type IA and type IB variations and addresses the data requirements for common type II variations.

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  Testing, Stability, On stability testing

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