Stability testing of existing active substances and related finished products - Scientific guideline
This document is an extension of the note for guidance on stability testing of new drug substances and products. It provides guidance on the information to be submitted in registration applications for existing active substances and related finished products. It is applicable to chemical active substances and related finished products, herbal drugs, herbal drug preparations and related herbal medicinal products.
Keywords: Stability, testing, data, chemical active substance, finished product, herbal, specification, storage conditions, re-test period, shelf life, veterinary medicinal product (VMP)
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Guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1 (PDF/119.51 KB)
Adopted
First published: 05/08/2008
Last updated: 05/08/2008
Legal effective date: 01/09/2011
EMEA/CVMP/QWP/846/99-Rev.1 -
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Overview of comments received on the draft revised guideline on stability testing: Stability testing of existing active substances and related finished products (PDF/65.27 KB)
First published: 05/08/2008
Last updated: 05/08/2008
EMEA/CVMP/QWP/360143/2008 -
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Guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1 (Corr) (PDF/161.03 KB)
Adopted
First published: 17/12/2003
Last updated: 17/12/2003
Legal effective date: 01/03/2004
CPMP/QWP/ 122/02 Rev. 1 corr -
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Draft guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1 (PDF/128.47 KB)
Draft: consultation closed
First published: 12/10/2007
Last updated: 12/10/2007
EMEA/CVMP/QWP/846/99-Rev.1 CON.