Stability testing of existing active substances and related finished products

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMEA/CVMP/846/99-Rev.1
Published05/08/2008
Effective from01/09/2011
KeywordsStability, testing, data, chemical active substance, finished product, herbal, specification, storage conditions, re-test period, shelf life, veterinary medicinal product (VMP)
DescriptionThis 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.


Document history

Revision 1

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

 

PDF iconConcept paper

In operation: 01/09/2011–present

 

Published: 05/08/2008

 

Published: 12/10/2007

 

Published: 23/04/2007

First version

Current version

PDF iconAdopted guideline

In operation: 01/07/2002–present


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