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)

Current effective version

Guideline on Stability Testing: Stability testing of existing active substances and related finished products

AdoptedReference Number: EMA/CVMP/QWP/709423/2022,Corr.1Legal effective date: 17/02/2023

Document history - Revision 1

Guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1

AdoptedReference Number: EMEA/CVMP/QWP/846/99-Rev.1Legal effective date: 01/09/2011

Overview of comments received on the draft revised guideline on stability testing: Stability testing of existing active substances and related finished products

Reference Number: EMEA/CVMP/QWP/360143/2008

Guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1 (Corr)

AdoptedReference Number: CPMP/QWP/ 122/02 Rev. 1 corrLegal effective date: 01/03/2004

Draft guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1

Draft: consultation closedReference Number: EMEA/CVMP/QWP/846/99-Rev.1 CON.

Document history - First version

Note for guidance for stability testing of existing active substances and related finished products

AdoptedReference Number: EMEA/CVMP/846/99 - FINALLegal effective date: 01/07/2002