Summary of requirements for active substances in the quality part of the dossier

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This guideline applies to human and veterinary medicines.

Current effective version

Revision 1 - Adopted guideline

Reference number

CHMP/QWP/297/97 Rev. 1 Corr.

EMEA/CVMP/1069/02

Published01/01/2005
Effective from01/02/2005
KeywordsActive substance, dossier, certificate of suitability of Monographs of the European Pharmacopoeia (CEP), active substance master file (ASMF), impurities, the European Pharmacopoeia (Ph. Eur.)
DescriptionThis document provides guidance on the data to be included for chemical and herbal active substances in the quality part of the dossier. Biological active substances and immunological active substances are excluded from the scope of this guideline.


Document history

Revision 1
Current version
Adopted guidelineDates in operation: 01/02/2005–present
First versionAdopted guidelineDates in operation: 01/06/1998–01/02/2005 


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