Summary of requirements for active substances in the quality part of the dossier - Scientific guideline
Table of contents
This guideline applies to human and veterinary medicines.
This 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.
Keywords: Active substance, dossier, certificate of suitability of Monographs of the European Pharmacopoeia (CEP), active substance master file (ASMF), impurities, the European Pharmacopoeia (Ph. Eur.)
Guideline on summary of requirements for active substances in the quality part of the dossier - Revision 1 (PDF/199.9 KB)Adopted
First published: 01/06/2004
Last updated: 01/06/2004
Legal effective date: 01/02/2005
CHMP/QWP/297/97 Rev. 1
Note for guidance on summary of requirements for active substances In part ii of the dossier (PDF/160.52 KB)Adopted
First published: 28/01/1998
Last updated: 28/01/1998
Legal effective date: 01/06/1998