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

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference number

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

EMEA/CVMP/1069/02

Published 01/01/2005
Effective from 01/02/2005
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.)
Description 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.


Document history

Revision 1
Current version
PDF iconAdopted guideline Dates in operation: 01/02/2005–present
First version PDF iconAdopted guideline Dates in operation: 01/06/1998–01/02/2005


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