Summary of requirements for active substances in the quality part of the dossier - Scientific guideline

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.)