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Technical guide for the elaboration of monographs
www.edqm.euThis document is a guide for the authors of monographs and also a means of communicating the principles for the elaboration of monographs to the users of the European Pharmacopoeia (Ph. Eur.), especially industry, licensing authorities and ofifcial medicines control laboeratoris.
Technical Guide - EDQM - European Directorate for the ...
www.edqm.euTECHNICAL GUIDE FOR THE ELABORATION OF MONOGRAPHS 1. INTRODUCTION 1.1. PURPOSE OF THE GUIDE This document is a guidance for the authors of monographs and also a means of communicating to the users of the European Pharmacopoeia, especially industry, licensing