Search results with tag "Of the european pharmacopoeia"
RESOLUTION AP-CSP (07) 1 Certification of …
www.edqm.eu2 1 INTRODUCTION 2 The manufacturer of a substance will be able to provide proof that the quality of the substance is 3 suitably controlled by the relevant monographs of the European Pharmacopoeia by means of a 4 certificate of suitability granted by the Certification Secretariat of the European Directorate for the 5 Quality of Medicines …
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
Section 3 Pharmaceutical Form - European Medicines Agency
www.ema.europa.euaccording to the European Pharmacopoeia and a visual description of the product. Section index. II.1 Term for pharmaceutical form 4 Section 3: Pharmaceutical form If a patient friendly term (formerly short term) of the European Pharmacopoeia is used on small immediate packaging material
1. Name of pharmacopoeia - WHO
www.who.int12 | 8. Collaboration with and/or being part of a (different) national/regional pharmacopoeia (3/4) Observership to the Ph. Eur.: – Allows for participation in the scientific work of the European Pharmacopoeia