EDQM 草药和草药制剂质量审评申报资料 2013.2 英文.pdfVIP

Certification of Substances Division PPR/CB PUBLIC DOCUMENT (LEVEL 1) (LEVEL 1) English only/Anglais seulement PA/PH/CEP (02) 6 1R Strasbourg, February 2013 Certification of suitability to Monographs of the European Pharmacopoeia CONTENT OF THE DOSSIER FOR HERBAL DRUGS AND HERBAL DRUG PREPARATIONS QUALITY EVALUATION Implementation date April 2013 Address: 7, allée Kastner, CS 30026 F - 67081 Strasbourg (France) Telephone: 33 (0) 3 88 41 30 30 - Fax: 33 (0) 3 88 41 27 71 - e-mail: cep@edqm.eu Internet : http://www.edqm.eu EDQM PA/PH/CEP (02) 6 1R Certification of Substances Division CONTENT OF THE DOSSIER FOR HERBAL DRUGS AND HERBAL DRUG PREPARATIONS QUALITY EVALUATION SUMMARY I. Introduction II. Module 1: Administrative information: (application form) III. Module 2: Quality Overall Summary IV. Module 3: Technical documentation for Herbal Drug V. Module 3: Technical documentation for Herbal Drug Preparation VI. References Page 2 of 16 EDQM PA/PH/CEP (02) 6 1R Certification of Substances Division I. INTRODUCTION Herbal Drugs and Herbal drug preparations are defined in General monographs (1433) and (1434) of the European Pharmacopoeia (Ph. Eur.). This document addresses the information to be provided for an application for a certific