CEP证书常见变更申请指南 2012.7 中英.pdfVIP

Certification of Substances Division FS/CB PUBLIC DOCUMENT (Level 1) English only/Anglais seulement PA/PH/CEP (11) 76 Strasbourg, July 2012 PA/PH/CEP (11) 76, EDQM关于“CEP常见变更申请指南”中文简译稿 斯特拉斯堡，2012年7月 欧洲药典适用性证书 CEP常见变更申请指南 Certification of Suitability to Monographs of the European Pharmacopoeia Guidance on frequent changes to applications for Certificates of Suitability (CEPs) Address: 7 all e Kastner CS 30026 - F 67081 Strasbourg Telephone: 33 (0) 3 88 41 30 30 - E-mail:cep@edqm.eu - Fax: 33 (0) 3 88 41 27 71 Internet : http://www.edqm.eu EDQM PA/PH/CEP (11) 76 Certification of Substances Division This document should be considered as an explicative note and should be read jointly with the EDQM Guideline on Revision/Renewal of Certif icates of Suitability to the Monograph s of the European Pharmacopoeia (PA/PH/CEP (04) 2). 该文件可视为对EDQM 《CEP （欧洲药典适用性证书）修订/更新指南》(PA/PH/CEP (04) 2) 的补充说 明，应与其一起参照阅读。 This document is intended as a guide to applicants when compiling their documentation for notification/revision/renewal of their applications for certificates of suitability (CEPs). It has arisen from frequent issues occurring in submissions of notifications and revisions of dossiers for chemical purity, and it describes the key points to be considered. 该文件可指导CEP 申请人进行通知或变更或更新文件的编写，其包括了化学合成品种通知或变更材料递交 时常见问题，并描述了所需考虑的 键点。 By improving the quality of the data submitted, the time for the evaluation of the dossiers will be reduced and requests for additional information will be limited. 旨在提高递交资料的质量，缩短申报材料的评估时间和减少补充信息的要求。 1. Requ