cep电子版纸版递交指南(中英文)cepguidanceforcepapplications.doc

201306 PA/PH/CEP(09)108 2R CEP电子提交和纸质提交指南（中英文）? 官网原文下载： http://www.edqm.eu/en/Guidance-for-electronic-and-paper-submissions-1585.html?mbID=107? 新版本生效日期：2013年8月1日 Certification of Substances Division FK/CB ? PUBLIC DOCUMENT?公开文件 (LEVEL 1)?第一层次 English only/Anglais seulement?仅英文版 PA/PH/CEP(09)108, 2R Strasbourg, June 2013 Certification of suitability to Monographs of the European Pharmacopoeia Guidance for electronic and paper submissions For Certificates of Suitability (CEP) applications CEP电子和纸质申报指南 Date of implementation: 1 August 2013 Address: 7, sllee 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 Table of content?目录 1?????Introduction?介绍 2?????Scope and general requirements?范围和一般要求 3?????Electronic submission formats?电子申报格式 3.1??????eCTD submission format eCTD申报格式 3.2??????NeeS submission format NeeS申报格式 3.3??????PDF format PDF格式 4?????Submission of paper dossiers?纸质文件提交 5?????Content and structure of an application?申报的内容和结构 6?????Lifecycle management of applications?申报的生命周期管理 6.1??????Granularity and updated sections?章节分类和更新部分 6.2??????When to submit a baseline Module 3??什么时候提交基准模块3 7?????Validation by the EDQM EDQM验证 8?????Routes (or pathways) of submission?递交方式（途径） 9?????Security?安全性 ? 1???????????Introduction?介绍 This document is guidance for electronic and paper submissions for Certificates of Suitability (CEPs) applications. Information and requirements described in this document are intended to facilitate the handling and assessment of submissions for certificates of suitability (CEPs) and to maintain their lifecycle even if the submission is not an eCTD. 本文件意在指导CEP的电子和纸质申报。本文件中描述的所有信息和要求意在使用CEP申报资料处理和评审更为便捷，更利于维护其生命周期，即使该申报并不是以eCTD格式提交。 ? 2???????????Scope and general requirements?范围和一般要求 This guidance should be applied for all submissions sent to EDQM in the context of applications for CEPs, and whatever the support selected (electronic o