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Certification of Substances Division CBW/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, 4R Strasbourg, November 2016 Certification ofsuitability to Monographs of the European Pharmacopoeia Guidance for electronicsubmissions For Certificates ofSuitability (CEP) applications CEP电子申报指南 Date of implementation: November 2016 生效日期：2016年11月 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
Table of content 目录
1 Introduction介绍This document provides guidance forelectronic submissions for Certificates of Suitability (CEPs) applicationssubmitted to the EDQM. Information and requirements described in this documentare intended to facilitate the handling and assessment of submissions for CEPsand to maintain their lifecycle even if the submission is not an eCTD. 本文件意在指导CEP的电子申报。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 Scopeand general requirements 范围和一般要求This guidance should be applied for all electronicsubmissions sent to EDQM in the context of applications for CEPs. 本指南适用于向EDQM递交的所有CEP电子申报。 From June 2016 the EDQM does not accept paper applications anymore.All submissions should be in electronic format, irrespective of whetherprocedures are ongoing or not. 自2016年6月起，EDQM不再接受纸质申报。所有申报均应以电子格式提交，不管其管理是否正在进行之中。 The following electronic submission formats are accepted: pdf, NeeS,and eCTD. Change to electronic format for a CEP application is possible at thestart of a procedure (e.g. when applying for a revision or renewal). This meansmoving from a PDF to a NeeS or eCTD, or from a NeeS to eCTD. Coming back to aprevious submission format is not allowed (e.g. sending a NeeS submission whenpreviously an eCTD submission was sent.) 以下三种电子提交格式是可以接受的：PDF, NeeS 和eCTD。在程序开始之时可以将CEP申报格式转成电子格式（例如，在申请修订或更新时）。这就是说从PDF转成NeeS或eCTD，或者从NeeS转成eCTD。再转换回去原来的申报格式则是不允许的（例如，之前提交的是eCTD格式，之后提交NeeS格式）。 3 Electronicsubmission formats 电子申报格式Three possible submission formats are accepted for electronic submissions:eCTD, NeeS, or a single bookmarked PDF file for Module 3. Submissions in eCTDformat are recommended by the EDQM. 有三种可以接受的电子申报格式：eCTD, NeeS和带书签的模块3单个PDF文件。EDQM建议以eCTD格式提交申报。 This is applicable to all types of applications and communication. Theidentification of the submission format type in the CEP application form isimportant. 这适用于所有类型的申报和信息交流。在CEP申请表格中标明申报格式类型是很重要的。 Electronic files should be in accordance with specific Guidance forIndustry on providing Regulatory Information in Electronic Format (see thelinks in the sections below for each submission format). 电子文件应符合相应的行业法规信息电子格式指南（见以下各部分提交格式的链接） All files should be in PDFand the folder and the file-naming convention of ICH M2 eCTD Specification andEU Module 1 Specification should be applied. Othertypes of files are not accepted (Word, JPEDG, Excel, …), with the exception ofthe files required for publishing an eCTD submission. 所有文件均应为PDF格式，文件夹和文件命名应采用ICH M2 eCTD指南，和欧盟模块1标准。其它类型文件将不被接受（Word, JPEDG,Excel, …），eCTD申报公布所需文件除外。 The use of attached files in a pdf file is not allowed nor are pdffiles with active javascripts (form fields, …) or containing watermarks. 在PDF文件中采用附件是不允许的，PDF文件中也不能有JAVA程序（表格域等），不能有水印。 CEP applications forthe TSE risk TSE风险CEP申请 The eCTD or NeeS submission format is not appropriate for CEPapplications for the TSE risk, consequently, applicants are invited to submit asingle pdf for Module 3, and adapt the directory structure/file naming asproposed in annex 1. TSE风险的CEP申请不适用eCTD和NeeS申报格式，因此，要求申请人提交模块3单个PDF文件，采用附件1中目录结构和文件命名。 CEP applications forsubstances for veterinary use only 仅兽用物质的CEP申报 单个PDF文件（见附件5）或NeeS申报格式（见下列链接指南）可以用于该类产品。
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