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
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.euInternet: http://www.edqm.eu
PA/PH/CEP(09)108, 2R Strasbourg, June 2013
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 or paper).
本指南适用于向EDQM递交的所有CEP申报，无论选用何种格式（电子或纸质）。
Currently the EDQM accepts paper dossier, as well as 3 electronic submission formats: pdf, NeeS, and eCTD. Paper submissions are still accepted but it is intended to move to 100% electronic submission in the future, therefore it is strongly recommended to initiate electronic submissions.
目前EDQM接受纸质申请和3种电子申报格式：pdf, NeeS 和eCTD。纸质申请虽然仍被接受，但将来会趋向于100%采用电子提交，因此强烈推荐初始申报即采用电子提交。
Changing the format for a CEP application is possible at the start of a procedure (eg. When applying for a revision or renewal). This means moving from paper to electronic submission, moving from a pdf to a NeesS or eCTD, or from a NeeS to eCTD.
在开始程序之初对CEP申报格式进行变更是可以的（例如，在申请修订或更新时）。这时，意味着从纸质提交转为电子提交，从PDF提交转为NeesS或eCTD提交，从NeeS转为eCTD提交。
Once a company has made an e-submission, changing back to paper is no longer possible. In addition, a mixture of paper and electronic files is not allowed (only the format chosen in the application form will be taken into consideration)
一旦公司采用了电子提交，就不能再改回纸质提交。另外，纸质和电子混合提交是不允许的（仅考虑申请表格中选择的格式）。
3
Electronic submission 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 eCTD format 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. The identification of the submission format type in the CEP application form is important.
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 for Industry on providing Regulatory Information in Electronic Format (see the links 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 PDF and the folder and the file-naming convention of ICH M2 eCTD Specification and EU Module 1 Specification should be applied. Other types of files are not accepted (Word, JPEDG, Excel, …), with the exception of the 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 pdf files 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 for the TSE risk TSE风险CEP申请 The eCTD or NeeS submission format is not appropriate for CEP applications for the TSE risk, consequently, applicants are invited to submit a single pdf for Module 3, and adapt the directory structure/file naming as proposed 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 and products for veterinary use only 仅兽用CEP申请和产品
A single pdf (see annex 5) or NeeS submission format (see the guidance available by the following link http://esubmission.ema.europa.eu/tiges/vetesub.htm) may be used for such products. 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。
3.1 eCTD submission format eCTD申报格式
The eCTD structure should be in accordance with the current versions of the related documents (specifications, guidance, etc) available on the following websites:
eCTD结构应符合现行相关文件要求（标准、指南等），这些文件在以下网址可获得 — http://esubmission.ema.europa.eu — http://estri.ich.org/eCET/index.htm
It should be clarified that the eCTD CEP dossier remains, from a technical perspective, a standalone dossier and is distinct from any marketing authorization eCTD dossier and lifecycle.
需要澄清的是，从技术角度来说，eCTD格式CEP文件仍是一个单独的申报资料，区分于任何上市申请eCTD文件和生命周期。 Building the envelope: 创建信封
According to the current EU Module 1 specification, for a CEP application, the envelope should be filled in as follows: 根据现行欧盟模块1标准，对于CEP申请，信封应填写如下
Element 因素 Eu-envelope 欧盟-信封 Envelope 信封 Attribute 属性 Description/Instructions 描述/要求 Country 国家 ema Submission 申报 Type Active Substance Master File (asmf) 类型 Mode 模式 Number 编号 Tracking number 追踪号 Applicant 申报人 Agency 官方 Code 代码 Procedure 程序 Type 类型 Invented-name 创建名 Inn Sequence 序列号 Submission-description 提交描述 活性物质主文件（asmf） Blank 空白 Blank 空白 Blank except if CEP application number known 空白除非已知CEP申请号 Holder/Intended Holder name for the CEP CEP持有人/意向持有人名称 EU-EMA Use “centralized” 采用“集成” Substance name 物质名称 Refer to the EU Module 1 specification. 索引至欧盟模块1标准 Blank 空白 Certificate of suitability/EDQM CEP/EDQM When submitting the first eCTD submission, an initial sequence 0000 should be provided. For the content of the submission refer to the section 5. 在首次eCTD提交时，初始序列号应为0000。申报资料内容参见第5部分。 When switching from another submission format to eCTD, any information already assessed and approved previously should be included in a ―baseline‖ sequence 0000 (refer to the section 6). If files or sections of the eCTD contain a lot of information, additional bookmarks or ―leverls of granularity‖ are recommended for facilitating the review (refer to annex 2). The use of bookmarks is allowed if needed, especially when responding to an EDQM deficiency letter (responses to questions and supportive data). 如果是从其它申报方式转换为eCTD提交，所有已经审核和批准过的内容应包括在一个―基准‖序列号为0000部分（参见第6部分）。如果eCTD文件或部分包括太多信息，推荐使用更多的书签或―分层标题‖以便审核（参见附件2）。书签可以在需要时使用，特别是在回复EDQM缺陷信时（回复问题的内容和支持性数据）。