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Submission of electronic applications
for Certificates of Suitability (CEPs):
Revised procedures
CEPs证书电子申请的递交
修订程序
1. Introduction
In order to run the Certification procedure efficiently and based on experience gained, the Certification Division has revised the requirements for electronic submissions.
This document gives the new instructions for electronic submissions related to CEP applications, which will apply from 1st September 2009.
1. 介绍
为了有效地执行证书递交程序,基于所获得的经验,证书修订委员会已对电子递交的要求进行了修订。
本文件给出了关于CEP申请电子递交的新说明,于2009年9月1日起开始执行。
2. Scope
All applications and communication related to CEP applications can be submitted electronically:
- New applications for CEPs
- Notifications
- Requests for revision or renewal
- Answers to EDQM deficiency letters
- Any other communication related to CEP applications.
It is possible to move from a paper submission to an electronic submission at any time of the life-cycle of a CEP application or a granted CEP. This choice can be selected in the relevant application form. However, once an electronic dossier is sent, any future data related to the application should then be also in electronic format (no mixture of paper/electronic data).
2. 范围
与CEP申请相关的所有申请与信息都能够以电子格式递交:
- 新的CEPs申请
- 通知
- 修订或更新申请
- EDQM缺陷信回复
- 与CEP申请有关的任何其它的信息
在CEP申请或已授予CEP证书生命周期的任何时间内,由纸质递交改为电子递交是可能的。在相关的申请表格中可以进行选择。但是,电子版文件一旦送出,与申请相关的任何随后的资料都应该也以电子格式递交(不要纸质与电子资料混合)。
3. Structure and format of the submissions
3 possible formats are accepted for electronic submissions: eCTD, NEES, or a simple pdf file. The required structure of these formats is described in the Annexes.
The documents should be placed in modules 1, 2 and 3 as defined by the ICH M2 EWG (Electronic Common Technical Document Specification), as well as the EDQM requirements given in Annex 1 and 2.
3. 递交的结构与格式
对于电子递交,有3个可能的格式被接受:eCTD, NEES, 或者一个单独的pdf文件。这些格式要求的结构在附件中有所描述。
根据ICH M2 EWG(电子通用技术文件规格)中的详细说明,文件应该放在模块1,2和3中,也就是在附件1和2中所列出的EDQM的要求。
NEW PAPHCEP 08 108 Submission of electronic applic