马上注册,结交更多好友,享用更多功能,让你轻松玩转社区
您需要 登录 才可以下载或查看,没有帐号?立即注册 ![](static/image/common/qq_login.gif)
x
The EDQM "Guidance for electronic submissi** for CEPs applicati**" has been revised and application forms have been updated accordinglyEDQM的CEPs申请电子申报指南已经进行了修订,申请表格也相应的进行了更新。 ( w% R& s- b: V9 a; X/ a: g
2018.01.29
, ?/ N: {$ t3 [3 c# RThe EDQM has revised the document « Guidance for electronic submissi** for Certificates of Suitability (CEPs) applicati** ». The requirements with regards the format of CEP submissi** have been updated: EDQM已经将《CEPs电子申报指南》进行了修订,关于CEP提交格式的要求已被更新。 - eCTD is mandatory for new CEP applicati**. 针对新CEP申请强制实施eCTD递交。
- EDQM stops accepting PDF submissi** for revisi** and renewal applicati**. Therefore, all such submissi** need to be either in NeeS (Non-eCTD electronic Submission) or eCTD format.
+ k8 F. t9 C5 u
针对修订和更新申请, EDQM停止接收的PDF格式的申报文件。因此,所有的此类申报文件需要采用NeeS(非eCTD电子提交)或eCTD格式。 Changing the electronic format of a dossier should be done at the start of a procedure. Ongoing procedures are not affected.
" b$ L1 s, m3 N0 PApplication forms for new applicati** and for revisi** of applicati** have been updated in order to remove reference to those formats no longer accepted and to introduce small changes.
3 i% ~& [: L. b7 u0 F0 `9 a- nImplementation: February 2018. 2018年2月起开始实施。 ( [& z( \5 W0 I/ L( O# e
|