EDQM新发布的CEP申请电子申报指南

The EDQM "Guidance for electronic submissi** for CEPs applicati**" has been revised and application forms have been updated accordingly

EDQM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。

  p0 v; E& K0 [0 W

2018.01.29

The 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.
  ) S1 q) N) d4 ]0 {

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.

7 a) _" x4 y0 k4 D

• Guidance for electronic submissi** for Certificates of Suitability (CEP) applicati**, PA/PH/CEP (09) 108, 5R, January 2018)
  

Application 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.

$ r2 P0 r( Z3 ~

• Application form “Request for new Certificate of Suitability” (FORM/055 rev15, January 2018)
• Application form “Request for Revision or renewal of Certificate of Suitability (FORM/056 rev12, January 2018)
  

Implementation: February 2018.

2018年2月起开始实施。

备用了，谢谢分享