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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。 * O! P7 r- R, Q" d- `2 q) y; v+ o& [
2018.01.29
. c2 L/ u5 a& N2 b; ~+ E5 E3 jThe 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.- `0 y4 |% ~2 Z- @) I# P
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.
$ j* E; C; B3 _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. ( p) E- F6 ]1 o+ r' }
Implementation: February 2018. 2018年2月起开始实施。
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