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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。 5 ^ `, W: e& Z0 K9 o" [" U1 o
2018.01.29
. E! `- H' \% Q$ j$ i: E1 WThe 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.9 \/ i/ [" H9 t5 C# d
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.
- n1 N/ N2 y+ q( gApplication 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. 9 E- v) T" i" L/ @# H9 `/ X
Implementation: February 2018. 2018年2月起开始实施。 - K' E3 }7 g. @ E
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