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标题: EDQM新发布的CEP申请电子申报指南 [打印本页]

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作者: 水仔笔的微笑    时间: 2018-1-30 01:50 PM
标题: 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。

2018.01.29

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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.
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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.

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

• 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)
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Implementation: February 2018.

2018年2月起开始实施。

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作者: Xspring    时间: 2018-1-31 10:43 AM
备用了，谢谢分享

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