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【EDQM】« Guidance for electronic submissions for Certificates of Suitability (CEPs) applications »

【EDQM】« Guidance for electronic submissions for Certificates of Suitability (CEPs) applications »

发布时间:2016-05-04 浏览量:571

The EDQM « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications » has been revised.

CERTIFICATION OF SUITABILITY (CEP)
 
PROCEDURE OF CERTIFICATION (GENERAL)
 
NEWS
 
04 MAY 2016
 
STRASBOURG, FRANCE

The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ».

The requirements with regards the format of CEP submissions have been updated and the new EU module 1 specifications for eCTD v. 3.0 have been included. Furthermore a table with the main issues which lead to blocking an application at receipt has been added.

This guideline will be in force on 1st June 2016, and from that date paper submissions are no longer accepted.

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