Centralised procedures news

Centralised Procedures News

EMA has announced a delay in replacing the Formatted Table Template with the eSubmission Gateway Delivery file.

EMA has announced a delay in replacing the Formatted Table Template with the eSubmission Gateway Delivery file.
January 25, 2019

EMA has announced a delay in replacing the Formatted Table Template with the eSubmission Gateway Delivery file.

The reason is the interdependency with other systems, extended testing and resource issue due to the move of the agency.

Until further notice, please continue to provide the Formatted Table Template for Human submissions as a part of the Cover Letter in Module 1 of eCTD submission sequences. As usual, users are required to fill in all the submission attributes correctly through the Delivery file UI. The attributes in the XML delivery files are used to support important searches in the Common Repository and they support EMA internal processes. Please note that incorrect submissions may lead to procedural delays of incoming applications.

In case of any questions, please contact us at: eCTD@asphalion.com

 

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