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Paediatric submissions

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Paediatric submissions
The use of the eSubmission Gateway and/or the Web Client became mandatory for all paediatric applications from 1 January 2018. To allow applicant to adapt to the new submission requirements, EMA will allow a transition period until 15 March 2018. After that date, the European Medicines Agency (EMA) will no longer accept submissions by Eudralink.

It is mandatory to use XML delivery files for submissions via the eSubmission Gateway and the Web Client. However, paediatric applications do not follow eCTD standards applicants should follow the submission guidance below.

News
19-11-2020

A new version of the eSubmission Gateway XML delivery file is now available

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced multiple changes for Paediatric submissions by completely transforming the delivery files for these types of submissions as we are preparing to extend the Common Repository to contain Paediatric submissions.

Users should note that the delivery files created prior to the new release will not work after the go live.

 

 

 

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

 

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