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Paediatric submissions

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Systems:

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eCTD v4.0

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Paediatric submissions

SPOR

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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.

 

 

 

 
 

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