EU Telematics PIM _

Paediatric submissions




Human eSubmission
eCTD v3.2
eCTD EU M1 specification

Veterinary eSubmission
eSubmission expert group

eSubmission expert group documents


External Links



Common Repository


CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PSUR Repository

Industry access

NCA access


eCTD v4.0

CESSP Dataset Module (AF)

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.





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