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Paediatric submissions

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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Systems:

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eAF

eASMF
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eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

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Projects:

eCTD v4.0

Paediatric submissions

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Paediatric submissions
eSubmission is mandatory for all paediatric applications including new submissions and updates at any time.
Before submission an XML delivery file must be created and included in the submission package. It is important that the guidance is followed step by step.


First, follow the links and guidance below (sections 12 and 14) to create an XML delivery file in:

Delivery file UI Then follow the guidance below for eSubmission in:

Syncplicity Web Client
  • How to send submissions via the Web Client - User Guidance
  • This document also contains VERY IMPORTANT information on how to register or re-set a password.
    Under the section Viewing sent submission receipts and acknowledgements you can find an explanation on how to access the Web Client's Inbox to ensure that your submission has been successful.
Further content about paediatric applications (what to submit, when, templates etc...):

News
Previous news can be found here

 

 

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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