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:
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...):