Posted Thu, 04 Jul 2024 09:20:10 GMT by Paolo Tomasi EMA
During the migration of old, closed paediatric procedures from EMA's previous system into IRIS, the standard submission receipt notification has been erroneously sent to the case contact person by an automated workflow. This has affected more than 5000 cases. 
Please ignore any submission receipt email for Paediatric cases with a case title starting with "EMEA-", as these are the migrated cases. There is no need to reply to the email or to undertake any action. 
We apologise for any confusion induced, and we thank you for your understanding. 
Posted Thu, 04 Jul 2024 11:25:32 GMT by Ennita Nilsson Regulatory Affairs Manager
Thank you. 
Posted Fri, 05 Jul 2024 13:06:27 GMT by Adriana Andric
Dear EMA IRIS Support Team,

I would like to report that at least for one such case of migration of a closed PIP for which a notification was sent out yesterday, apart from the PIP becoming visible as a regulatory entitlement, a draft procedure request with the Submission Number identical to the previous PIP procedure number (in the format EMEA-00XXXX-PIP0X-XX) was automatically generated by the system as a draft submission, with the submission type being 'Modification of Paediatric Investigation Plan'.
Could you kindly advise if such drafts are safe to be deleted, and that in doing so there is no risk of automatically deleting the corresponding regulatory entitlement.
Thank you for your guidance.
Posted Mon, 08 Jul 2024 07:04:17 GMT by Paolo Tomasi EMA
Draft submissions should not be deleted. They are part of the procedure and are necessary. As mentioned in the notice, no action is required or necessary. Draft submissions will be changed to "completed" at the end of the migration process. 
Posted Mon, 08 Jul 2024 09:31:49 GMT by Adriana Andric
Thank you for the clarification, much appreciated.

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