Posted Wed, 04 Sep 2024 11:11:46 GMT by Eva Linne Larsson Regulatory Affairs Manager
I have searched both EMA's and IRIS homepages for information on how to submit responses to questions raised by PDCO in their Day60 assessment report to an initial PIP which has been transferred to IRIS.
This is the only location where I have found some info about correspondence for ongoing procedures ( eSubmission: Projects (europa.eu) (Paediatric submissions)):

"17-05-2024

New Paediatric submissions are mandatory via IRIS platform from 4 June 2024

Please note that from 4 June 2024, the following types of new paediatric submissions must be carried out via IRIS:

  • Initial paediatric investigation plan (PIP)
  • .........

The gateway is open for ongoing paediatric procedures only."

My interpretation is that the responses to Day60 assessment questions should be sent via the gateway (despite the PIP has been transferred to IRIS) is this true?
For how long time does this apply?
 
Posted Wed, 04 Sep 2024 20:16:47 GMT by Paolo Tomasi EMA
In principle, resubmissions for procedures in clock-stop should also be done in IRIS. The vast majority of cases in clock-stop have been migrated to IRIS and therefore the submission is visible in the IRIS Industry Portal under "Draft submissions" or "Ongoing submissions"; in such cases, the submission can be edited, and new documents can be uploaded directly. This applies for example to one of your submissions that went in clock-stop in October 2023. 

Some procedures that went in clock-stop recently (after 1 May 2024) are still in the process of being imported into IRIS; additionally, it is possible that the contact person (portal contact) needs an update. It is advisable to proceed as follows:

 
  1. An IRIS user affiliated to the applicant with the role of IRIS Industry Global coordinator should check the "Draft submissions" or "Ongoing submission" to verify if the submission is present, and in this case add new IRIS Industry Managers to the submission as applicable, and change the Portal Contact if appropriate.
     
  2. If the submission is not visible in IRIS, please Report an issue with IRIS, this will be forwarded to the Paediatric Medicines Office at EMA who will inform you of further steps. 

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