Paolo Tomasi EMA

Applicants should be aware that deadlines for resubmission have been implemented in IRIS. Whenever a submission is reopened, a date is set by the case manager for automatic re-lock of the submission. After that date, it will not be possible to edit the submission. You will be informed of the deadline via email. 
Please remember to complete any resubmission by re-closing it using the "Declare and submit" button. 
 

Resubmission modalities

• Before validation: for cases (procedures) before validation, it is possible to edit the data in the portal and to upload new or revised documents (these last will overwrite any existing document with the same name).
  It is not possible to delete previously submitted documents. 
• After validation: for cases after the start date, e.g. at the time of the list of questions, it will be possible to upload new or revised documents (these last will overwrite any existing document with the same name).
  It is not possible to delete previously submitted documents, and it is not possible to edit the data in the portal.

Dear IRIS portal users, this forum is available for your discussions on the IRIS system, to discuss aspects of common interest and provide preferred approaches. Please note that EMA does not guarantee a reply and this forum does not replace the need to contact the appropriate channel for specific problems.

This  forum is intended as a service to the user community, to provide self-help on common issues. 
Please note that posts with inappropriate content or language may be removed by EMA without warning.