As a general rule, once an application in IRIS is submitted to EMA for the first time, it becomes locked and it is not possible to edit the data in the portal or upload new documents. EMA staff can reopen the submission, thus allowing the applicant to edit data and upload new documents (before validation) or to upload new documents only (after validation).
For additional information on a specific application, please reply to an email regarding that procedure, received from the IRIS system. Your reply email will be automatically routed to the appropriate EMA office.
