Posted Fri, 23 Oct 2020 11:51:10 GMT by Isha Arora Dr.
Hi, this is a general question about timelines to be respected for SA applications and IRIS system features/notifications.
1- For example, for the next SA with preparatory meeting, the applicant has to submit application via IRIS by 30-Oct, right? and not on 30-Oct ? This is a general question that the document "Dates of 2021 SAWP meetings and submission deadlines" still refers to deadlines dates by when the applicant should submit, and not actual date for submission in IRIS?
2- How does it work afterwards, can the applicant still edit the application? or is it system locked for validation phase? will the applicant be automatically notified when editing would be possible again to provide final application ?
We would like to have some detailed information please on how the SA process is supported by the system exactly (deadlines, ability to edit, status for submission / notifications).
Thank you in advance,
Isha
Posted Mon, 26 Oct 2020 08:27:40 GMT by Paolo Tomasi EMA
Your understanding is correct.
  1. An application for Scientific Advice (or any other procedure) can be submitted at any time, the deadline only determines at which SAWP (COMP) meeting the submission will be discussed the first time. 
  2. After submission, the application is indeed locked and cannot be edited unless reopened by EMA (for example to make changes needed for validation). If the submission is unlocked by EMA before validation, all data can be changed, and documents can be overwritten or added (they cannot be removed after submission). If the submission is unlocked after validation and start date, the data cannot be edited but documents can still be overwritten or added (but not deleted). A document can be deleted from a submission only if the submission is in "draft" state (i.e. before being submitted to EMA for the first time). 

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