Posted Tue, 21 Dec 2021 15:21:09 GMT by Margit Pelcman Senior Regulatory Operations Manager
Like many others I have encountered technical problems when trying to perform a bulk upload of the baseline for Market status reporting.

One of my product has not been marketed in all regions, but when I tried to upload the excel sheet containing rows with the information “No data provided” I received validation errors. Therefore, I removed those rows and only submitted rows that contained data. Was that correct/acceptable?

Under my ongoing submissions I can see that the information has been submitted. How and when do I know that the data I have submitted has been registered at EMA? How do I know when I can send updates to the data I have already submitted?

In addition to this I have an upcoming submission with an older product that requires the two-step solution – first submitting the data when the product was placed on the market and then submitting the data when it was removed from market. How do I know when I can proceed with step 2?

Could you please confirm that the last date for submitting the baseline via IRIS presently is set to April 30, 2022?
 
Posted Wed, 22 Dec 2021 12:05:48 GMT by Paolo Tomasi EMA
When a submission is processed by IRIS and the data have been correctly updated in the system, the following happens:
  1. you receive an email with the subject like "Case closed: EMA/PA/XXXXXXXXX Marketing Status Notification" that informs you of the correct processing and closure of your submission (see attached email example);
  2. your submission in the IRIS Industry Portal changes status, from "In Progress" "Processed", and is now visible in the list of "Completed submissions" rather than "Draft Submissions" or "Ongoing submissions".
For your other question, see IRIS Marketing Status - New deadline for submission of Mkt status reports for marketed CAPs · IRIS (europa.eu)

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