• How do I know when my IRIS Market status report baseline has been accepted, and other questions

    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?