How to report the Marketing Status of presentations that have never been on the market

A specific Marketing Status category has been added for products that have never been on the market.
‘Never marketed’ should be chosen from the list of Marketing Status options. Reason for Cessation and the Date of Marketing Status change can be left blank since they won't be mandatory fields when this option is chosen. Newly authorized products will be showing in IRIS with the status ‘Never marketed’ by default. The Regulatory guidance and the IRIS guide for applicants will be updated shortly to include this new feature.
 

Thank you, Paolo, for this good news!
Should we use this new status for baseline submissions of initial launch dates?
Formerly when we tried to submit bulk notifications we had to delete the rows with products "Never marketed".
Could this be the reason why our bulk submissions are not completed but still in progress?
Kind regards, Susanne

The new status can be used in the bulk upload for the baselines, for presentations that have never been on the market. It should not lead to a validation error. Please replace "No data provided" with "Never marketed" when needed. If you still experience difficulties, please contact EMA ServiceDesk, indicating the case number and providing the Excel file that you are trying to upload.

Will the new category be added to the relevant RMS list (100000072052)?<br> Currently the Marketing Status RMS list includes only:&nbsp; <ul> <li>Not marketed</li> <li>Marketed</li> <li>No data provided</li> <li>Temporarily unavailable</li> </ul> Thanks.<br> Kind Regards, Roberta

The Marketing Status 'Never marketed' is part of the list and visible when doing a submission. If you experience any difficulties, please contact EMA ServiceDesk.