Marketing Status Notification

Please do not include product specific information in the Forum, since this is public domain. For any questions related to a specific product/case please contact EMA Service Desk. Please notice that in the context of the baseline, the marketing status should be submitted for all presentations in all Member States. If a product/presentation has never been on the market in a particular MS, please submit the status as Never marketed. If it's been in the market and removed later on, then the status needs to be reported in 2 steps. First the presentation should be reported as Marketed with the date of initial placing in the market for each MS as Date of marketing status change. Once this is completed, the presentation should be reported as Not marketed and the Date of marketing status change, Reason for cessation and Does cessation leads to shortages should be populated. The 2 step approach is to allow for the date of initial placing in the market to be visible in the report. Please review the links below for more information: <ul role="list"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="1" data-font="Symbol" data-leveltext="" data-listid="29" role="listitem"> <a href="https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-applicants_en.pdf" rel="noreferrer noopener" target="_blank">IRIS guide to applicants (scientific applications)</a>  </li> </ul> <ul role="list"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="1" data-font="Symbol" data-leveltext="" data-listid="29" role="listitem"> <a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/notifying-change-marketing-status" rel="noreferrer noopener" target="_blank">Notifying a change of marketing status | European Medicines Agency (europa.eu)</a>  </li> </ul>