Virginia Rojo Guerra

The date of 01/01/1900 was only to be used for the date of initial placing in the market for a presentation already in the market for which the company has no record on the date of initial placing in the market in a particular country. So, for old products for which there may be no records.

This date (01/01/1900) was not intended for an expected date of reintroduction, which cannot be in the past. The expected date of reintroduction should be provided to the best knowledge of the company at the date of reporting, accepting that this may change in the future if the circumstances change.

The date of marketing status change when moving from Marketed to Not market is the date of the last release into the distribution chain. Please review question 2 in Notifying a change of marketing status | European Medicines Agency (europa.eu)

The system does not change status automatically, since the situation may have changed from the initial reporting. Companies are required to submit the new status within 30 days of the reintroduction in the market. For more info, please review Notifying a change of marketing status | European Medicines Agency (europa.eu).

The Marketing Status in IRIS should only be reported for Centrally Authorised Product for Human use. National authorities from the individual member states may have specific requirements to report the Marketing status in their countries. National legislation should be followed for Nationally Authorized Products and those authorised with a Mutual Recognition Procedure (MRP), or a DeCentralised Procedure (DCP). 

If the Marketing Cessation has been notified via IRIS, there is no need to report the same information via email.

Presentations that have been removed from the Marketing Authorization via variation are cancelled in IRIS once the variation is approved. There is currently an issue with data integration between our systems that will be fixed soon, so there may be a delay in removing cancelled presentations from the IRIS view. No action is expected from your side if the presentation has been cancelled via the corresponding variation to the terms of the marketing authorization. The Withdrawal notification is only intended when the entire product is withdrawn.

Currently there is no expectation for double reporting. The Marketing Status is reported through IRIS just indicating if a shortage is expected yes/no, but the report of the shortage itself needs to be done as per current process. Changes to the shortage reporting process will be communicated to Industry in due time.

That is correct. Since imports are not required to be reported, the correct status would be Never marketed. That means that the Sunset clause provision may apply if the product is not considered Marketed in the European Union for a period of 3 years.

<span style="font-size:9.0pt"><span style="font-family:&quot;Verdana&quot;,sans-serif">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.<br> Please notice that in the context of the baseline, the marketing status should be submitted for all presentations in all Member States.<br> If a product/presentation has never been on the market in a particular MS, please submit the status as <strong>Never marketed</strong>.<br> If it's been in the market and removed later on, then the status needs to be reported in 2 steps. F</span></span><span lang="en-NL" style="font-size:9.0pt"><span style="font-family:&quot;Verdana&quot;,sans-serif">irst 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.<br> Please review the&nbsp;</span></span><span lang="EN-US" style="font-size:11.0pt"><span style="background:white"><span style="font-family:&quot;Calibri&quot;,sans-serif"><span style="color:black">links below for more information:</span></span></span></span> <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"> <p paraeid="{bdf396e5-0720-4adf-a2c8-644bcf5c26e7}{207}" paraid="1444404640"><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>&nbsp;</p> </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"> <p paraeid="{bdf396e5-0720-4adf-a2c8-644bcf5c26e7}{215}" paraid="742772762"><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>&nbsp;</p> </li> </ul>

Please do not post product specific information on the Forum, since this is a public domain. In case of product specific issues, please raise a ticket with EMA Service Desk indicating the case number and attaching the excel you are trying to upload. Similar cases that are left ongoing for extended periods of time were due to errors in the excel. Please review the excel together with the IRIS guide to ensure there are no errors, create a new case and resubmit. If the issue is not sorted, please contact the EMA Service Desk.