Virginia Rojo Guerra

<span lang="EN-GB" style="font-size:9.0pt"><span style="font-family:&quot;Verdana&quot;,sans-serif">The marketing status that needs to be reported in IRIS corresponds to the “placing on the market” which is defined in Chapter 1 of volume 2A of the Notice to Applicants as the date of release into the distribution chain i.e. out of the direct control of the&nbsp;<a href="https://www.ema.europa.eu/en/glossary/marketing-authorisation-holder" style="color:#0563c1; text-decoration:underline" target="_blank" title="The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States."><span style="text-decoration:none"><span style="text-underline:none">Marketing Authorisation Holder</span></span></a>. If the product is released for the Swiss market and later on imported in Liechtenstein, it does not need to be reported, since there is no obligation to report Imports in the Marketing Status portal, regardless if the import activity is done by the MAH or by another entity. Parallel imports are under the remit of National Competent Authorities. If the product is released for the Liechtenstein market (not an import), then it needs to be reported in IRIS.&nbsp;</span></span>

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.

In case of errors in columns F, G, H, I, J or K the IRIS submission form will refer you to the row with a mistake and an explanation of what needs to be corrected. For errors in other columns&nbsp;there will be no explanation in IRIS. Please review the data using the IRIS guide to applicants. If you are not able to find the mistake, please log a Service Desk ticket, attach the Excel file and a print screen of the error. Please notice that some cases are taking longer than usual to get closed due to system overload.

<font color="#000000" face="Calibri, sans-serif"><span style="font-size: 14.6667px;">For presentations that were marketed in the past and are no longer in the market, the status should be reported as Not marketed.&nbsp;</span></font><span style="font-size:11.0pt"><span style="font-family:&quot;Calibri&quot;,sans-serif">This should be done 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. If the presentation was never on the market in a particular MS, it should be reported as Never marketed for that particular country.</span></span><br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Please check also&nbsp;<a href="https://iris.ema.europa.eu/forums/whats-new/141d48a7-b31e-ec11-b76a-0003ff4a48b7" style="color:#0563c1; text-decoration:underline" title="Questions and answers on Marketing Status reporting submissions"><span style="font-size:10.5pt"><span style="background:#fbfbfb"><span style="color:#3366ff">Questions and answers on Marketing Status reporting submissions</span></span></span></a>&nbsp;and&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"><a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/notifying-change-marketing-status" style="color:#0563c1; text-decoration:underline"><span style="color:#3366ff">https://www.ema.europa.eu/en/human-regulatory/post-authorisation/notifying-change-marketing-status</span></a></span></span></span></span><br> &nbsp;

The answer will differ depending on what is meant by 'withdrawn' presentations. Presentations that have been removed from the Marketing Authorization via variation and are no longer valid should not be visible in IRIS. If they are, please raise a ticket with EMA HelpDesk to correct it. Presentations that are no longer in the market but are still valid in the MA will be visible in IRIS. In that case, if the presentation was marketed and removed from the market later on, the status should be reported as Not Marketed. This should be done 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. If the presentation was never on the market in a particular MS, it should be reported as Never marketed for that particular country.

You are correct. This information is only applicable to Human Medicines. Please disregard the message in case you only have Veterinary medicines.

Thank you for your question. For products that have ceased to be on the market, the reason for the 2 step approach is to be able to state the date of initial placing on the market. So still needs to be reported in 2 steps if a product was initially launched and ceased later on. This is only needed during the report of the baseline submission. For newly authorized products, the status Never marketed will be assigned by default. This is the same for bulk or single submissions.

Please report the initial launch using the usual email to report Marketing Status&nbsp;<a href="mailto:marketingstatus@ema.europa.eu">marketingstatus@ema.europa.eu</a>&nbsp;with the EMA Product Lead and the product mailbox in copy. This is enough for the CPP team.

The Marketing Status value Never marketed should be used for presentations that have never been on the market in that particular MS. In this case, the fields Date of marketing status change and Reason for cessation do not apply (since the product has never been on the market, it has never been launched on that particular MS). The fields can be left blank and this should not trigger a validation error.

The value Not marketed should only be used for presentations that have been on the market before (they were launched in the past in a particular MS) but have been removed from the market (i.e. withdrawal, temporary cessation) and are no longer marketed. In this case the fields Date of marketing status change and Reason for cessation are mandatory and should be reported.

Example:
Presentation 001 has never been launched in Austria. Marketing Status value should be reported as Never marketed in Austria. Date of marketing status change and reason for cessation should be left blank.
Presentation 002 was launched in France and later removed for commercial reasons. Marketing Status should be reported in 2 steps. An initial reporting as Marketed with the Date of marketing status change when it was initially launched in France and once that is reflected in the IRIS report (as date of initial placing on the market), then a second reporting as Not marketed with the Date of marketing status change when the product was removed from the market and Reason for cessation as Commercial reasons.

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.