IRIS Marketing Status – Update on actions to address submission validation issues

This update is to communicate the Agency is working on further improving the submission process of Marketing Status reports for marketed CAPs through IRIS, as well as addressing the issue of the newly authorised products and product presentations not being visible on the portal. Part of the issues are linked to wrong format of the data in the uploaded Excel files. A set of improved validation rules are implemented on the content of the Excel file uploaded by MAHs in the section ‘Uploaded proposed marketing status’.
In relation to the reported issue of new products/product presentations, a new routine for data integration is expected to be deployed within the next couple of weeks.


Actions taken by EMA
Please find below a summary of steps taken recently by the Marketing Status team:

• A release of a major fix which is aimed to address most of the validation issues in the key columns of the file (Country, Marketing Status, Date of Marketing Status Change, Reason for Cessation, Estimated Date of Reintroduction, Does Cessation lead to Shortage?).
• Validation error email is sent when the data in the key columns of the file could not be validated.
• The required corrections are listed in ‘Upload proposed marketing status’ section of the submission form.
• Date format is set to the local date and time.
• Updated Q&A published on the IRIS Forum with more practical information.

Actions to be taken by MAHs
Please consult the updated Q&A available from the IRIS Forum (Questions and answers on Marketing Status reporting submissions · IRIS (europa.eu)) listing the actions which are expected to facilitate the submission process and avoid validation errors, as well as the steps to follow when receiving validation errors emails.
Currently the deadline for the baseline submissions remains 30 April 2022.

For any technical query related to a specific IRIS Marketing Status submission, please do not hesitate to contact the Agency through the EMA ServiceDesk Portal.

For more information follow the links below:

• IRIS guide to applicants (scientific applications)
• Notifying a change of marketing status | European Medicines Agency (europa.eu)

Hello,<br> <br> Many thanks for the communication, this is great news. I would like to confirm with you one thing that is still unclear to me: for the bulk submission of the baseline marketing status report for a product, can we now use any o the 3 values - Marketed, Not Marketed, Never Marketed -&nbsp; from the first upload or does the upload still need to be performed in 2 steps for ceased products (Not Marketed status) as it was previously suggested in the forum:&nbsp;<a href="https://iris.ema.europa.eu/forums/general-discussion/17212e1d-c990-ec11-826d-0003ff4ad026">Marketing status for presentations marketed in at least 1 EU Member State&nbsp;· IRIS (europa.eu)</a>?<br> <br> Many thanks in advance for the clarification!<br> &nbsp;

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.

Many thanks for the confirmation on the 2-step submission process for the baseline submission, all clear now on this topic!
All the best,
Irina

Hello,<br> <br> Please note the following: after receiving a validation error the submission was moved in my draft submissions folder. I have corrected the error and re-uploaded the corrected excel for the bulk re-submission. However the submission button is not active and I am not able to click on it (see how the mouse arrow looks like when trying to click on it in the attached photo).&nbsp;<br> <br> What to do?<br> <br> Best,<br> Irina<br> &nbsp;

Once the submission is invalidated, the case is closed. Therefore you need to make a new submission and upload the corrected file.

Hello.<br> <br> I have received a validation error for my submission via email. The submission is still sitting in 'ongoing submissions'&nbsp; and the marketing status is visible under 'view proposed marketing status' and appears to have uploaded without issue. Is it possible to view what exactly is the validation error?<br> <br> Thanks<br> Aoife

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.