Paolo Tomasi EMA

<strong>IRIS will not remove ongoing submissions automatically, only those in draft status. I assume you are referring to Marketing Status submissions: it should be possible to withdraw them manually, using the menu on the rightmost column of the submissions table (this may require horizontal scrolling, possible from the bottom of the table). If you are unable to request withdrawal of a submission, please raise a servicedesk ticket.&nbsp;</strong>

<strong>No, at present completed submissions, i.e. those that were successfully submitted and then received an outcome or were withdrawn, are retained indefinitely. The only submissions that are deleted and removed are those remaining in "draft" status for more than 7 months without any edit of the data.&nbsp;</strong>

This is a small bug in IRIS. The list displayed in IRIS includes all hierarchical levels from SPOR (RMS), whereas it should only include terms in the bottom level. Only "therapeutic medicines" should be used.

A video on how to prepare a submission for an orphan designation has been published here: Additional guidance  · IRIS (europa.eu)

<strong>This is detailed in the&nbsp;<a href="https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration-rpis_en.pdf">IRIS guide to registration v2.3 (europa.eu)</a>, chapter 5.4.&nbsp;</strong>

<a href="https://iris.ema.europa.eu/public/e9393f08-878e-e911-a89e-000d3a265cb7/forum-posts" title="Robert Castelow-Sturges">Robert Castelow-Sturges</a>, there are currently 354 completed submissions for Marketing Status in IRIS. That said, we acknowledge that there are unfortunately a number of bugs in the functionalities for marketing status reporting, which we are currently addressing. Please bear with us while the issues are fixed. You are welcome to report general difficulties in the other Forum (General Discussion and self-help · IRIS (europa.eu)), as this thread is being closed. Also, for specific errors you can raise a <a href="https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals">Servicedesk </a>request.&nbsp;

sSwapna Bapatla please note that in the IRIS system I can see only one submission in your name, and it is marked as "Cancelled from Industry" (EMA/PA/0000081147).
As such, you won't receive further notifications.

A new versions of the IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (europa.eu) has been published in the Guidance and Support section of the IRIS website. It contains a new section on how Marketing Authorisation Holders can submit Annual statements and ad-hoc Signal management submissions. These procedures are now available in the IRIS website.

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.