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RE: Data is not available in the Downloaded excel from IRIS for bulk upload
<strong>Dear Sailaja Bodapati, for specific issues regarding a submission, you should create a ServiceDesk ticket rather than a post in the Forum, as it may be necessary to share confidential information. Everything published in this Forum, including your attached Excel file, is in the public domain. In addition, for questions or discussion in the Forum, please use the specific Forum for that, <a href="https://iris.ema.europa.eu/forums/general-discussion">General Discussion and self-help · IRIS (europa.eu)</a>, rather than this Forum which is dedicated for EMA communication on new features or other notices. </strong> -
RE: Automatic deletion of inactive submissions
Yes, that is correct and it is by design: once a draft submission is actually submitted, it cannot be deleted by a user, even if it returns to a draft status (because of errors, or because EMA staff has reopened it, as occurs in other procedures). These submissions have become associated to a case and cannot be deleted directly by the user. -
RE: Portal error while trying to make a submission
<strong>Technical issues with single submissions should be submitted as a <a href="https://servicedesk.ema.europa.eu/">Servicedesk </a>ticket (incident), providing as much information as possible and relevant screenshots. </strong> -
RE: Receiving a validation error that is not actually an error
<strong>Technical issues with single submissions should be submitted as a <a href="https://servicedesk.ema.europa.eu/">Servicedesk </a>ticket (incident), providing as much information as possible and relevant screenshots. </strong> -
RE: Automatic deletion of inactive submissions
<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. </strong> -
RE: Automatic deletion of inactive submissions
<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No, at present completed submissions, i.e. those that were successfully submitted and then received an outcome or were withdrawn, are retained indefinitely.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. </strong>
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RE: Medicine profile - what is the difference between Therapeutic & Therapeutic medecines
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.
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A video on how to prepare a submission for an orphan designation has been published
A video on how to prepare a submission for an orphan designation has been published here: Additional guidance · IRIS (europa.eu) -
RE: What is the importance of Managers and Contributors while making a submission
<strong>This is detailed in the <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. </strong> -
RE: Questions and answers on Marketing Status reporting submissions
<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.