Paolo Tomasi EMA

To all IRIS Industry applicants:
please note that once a draft submission is deleted from the system, either by the applicant or automatically by the system after 7 months of inactivity,  it is not possible to recover it in any way. The same applies to the files that were uploaded with it. This IRIS feature was included at the request of Industry representatives, who stressed the requirement for Industry to be able to remove definitively any draft data or documents, should the application not be submitted. It is of course always possible to create a new submission, at any time.
 

Dear Betina Berthelsen, this "followup" question is about a different issue altogether, and should be asked in a separate thread with an appropriate subject.

The IRIS system does not send notifications or reminders to solicit annual reports on orphan designations. According to Art. 5.10 of the Orphan Regulation, it is the responsibility of the Sponsor to provide an annual report on the state of the development of the designated product. More information can be found in the specific page on the EMA website: Submitting annual reports on medicine development. 

As a general rule, it is always advisable to nominate more than one manager for each submission in IRIS. In this way, the submission will still be visible, and the portal contact can be changed, even if the creator of the submission or one of the managers associated to it leaves the company, or is unavailable. 

In addition, a new role of "IRIS Industry Coordinator" will soon be introduced, and made available to be requested in the EMA Account Management System. Users affiliated to an Organisation with this role will be able to see all submissions for all locations of the Organisation, and will be able to assign new Managers (including themselves) to a submission, and to change the submission contact (a.k.a. portal contact, the person that receives IRIS communications by default). The role has just passed the User Acceptance Testing, and should be introduced in production soon. An announcement will be made in the "What's new" Forum, once a beta-test is completed in the production system.

<strong>As the scope of the RPI is to allow tracking of a medicinal product development across all its lifecycle, EMA holds a single RPI for every development product, across all indications and even if the product is transferred/sold to another organisations, or if a submission is prepared by a different organisation (e.g. a consultant). It is the responsibility of the holder of the RPI to transfer it to another organisation, which can be done quickly and easily in IRIS - the operation is automated (no EMA validation or assessment) and the transfer is almost instantaneous. The RPI can then be transferred back, or to another organisation, any number of times - there is no limit.&nbsp;</strong>

RPIs and authorisation products are different records, and the parent RPI of an "Authorisation Product" is not transferred automatically if the MA applicant / holder of the "Authorisation Product" changes. Conceptually, there are possible situations in which an RPI is parent to two or more Authorisation Products (e.g. orphan, non-orphan and generic, or duplicates/informed consent), and therefore the Authorisation Products may have different MA holders after a transfer. The current holder of the RPI can transfer the RPI quickly and automatically via the IRIS portal, and the transfer can be repeated any number of times.

The transferred Authorisation product will be, of course, visible to the new MA applicant / holder in IRIS after the transfer. 

Please note that the change of the MA holder in IRIS is currently done manually, which can occasionally lead to a temporary desynchronisation of the MA holder between the Packaged Medicinal Product (presentation) record and the Authorisation Product record. If this is noticed, please wait a few days before raising a ServiceNow ticket to inform EMA of the issue. 

<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,&nbsp;<a href="https://iris.ema.europa.eu/forums/general-discussion">General Discussion and self-help&nbsp;· IRIS (europa.eu)</a>, rather than this Forum which is dedicated for EMA communication on new features or other notices.&nbsp;</strong>

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. 

<strong>Technical issues with single submissions should be submitted as a&nbsp;<a href="https://servicedesk.ema.europa.eu/">Servicedesk&nbsp;</a>ticket (incident), providing as much information as possible and relevant screenshots.&nbsp;</strong>

<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.&nbsp;</strong>