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RE: Organisation affiliation
Dear Alex Xuereb, your screenshot does display the affiliation in the EMA Account Management System, however this affiliation has not been propagated to IRIS due to a bug, unfortunately. Please submit a Servicedesk Request to have your account re-synced.
In general, if an affiliation is visible in the EMA Account Management System, but the organisation is not shown when attempting to create a new submission, this suggests that the propagation has failed. The re-sync can be obtained via a request to EMA Servicedesk. -
RE: When will MAHs become available for i-SPOC registration?
Dear Susanne Hense, please raise a ticket with Servicedesk. There may be additional problems, specific to your account - a re-sync may be needed. Meanwhile, please make sure that you request the "IRIS Industry Manager" affiliation in the EMA Account Management System, for all organisations on whose behalf you intend to create submissions. -
RE: When will MAHs become available for i-SPOC registration?
Dear Susanne Hense, I have checked your account and you have the IRIS Industry Manager role for only three organisations, and therefore when creating a new submission you will see only those three. You also have the IRIS Industry Coordinator role for many other organisations (>30), but that does not grant you the right to create new submissions on their behalf; it grants you only the possibility to see all existing submissions for those organisations, and add/remove participants (Managers or Contributors) to those existing submissions. We ackonwledge that, unfortunately, the currently published guidance is not clear on this aspect, and the revised version has not been published yet due to a mistake (but it will be soon).
To be able to create submissions for the companies where you already have only the affiliation as Industry Coordinator, you need to request also (or instead) the affiliation as Industry Manager to each of them. -
RE: IRIS doesnt display my Organisation
Please create a Servicedesk ticket for this type of access problems, as individual requests are necessary. -
RE: IRIS doesnt display my Organisation
Dear Vineet Bajaj, I can see in the system that for Pharmazz Europe Limited you have only the roles of Industry Coordinator and Industry Contributor, but not that of Industry Manager. The role of coordinator allows you to visualise submissions created by other users affiliated to the same organisation: for example, you should be able to see the draft submission EMA/SA/0000100668 already reated by your colleague in IRIS - please confirm if this is the case.
However, if you want to be able to create a new submission on behalf of an Organisation, you need to be affiliated to that Organisation with the role of Industry Manager, to be requested via the EMA Account Management system.
If the above comments do not help to solve your issue, please create a Servicedesk ticket. -
RE: IRIS doesnt display my Organisation
There has been a sync issue between IAM and IRIS that has caused the loss of the affiliation of some users to their organisation(s). We are aware of the issue and working on it. However, at least for two of you (Emna Clam and Vineet Bajaj) I do see an affiliation available in IRIS, can you please try again? -
RE: Linked Organization
Please consult the IRIS guidance, avalaible in this website (Home - news · IRIS (europa.eu)). If you have problems with a specific submission, please create a ticket in the EMA servicedesk site. -
RE: Add additional member or delegate role to employee
It is not clear what the desired function is, but in IRIS there is no concept of delegate or team member.
An organisation can have any number of affiliated users, who can create and manage submissions on behalf of the organisation. To be able to see a specific submission, an affiliated uer must be added to that submission as a manager or contributor. It is also possible for Industry Users, in the IRIS portal, to reassign the "Portal contact" role of a given submission (the person who receives all emails by default) to any other user who is already added to that particular submission.
For additional information, please check the IRIS guide to registration (chapters 5 and 6) and the IRIS guide for applicants (chapters 2.4, 2.5, 2.6) in the IRIS guidance page. -
RE: I can not register one of our IRIS managers as an iSPOC
The affiliation of users as IRIS Industry managers (or any other Industry role) is subject to the authorisation by the IRIS Industry Admin user of the relevant Organisation. EMA is not involved in granting new affiliations to organisations for users, as the authorisation process is managed by Industry. If a technical malfunction is suspected for a specific situation, please raise a ticket in the EMA Servicedesk, providing the name of the users involved and any relevant screenshot. -
RE: Harmonisation of locations used in IRIS
At present, it is not possible to transfer Regulatory Entitlement records of the type "Marketing Authorisation" via a submission in the IRIS portal. As the transfer of the Marketing Authorisation is agreed by the European Commission, similarly to the transfer of an Orphan designation, a specific procedure will be developed in the future, once also initial Marketing Authorisations and Variations/Extensions are onboarded to IRIS. However, if any misattributed records are identified, please submit a incident report via EMA Servicedesk, so that the Marketing authorisation record can be updated in the back end by EMA.
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