Posted Tue, 19 Jul 2022 08:39:27 GMT by Susanne Hense
The IRIS guide for applicants strongly recommends to use only one location for all IRIS submissions, RPIs and regulatory entitlements. 
We started with different locations for the same MAH in IRIS.
Now, we have transferred all RPIs to one location.
Unfortunately, in various submissions types still the different locations are used.
Can you please advise how to harmonise locations in IRIS?
 
Posted Tue, 19 Jul 2022 11:40:58 GMT by Paolo Tomasi EMA
When creating a new application in IRIS, the system does allow to choose among all the locations associated to the parent organisation (legal entity). However, it is recommended to use always the same location, ideally that where the legal seat of the organisation is situated. Unfortunately OMS, the master data system for organisations which is used by IRIS, does not specify which of the locations corresponds to the legal seat of the organisation, but this information should be available to applicants, of course.

Once a (draft) application is created, the location associated to the application cannot be changed in the IRIS Portal anymore, irrespective of the status of the submission (draft, ongoing or completed). However, all submissions are visible in the portal, regardless of the location chosen, to users that are affiliated to the parent organisation. 

It is however possible to transfer an RPI to a different location of the same organisation, or to any location of another organisation, via the specific submission in IRIS. In addition, it is possible to transfer a Scientific Advice "regulatory entitlement" (outcome) via a self-service, automated procedure in IRIS. Other types of regulatory entitlements, such as an Orphan Designation, can also be transferred via IRIS but as the procedure requires an EMA Opinion and an EC decision, the procedure cannot be automated.

Please note that when creating a new application on behalf of a given location, only RPIs and Regulatory Entitlements also assigned to the same location will be selectable for the submission; this is one of the reasons why it is advisable to use the same location (legal seat) consistently across all IRIS procedures for a given organisation.
Posted Tue, 19 Jul 2022 13:07:18 GMT by Susanne Hense
Thank you, Paolo, for this useful comments!
Kind regards, Susanne
Posted Tue, 26 Jul 2022 09:46:54 GMT by Susanne Hense
I understand that for SA and OD procedures I can use the submissions types "transfer".
But how can I harmonise the location of the MAH for Marketing Authorisations?
Is there a submission type available in IRIS that can be used for this purpose?
Kind regards, Susanne
Posted Tue, 26 Jul 2022 11:00:12 GMT by Paolo Tomasi EMA
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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