Posted Fri, 02 Oct 2020 14:05:18 GMT by Laurent Desqueper Mr
We are looking at the best way to organize ourselves within our company, especially with the number of sites we have in Europe. 
We would like to understand the impact of selecting an Organization or a Location on the outcome of the submission, either OD or SA (from business perspective). 
 
We would also like to understand the consequences of choosing an Organization or another, a Location or another, on the visibility of RPIs, ODs, SAs… If we start a submission for a given Organization and Location, does that limit the RPIs that can be assigned to that submission? Can we link the RPIs from all Organizations linked to our profile, or only the RPIs linked to the Organization/Location selected for the ongoing submission?
Posted Sun, 04 Oct 2020 07:46:41 GMT by Paolo Tomasi EMA
In answer to your question, indeed the location chosen at the start of a submission does limit the RPI or the Regulatory Entitlement (e,g. Orphan designation, previous Letter of Advice): only an RPI or a Regulatory Entitlement which is owned by that location can then be chosen for the submission. However, an user affiliated to an Organization can choose any location for a submission. 
It is therefore recommended to have all RPIs and all Regulatory entitlements of an Organization assigned to a single location (normally the legal seat/address of the Organization) to simplify the management of submissions. Both transfers can be done in the IRIS portal, and for RPI transfers the procedure is automatic (it does not require EMA approval). 

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