web
You’re offline. This is a read only version of the page.
close


Posted Mon, 23 Dec 2024 11:28:27 GMT by Costanza Vignoli
In case of a company (A) that performed some application submissions via IRIS portal on behalf of another company (B) and from January 2025 company A will no longer exist, how will the previous submissions be managed? Will company B be still able to see them?
Posted Tue, 31 Dec 2024 13:56:52 GMT by Paolo Tomasi EMA
The visibility of submission, product and regulatory entitlement records in the IRIS Industry portal is not by organisation, but by user and affiliation. So an employee of Company B who is also affiliated to the ceased Company A with an appropriate role (e.g., Coordinator) should be able to see the closed submissions of Company A.

As a general rule, however, records that are assigned to an organisation that does not exist anymore cannot be used to support new procedures, even if they are visible (which is not guaranteed). Of note, even some regulatory entitlements such as orphan designations cease to be valid if the holder has also ceased to exist and cannot be transferred to a new owner. 

it is therefore recommended to transfer all products (RPIs), marketing authorisations and other regulatory entitlements such as Paediatric Investigation Plans, Scientific Advice RE, and Orphan Designations, via the appropriate procedures, before terminating the operations of the closing company. 

You must be signed in to post in this forum.