Posted Mon, 30 May 2022 15:41:48 GMT by Gemma Swaisland
When a change of MA Holder for a product has been affected, are the RPIs, products and marketing status etc. automatically transferred and visible in the new organisation's IRIS account or do they need to be transferred over using the RPI process detailed in the 'guide to registration'?
Posted Tue, 31 May 2022 08:05:56 GMT by Paolo Tomasi EMA
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. 

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