Posted Mon, 20 Sep 2021 17:58:42 GMT by Alex Meldrum Mr
I have read the guidance on an RPI covering development of the same research product by different organisations but remain confused in the following scenario.

I have a manager role for company A.
Company A was developing the RPI "product" for indications 1 and 2 but has now transferred development of indication 2 to company B.
Company A will  require IRIS-related submissions for indication 1 (and maybe other programs) and Company B will require IRIS submissions for indication 2 (and other programs),
If I transfer the current RPI from Company A to B, this will restrict Company A from making future IRIS submissions. To avoid this should Company B obtain a new RPI? Is there another solution?

Thanks for your recommendations
 
Posted Tue, 21 Sep 2021 07:55:37 GMT by Paolo Tomasi EMA
An RPI can be transferred any number of times, to allow different organisations to create new submissions using that RPI. More details can be found in the IRIS guide to registration v2.6 (europa.eu) (last three pages, Transfer of RPIs).
Posted Thu, 02 Jun 2022 08:59:29 GMT by Peter Spychal
Thanks so much Alex for the thread and thank you Paolo for your reply. I currently have the same problem, unfortunately the suggested route of multiple transfers is not workable for my company and we would like multiple RPIs to be created on a per indication basis for practical reasons. Is this possible?
Posted Mon, 13 Jun 2022 08:42:09 GMT by Paolo Tomasi EMA
<strong>As the scope of the RPI is to allow tracking of a medicinal product development across all its lifecycle, EMA holds a single RPI for every development product, across all indications and even if the product is transferred/sold to another organisations, or if a submission is prepared by a different organisation (e.g. a consultant). It is the responsibility of the holder of the RPI to transfer it to another organisation, which can be done quickly and easily in IRIS - the operation is automated (no EMA validation or assessment) and the transfer is almost instantaneous. The RPI can then be transferred back, or to another organisation, any number of times - there is no limit.&nbsp;</strong>

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