Posted Fri, 02 Oct 2020 14:07:18 GMT by Laurent Desqueper Mr
The main question is how to refer to an RPI from another company?

We can have a combination product that combines an RPI from one company and an RPI from another company. In the paper form, it was possible to encode the RPI reference that we received from the partner. How to proceed in IRIS as we cannot see the RPIs from the other companies (which is as expected) but cannot enter the reference as received from the partner? 
Posted Sun, 04 Oct 2020 07:55:38 GMT by Paolo Tomasi EMA
In this answer I assume that by "combination product" you are not referring to a "fixed dose combination product", since this last one would have a single RPI rather than two (RPIs are assigned for development products, substances are mastered in SMS). 
In IRIS, it is not possible to add an RPI assigned to another Organization (legal entity) to the submission data, even if the other Organization belongs to the same multinational group. This is to ensure the necessary confidentiality of the RPI data that are used and displayed in the submission.
  • In Orphan designations, only one product can be the subject of a procedure.
  • In a Scientific Advice submission, additional RPIs can be chosen but they must belong to the same Organization; additional products for a combination treatment, but belonging to a different Organization, can be mentioned and discussed in the Scientific Document that will be uploaded with the submission.
Posted Fri, 16 Oct 2020 12:56:11 GMT by Karl-Heinz Loebel
Not sure if this is of relevance here, but during Tuesday's EMA webinar on IRIS & Scientific Advice there was also a screen shown with the statement that "... if the new RPI is not being requested for a single medicinal product ... but for multiple products, .... the [RPI] request should be sent directly to the relevant EMA service (e.g. ... scientificadvice@ema.europa.eu ...)
 
Posted Mon, 19 Oct 2020 13:34:35 GMT by Paolo Tomasi EMA
RPIs that refer to multiple products are generally used only for ITF submissions. 

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