Paolo Tomasi EMA

An RPI name is the concatenation of the preferred terms for each substance contained in the RPI, in alphabetical order. To change the name of an RPI it is necessary to update the name of the concerned substance(s) in SMS. You can update the name by providing the necessary information, including the substance ID, in this form: Request SMS services.
Once the substance name is updated in SMS, the RPI name will change automatically. If there is any ongoing case associated to the RPI, before the Opinion, the name of the product in the case will also change automatically, and this will be reflected in the Regulatory entitlement created or modified (if any). 

For a fixed-dose combination (FDC) product, the RPI should be asked in the normal way, in the IRIS portal, simply adding two or more SMS substances in the submission request. "Special RPIs" are not intended for FDCs, they are intended to model situations in which an applicant is requesting an ITF briefing meeting, scientific advice or biomarker qualification procedure in instances where the request is not for a single medicinal product (single substance or FDC), but rather for a methodology, technology, or (for ITF) an initial pipeline of multiple substances/products where it is not known yet which one will be developed. 

Apologies for the misunderstanding. I have asked the Servicedesk colleagues to have another look at your incident, with a view to forwarding it to the appropriate Department. 

Yes. A fixed dose combination product is a different product from any of its components. 

If you are able to create a draft submission for a specific Location of your organisation, and see the RPI, you should appear in the popup menu that allows the selection of a different contact. If this is not the case, please raise an incident in ServiceNow, providing details about the submission number of your draft and the RPI number. There have been a few instances where an Industry Manager was not affiliated to all locations of the same parent organisation, due to a bug. 

Your understanding is correct. The portal and the guidance will be updated to spell out the abbreviation, so that it is  clearer.

The IRIS portal can be used to upload documents into IRIS whenever a submission is "open for edit" or "open to upload". For post-authorisation submission, at present the initial upload of documents remains via the Gateway and Repository. 

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. 

Please note that questions from users should be submitted in the other Forum, General Discussion and self-help · IRIS. As detailed in this Forum description, the "What's New in IRIS" Forum is intended for the announcement of new features in IRIS and communication from EMA to applicants.

In reply to your request: at present, the contact person for an RPI can be changed only in the course of a new submission, such as a new Scientific Advice, Orphan designation or Paediatric procedure. The functionality to allow direct update on the RPI record is planned but not developed yet. While not mandatory, a workaround to change the RPI contact person is to create a "dummy" new draft submission of the above categories, update the RPI data in the specific tab (including the RPI contact person), and save the tab: this will push the new data to the RPI record. It is then possible to just delete the incomplete draft submission in the portal.

For problems and technical issues about IRIS, please create an incident ticket in EMA ServiceNow, attaching relevant screenshots for a faster response.