Paolo Tomasi EMA

The function is at present intended to support Orphan Designations only. The process will be expanded to allow self-management by Industry of the contact points for public enquiries regarding orphan designations, currently managed via the standard EMA website. While the process is being improved, sponsors of Orphan-designated medicinal products are welcome to update the data in the Industry portal. 

Name review requests are not processed in IRIS at present. Currently we are not planning to move this feature to IRIS in 2021. 

Your request for RPI has been approved yesterday. When a withdrawal is requested, the system automatically sends an acknowledgment, asking the applicant to inform us if this has been a mistake. In such cases, the procedure will not be closed but will be progressed normally in the system. 
 

Dear Ms Bettendorf, I have checked the ServiceDesk ticket and you were contacted 3 days ago with additional information, which I have now supplemented. 

This situation usually occurs when the Initial Scientific advice of reference (Regulatory Entitlement) was given to a different Organization (legal entity in a country, for example Initial advice given to ACME France, but now ACME Germany is requesting the follow up), or even to a different Location of the same organization (e.g. initial advice given to ACME France, Paris, but follow up being requested on behalf of ACME France, Lyon).  This is a general rule of IRIS: currently only Regulatory Entitlements and RPIs assigned to the same Location are visible when creating a submission on behalf of a specific location.

There are two workarounds for Scientific Advice:

1. If the initial Scientific Advice was granted to another Organization: the initial Organization can transfer the Scientific Advice Regulatory Entitlement to the new Organization. This is done in IRIS with a specific, automated process.
    
2. If the initial Scientific Advice was granted to another Location of the same Organization: c​​​​​​reate the submission on behalf of the same Location of the Initial Scientific Advice. (workaround 1 could also be applied here). 

Of note, we are working to remove the issues caused by the second situation, by making visible all Regulatory Entitlements (Orphan designations, Initial Scientific Advice letters, etc.) and RPIs associated to a given Organization, regardless of the Location, but this is not yet in production. 
If the workarounds above do not solve your issue, please send a ServiceDesk ticket with the specific details of the Scientific Advice procedure in question. 

It is likely that there is a problem with the permissions of your account. Please raise a Servicedesk ticket for this, providing the name of your account, and the organization on behalf of which you are attempting to create a submission. 

Your understanding is indeed correct!
 

• New process type: “Transfer Scientific Advice”. Owners of Scientific Advice Regulatory Entitlements (Letters of Advice) are now able to transfer them automatically to another owner, similarly to the RPI transfer process. Only scientific advice entitlements can be transferred with this new automated process, which is necessary when the applicant for a follow-up scientific advice or protocol assistance is not the same of the initial advice. No fee is charged.
• New process type: “Reassignment of notices for parallel distribution”. This new type of bulk change procedure is now available for Parallel Distribution. The procedure allows reassigning all notices for parallel distribution held by an applicant to a new owner, where as a result of a merger/acquisition the parallel distributor is dissolved, or the legal form has changed.  Applicants are invited to consult the updated FAQ and User guide for Parallel Distribution for more information. 
• Applicants have to add at least one therapeutic area (top level MedDRA term / SOC) when requesting a new RPI.
• The Regulatory Entitlements section in the Industry portal now shows the Entitlement Status (active, expired, withdrawn, etc.)

Your understanding is correct. A EMA user affiliated to an Organization can see all the RPIs "owned" by that organization, and all Regulatory Entitlements assigned to that Organization. This is necessary to allow the person to submit applications that require reference to an existing RPI or an existing Regulatory Entitlement belonging to that organization. 

It is not possible to grant selective access to RPIs "owned" by an organization. The only strategy in this case would be to transfer the RPI temporarily to Company B, which then would be the applicant and would receive the outcome of the procedure. Once the application is submitted, the RPI can be transferred back to Company A (or to a third company).

Multiple parallel procedures with same RPI, but from different applicants, should be possible in IRIS. 

RPI transfers can be performed by the current "owner" directly in IRIS, and the procedure is completely automated. 

If person X working for Company B, which does not "own" the RPI since Company A does, wants to create a submission for that RPI and be the portal contact for the submission, then person X can ask an IRIS Industry Manager role to Company A (owning the RPI). In this way, person X will be the portal contact, the RPI will remain assigned to Company A, and the outcome of the SA will be in the name of Company A.