Paolo Tomasi EMA

As an Industry Coordinator, you should be able to change the submission contact for a GMP Inspection, and to add Managers/Contributors to it. If this is not the case, please submit a ServiceNow ticket here: IRIS – Report an issue - Employee Center (service-now.com). 

Q&A updated 07 November 2023

Scientific Advice regulatory entitlement (RE) records are different from other REs, in that they do not actually grant a legal entitlement to the holder unlike for example orphan designations, PIP or waiver decisions, or a Marketing Authorisation. Scientific Advice REs have been introduced only to allow appropriate management of requests for follow-up SA or follow-up  Protocol Assistance.

As such, the current list of regulatory entitlements does not include them, and it is not currently possible to filter them or download them in that view. It is possible to check SA/PA RE by creating a new request for follow-up advice, where the step for selection of the RE displays a searchable list of those REs. It is of course also possible, for Industry coordinators, to search and download all submissions for SA/PA in the Submissions tab, with an appropriate filter. If you would like to propose a change to the system, please raise an incident in ServiceNow detailing your requirements. 

The full list of Orphan designations (and amendments) is now available in IRIS, in the public section of the website (no need for a user account). The register is available in the Public registers and lists section of the IRIS website, and is directly accessible at this link: List of Opinions on Orphan Medicinal Product Designation. You can download the list to an Excel file; please note that the column "grounds for opinion" is only visible for individual records and is not downloadable. 

All PRIME submissions are now available in IRIS, to request PRIME designations, PRIME meetings, to withdraw or transfer a PRIME designation, and for periodic updates. The process is very similar to all other IRIS-based submissions, and it requires an RPI (Research Product Identifier). 

Please note that RPIs have no relationship with marketing status submissions. All "Authorisation Products" have a parent RPI, and multiple authorisation products may share the same RPI, for example in the case of duplicates, informed consent, orphan and non-orphan products containing the same active substance(s). 

Marketing status submissions must be done for an "Authorisation Product" which has a valid Marketing Authorisation, not for an RPI. 

Regarding transfers:

• an RPI can be transferred to another location of the same organisation, or to a different organisation, directly by the current RPI owner via an IRIS submission. The process is completely automated and is almost immediate.
• On the other hand, a transfer of MAH for an authorised product is a different procedure, requires a decision from the EC, and is not currently managed in IRIS. Once a transfer of MAH for an authorised product is completed, the new MAH is (manually) updated in IRIS as well. This may require a few days. If you suspect that this update has not been done in IRIS, please raise a ServiceNow incident. 

 

This is a bug in the system. An incident has been raised in the internal development database, Azure DevOps (n. 29838). 

Dear Beatriz Ugalde, your IRIS account is not affiliated to any organization. As such, it is expected that you cannot see any authorized product: the system only shows the products authorised to the organization(s) that you are affiliated to. Please request affiliation as detailed in the IRIS guide to registration, included in the IRIS guidance page: Home - news  · IRIS (europa.eu). 

Dear Stian Morch Aaen, in our records there is no request for affiliation to any organisation for your user role. Please consult the instructions provided in the IRIS guide to registration and request affiliation to your organisation(s) in the EMA Account Management System.

Of note, we see that you have a different email in your ServiceNow account than the one you used for the EMA Account Management System. This may lead to confusion when you ask for support, as these are effectively two different accounts.

Dear Mr Petric, please try again and see if you can see the submissions now. If not, please let us know here and raise a Servicedesk request. Please note that you only have the Coordinator role, but not that of Manager, which means that in any case you won't be able to create new submission, or send/withdraw existing one unless you request and obtain the Manager role as well.