Posted Thu, 02 Nov 2023 14:53:28 GMT by Isha Arora Dr.

In the IRIS guide to registration and RPIs, section 5.4, it states the following:
''Every IRIS Industry Manager or Contributor affiliated to an Organisation can see all Regulatory Entitlements associated to the Organisation (such as Orphan Designations and Scientific Advice outcome).''
Where can we see all SA outcomes for an ORG ? can we also extract/download the list for SA?

Posted Mon, 06 Nov 2023 08:12:37 GMT by Paolo Tomasi EMA

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. 

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