Posted Mon, 07 Dec 2020 10:16:15 GMT by Petra Bettendorf Dr.
Dear colleagues,
we would like to apply for a follow up Scientific advice. The previous SA meeting was held in 2018 and we need to refer to this Scientic advice in the application form in IRIS. However, it is not possible to enter the previous SA procedure number as it is not given in the drop down menue. As this field is a mandatory field which needs to be completed, I would like to ask you how we can refer to  a previous SA procedure, if the procedure number is not provided in the drop down list. Do we have to apply to include this in the drop down list? If yes, could you please provide me some guidance?
Thanks and kind regards,
Petra Bettendorf 
Posted Tue, 08 Dec 2020 08:52:34 GMT by Paolo Tomasi EMA
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. 
Posted Mon, 14 Dec 2020 11:20:23 GMT by Petra Bettendorf Dr.
Dear Mr. Tomasi,
thanks for your explanations. However, the Scientific advice was performed at the EMA in 2018, so no other organisation was involved and regulatory entitlement is within EMA. I have already send a Service Desk ticket last week, but unfortunately did not receive any feedback.  Any support from your end is highly appreciated.

Thanks in advance for your kind support.
Petra Bettendorf
Posted Tue, 15 Dec 2020 08:11:21 GMT by Paolo Tomasi EMA
Dear Ms Bettendorf, I have checked the ServiceDesk ticket and you were contacted 3 days ago with additional information, which I have now supplemented. 

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