Posted Tue, 20 Sep 2022 11:39:23 GMT by Pia Lorenzen Global Regulatory Lead
I have had one initial scientific advice (SA) and following this a "Follow-up SA". Both are completed. I now have a new SA related to same topic. Should it be made as a follow-up to the "Initial advice", or to the "Follow-up SA"?
Posted Sun, 25 Sep 2022 07:35:19 GMT by Paolo Tomasi EMA
It should be requested as a followup to the initial advice.
Posted Wed, 17 Jan 2024 10:55:24 GMT by Christopher Hatton Senior Regulatory Affairs Manager

On a related note: I would like to apply for a follow-up to our 2013 protocol assistance, however this advice from 2014 is not available (not viewable in drop-down menu) and the box remains grey and no option to add text. Therefore I cannot progress with the application, until this section it completed. I have made a specific request vial EMA Helpdesk, however it would be helpful for users to know what to do if previous advice is not viewable/or if possible to manually add previous advice.

Posted Thu, 18 Jan 2024 11:36:17 GMT by Christopher Hatton Senior Regulatory Affairs Manager
I've found an answer to my request above, due to a change in location (LOC) the previous protocol assistance/scientific advice is only available under the former company location but not the new one.

 
Posted Mon, 22 Jan 2024 12:40:15 GMT by Paolo Tomasi EMA
When creating a new submission in IRIS, on behalf of a specific Location of a parent Organization, the system will show RPIs and Regulatory entitlements belonging to that location. For follow-up Scientific Advice, this is described in page 22 of the IRIS Guidance for Applicants. For this reason, it is recommended that all RPIs and all REs belonging to an Organization are transferred to a single location, which should be the one matching the legal seat of the organisation. This simplifies the creation of new submissions in IRIS. 

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