Posted Fri, 31 Jan 2025 14:45:03 GMT by Michael Moos
We have a product in development and had previous scientific advice. Now we have a question of purely regulatory question. According to EMA instructions on Scientific Advice, these purely regulatory questions should not be part of a scientific advice but users are asked to "use the ‘Submission Details’ field in your submission via the IRIS portal". I am not sure what this means. When I am creating a new draft submission, what should be entered at "Submission Type"? Were is the "Submission Details" field?
Thank you!
Posted Mon, 03 Feb 2025 10:07:32 GMT by Paolo Tomasi EMA
The "Submission details" section of a new application is also called "Submission notes" and is one of the tabs in the main page of the submission (see attached file). 

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