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!