You are here
Frequently Asked Questions (FAQ) - Topic-related Questions
Yes, but not in a separate template.
Yes, and as topic says: you should have granted the orphan drug designation at the time of stage 2 submission.
The topic says “based on clinical trials and/ or real world data”. Duration depends fully on your concept and approach.
I understand the topic PHC 12 in a way that it can be and/ or medical device, so I would say, the evaluators have decided accordingly.