Orphan Designation
A status used for Marketing authorisation applications for designated orphan medicines.
The Orphan Designation status in Ennov InSight allows you to indicate if a product authorised in a jurisdiction is qualified to be treated as an orphan drug.
The following guidelines apply when using Orphan Designation in
Ennov InSight :
- The Application type must be Marketing Authorization Application (MAA).
- The Application country must belong to EMA.
- The Orphan Drug flag on the Application Attributes page is set to Yes.