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.