Orphan designation: marketing authorisation

The European Medicines Agency (EMA) is responsible for the scientific evaluation of marketing authorisation applications for all orphan medicines in the European Economic Area (EEA), as they fall under the mandatory scope of the centralised procedure.

• Applying for marketing authorisation: orphan medicines

In other sections

Sponsors of designated orphan medicines at the marketing authorisation stage should also consider the regulatory information in the sections below:

• Centralised procedure
• Conditional marketing authorisation
• Orphan incentives
• Activities after orphan designation
• Submitting annual reports on medicine development
• Changing the name or address of a sponsor
• Transfering a designation to a new sponsor
• Applying for orphan designation
• Paediatric investigation plan compliance verification
• Market exclusivity