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.
United Kingdom's (UK) withdrawal from the European Union (EU)
EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the EEA. For more information, see UK's withdrawal from the EU.
In this section
In other sections
- 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