The European Medicines Agency (EMA) is responsible for the scientific evaluation of marketing authorisation applications for all orphan medicines in the European Economic Area, as they fall under the mandatory scope of the centralised procedure.
In this section
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
- Changing the name or address of a sponsor
- Conditional marketing authorisation
- Orphan similarity
- Paediatric investigation plan compliance verification
- Review of maintenance of orphan designation
- Transfer of orphan designation
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