Orphan designation: marketing authorisation

  • Email
  • Help

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

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


How helpful is this page?

Average rating:

 Based on 48 ratings

Add your rating:

See all ratings
9 ratings
10 ratings
9 ratings
9 ratings
11 ratings

Tell us more

Related content