Orphan designation: post-authorisation
The pages listed below are relevant for sponsors of medicines that have obtained orphan designation and are at the post-authorisation stage of the product lifecycle.
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 European Economic Area (EEA). For more information, see UK's withdrawal from the EU.
In this section
In other sections
Sponsors of designated orphan medicines at the post-authorisation stage should also consider the regulatory information in the sections below:
- Orphan incentives
- Activities after orphan designation
- Changing the name or address of a sponsor
- Transfering a designation to a new sponsor
- Removing an orphan designation
- Article 8(2) of Regulation (EC) No 141/2000: removal of market exclusivity on the basis that the product is sufficiently profitable not to justify its maintenance.
- Applying for orphan designation