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.
Rare diseases
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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
- Transferring 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