The pages listed below are relevant for sponsors of medicines that have obtained orphan designation and are at the post-authorisation (PA) stage of the product lifecycle.
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:
- Review of market exclusivity before initiation by a Member State of Article 8(2) of Regulation (EC) No 141/2000 on orphan medicinal products
- Transfer of orphan designation
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