Removing an orphan designation
The sponsor of a designated orphan medicine can request removal of its orphan designation from the European Commission's Community register of orphan medicinal products at any time.
Sponsors need to use EMA's IRIS system to submit all post-designation activities. EMA will not be able to process any submissions outside of IRIS. including removal of an orphan designation from the EC register. For information and guidance on using IRIS, see the IRIS homepage.
To request removal, the sponsor should:
• prepare a letter requesting the removal of the orphan designation, signed by a person having the legal mandate to request a removal
• create and submit the removal request in the IRIS portal, selecting as submission type ‘Removal of an orphan designation from the EU register’. An electronic copy of the letter above should be included with the submission
It should be noted that prior to the submission via the online portal the sponsor should have acquired all IRIS access rights to complete the request.
Upon receiving the submission, EMA will forward the request to the European Commission, who will confirm the removal to the sponsor in due course.
The removal of an orphan designation from the Community register is irreversible.
Removal of an orphan designation is in accordance with Article 5(12) of the Orphan Regulation.
Once all of the orphan designations associated with an approved medicine have expired or been removed by the sponsor, the medicine ceases to be classified as an orphan medicine and no longer benefits from the orphan incentives.
Publication of removal
After removal of an orphan designation, the Agency will update its published information to reflect the fact that the orphan designation has been removed from the Community register at the request of the sponsor.
The European Commission will also update the Community register to reflect the removal of the designation.