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.

Update: From 19 September 2018, sponsors need to use EMA's IRIS system to submit all post-designation activies. EMA will not be able to process any submissions outside of IRIS. For information and guidance on using IRIS, please see Applying for orphan designation.

To request removal, the sponsor should:

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.

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