Removal of an orphan designation

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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.

To request removal, the sponsor should:

  • prepare a letter requesting removal of the orphan designation, signed by a person having the legal mandate to request a removal;
  • send a PDF version of the letter to the European Commission at sante-pharmaceuticals-B5@ec.europa.eu, with the Orphan Medicines Office at the European Medicines Agency (orphandrugs@ema.europa.eu) copied into the email.

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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