Changing the name or address of a sponsor

A change in the name and/or address of the existing sponsor for an orphan designation does not require a new legal act, provided that the sponsor remains the same person or legal entity.

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.

A change in the name and/or address should be used only after a designation has been granted by the European Commission.

To apply for the change, the orphan designation(s) holder should provide a signed letter (PDF) to the Agency via the IRIS system, and email a copy to the European Commission (sante-pharmaceuticals-B5@ec.europa.eu).

The Agency and the European Commission will update their records with the new information.

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