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 activities. 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 can be requested only after a designation has been granted by the European Commission.
Prior to the submission of the request the sponsor should update their organisation details within the ‘change request’ functionality in the Organisations Management Service (OMS) interface, in accordance with the published rules. Sponsors that are individuals will just need to update their details in the EMA's Account Management portal.
To apply for the change, the orphan designation(s) holder should provide a a signed letter to the Agency via the IRIS system, and email a copy to the European Commission (sante-pharmaceuticals-B5@ec.europa.eu).
Sponsors wishing to amend more than one designation should list all procedures in the letter and submit one single request.
The Agency and the European Commission will update their records with the new information.