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.

Sponsors need to use EMA's IRIS platform to submit 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 submitting the request, the sponsor should update their organisation details within the ‘change request’ functionality in EMA's 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

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.

Update: To update only the sponsor's telephone number or email address appearing on the public summary of orphan designation on EMA's corporate website (under 'Sponsor's contact details'), sponsors should simply contact the EMA Service Desk providing the updated details. 

Updating the contact person in IRIS

The IRIS platform allows an applicant (with the role of “IRIS Industry Manager” for a submission) to change the contact person assigned to an ongoing case. This is the person who will receive all EMA communications, and needs to have an “IRIS Industry Manager” role for that submission. As an alternative, applicants may wish to set up an auto-forwarding rule on the email account of the contact person, so that IRIS emails are redirected to another recipient(s).

If an IRIS contact person, manager or contributor for any submission leaves their function or the organisation, an “IRIS Industry Admin” user should consider removing his/her affiliation to the OMS organisation in EMA's Account Management portal, otherwise the EMA account of that user will still be usable to modify applications on behalf of the affiliated organisation. 

For more information about EMA accounts and affiliation, see the IRIS Quick Guide to Registration or contact EMA Service desk

How useful was this page?

Add your rating