Sponsors can request to change their name or address listed in the orphan designation without transferring the designation, provided that the sponsor remains the same person or legal entity.

This excludes changing the address to another country, which requires a transfer application.

Submitting a request to change the name or address

Sponsors need to use EMA's IRIS platform to request changes to their name or address. The European Medicines Agency (EMA) is not able to process any requests outside of IRIS.

Guidance on using IRIS is available:

Sponsors can only request to change their name or address using the process below after the European Commission has granted the orphan designation.

If they need to request a change during the validation or evaluation process, they should contact EMA's Orphan Medicines Office instead via the IRIS platform.

Before submitting the request in IRIS, the sponsor should update their organisation details using the ‘change request’ functionality on the Organisations Management Service (OMS) interface on EMA's substances, products, organisations and referentials (SPOR) portal.

They should follow the guidance entitled 'E-OMS change request', which is available on the SPOR OMS interface (under 'Documents').

Sponsors that are individuals should update their details in the EMA's Account Management portal instead.

Once the sponsor has updated their records in OMS, they should submit a 'Change of name and address' application via the IRIS platform. 

EMA informs the European Commission about the sponsor’s application so that it can update the Union Register. Once the register is updated, the sponsor receives a confirmation from the European Commission. 

EMA updates the sponsor’s details on the EMA website. 

If the sponsor needs to update the telephone number or email address on the EMA website (under 'Sponsor's contact details'), they should contact the EMA Service Desk and provide the updated details. 

Updating the contact person

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 organisation via the 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.

On occasions a previous or ongoing submission created by a user who then left the company, without any other contact associated to that application can be re-assigned by a user with the ‘IRIS Industry Co-ordinator’ role. Users with this role will be able to see the submission, add themselves or any other users affiliated to the same organisation as a manager for that submission, and finally change the submission contact of the procedure, the person who receives all the emails. IRIS guide to registration and RPIs includes details all of different access roles mentioned above.

The IRIS platform also allows industry users to change the contact person assigned to a regulatory entitlement (e.g. orphan designation) by editing the regulatory entitlement record directly in the portal. The record includes fields for: 

  • ‘contact person for entitlement’ (who must have an IRIS role and affiliation to the sponsor);
  • ‘contact email for general public enquiries’ (any email is acceptable);
  • ‘contact phone number for general public enquiries’ (any phone number is acceptable. Please provide a full format, including country code). 

All these fields are editable in the ‘My Individual RE’ and 'My Organization RE' tabs in the IRIS platform.

For more information about EMA accounts and affiliation, see the Quick interactive guide to IRIS registration process or contact EMA Service desk.

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