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 submit a signed letter (PDF) via the IRIS portal and to the EC at sante-pharmaceuticals-B5@ec.europa.eu, listing EU designation(s) numbers and clearly indicating the new name and/or address and a statement that the identity of the company remains the same. If the company's name has changed, the sponsor should attach a copy of the certificate of incorporation.
The Agency and the EC will update their records with the new information.
If you are a sponsor and you need to update the telephone number or email address on this website (under 'Sponsor's contact details'), please contact the EMA Service Desk and provide 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.
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.