Europe – Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation

Sponsors (holders of the OMP designations) are advised to provide to the European Medicines Agency the following supporting information with their application for the transfer of the sponsor, submitted online via the IRIS system1:

1. Proof that the new sponsor is established in the European Economic Area2 (EEA), e.g. a copy of a certificate of registration in the register of legal entities or a certificate of incorporation for organisations; a copy of a passport or ID card in case of an individual sponsor. The relevant documents should be uploaded with the application. For sponsor applying as ‘individual’ the passport/ID card documents will be deleted from the EMA systems immediately after validation of the application.

2. Translations of the name of the active ingredient and of the indication in the official languages of the Member States, using the specific form. The sponsors are advised to complete the relevant translations required as part of the online application form as follows…