Common EMEA/FDA Application for Orphan Medicinal Product Designation
The Sponsor of a medicinal product for human use may desire to seek orphan designation of its medicinal product for use to diagnose, treat, or prevent a rare disease or condition from the European Commission in accordance with Regulation (EC) No 141/2000 of 16 December 1999 and Commission Regulation (EC) No 847/2000, and from the United States Food and Drug Administration (FDA) in in accordance with section 526 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 360bb). In such case, the sponsor may apply for orphan designation of the same medicinal product for the same use in both jurisdictions by using this common application for for its submissions to the European Medicines Agency (EMEA) and FDA.
Please use the following link to access the Common EMEA/FDA Application for Orphan Medicinal Product Designation form/template.