Is it possible to have multiple different Orphan designation holders for the same combination of medicinal product - indication?
It is possible to have multiple different orphan designation holders for the same combination of medicinal product and indication. According to Article 2(4b) of Regulation No 847/2000 of the European Commission, more than one sponsor can obtain designation as an orphan medicinal product for the same medicinal product intended to prevent, treat, or diagnose the same disease or condition, provided that each sponsor submits a complete and separate application for designation.
In simpler terms, a product can have multiple orphan designations, and even for the same disease. It is important to note that the market exclusivity associated with an orphan designation only comes into effect once the product receives marketing authorization
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