Orphan medicinal product is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. Applications for orphan designation are examined by the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP), using the network of experts that the Committee has built up. The evaluation process takes a maximum of 90 days from validation.
Please see your Orphan medicinal product download for more information.
SEQ can help you collect data on the prevalence of the condition being considered for orphan designation, research any existing authorised products in the EU Zone, make the case for medical plausibility, and review the evidence for significant benefit.