EMA: Procedure for orphan-medicinal-product designation: Guidance for sponsors.

This Regulation lays down a Community procedure for the designation of medicinal products as orphan medicinal products and provides incentives for the development and placing on the market of designated orphan medicinal products. The Regulation also establishes the Committee for Orphan Medicinal Products (COMP) within the EMA, which is responsible for examining applications for orphan medicinal product designation.