Procedural advice for orphan medicinal product designation

On 21 January 2020 EMA updated this guidance for sponsors.

The legislation on orphan medicinal products, Regulation (EC) No 141/2000 of the European Parliament and of the Council, was adopted on 16 December 1999 and published in the Official Journal of the European Communities on 22 January 2000 (Ref. L18/1). 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.

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