Article 3
Criteria for designation 1. A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (a) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment; and (b) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition. 2. The Commission shall adopt the necessary provisions for implementing this Article in the form of an implementing Regulation in accordance with the procedure laid down in Article 72 of Council Regulation (EEC) No 2309/93(6).