some conditions occur so infrequently that the cost of developing and bringing to the market a medicinal product to diagnose, prevent or treat the condition would not be recovered by the expected sales of the medicinal product; the pharmaceutical industry would be unwilling to develop the medicinal product under normal market conditions; these medicinal products are called "orphan"
For the purposes of this Regulation:
(a) "medicinal product" means a medicinal product for human use, as defined in Article 2 of Directive 65/65/EEC;
(b) "orphan medicinal product" means a medicinal product designated as such under the terms and conditions of this Regulation ...
