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;
(c) "sponsor" means any legal or natural person, established in the Community, seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product;
(d) "Agency" means the European Agency for the Evaluation of Medicinal Products.