For the purposes of this Regulation:

1. (a)

   ‘medicinal product’ means a medicinal product for human use, as defined in Article 2 of Directive 65/65/EEC;

2. (b)

   ‘orphan medicinal product’ means a medicinal product designated as such under the terms and conditions of this Regulation;

3. (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;

4. (d)

   ‘Agency’ means the European Agency for the Evaluation of Medicinal Products.