Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (c. 141)

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Article 2 U.K. Definitions

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.