# Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, Article 2: Definitions

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2000/141/article/2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2000-141/article-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.