Definitions
Article 2
For the purposes of this Regulation:
1. ‘medicinal product’ means a medicinal product for human use, as defined in Article 2 of Directive 65/65/EEC;
2. ‘orphan medicinal product’ means a medicinal product designated as such under the terms and conditions of this Regulation;
3. ‘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. ‘Agency’ means the European Agency for the Evaluation of Medicinal Products.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(f) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)