The Clinical Trials Directive (2001/20/EC) requires that for all clinical drug trials in the EU a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area. The various member states have implemented this Directive into regulations that apply within each territory separately. Directive 2001/83/EC concerning medicinal products for human use re- quires that for a marketing authorization application the applicant must be established in the EU. The Orphan Drug Regulation (EC) No 141/2000 requires that the sponsor seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product must be established in the EU. The Medical Device Directive 93/42 EEC requires that for clinical trials involving medical devices a manufacturer or an authorized representative must be established in the EU. FGK Representative Service GmbH Heimeranstrasse 35 80339 Munich Germany T | +49 (0) 89 893 119-22 F | +49 (0) 89 893 119-20 www.fgk-rs.com info@fgk-rs.com