FGK Representative Service GmbH acts as a legal representative for pharmaceutical and biotechnology companies which have no subsidiary within the EU and which submit regulatory applications to the European authorities. The Clinical Trials Directive (2001/20/EC), implemented May 1, 2004, requires that a legal representative of the sponsor be established in the EU for all clinical trials conducted in the EU. This is why it is no longer possible for a company outside the EU to conduct a clinical study without an entity representing them in the EU. Directive 2001/83/EC requires that for a marketing authorization application in the EU the applicant has to be established in the EU. 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 from the EMEA must be established in the EU. www.fgk-rs.com FGK Clinical Research GmbH Heimeranstrasse 35 80339 Munich Germany T | +49 (0) 89 893 119-0 F | +49 (0) 89 893 119-20 www.fgk-cro.com info@fgk-cro.com