The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 6.0 of this document is available here.
New is the Question 2.5 and its respective answer:
Question: Can a sponsor established in a third country open a subsidiary or branch in a Member State in order to comply with the requirement of Directive 2001/20/EC that the sponsor or a legal representative of the sponsor must be established in the EU?
The answer is yes. Article 19 of Directive 2001/20/EC requires that the sponsor or a legal representative of the sponsor is established in the EU. This does not exclude the possibility that this establishment is a branch or subsidiary of a legal person having its principal seat outside the EU. This establishment could be the sponsor or act as legal representative of the sponsor established outside the EU.