SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
Sponsor (pursuant to Art 2 (37a) of the Pharmaceutical Law 2001):
“A sponsor shall mean a natural person, a legal person or an organisational unit without legal personality, responsible for initiating, conducting and financing a clinical trial, with the registered office in the territory of one of the European Union Member States or European Free Trade Association (EFTA) Member States – parties to the Agreement on the European Economic Area, if the sponsor does not have its registered office in the territory of one of the European Economic Area Member States, it may act solely through its legal representative having its registered office in this territory”
Sponsorship mandatory
Yes
Co-Sponsor - Definition available in national law
No
Co-sponsorship allowed
No
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes