SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
Trial Sponsor: an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of the the clinical trial (Art 2 Legislative Decree 211/2003)
Sponsorship mandatory
Yes
Co-Sponsor - Definition available in national law
No
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes
Additional Information
The sponsor or a legal representative must be established in the EU (pursuant to Section 20 Legislative Decree 211/2003).
