SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
„any natural person or legal entity, unincorporated business entity initiating, leading or funding the clinical trial. The investigator and the sponsor may be the same entity“ (pursuant to Section 2(d) of Decree No 35/2005).
Sponsorship mandatory
Yes
Sponsorship mandatory - Additional information
It is mandatory to have a sponsor or a legal representative established in a state being a party to the EEA-agreement (pursuant to 12(1) Decree No 35/2005).
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
