SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
An individual, company, institution or organisation that takes responsibility for the initiation, management or financing of a clinical trial. If an outside party participates in the trial only by financing it, the investigator and the sponsor can agree between themselves that the investigator is also the sponsor. The investigator himself is regarded as the sponsor in the case of trials where there is no outside sponsor. (pursuant to Section 2 of Regulation 2/2012)
Sponsorship mandatory
Yes
Sponsorship mandatory - Additional information
Each clinical trial on a medicinal product must have a sponsor (or a legal representative in the EU).
Legal representative based in the EU/EEA is mandatory where Sponsor is located outside EU/EEA:
Yes
