SSSponsor object
Sponsor - Definition available in national law
Yes
Sponsor - Definition (pursuant to national law)
'the person, institution or company being responsible for the initiation, management and possibly financing of a clinical trial' (pursuant to Art 88 (2) Danish Medicines Act)
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 its legal representative must have a permanent address in an EU/EEA country (pursuant to section 88(7) Danish Medicines Act.