SSSponsor object

Sponsor - Definition available in national law

Yes

Sponsor - Definition (pursuant to national law)

Clinical trial sponsor is an individual or a legal entity that takes responsibility for
commencing, conducting, and/or financing a clinical trial (Art 2 Law on MP & MD 2010)
Clinical trial sponsor can be a manufacturer, legal or physical entity, who is responsible for the initiation, management, quality and financing of the clinical trial conduct. (Art 71 Law on MP & MD 2010)

Sponsorship mandatory

Yes

Co-Sponsor - Definition available in national law

No

Co-sponsorship allowed

No

Additional Information

Sponsor can transfer a part or all of its obligations in relation to clinical trials conduct to a contract research organization based in the Republic of Serbia, which is responsible for the activities the sponsor has transferred onto them, in the procedures for approval and conduct of clinical trials on the territory of the Republic of Serbia.

Sponsors who are not based in the Republic of Serbia can have a legal entity as a representative, or an agent based in the Republic of Serbia. (Art 71 Law on MP & MD 2010)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
Feedback