S.L. 458.47 Art. 5Sponsors.

(1) A sponsor may delegate any or all of his trial-related functions to an individual, a company, an institution or an organisation:

Provided that in such cases, the sponsor shall remain responsible for ensuring that the conduct of the trials and the final data generated by those trials comply with Directive 2001/20/EC as well as Directive 2005/28/EC.

(2) The investigator and the sponsor may be the same person.