(1) Where a favourable opinion is provided to the chief investigator under section 10, the sponsor of the clinical trial may make an application for the authorization to conduct a clinical trial.
(2) An application under subsection (1) must —
(a) be in writing and signed by or on behalf of the sponsor; and
(b) be accompanied by —
(i) the particulars and documents specified in Schedule 3;
(ii) the prescribed fee.