Section 13: Grant of application

13. Grant of application (1) The Council may, after consideration of the opinion of the Ethics Committee, grant an application made under section 12 where it is satisfied that— (a) the measures to be taken for the health, welfare, safety and protection of subjects are adequate; (b) the anticipated benefits of the clinical trial outweigh its risks; (c) the insurance cover to be contracted for the protection of subjects is adequate; (d) the investigator is a suitably qualified person; (e) the site for the clinical trial is suitable; (f) the sponsor and the investigator will at all times comply with this Act and any regulations made under it; and (g) the clinical trial is to be conducted in compliance with the guidelines referred to in section 4 (f). (2) The Council may, when considering an application made under section 12, require the sponsor to furnish such additional information as may be necessary, within such time as it may determine. (3) On granting an application under subsection (1), the Council shall issue a trial licence to the sponsor on such terms and conditions as it thinks fit and on payment of the prescribed licence fee.