(1) A person shall not —
(a) start a clinical trial or cause a clinical trial to be started;
(b) conduct a clinical trial;
(c) recruit an individual to be a subject in a clinical trial; or
(d) issue an advertisement for the purpose of recruiting individuals to be subjects in a clinical trial,
unless that person receives a favourable opinion from the Ethics Committee and an authorization from the National Competent Authority under this Act.
(2) A person who contravenes subsection (1) commits an offence and is liable on summary conviction to a fine not exceeding $10,000 or to imprisonment for a period not exceeding 2 years or to both fine and imprisonment.