Section 5: Clinical trials.

(1) No person shall, in the course of his business
(a) import or supply a drug, drug product, cosmetic or medical device; or
(b) procure the importation or supply of a drug, drug product, cosmetic or medical device; or
(c)
procure the manufacture or assembly of a drug, drug product, cosmetic or medical device,
for the purpose of a clinical test, unless he is a holder of a valid clinical trial, certificate and the trial is to be carried out in accordance with the terms of the certificate and the provisions of any regulation in force.
(2) Application for a clinical trial, certificate shall be made to the Agency in such from and manner as the Agency may prescribe by regulations.