(1) A person shall not, in the course of a business carried on by

that person,

(a) sell, supply or donate a drug, herbal medicinal product, cosmetic or medical device for the purpose of a clinical trial, or

(b) procure, import, manufacture or assemble a drug, herbal medicinal product, cosmetic, medical device for sale or supply for the purpose of a clinical trial, unless that person is a holder of an approved valid certificate issued by the Authority.

(2) A person shall not conduct a clinical trial of a drug, herbal medicinal product, cosmetic, medical device or procedure without an approved valid certificate issued by the Authority.

(3) A person who desires to conduct a clinical trial of a medicine, herbal medicinal product, cosmetic, medical device or procedure shall submit to the Authority an application in the prescribed form duly signed and accompanied with

(a) the prescribed fee,

(b) an ethical clearance issued by an approved institute for medical research where applicable, and the relevant information as provided under the guidelines for conducting clinical trials, and

(c) an international registration number in respect of the product.

(4) Where a clinical trial is to be conducted in a hospital, veterinary institution or designated institution, the application referred to in subsection (3) shall be signed by the principal investigator for the trial.

(5) For the purposes of this section a designated institution includes a medical or veterinary institution or any other institution approved by the Authority.