30 No. of 2013] Medicines and Allied Substances 49. (1) A person shall not conduct a clinical trial involving a medicine or allied substance without a clinical trial certificate. Prohibition of conducting clinical trial without certificate Application for clinical trial certificate (2) A person who contravenes subsection (1) commits an offence and is liable, upon conviction, to a fine not exceeding three million penalty units or imprisonment for a period not exceeding five years, or to both. 50. (1) A person who intends to conduct a clinical trial shall apply to the Authority for a clinical trial certificate in the prescribed manner and form upon payment of the prescribed fee. (2) The Authority shall reject an application for a clinical trial certificate if— (a) the application does not meet the requirements of this Act; (b) the activity to be carried out contravenes any law in force; (c) the clinical trial certificate previously held by the applicant has been revoked by the Authority; (d) the applicant submits false information in relation to the requirements for the application; (e) the premises to be used for the clinical trials is not suitable for the intended purpose; or (f) there is some risk to the health or well-being of a participant and the potential benefit of the clinical trial does not significantly outweigh that risk. (3) The Authority shall, where it rejects an application under subsection (1), inform the applicant accordingly and give the reasons therefor. (4) The Minister may, on the recommendation of the Authority, by statutory instrument, provide for— (a) the criteria for the regulation of persons under subsection (1); (b) the procedure for applying for a clinical trial certificate and the grant, amendment, renewal, transfer and revocation of a clinical trial certificate; (c) the terms and conditions attaching to an application, grant, amendment, refusal, renewal, transfer or revocation of a clinical trial certificate; and (d) such other matters as are necessary or incidental to the effective regulation of clinical trials under this Part. 51. (1) The Authority shall, within ninety days of receipt of an application under section fifty, issue the applicant with a clinical