Food and Drugs Act ( R.S.C. , 1985, c. F-27)

PART I Foods, Drugs, Cosmetics and Devices (continued)

General (continued)

Marginal note: Prohibition — clinical trials

3.1 No person shall conduct a clinical trial in respect of a drug, device or prescribed food for a special dietary purpose unless the person holds an authorization issued under the regulations that authorizes the conduct of the clinical trial.

Marginal note: Terms and conditions — clinical trial authorizations

3.2 The holder of an authorization referred to in section 3.1 shall comply with any terms and conditions of the authorization that are imposed by the Minister under regulations made under paragraph 30(1)(b.3).

Marginal note: Duty to publicize clinical trial information

3.3 The holder of an authorization referred to in section 3.1 shall ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner.

Food

Marginal note: Prohibited sales of food