Food and Drug Regulations

Marginal note:Issuance of registration number

J.01.007 On completion of the review of the application for a registration number, the Minister must issue a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that it contains

• (a) a restricted drug and an adulterating or denaturing agent that are combined in such a manner and in such a quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential; or

• (b) such small quantities or concentrations of any restricted drug as to have no significant drug abuse potential.