Food and Drug Regulations

G.06.002.2 The manufacturer of a test kit that contains a controlled drug may apply for a registration number therefor by submitting to the Minister an application containing

• (a) particulars of the design and construction of the test kit;

• (b) a detailed description of the controlled drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

• (c) a statement of the proposed use of the test kit; and

• (d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.