Food and Drug Regulations
J.01.033.2 The manufacturer of a test kit that contains a restricted drug may apply for a registration number therefor by submitting to the Director an application containing
(a) particulars of the design and construction of the test kit;
(b) a detailed description of the restricted 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.
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