Food and Drug Regulations

C.01.014.1 (1) A manufacturer of a drug, a person authorized by a manufacturer or, in the case of a drug to be imported into Canada, the importer of the drug may make an application for a drug identification number for that drug.

(2) An application under subsection (1) shall be made to the Director in writing and shall set out the following information:

• (a) the name of the manufacturer of the drug as it will appear on the label;

• (b) the pharmaceutical form in which the drug is to be sold;

• (c) in the case of any drug other than a drug described in paragraph (d), the recommended route of administration;

• (d) in the case of a drug for disinfection in premises, the types of premises for which its use is recommended;

• (e) a quantitative list of the medicinal ingredients contained in the drug by their proper names or, if they have no proper names, by their common names;

• (f) the brand name under which the drug is to be sold;

• (g) whether the drug is for human use, veterinary use or disinfection in premises;

• (h) the name and quantity of each colouring ingredient that is not a medicinal ingredient;

• (i) the use or purpose for which the drug is recommended;

• (j) the recommended dosage of the drug;

• (k) the address of the manufacturer referred to in paragraph (a) and, where the address is outside the country, the name and address of the importer of the drug;

• (l) the name and address of any individual, firm, partnership or corporation, other than the names and addresses referred to in paragraphs (a) and (k), that will appear on the label of the drug;

• (m) the written text of all labels and package inserts to be used in connection with the drug and of any further prescribing information stated to be available on request; and

• (n) the name and position of the person who signed the application and the date of signature.

(3) In the case of a new drug, a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission filed under section C.08.002, C.08.002.01 or C.08.002.1 shall be regarded as an application for a drug identification number.