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 Minister in writing and shall include the following information and material:

• (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) an indication of whether the drug is for human use or veterinary use;

• (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) in the case of a drug for veterinary use, the written text of every label to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug;

• (m.1) in the case of a drug for human use, mock-ups of every label to be used in connection with the drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug — and mock-ups of the drug’s packages;

• (n) the name and title of the person who signed the application and the date of signature; and

• (o) in the case of a drug for human use, an assessment as to whether there is a likelihood that the drug will be mistaken for any of the following products due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of any of those products:

  • (i) a drug in respect of which a drug identification number has been assigned,

  • (ii) a radiopharmaceutical, as defined in section C.03.201, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01, and

  • (iii) a kit, as defined in section C.03.205, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01.

(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.