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.
- SOR/81-248, s. 2;
- SOR/93-202, s. 4;
- SOR/98-423, s. 3;
- SOR/2011-88, s. 2.
C.01.014.2. (1) Subject to subsection (2), if a manufacturer or importer has provided all the information described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Director shall issue to the manufacturer or importer a document that
(a) sets out
(i) the drug identification number assigned for the drug, preceded by the letters “DIN”, or
(ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”; and
(b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).
(2) Where the Director believes on reasonable grounds that a product in respect of which an application referred to in section C.01.014.1 has been made
(a) is not a drug, or
(b) is a drug but that its sale would cause injury to the health of the consumer or purchaser or would be a violation of the Act or these Regulations,
he may refuse to issue the document referred to in subsection (1).
(3) Where the Director, pursuant to subsection (2), refuses to issue the document, the applicant may submit additional information and request the Director to reconsider his decision.
(4) On the basis of the additional information submitted pursuant to subsection (3), the Director shall reconsider the grounds on which the refusal to issue the document was made.
- SOR/81-248, s. 2;
- SOR/92-230, s. 1;
- SOR/98-423, s. 4;
- SOR/2011-88, s. 3.
- Date modified: