Food and Drug Regulations

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 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.