Food and Drug Regulations
C.01.014.2 (1) Subject to subsection (2), if a manufacturer has provided all the information and material 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 Minister shall issue to the manufacturer a document that
(a) sets out
(i) the drug identification number assigned for the drug, preceded by the abbreviation “DIN”, or
(ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Minister for the drug, each of which pertains to one of the brand names and is preceded by the abbreviation “DIN”; and
(b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).
(2) The Minister may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the 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 its sale would cause injury to the health of the purchaser or consumer or would be a contravention of the Act or these Regulations.
(3) If the Minister refuses to issue the document under subsection (2), the manufacturer may submit additional information or material and request the Minister to reconsider his or her decision.
(4) On the basis of the additional information or material submitted under subsection (3), the Minister 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
- SOR/2017-259, s. 5
- SOR/2018-69, ss. 16, 27, 37
- Date modified: