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Food and Drug Regulations

Version of section C.01.014.2 from 2018-04-04 to 2018-06-12:

  •  (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 Minister 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 Minister 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 Minister 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 or she may refuse to issue the document referred to in subsection (1).

  • (3) Where the Minister, pursuant to subsection (2), refuses to issue the document, the applicant may submit additional information and request the Minister to reconsider his or her decision.

  • (4) On the basis of the additional information submitted pursuant to 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/2018-69, ss. 16, 27

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