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Food and Drug Regulations

Version of section J.01.007.2 from 2010-10-21 to 2014-11-06:


 Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under sections J.01.007 and J.01.007.1, issue a dealer’s licence that contains

  • (a) the licence number;

  • (b) the name of the holder of the licence or the title of the position they hold, as the case may be, or, if the holder is a corporation, its corporate name;

  • (c) a list of the activities that are permitted;

  • (d) the address of the premises at which the licensed dealer may carry on the permitted activities;

  • (e) the name of the restricted drug for which the activities are permitted;

  • (f) the security level at the premises, determined in accordance with the Security Directive;

  • (g) the effective date of the licence;

  • (h) the expiry date of the licence, which may not be later than three years after its effective date;

  • (i) any conditions to be met by the holder of the licence to

    • (i) ensure that an international obligation is respected,

    • (ii) provide the security level referred to in paragraph (f), or

    • (iii) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use;

  • (j) in the case of a producer of a restricted drug, the quantity of the restricted drug that may be produced under the licence and the period during which that quantity may be produced; and

  • (k) in the case of the maker or assembler of a product or compound that contains a restricted drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:

    • (i) the licence number,

    • (ii) the name, number or identifying mark, if any, of each product or compound,

    • (iii) the restricted drug in each product or compound,

    • (iv) the strength per unit of the restricted drug in each product or compound, and

    • (v) the quantity or package sizes of each product or compound.

  • SOR/2004-238, s. 33
  • SOR/2010-222, ss. 26, 35(F)

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