Food and Drug Regulations

J.01.007.2 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 licensed dealer or the title of the position they hold, or, if the licensed dealer 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 licensed dealer 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.