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Benzodiazepines and Other Targeted Substances Regulations (SOR/2000-217)

Regulations are current to 2019-08-28 and last amended on 2018-10-17. Previous Versions

PART 1Licensed Dealers (continued)

Application for a Dealer’s Licence

Marginal note:Information and documents

  •  (1) To apply for a dealer’s licence, a person must submit the following information to the Minister;

    • (a) with respect to the applicant,

      • (i) their name or, if the applicant is a corporation, their corporate name and any other name registered with a province, under which the applicant will carry out the activities set out in its dealer’s licence or will identify itself,

      • (ii) the address, telephone number and, if applicable, the facsimile transmission number and e-mail address of the premises to which the dealer’s licence would apply, and

      • (iii) if different from the address of the premises referred to in subparagraph (ii), the applicant’s mailing address;

    • (b) the name, date of birth and gender of the individual in charge of the premises referred to in subparagraph (a)(ii);

    • (c) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises referred to in subparagraph (a)(ii),

      • (i) their name, date of birth and gender,

      • (ii) their academic qualifications, training and work experience relevant to the duties of the qualified person in charge or, if applicable, of the alternate qualified person in charge,

      • (iii) their hours of work,

        • (A) at the premises referred to in subparagraph (a)(ii), and

        • (B) at any other work location,

      • (iv) their title at each work location,

      • (v) the name and title of their immediate supervisor at each work location, and

      • (vi) in the case of a pharmacist or a practitioner, the name of the province in which the person’s current professional licence, certification or authorization was issued and the professional licence, certification or authorization number;

    • (d) a list of the names of the individuals authorized to place an order for a targeted substance on behalf of the applicant;

    • (e) the activities set out in subsection 15(1) for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;

    • (f) in the case of a product or compound that contains a targeted substance, but that is not a test kit, that would be made or assembled for or by the applicant, a list that sets out

      • (i) the brand name of each product or compound,

      • (ii) the specified name of the targeted substance in each product or compound,

      • (iii) the strength per unit of the targeted substance in each product or compound,

      • (iv) the quantity or package sizes of each product or compound, and

      • (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and dealer’s licence number of that other licensed dealer;

    • (g) if the licence is sought to produce a controlled substance included in Schedule 1,

      • (i) the specified name of the substance,

      • (ii) the quantity, other than a product or compound that contains a controlled substance that is included in Schedule 1, that the applicant expects to produce under the dealer’s licence and the period during which that quantity would be produced, and

      • (iii) if the substance would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of that other licensed dealer;

    • (h) a description of the security measures, as determined in accordance with the Security Directive, at the applicant’s premises referred to in subparagraph (a)(ii);

    • (i) a description of the method that the applicant proposes to use for recording their targeted substance transactions; and

    • (j) for any activity set out in subsection 15(1), other than the activities described in paragraphs (f) and (g), the specified name of the targeted substance and the purpose for carrying out the activity.

  • Marginal note:Statement by signatory

    (2) An application for a dealer’s licence must

    • (a) be signed by the individual in charge of the premises to which the licence would apply; and

    • (b) include a statement signed by the individual in charge indicating that

      • (i) all information and documents submitted in support of the application are correct and complete to the best of that individual’s knowledge, and

      • (ii) the individual in charge has the authority to bind the applicant.

  • Marginal note:Accompanying documents

    (3) An application for a dealer’s licence must be accompanied by

    • (a) a signed declaration from the individual in charge of the premises, a signed declaration from the qualified person in charge and, if applicable, a signed declaration from the alternate qualified person in charge, stating that they have not been convicted, as an adult, in the previous 10 years, of

      • (i) in Canada, a designated drug offence, and

      • (ii) in a country other than Canada, an offence that, if committed in Canada, would have constituted a designated drug offence;

    • (b) a document issued by a Canadian police force with respect to each of the following individuals, stating whether the person has or has not been convicted, as an adult, in the previous 10 years, of a designated drug offence:

      • (i) the individual in charge of the premises as set out in the application,

      • (ii) the qualified person in charge, and

      • (iii) if applicable, the alternate qualified person in charge;

    • (c) if the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has ordinarily resided in a country other than Canada in the previous 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted, as an adult, in the previous 10 years, of an offence that, if committed in Canada, would have constituted a designated drug offence;

    • (d) a statement, signed and dated by the individual in charge of the premises, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience set out in paragraph 19(2)(a);

    • (e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner of medicine, dentistry or veterinary medicine authorized or entitled to practise by a provincial professional licensing authority, a copy of the person’s degree referred to in subparagraph 19(2)(b)(ii);

    • (f) where the applicant’s name appears on the label of a product or compound that contains a targeted substance, a copy of the inner label, as defined in section A.01.010 of the Food and Drug Regulations, for each product or compound to which the licence would apply; and

    • (g) if the applicant is a corporation, a copy of

      • (i) the certificate of incorporation or other constituting instrument, and

      • (ii) any document filed with the province in which the premises to which the licence would apply is located that states its corporate name or any other name registered with the province, under which the applicant will carry out the activities set out in its dealer’s licence or will identify itself.

  • Marginal note:Recording Method

    (4) The method proposed by the applicant under paragraph (1)(i) must

    • (a) be capable of accounting for all targeted substances, including the strength of each targeted substance per unit in each product or compound and the number of doses in each container of a targeted substance, in the possession of the licensed dealer as required under section 35; and

    • (b) permit the Minister to audit the activities of the licensed dealer with respect to targeted substances.

  • SOR/2010-223, ss. 6, 42(E)
  • SOR/2012-230, s. 27
  • SOR/2014-260, ss. 31, 39(F)

Issuance of a Dealer’s Licence

Marginal note:Content of licence

 Subject to section 22, the Minister must, after examining the information and documents required under sections 11 and 20, issue a dealer’s licence that sets out the following particulars:

  • (a) the licence number;

  • (b) the name of the licensed dealer or, if the licensed dealer is a corporation, its corporate name;

  • (c) the activities that are permitted and, if the licence authorizes destruction, whether the licensed dealer may destroy targeted substances other than those that the licensed dealer produced, made, assembled, sold or provided;

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

  • (e) the targeted substance for which the activities are permitted;

  • (f) the security level and the applicable inventory limitation required at the premises referred to in paragraph (d);

  • (g) the date of issuance;

  • (h) the date of expiry;

  • (i) any conditions that are necessary to

    • (i) comply with an international obligation,

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

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

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

  • (k) in the case of the maker or assembler of a product or compound that contains a targeted substance, but that 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 brand name of each product or compound,

    • (iii) the specified name of the targeted substance in each product or compound,

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

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

  • SOR/2010-223, s. 43(F)
  • SOR/2014-260, s. 32
 
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