Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2016-04-03 and last amended on 2016-02-09. Previous Versions

 A licensed dealer is authorized to have a restricted drug in his possession for the purpose of exporting the restricted drug from Canada if he has obtained the restricted drug pursuant to these Regulations.

  • SOR/97-515, s. 5.

 The Minister may, upon application therefor, after such investigation as he deems proper and subject to such terms and conditions as he deems proper, issue to any licensed dealer a permit for the importation or exportation of a restricted drug.

 An application for a permit shall be in a form approved by the Minister.

  •  (1) To apply for a dealer’s licence, a person shall submit an application to the Minister containing

    • (a) if the licence is sought for

      • (i) an individual, the individual’s name,

      • (ii) a corporation, the corporation’s name and any other name registered with a province, under which it intends to carry out the activities specified in its dealer’s licence or intends to identify itself; and

      • (iii) the holder of a position mentioned in paragraph J.01.003.1(c), the applicant’s name and the title of the position;

    • (b) the address, telephone number and, if applicable, the facsimile transmission number and e-mail address for the premises to which the dealer’s licence would apply and, if different, the mailing address for the premises;

    • (c) the name, date of birth and gender of the individual in charge of the premises;

    • (d) with respect to the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge,

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

      • (ii) their academic qualifications, training and work experience relevant to their duties,

      • (iii) their hours of work, at the premises,

      • (iv) their title at the premises,

      • (v) the name and title of their immediate supervisor at the premises, 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;

    • (e) the name and gender of the individuals authorized to place an order for a restricted drug on behalf of the applicant;

    • (f) the activities referred to in section J.01.003 for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;

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

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

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

      • (iii) the strength per unit of the restricted drug 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 the other licensed dealer;

    • (h) if the licence is sought to produce a restricted drug other than a product or compound that contains a restricted drug

      • (i) the restricted drug to be produced,

      • (ii) the quantity 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 restricted drug would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other licensed dealer;

    • (i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive;

    • (j) a detailed description of the method that the applicant proposes to use for recording their restricted drug transactions; and

    • (k) for any activity referred to in section J.01.003, other than the activities described in paragraphs (g) and h), the restricted drug and the purpose for carrying out the activity.

  • (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) be accompanied by 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 their knowledge, and

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

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

    • (a) declarations signed by the individual in charge of the premises to which the application applies, the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge, stating that they have not been convicted, as an adult, within the preceding 10 years of

      • (i) a designated drug offence,

      • (ii) a designated criminal offence, or

      • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

    • (b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years of a designated drug offence or a designated criminal offence;

    • (c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada;

    • (d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the proposed qualified person in charge and, if applicable, the alternate proposed qualified person in charge have the knowledge and experience required under paragraph J.01.003.2(2)(a);

    • (e) if the proposed qualified person in charge or, if applicable, the alternate proposed qualified person in charge is not a pharmacist or a practitioner registered with a provincial professional licensing authority, a copy of the person’s degree required under paragraph J.01.003.2(2)(b) and a copy of the course transcript for that degree;

    • (f) if the applicant’s name appears on the label of a product or compound that contains a restricted drug, a copy of the inner label, as defined in section A.01.010, 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 are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer’s licence or intends to identify itself.

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

    • (a) allow for the recording of restricted drug transactions in accordance with section J.01.021; and

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

  • (5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing

  • SOR/2004-238, s. 33;
  • SOR/2010-222, s. 25;
  • SOR/2014-260, ss. 9, 16(F).
 
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