Food and Drug Regulations

Marginal note:Application

• J.01.014 (1) A person who intends to conduct an activity referred to in section J.01.009 must obtain a dealer’s licence for each site at which they intend to conduct activities by submitting an application to the Minister that contains the following information:

  • (a) if the licence is requested by

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

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

    • (iii) the holder of a position mentioned in paragraph J.01.010(c), the applicant’s name and the title of the position;

  • (b) the municipal address, telephone number and, if applicable, the email address of the proposed site and, if different from the municipal address, its mailing address;

  • (c) the name, date of birth, telephone number and email address of the proposed senior person in charge;

  • (d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge,

    • (i) their name, date of birth, telephone number and email address,

    • (ii) the title of their position at the site,

    • (iii) the name and title of the position of their immediate supervisor at the site,

    • (iv) if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and

    • (v) their education, training and work experience that are relevant to their duties;

  • (e) the activities that are to be conducted and the restricted drugs in respect of which each of the activities is to be conducted;

  • (f) if the licence is requested to manufacture or assemble a product or compound that contains a restricted drug, other than a test kit, a list that includes, for each product or compound,

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

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

    • (iii) the strength per unit of the restricted drug in it, the number of units per package and the number of packages,

    • (iv) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and dealer’s licence number of the other licensed dealer, and

    • (v) if the applicant’s name appears on the label of the product or compound, a copy of the inner label;

  • (g) if the licence is requested in order to produce a restricted drug other than a product or compound that contains a restricted drug,

    • (i) the name of the restricted drug,

    • (ii) the quantity that the applicant expects to produce under their licence and the period during which that quantity would be produced, and

    • (iii) if it is to be produced for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer;

  • (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the restricted drug for which the activity is to be conducted and the purpose of the activity;

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

  • (j) a detailed description of the method for recording information that the applicant proposes to use for the purpose of section J.01.075.

• Marginal note:Documents

  (2) An application for a dealer’s licence must be accompanied by the following documents:

  • (a) 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 its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself;

  • (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section J.01.013;

  • (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph J.01.013(a)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii);

  • (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph J.01.013(b)(i) or received a sentence as specified in subparagraph J.01.013(b)(ii);

  • (e) declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs J.01.012(3)(c) and (d); and

  • (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph J.01.012(3)(b)(i), either

    • (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph J.01.012(3)(b)(ii) or (iii), or

    • (ii) a detailed description of the education, training and work experience that is required under paragraph J.01.012(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.

• Marginal note:Signature and attestation

  (3) The application must

  • (a) be signed and dated by the proposed senior person in charge; and

  • (b) include an attestation by that person that

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

    • (ii) they have the authority to bind the applicant.

• Marginal note:Additional information and documents

  (4) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.