Controlled Substances Regulations (SOR/2025-242)

Marginal note:Application

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  11 (1) An application to obtain a dealer’s licence must be submitted to the Minister and must contain

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    (a) if the licence is requested by

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

    • (ii) an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and

    • (iii) the holder of a position described in paragraph 7(2)(c), the applicant’s name and the title of the position;

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    (b) the municipal address, telephone number and, if applicable, the email address of the site specified in the licence application and, if different from the municipal address, its mailing address;

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

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    (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;

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    (e) the activities that are to be conducted and the controlled substance in respect of which each of the activities is to be conducted;

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    (f) if the licence is requested in order to produce or package a controlled substance set out in any of Schedules 1 to 4, for each substance,

    • (i) its name, its CAS registry number, if any, as well as its form, the quantity that the applicant intends to produce under the licence and the period during which that quantity would be produced, and

    • (ii) if it is to be produced or packaged for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer;

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    (g) if the licence is requested to produce or package a mixture or finished product, for each mixture or finished product,

    • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

    • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container,

    • (iii) its drug identification number, if any,

    • (iv) if it is to be produced or packaged by or for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer, and

    • (v) if the applicant’s name appears on any label, as defined in section 2 of the Food and Drugs Act, of the finished product, a copy of that label;

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

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

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    (j) a detailed description of the method of recording information that the applicant proposes to use for the purposes of section 86.

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  Marginal note:Documents

  (2) The application must be accompanied by the following documents:

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    (a) if the applicant is an organization, a copy of

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

    • (ii) any document filed with the province in which its site is located that states the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and

    • (iii) the permit or licence that is issued by the municipality in which its site is located that authorizes the business to operate, if applicable;

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    (b) individual declarations, signed and dated by each of the proposed senior person in charge, the qualified person in charge and any proposed alternate qualified person in charge, attesting that the signatory is not ineligible for a reason specified in section 10;

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    (c) a document issued by a Canadian police force or by a business that is accredited by the Royal Canadian Mounted Police 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 10(1)(a)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii);

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    (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 10(1)(b)(i) or received a sentence as specified in subparagraph 10(1)(b)(ii);

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    (e) a declaration, signed and dated by the proposed senior person in charge, attesting that they have the knowledge required under subsection 8(2) and that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 9(3)(c) and (d);

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    (f) with respect to the proposed qualified person in charge or any proposed alternate qualified person in charge, a copy of their diploma, certificate or credential referred to in paragraph 9(3)(b) and, if applicable, the equivalency assessment referred to in subparagraph 9(3)(b)(ii); and

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    (g) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement set out in paragraph 9(3)(b), a detailed description of the education, training and work experience that is required under paragraph 9(4)(c), together with supporting documents, such as a copy of a course transcript or an attestation by the person who provided the training.

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  Marginal note:Signature and attestation

  (3) The application must

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

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    (b) include an attestation by that person that

    • (i) all of the 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.

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  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.

Marginal note:Issuance

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  12 (1) Subject to section 14, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains

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    (a) the licence number;

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    (b) if the licensed dealer is an individual, their name and, if applicable, title, or if the licensed dealer is an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence;

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    (c) the specified activities and, for each activity, the name of the controlled substance that is set out in any of Schedules 1 to 4 or that is contained in a mixture or finished product;

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    (d) the municipal address of the site at which the activity is to be conducted;

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    (e) the security level at the site, determined in accordance with the Security Directive;

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    (f) the effective date of the licence;

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    (g) the expiry date of the licence, which must not be later than three years after its effective date;

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    (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

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

    • (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or

    • (iii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use; and

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    (i) if the licensed dealer produces a controlled substance that is set out in any of Schedules 1 to 4, the quantity that the licensed dealer may produce and the production period.

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  Marginal note:Licence integrity

  (2) A person must not alter or deface in any manner a dealer’s licence.

Marginal note:Validity

13 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 32 or 33.

Marginal note:Refusal

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  14 (1) The Minister must refuse to issue a dealer’s licence if

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    (a) the applicant does not meet the requirement set out in subsection 7(2);

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    (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened

    • (i) a provision of the Act, the Cannabis Act or their regulations, or

    • (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;

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    (c) during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);

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    (d) an activity for which the licence is requested would contravene an international obligation;

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    (e) in the case of a narcotic, an activity for which the licence is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;

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    (f) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

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    (g) the method referred to in paragraph 11(1)(j) does not permit the recording of information as required under section 86;

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    (h) the applicant has not provided the Minister with the information or documents required under subsection 11(4) or before the date specified in the written request referred to in that subsection, or the information or documents that the applicant has provided before that date are not sufficient to complete the review of the licence application;

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    (i) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;

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    (j) information received from a peace officer, a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance to an illicit market or use or has been involved in an activity that contravenes an international obligation; or

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    (k) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

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  Marginal note:Exceptions

  (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (i) if the applicant meets the following conditions unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use:

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    (a) the applicant does not have a history of non-compliance with the provisions of the Act, the Cannabis Act or their regulations; and

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    (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the provisions of the Act, the Cannabis Act and their regulations.

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  Marginal note:Prior notice

  (3) Before refusing to issue a licence, the Minister must

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    (a) provide the applicant with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and

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    (b) consider the applicant’s submissions, if applicable.