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

Marginal note:Issuance

J.01.015 Subject to section J.01.017, 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

• (a) the licence number;

• (b) the name of the licensed dealer, their corporate name or the title of the position they hold;

• (c) the activities that are authorized and the names of the restricted drugs in respect of which each activity may be conducted;

• (d) the municipal address of the site at which the dealer may conduct the authorized activities;

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

• (f) the effective date of the licence;

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

• (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 of a restricted drug being diverted to an illicit market or use; and

• (i) if the licensed dealer produces a restricted drug, the quantity that they may produce and the authorized production period.

Marginal note:Validity

J.01.016 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 J.01.035 or J.01.036.

Marginal note:Refusal

• J.01.017 (1) The Minister must refuse to issue a dealer’s licence if

  • (a) the applicant may not apply for a licence under section J.01.010;

  • (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;

  • (c) during the 10 years before the day on which the licence 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 J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii);

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

  • (e) 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;

  • (f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.075;

  • (g) the applicant has not complied with the requirements of subsection J.01.014(4) or the information and documents that they have provided are not sufficient to complete the review of the licence application;

  • (h) 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;

  • (i) information received from 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 restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or

  • (j) 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 of a restricted drug being diverted to an illicit market or use.

• Marginal note:Exceptions

  (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (h) 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 restricted drug from being diverted to an illicit market or use:

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

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

• Marginal note:Notice

  (3) Before refusing to issue a licence, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

Renewal of Licence

Marginal note:Application

• J.01.018 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections J.01.014(1) and (2).

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the senior person in charge of the site specified in the application; and

  • (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 licensed dealer.

• Marginal note:Additional information and documents

  (3) The licensed dealer 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:Renewal

• J.01.019 (1) Subject to section J.01.021, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in section J.01.015.

• Marginal note:Terms and conditions

  (2) When renewing a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

  • (a) ensure that an international obligation is respected;

  • (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or

  • (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Marginal note:Validity

J.01.020 A renewed 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 J.01.035 or J.01.036.

Marginal note:Refusal

• J.01.021 (1) The Minister must refuse to renew a dealer’s licence if

  • (a) the licensed dealer may no longer apply for a licence under section J.01.010;

  • (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer 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 dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;

  • (c) during the 10 years before the day on which the renewal 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 J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii);

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

  • (e) the licensed dealer 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 renewal is requested;

  • (f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.075;

  • (g) the licensed dealer has not complied with the requirements of subsection J.01.018(3) or the information or documents that they have provided are not sufficient to complete the review of the renewal application;

  • (h) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the renewal application;

  • (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or

  • (j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

• Marginal note:Exceptions

  (2) The Minister must not refuse to renew a licence under paragraph (1)(b) or (h) if the licensed dealer 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 restricted drug from being diverted to an illicit market or use:

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

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

• Marginal note:Notice

  (3) Before refusing to renew a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Amendment of Licence

Marginal note:Application

• J.01.022 (1) Before making a change affecting any information referred to in section J.01.015 that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section J.01.014 that are relevant to the proposed amendment.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the senior person in charge of the site specified in the application; and

  • (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 licensed dealer.

• Marginal note:Additional information and documents

  (3) The licensed dealer 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.