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

G.02.011.1 [Repealed, SOR/2019-171, s. 1]

G.02.011.2 [Repealed, SOR/2019-171, s. 1]

Marginal note:Validity

G.02.012 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 G.02.027 or G.02.028.

Marginal note:Refusal

• G.02.013 (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 G.02.002;

  • (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 G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(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 G.02.006(1)(j) does not permit the recording of information as required by section G.02.071;

  • (g) the licensed dealer has not complied with the requirements of subsection G.02.010(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 controlled 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 controlled 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 controlled 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

• G.02.014 (1) Before making a change affecting any information referred to in section G.02.007 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 G.02.006 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.

Marginal note:Amendment

• G.02.015 (1) Subject to section G.02.017, on completion of the review of the amendment application, the Minister must amend the dealer’s licence.

• Marginal note:Terms and conditions

  (2) When amending 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 amendment; or

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

Marginal note:Validity

G.02.016 An amended 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 G.02.027 or G.02.028.

Marginal note:Refusal

• G.02.017 (1) The Minister must refuse to amend a dealer’s licence if

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

  • (b) 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 licence amendment is requested;

  • (c) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required by section G.02.071;

  • (d) the licensed dealer has not complied with the requirements of subsection G.02.014(3) or the information or documents that they have provided are not sufficient to complete the review of the amendment application;

  • (e) 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 amendment application; or

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

• Marginal note:Exceptions

  (2) The Minister must not refuse to amend a licence under paragraph (1)(e) 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 controlled 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 amend 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.

Changes Requiring Prior Approval by Minister

Marginal note:Application

• G.02.018 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written request to the Minister:

  • (a) a change affecting the security measures at the site specified in the dealer’s licence;

  • (b) the replacement of the senior person in charge;

  • (c) the replacement of the qualified person in charge; or

  • (d) the replacement or addition of an alternate qualified person in charge.

• Marginal note:Information and documents

  (2) The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1):

  • (a) in the case of a change affecting the security measures in place at the site specified in the dealer’s licence;

  • (b) in the case of the senior person in charge,

    • (i) the information specified in paragraph G.02.006(1)(c), and

    • (ii) the declaration specified in paragraph G.02.006(2)(b) and the documents specified in paragraphs G.02.006(2)(c) and (d); and

  • (c) in the case of the qualified person in charge or an alternate qualified person in charge,

    • (i) the information specified in paragraph G.02.006(1)(d), and

    • (ii) the declarations specified in paragraphs G.02.006(2)(b) and (e) and the documents specified in paragraphs G.02.006(2)(c), (d) and (f).

• 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:Approval

• G.02.019 (1) Subject to section G.02.020, on completion of the review of the application for approval of the change, the Minister must approve the change.

• Marginal note:Terms and conditions

  (2) When approving a change, 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 the licence 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

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

Marginal note:Refusal

• G.02.020 (1) The Minister must refuse to approve the change if

  • (a) during the 10 years before the day on which the application for approval of the change 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 G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii);

  • (b) the licensed dealer has not complied with the requirements of subsection G.02.018(3) or the information or documents that they have provided are not sufficient to complete the review of the application for approval of the change;

  • (c) 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 application for approval of the change; or

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

• Marginal note:Exception

  (2) The Minister must not refuse to approve a change under paragraph (1)(c) if 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, 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 drug from being diverted to an illicit market or use.

• Marginal note:Notice

  (3) Before refusing to approve a change, 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 in respect of them.

Changes Requiring Notice to Minister

Marginal note:Prior notice

• G.02.021 (1) A licensed dealer must notify the Minister in writing before

  • (a) making or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph G.02.006(1)(f) that has been submitted to the Minister; or

  • (b) making a change to a product or compound that is set out in the list, if the change affects any of the information that has previously been submitted.

• Marginal note:Information and list

  (2) The notice must contain the information referred to in paragraph G.02.006(1)(f) that is necessary to update the list and be accompanied by the revised version of the list.