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

Marginal note:Approval

• J.01.027 (1) Subject to section J.01.028, 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 restricted drug being diverted to an illicit market or use.

Marginal note:Refusal

• J.01.028 (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 subpa/ragraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.0013(a)(ii) or (b)(ii);

  • (b) the licensed dealer has not complied with the requirements of subsection J.01.026(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 restricted 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 restricted 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

• J.01.029 (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 J.01.014(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 J.01.014(1)(f) that is necessary to update the list and be accompanied by the revised version of the list.

Marginal note:Notice — five days

J.01.030 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Marginal note:Notice — 10 days

• J.01.031 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:

  • (a) a person ceases to act as the senior person in charge; or

  • (b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph J.01.014(1)(f) that has been submitted to the Minister.

• Marginal note:Information and list

  (2) A notice submitted under paragraph (1)(b) must specify which information referred to in paragraph J.01.014(1)(f) is being changed and be accompanied by the revised version of the list.

Marginal note:Notice of cessation of activities

• J.01.032 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

• Marginal note:Content of notice

  (2) The notice must be signed and dated by the senior person in charge and contain the following information:

  • (a) the expected date of the cessation of activities at the site;

  • (b) a description of the manner in which any remaining restricted drugs on the site as of that date will be disposed of by the licensed dealer, including

    • (i) if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, the name of that dealer,

    • (ii) if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, the name of that dealer and the municipal address of their site, and

    • (iii) if some or all of them will be destroyed, the date on which and the municipal address of the location at which the destruction is to take place;

  • (c) the municipal address of the location at which the licensed dealer’s documents will be kept after activities have ceased; and

  • (d) the name, municipal address, telephone number and, if applicable, the email address of a person who the Minister may contact for further information after activities have ceased.

• Marginal note:Update

  (3) After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge.

J.01.032.1 [Repealed, SOR/2019-171, s. 22]

Changes to Terms and Conditions of Licence

Marginal note:Addition of or modification to term or condition

• J.01.033 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so 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 restricted drug being diverted to an illicit market or use.

• Marginal note:Notice

  (2) Before adding a term or condition to a licence or modifying one, 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.

• Marginal note:Urgent circumstances

  (3) Despite subsection (2), the Minister may add a term or condition to a licence or modify one without prior notice if 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.

• Marginal note:Urgent circumstances — notice

  (4) The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister sends the licensed dealer a notice that

  • (a) sets out the reasons for the addition or modification;

  • (b) gives the dealer an opportunity to be heard; and

  • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

J.01.033.1 [Repealed, SOR/2019-171, s. 22]

J.01.033.2 [Repealed, SOR/2019-171, s. 22]

J.01.033.3 [Repealed, SOR/2019-171, s. 22]

J.01.033.4 [Repealed, SOR/2019-171, s. 22]

Marginal note:Deletion of term or condition

• J.01.034 (1) The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.

• Marginal note:Notice

  (2) The deletion takes effect as soon as the Minister sends the licensed dealer a notice to that effect.

Suspension and Revocation of Licence

Marginal note:Suspension

• J.01.035 (1) The Minister must suspend a dealer’s licence without prior notice if 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.

• Marginal note:Notice

  (2) The suspension takes effect as soon as the Minister sends the licensed dealer a notice that

  • (a) sets out the reasons for the suspension;

  • (b) gives the dealer an opportunity to be heard; and

  • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

• Marginal note:Reinstatement of licence

  (3) The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Marginal note:Revocation

• J.01.036 (1) Subject to subsection (2), the Minister must revoke a dealer’s licence if

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

  • (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence;

  • (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence;

  • (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice;

  • (e) 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;

  • (f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or any 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);

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

  • (h) 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.

• Marginal note:Exceptions

  (2) The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) 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 revoking 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.

Marginal note:Return of licence

J.01.037 The licensed dealer must return the original of the licence to the Minister within 15 days after the effective date of the revocation.

Import Permits

Marginal note:Application

• J.01.038 (1) A licensed dealer must submit to the Minister, before each importation of a restricted drug, an application for an import permit that contains the following information:

  • (a) their name, municipal address and dealer’s licence number;

  • (b) with respect to the restricted drug to be imported,

    • (i) its name, as specified in the dealer’s licence,

    • (ii) if it is a salt, the name of the salt,

    • (iii) its quantity, and

    • (iv) in the case of a raw material, its purity and its anhydrous content;

  • (c) if the restricted drug is contained in a product to be imported,

    • (i) the brand name of the product,

    • (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and

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

  • (d) the name and municipal address, in the country of export, of the exporter from whom the restricted drug is being obtained;

  • (e) the name of the customs office where the importation is anticipated; and

  • (f) each proposed mode of transportation and any proposed country of transit or transhipment.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and

  • (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.

• 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.