Controlled Substances Regulations (SOR/2025-242)

Changes Requiring Prior Approval by the Minister

Marginal note:Application

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

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

  • (b) a change affecting the method of recording information referred to in paragraph 11(1)(j);

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

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

  • (e) 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 or the method of recording information referred to in paragraph 11(1)(j), details of the change;

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

    • (i) the information specified in paragraph 11(1)(c), and

    • (ii) the documents specified in paragraphs 11(2)(b) to (e); and

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

    • (i) the information specified in paragraph 11(1)(d), and

    • (ii) the documents specified in paragraphs 11(2)(b) to (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

• 24 (1) Subject to section 25, on completion of the review of the application for approval of the change, the Minister must approve the change.

• Marginal note:Terms or conditions

  (2) When approving a change, the Minister may, if the Minister has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete a term or condition 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 that a controlled substance could be diverted to an illicit market or use.

Marginal note:Refusal

• 25 (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 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii) or (b)(ii);

  • (b) the licensed dealer has not provided the Minister with the information or documents required under subsection 23(3) or before the date specified in the written request referred to in that subsection, or the information or documents that the dealer has provided before that date 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 that a controlled substance could be diverted to an illicit market or use.

• Marginal note:Exceptions

  (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 provisions of 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 substance from being diverted to an illicit market or use.

• Marginal note:Prior notice

  (3) Before refusing to approve a change, the Minister must

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

  • (b) consider the licensed dealer’s submissions, if applicable.

Changes Requiring a Notice to the Minister

Marginal note:Prior notice

• 26 (1) A licensed dealer must notify the Minister in writing before

  • (a) producing or packaging a mixture or finished product that is not set out in the most recent update of the information and label referred to in paragraph 11(1)(g); or

  • (b) making a change to a mixture or finished product that is set out in that most recent update, if the change affects any of the information or label that has previously been submitted.

• Marginal note:Information and document

  (2) The notice must contain the information that is necessary to update the information or label referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label referred to in that paragraph or, if applicable, a copy of the updated label.

Marginal note:Notice — five days

27 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

• 28 (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 produce or package a mixture or finished product that is set out in the most recent update of the information and label referred to in paragraph 11(1)(g).

• Marginal note:Information and document

  (2) A notice concerning a change referred to in paragraph (1)(b) must contain the information that is necessary to update the information referred to in paragraph 11(1)(g) and must be accompanied by a document containing all the information referred to in that paragraph, including those updates, and a copy of the label for any other controlled substance.

Marginal note:Notice of cessation of activities

• 29 (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 controlled substances 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, their name and, if applicable, title,

    • (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, their name and, if applicable, title, as well as the municipal address of their site, and

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

  • (c) the municipal address of the place 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 whom 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.

Changes to the Terms and Conditions of a Licence

Marginal note:Addition or modification

• 30 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add or modify a term or condition if the Minister has reasonable grounds to believe that it is necessary to do so to

  • (a) ensure conformity with the provisions of the Act, the Cannabis Act and their regulations;

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

  • (c) ensure conformity with the requirements associated with the security level specified in the licence; or

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

• Marginal note:Prior notice

  (2) Before adding a term or condition to, or modifying a term or condition of, a licence, the Minister must

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

  • (b) consider the licensed dealer’s submissions, if applicable.

• Marginal note:Urgent circumstances

  (3) Despite subsection (2), the Minister may immediately add a term or condition to, or modify a term or condition of, a licence, subject to subsection (4), 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 controlled substance 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 provides the licensed dealer with a written 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.

Marginal note:Deletion of term or condition

• 31 (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 provides the licensed dealer with a written notice to that effect.

Suspension and Revocation of a Licence

Marginal note:Suspension

• 32 (1) Subject to subsection (2), the Minister must immediately suspend a dealer’s licence in respect of any activities in relation to any controlled substance 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 controlled substance from being diverted to an illicit market or use.

• Marginal note:Notice

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

  • (a) sets out the authorized activity and controlled substance that are the subject of the suspension, as well as 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

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

  • (a) the licensed dealer no longer meets the requirement set out in subsection 7(2);

  • (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 10(1)(a)(i) or (b)(i) or received a sentence as specified in subparagraph 10(1)(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 peace officer, 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 substance to an illicit market or use or has been involved in an activity that contravened an international obligation.

• 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 controlled substance from being diverted to an illicit market or use:

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

• Marginal note:Prior notice

  (3) Before revoking a licence, the Minister must

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

  • (b) consider the licensed dealer’s submissions, if applicable.

Import Permit

Marginal note:Application

• 34 (1) A licensed dealer must submit to the Minister, before each importation of a controlled substance, an application for an import permit that contains the following information:

  • (a) their name and, if applicable, title, as well as their municipal address;

  • (b) their dealer’s licence number and their business registration number assigned by the Minister of National Revenue;

  • (c) the name and municipal address of the proposed customs broker for the licensed dealer, if any;

  • (d) the name of the customs office where the importation is anticipated and the proposed date of importation;

  • (e) the name and municipal address, in the country of export, of the exporter from whom the controlled substance is being obtained;

  • (f) the name of the carrier that is proposed to transport the controlled substance to the customs office where the importation is anticipated;

  • (g) each proposed mode of transportation and any proposed country of transit or transhipment;

  • (h) in the case of a controlled substance set out in any of Schedules 1 to 4,

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

    • (ii) its CAS registry number, if any,

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

    • (iv) its form,

    • (v) its purity and anhydrous content, and

    • (vi) its quantity; and

  • (i) in the case of a 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, and

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

• 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, to the best of their knowledge,

    • (i) the importation does not contravene the laws of the country of exportation or any country of transit or transhipment, and

    • (ii) all of the information and documents submitted in support of the application are correct and complete.

• 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.