Controlled Substances Regulations (SOR/2025-242)

Marginal note:Issuance

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  43 (1) Subject to section 45, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains

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    (a) the permit number;

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    (b) the information set out in paragraphs 42(1)(a) to (i) and the number of the import authorization referred to in paragraph 42(1)(j);

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    (c) the effective date of the permit;

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    (d) the expiry date of the permit, being the earliest of

    • (i) a date specified by the Minister that is not more than 180 days after its effective date,

    • (ii) the expiry date of the dealer’s licence, and

    • (iii) the expiry date of the import authorization issued by the competent authority in the country of final destination; and

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

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

    • (ii) reduce 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:Permit integrity

  (2) A person must not alter or deface in any manner an export permit.

Marginal note:Validity

44 An export permit is valid until the earliest of

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  (a) the expiry date set out in the permit,

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  (b) the date of the suspension or revocation of the permit under section 48 or 49,

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  (c) the date of the suspension or revocation of the dealer’s licence under section 32 or 33, and

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  (d) the date of the expiry, suspension or revocation of the import authorization that applies to the controlled substance to be exported and that is issued by the competent authority in the country of final destination.

Marginal note:Refusal

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  45 (1) The Minister must refuse to issue an export permit if

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    (a) the licensed dealer is not authorized by their dealer’s licence to export the relevant controlled substance or their dealer’s licence will expire before the date of export;

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    (b) the Minister has reasonable grounds to believe that the exportation would contravene an international obligation;

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    (c) the licensed dealer has not provided the Minister with the information or documents required under subsection 42(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 permit application;

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    (d) 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 permit application;

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    (e) the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import authorization issued by the competent authority of the country of final destination;

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    (f) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or

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    (g) the Minister has reasonable grounds to believe that the issuance of the permit 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:Prior notice

  (2) Before refusing to issue an export permit, the Minister must

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    (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

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

Marginal note:Providing copy of permit

46 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.

Marginal note:Declaration

47 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled substance specified in the permit, with a declaration that contains the following information:

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  (a) their name and, if applicable, title;

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  (b) their dealer’s licence number and the number of the export permit;

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  (c) the name of the customs office from which the controlled substance was exported and the date of export;

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  (d) 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) if it is a salt, the name of the salt,

  • (iii) its form, and

  • (iv) its quantity; and

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  (e) 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:Suspension

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  48 (1) Subject to subsection (2), the Minister must immediately suspend an export permit if

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    (a) the dealer’s licence is suspended;

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    (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or

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    (c) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.

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  Marginal note:Notice

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

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    (a) sets out the reasons for the suspension;

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

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

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  Marginal note:Reinstatement of permit

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

Marginal note:Revocation

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  49 (1) The Minister must revoke an export permit if

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    (a) the dealer’s licence has been revoked;

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

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    (c) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 48(2)(c) by the specified date; or

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    (d) the Minister has reasonable grounds to believe that the licensed dealer submitted misleading information or falsified documents in or in support of the application for the permit.

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  Marginal note:Prior notice

  (2) Before revoking an export permit, the Minister must

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    (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

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

Marginal note:Authorized activities

50 A licensed dealer may conduct the following activities if it does so in accordance with their dealer’s licence and any permit issued under these Regulations:

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  (a) produce a controlled substance;

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  (b) sell or provide a controlled substance to

  • (i) another licensed dealer,

  • (ii) with the exception of a restricted drug, a pharmacist, other than one who is practising in a hospital,

  • (iii) a practitioner,

  • (iv) with the exception of a restricted drug, a hospital,

  • (v) a person exempted under subsection 56(1) of the Act with respect to that controlled substance, if there are terms and conditions for the sale or provision by a licensed dealer that are specified in the exemption,

  • (vi) the Minister, or

  • (vii) a government laboratory;

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  (c) transport, send or deliver a controlled substance; or

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  (d) import or export a controlled substance.

Marginal note:Packaging — conditions

51 A licensed dealer that packages a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Marginal note:Destruction

52 A licensed dealer specialized in destruction that destroys a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Marginal note:Qualified person in charge present

53 A licensed dealer may conduct an activity in relation to a controlled substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Marginal note:Identification

54 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which it identifies itself in regard to their activities in relation to a controlled substance, including labels, shipping documents, invoices and advertising.

Marginal note:Information and documents

55 A licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any relevant information or document to demonstrate their compliance with the provisions of the Act and these Regulations.

Marginal note:Sale to another licensed dealer

56 A licensed dealer that sells or provides a controlled substance to another licensed dealer may only do so if it first receives from the other licensed dealer a written order that is signed and dated and that contains the following:

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  (a) with respect to the other licensed dealer placing the order, their name and, if applicable, title, as well as their municipal address;

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  (b) with respect to the licensed dealer selling or providing the controlled substance, their name and, if applicable, title, as well as their municipal address;

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  (c) the date of the order;

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  (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;

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  (e) 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; and

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  (f) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.