Controlled Substances Regulations (SOR/2025-242)

Marginal note:Revocation

• 220 (1) The Minister must revoke an export permit if

  • (a) the government laboratory 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;

  • (b) the government laboratory does not carry out the corrective measures specified by the Minister under paragraph 219(2)(c) by the specified date; or

  • (c) the Minister has reasonable grounds to believe that the government laboratory submitted misleading information or falsified documents in or in support of the application for the permit.

• Marginal note:Prior notice

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

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

  • (b) consider the government laboratory’s submissions, if applicable.

Particular Persons

Sale of Controlled Substances

Marginal note:Authorization

221 A particular person may sell or provide a controlled substance to a licensed dealer, pharmacist or police force for the purposes of destruction.

Delivery, Sending and Transportation

Marginal note:Authorization

222 A particular person may deliver, send or transport a controlled substance to a licensed dealer, pharmacist or police force for the purposes of destruction.

Individuals

Marginal note:Transportation and provision

223 An individual who has obtained, in accordance with the provisions of the Act and its regulations, a controlled substance identified in a prescription for another individual named in that prescription may deliver, transport, sell or provide the substance to that individual.

Marginal note:Return for destruction

224 An individual who has reasonable grounds to believe that a controlled substance in their possession was obtained in accordance with the provisions of the Act and its regulations may, for the purposes of destruction, deliver, transport, sell or provide the substance directly to one of the following persons:

• (a) a pharmacist or pharmacy technician, other than one who is practising in a hospital;

• (b) a practitioner, other than one who is practising in a hospital;

• (c) a hospital; or

• (d) a particular person.

Marginal note:Import

225 On entering Canada, an individual may import a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if

• (a) the individual is importing the substance

  • (i) for their own use,

  • (ii) for the use and on the behalf of an accompanying individual, or

  • (iii) for administration to an animal for which the individual is responsible and that is accompanying the individual;

• (b) the substance is declared to a customs officer at the port of entry into Canada;

• (c) the substance, except a finished product referred to in subsection 98(2) that contains low-dose codeine phosphate, is in a container obtained from a health care provider and that container carries a label on which the following information appears:

  • (i) the name of the individual for whom, or the animal for which, the substance was lawfully obtained,

  • (ii) the name of the health care provider who authorized the substance to be obtained,

  • (iii) with respect to the substance,

    • (A) its name or, if applicable, brand name,

    • (B) its form, strength and quantity, and

    • (C) its drug identification number, if any, and

  • (iv) the daily dose of the substance authorized by the health care provider; and

• (d) the imported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.

Marginal note:Export

226 On departing Canada, an individual may export a substance containing a controlled substance set out in any of Schedules 1 to 3 that is in their actual possession or that forms part of their baggage if

• (a) the individual is exporting the substance

  • (i) for their own use,

  • (ii) for the use and on the behalf of an accompanying individual, or

  • (iii) for administration to an animal for which the individual is responsible and that is accompanying the individual;

• (b) the substance, except a finished product referred to in subsection 98(2) that contains low-dose codeine phosphate, is in a container obtained from a health care provider and that container carries a label on which the following information appears:

  • (i) the name of the individual for whom, or the animal for which, the substance was lawfully obtained,

  • (ii) the name of the health care provider who authorized the substance to be obtained,

  • (iii) with respect to the substance,

    • (A) its name or, if applicable, brand name,

    • (B) its form, strength and quantity, and

    • (C) its drug identification number, if any, and

  • (iv) the daily dose of the substance authorized by the health care provider; and

• (c) the exported quantity of the substance does not exceed a 90-day supply required to treat a condition, based on the daily dose shown on the label.

Test Kits

Marginal note:Application

227 Only sections 1, 7 to 33 and 228 to 234 apply to a test kit.

Marginal note:Requirement to obtain registration number

228 The following persons are required to obtain a registration number for a test kit:

• (a) a person that intends to produce a test kit; and

• (b) a person for whom another person, in accordance with a custom order, intends to produce a test kit.

Marginal note:Application for registration number

• 229 (1) An application to obtain a registration number for a test kit must be submitted to the Minister and contain the following information with respect to the test kit:

  • (a) its brand name;

  • (b) a detailed description of its design and construction;

  • (c) with respect to the controlled substance set out in any of Schedules 1 to 4 and any other substance it contains, their names, forms and quantities;

  • (d) a description of its proposed use; and

  • (e) its directions for use.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the person authorized by the applicant for that purpose; 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 applicant 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:Issuance of registration number

• 230 (1) Subject to section 231, on completion of the review of the application for a registration number, the Minister must issue to the applicant a document that sets out a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

• Marginal note:Registration number integrity

  (2) A person must not alter or deface in any manner the document that sets out the registration number.

Marginal note:Refusal to issue registration number

• 231 (1) The Minister must refuse to issue a registration number for a test kit if the Minister has reasonable grounds to believe that

  • (a) the test kit poses a risk to public health or safety, including the risk that the controlled substance in the test kit could be diverted to an illicit market or use, because

    • (i) the total amount of the controlled substance is too high, or

    • (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter the consumption of the controlled substance in the test kit by an individual or animal or the administration of that substance to an individual or animal; or

  • (b) the test kit will be used for a purpose other than one referred to in subsection 230(1).

• Marginal note:Prior notice

  (2) Before refusing to issue a registration number, the Minister must

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

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

Marginal note:Notice to Minister

232 A person must inform the Minister in writing of any of the following facts within 30 days after their occurrence:

• (a) the person has ceased to conduct all activities authorized under section 234 with respect to the test kit;

• (b) the person has transferred the production of the test kit to another person;

• (c) the person has increased the quantity of the controlled substance in the test kit;

• (d) the person has changed the brand name of the test kit;

• (e) the person has altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or

• (f) the person has substituted the adulterating or denaturing agent with another one.

Marginal note:Cancellation of registration number

• 233 (1) The Minister must cancel the registration number of a test kit if

  • (a) the Minister receives a notice from the person to whom the document that sets out the registration number was issued, stating that production of the test kit has ceased; or

  • (b) the Minister has reasonable grounds to believe that one of the circumstances referred to in paragraph 231(1)(a) or (b) exists.

• Marginal note:Prior notice

  (2) Before cancelling a registration number, the Minister must

  • (a) provide the person to whom the document that sets out the registration number was issued with a prior written notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard; and

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

• Marginal note:Effect of cancellation

  (3) The following rules apply when the registration number of a test kit is cancelled:

  • (a) in the case of a test kit produced before a cancellation under paragraph (1)(a),

    • (i) the activities set out in section 234 remain authorized, and

    • (ii) the registration number must remain on the label of the test kit; and

  • (b) in the case of a test kit produced either before or after a cancellation under paragraph (1)(b), the registration number must not be displayed on its label.

Marginal note:Authorized activities

• 234 (1) Any person, other than a person referred to in subsection (2), may possess, sell, provide, transport, send, deliver, import or export a test kit if the following conditions are met:

  • (a) subject to subparagraph 233(3)(a)(i), the registration number of the test kit has not been cancelled under subsection 233(1);

  • (b) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

  • (c) the test kit carries a label on which the following information appears:

    • (i) the registration number of the test kit, and

    • (ii) in the case of a test kit that is not subject to the labelling requirements set out in the Medical Devices Regulations,

      • (A) the name and municipal address of the person that produced the test kit or, if the test kit is produced in accordance with a custom order, of the other person for whom the test kit was produced, and

      • (B) its brand name.

• Marginal note:Member of police force

  (2) A person referred to in section 2 may possess a test kit.

Miscellaneous Provisions

Advertising

Marginal note:Restrictions

235 A person that advertises a controlled substance may only do so if

• (a) the substance is not a restricted drug;

• (b) the advertisement is directed to a person that is not part of the general public; and

• (c) in the case of a written advertisement,

  • (i) the advertisement appears in a document distributed to, or in a trade publication for,

    • (A) a licensed dealer,

    • (B) a pharmacist, pharmacy technician or practitioner, or

    • (C) a hospital, and

  • (ii) the advertisement contains, in a conspicuous place, a legible and intelligible statement that the substance is a controlled substance.

Notification of an Application for an Order of Restoration

Marginal note:Written notification

• 236 (1) For the purposes of subsection 24(1) of the Act, the prior notification of an application for an order of restoration given to the Attorney General must be made in writing and provided by registered mail at least 15 days before the date on which the application is to be made to a justice.

• Marginal note:Content of notification

  (2) The prior notification must specify

  • (a) the name of the justice to whom the application is to be made;

  • (b) the time and place at which the application is to be heard;

  • (c) details concerning the controlled substance or other thing in respect of which the application is to be made; and

  • (d) the evidence on which the applicant intends to rely to establish that the applicant is entitled to possession of the controlled substance or other thing referred to in paragraph (c).