Controlled Substances Regulations (SOR/2025-242)

Marginal note:Sale to exempted person

190 The Minister may sell or provide a controlled substance to a person that the Minister has exempted under subsection 56(1) of the Act with respect to that substance.

Marginal note:Authorization

191 The Minister may deliver, send or transport a controlled substance.

Marginal note:Import

192 The Minister may import a controlled substance that is intended to be sold or provided to one of the following persons:

• The following provision is not in force.

  (a) a practitioner named in a letter of authorization; or

• The following provision is not in force.

  (b) a person exempted under subsection 56(1) of the Act with respect to that substance.

Marginal note:Export

193 The Minister may export a controlled substance.

Marginal note:Provincial government or regulatory authority — entitled persons

• The following provision is not in force.

  194 (1) The Minister may provide in writing any factual information that has been obtained under the Act or these Regulations about a pharmacist, pharmacy technician, practitioner or any other health professional to any relevant provincial government or to any provincial professional regulatory authority of a province in which the person is or was entitled by that authority to practise their profession, if

  • The following provision is not in force.

    (a) the government or authority submits to the Minister a written request that sets out the person’s name and municipal address, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the government or authority;

  • The following provision is not in force.

    (b) the Minister has reasonable grounds to believe that the person has

    • (i) contravened a rule of conduct established by the authority,

    • (ii) been convicted of a designated substance offence, or

    • (iii) contravened these Regulations; or

  • The following provision is not in force.

    (c) the Minister has reasonable grounds to believe that the provision of the information is necessary to assist the government or authority in monitoring the person’s professional conduct for compliance with the laws of the province for the purpose of protecting public health or safety.

• The following provision is not in force.

  Marginal note:Provincial government or regulatory authority — persons not entitled

  (2) The Minister may provide in writing any factual information that has been obtained under the Act or these Regulations about a pharmacist, pharmacy technician, practitioner or any other health professional to any relevant provincial government or any provincial professional regulatory authority of a province in which the person is not entitled by that authority to practise their profession, if the government or authority submits to the Minister

  • The following provision is not in force.

    (a) a written request that sets out the person’s name and municipal address and a description of the information being requested; and

  • The following provision is not in force.

    (b) a document that shows that

    • (i) the person has applied to that authority to practise in that province, or

    • (ii) the government or authority has reasonable grounds to believe that the person is practising in that province without being authorized to do so.

Marginal note:Customs officer

195 The Minister may, for the purpose of verifying whether an importation or exportation of a controlled substance complies with these Regulations, provide the following to a customs officer:

• The following provision is not in force.

  (a) information provided in the permit application under section 34, 42, 205 or 213;

• The following provision is not in force.

  (b) information listed on the permit under subsection 35(1), 43(1), 206(1) or 214(1);

• The following provision is not in force.

  (c) information provided in the declaration under section 39, 47, 210 or 218; or

• The following provision is not in force.

  (d) information concerning the suspension or revocation of an import or export permit.

Marginal note:International Narcotics Control Board

196 The Minister may provide to the International Narcotics Control Board any information that is obtained under the Act or these Regulations if the provision would allow Canada to respect its international obligations in relation to controlled substances.

Marginal note:Competent authorities

197 The Minister may, for the purposes of the administration or enforcement of the Act or these Regulations or if it would allow Canada to respect its international obligations in relation to controlled substances, provide to a competent authority

• The following provision is not in force.

  (a) information obtained from a licensed dealer that has applied for or that holds an import or export permit;

• The following provision is not in force.

  (b) information relating to

  • (i) an import or export permit, or

  • (ii) an activity specified on a dealer’s licence held by a licensed dealer that has applied for or that holds an import or export permit;

• The following provision is not in force.

  (c) any document that the holder or former holder of an import or export permit is required to retain, including any document that relates to the dealer’s licence that the dealer holds or held; and

• The following provision is not in force.

  (d) a copy of any import or export permit.

Marginal note:Restricted drugs

• The following provision is not in force.

  198 (1) The Minister may, by order, add to Part 3 of Schedule 4 to these Regulations any item or portion of an item listed in Schedule V to the Act.

• The following provision is not in force.

  Marginal note:Deletion

  (2) The Minister may, by order, delete any item or portion of an item from Part 3 of Schedule 4.

• The following provision is not in force.

  Marginal note:Deletion — Schedule V to Act

  (3) An item or portion of an item listed in Part 3 of Schedule 4 to these Regulations is deemed to be deleted on the day on which the equivalent item or portion of an item is no longer listed in Schedule V to the Act.

Marginal note:Authorization

199 A government laboratory may produce a controlled substance.

Marginal note:Sale to licensed dealer

200 A government laboratory may sell or provide a controlled substance to a licensed dealer.

Marginal note:Sale to Minister

201 A government laboratory may sell or provide a controlled substance to the Minister.

Marginal note:Sale to another government laboratory

202 A government laboratory may sell or provide a controlled substance to another government laboratory.

Marginal note:Authorization

203 A government laboratory may deliver, send or transport a controlled substance.

Marginal note:Condition

204 A government laboratory may import or export a controlled substance if it does so in accordance with an import or export permit issued under these Regulations.

Marginal note:Application

• The following provision is not in force.

  205 (1) A government laboratory must submit to the Minister, before each importation of a controlled substance, an application for an import permit that contains the following information:

  • The following provision is not in force.

    (a) the government laboratory’s name and municipal address;

  • The following provision is not in force.

    (b) the name and municipal address of the proposed customs broker for the government laboratory, if any;

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

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

  • The following provision is not in force.

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

    • (i) its name,

    • (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

  • The following provision is not in force.

    (h) 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.

• The following provision is not in force.

  Marginal note:Signature and attestation

  (2) The application must

  • The following provision is not in force.

    (a) be signed and dated by the person in charge of the government laboratory; and

  • The following provision is not in force.

    (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.

• The following provision is not in force.

  Marginal note:Additional information and documents

  (3) The government laboratory 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

• The following provision is not in force.

  206 (1) Subject to section 208, on completion of the review of the import permit application, the Minister must issue to the government laboratory an import permit that contains

  • The following provision is not in force.

    (a) the permit number;

  • The following provision is not in force.

    (b) the information set out in subsection 205(1);

  • The following provision is not in force.

    (c) the effective date of the permit;

  • The following provision is not in force.

    (d) the expiry date of the permit, which must be not later than 180 days after its effective date; and

  • The following provision is not in force.

    (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.

• The following provision is not in force.

  Marginal note:Permit integrity

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

Marginal note:Validity

207 An import permit is valid until the earliest of

• The following provision is not in force.

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

• The following provision is not in force.

  (b) the date of the suspension or revocation of the permit under section 211 or 212, and

• The following provision is not in force.

  (c) the date of the expiry, suspension or revocation of the export authorization that applies to the controlled substance to be imported and that is issued by the competent authority in the country of export.

Marginal note:Refusal

• The following provision is not in force.

  208 (1) The Minister must refuse to issue an import permit if

  • The following provision is not in force.

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

  • The following provision is not in force.

    (b) the government laboratory has not provided the Minister with the information or documents required under subsection 205(3) or before the date specified in the written request referred to in that subsection, or the information or documents that it has provided before that date are not sufficient to complete the review of the permit application;

  • The following provision is not in force.

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

  • The following provision is not in force.

    (d) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or

  • The following provision is not in force.

    (e) 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.

• The following provision is not in force.

  Marginal note:Prior notice

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

  • The following provision is not in force.

    (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

  • The following provision is not in force.

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