Cannabis Regulations (SOR/2018-144)

Definitions of adverse reaction and serious adverse reaction

248 The following definitions apply in this section and sections 248.1 and 248.2.

adverse reaction

adverse reaction means a noxious and unintended response to cannabis or a cannabis accessory that contains cannabis. (réaction indésirable)

serious adverse reaction

serious adverse reaction means an adverse reaction that requires inpatient hospitalization or a prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. (réaction indésirable grave)

Marginal note:Cannabis products

• 248.1 (1) A holder of a licence that sells or distributes a cannabis product must

  • (a) within 15 days after becoming aware of a serious adverse reaction to the cannabis product, provide the Minister with a detailed report containing all information in their possession that is associated with the use of the product by the individual who experienced the serious adverse reaction; and

  • (b) prepare an annual summary report that contains a concise and critical analysis of all adverse reactions to the cannabis product that the holder became aware of during the previous 12 months.

• Marginal note:Retention period

  (2) The holder must retain the reports for at least 25 years after the day on which they are prepared.

• Marginal note:Non-application

  (3) This section does not apply in respect of an adverse reaction to cannabis, or a cannabis accessory that contains cannabis, that is distributed to human participants in the conduct of non-therapeutic research on cannabis.

Marginal note:Non-therapeutic research on cannabis

• 248.2 (1) During the conduct of non-therapeutic research on cannabis, the holder of a licence for research that distributes cannabis, or a cannabis accessory that contains cannabis, to human participants must,

  • (a) within seven days after becoming aware of a serious adverse reaction to the cannabis or cannabis accessory that is life-threatening or that results in death, notify the Minister of the serious adverse reaction; and

  • (b) within eight days after notifying the Minister under paragraph (a), provide the Minister with a detailed report containing all information in their possession that is associated with the use of the cannabis or cannabis accessory by the individual who experienced the serious adverse reaction, including the intended use of the cannabis or cannabis accessory, an assessment of the cause of the serious adverse reaction and a statement of what further action, if any, needs to be taken by the holder of the licence.

• Marginal note:Serious adverse reaction not life threatening

  (2) The holder of the licence must, within 15 days after becoming aware of a serious adverse reaction to the cannabis or cannabis accessory that is not life-threatening and does not result in death, provide the Minister with a detailed report containing all information in their possession that is associated with the use of the cannabis or cannabis accessory by the individual who experienced the serious adverse reaction, including the intended use of the cannabis or cannabis accessory, an assessment of the cause of the serious adverse reaction and a statement of what further action, if any, needs to be taken by the holder of the licence.

• Marginal note:Record keeping

  (3) The holder must retain a record of each adverse reaction and serious adverse reaction that occurs during the holder’s conduct of non-therapeutic research on cannabis and that the holder becomes aware of.

• Marginal note:Retention period

  (4) The holder must retain the reports and record for at least 15 years after the day on which they are prepared.

Disclosure of Information to Third Parties

Marginal note:Notices to local authorities

• 249 (1) The Minister may, at the request of the government of a province or any police force or other law enforcement agency in a province, disclose to the government, police force or agency any information set out in a notice that is referred to in section 7 or 35 and that relates to a site located in that province if the disclosure is for a purpose related to verifying compliance or preventing non-compliance with the provisions of

  • (a) the Act;

  • (b) these Regulations;

  • (c) a provincial Act; or

  • (d) regulations made under a provincial Act.

• Marginal note:Police investigation

  (2) The Minister may disclose any information that is set out in a notice referred to in section 7 or 35 to a Canadian police force, or a member of a Canadian police force, that requests the information in the course of an investigation under the Act.

• Marginal note:Use of information

  (3) Information that is disclosed under subsection (2) must be used only for the purposes of the investigation or the administration or enforcement of the Act or these Regulations.

Marginal note:Disclosure to province

• 250 (1) For the purpose of paragraph 83(f) of the Act, information contained in the national cannabis tracking system may be disclosed to the government of a province, at its request, if the disclosure is for a purpose related to the implementation of public health programs or activities that are related to cannabis.

• Marginal note:Public health programs and activities

  (2) The Minister may, at the request of the government of a province, disclose to the government any information obtained under section 297 if the disclosure is for a purpose related to the implementation of public health programs or activities that are related to cannabis.

Marginal note:International Narcotics Control Board

• 251 (1) In addition to the information that may be disclosed under sections 83, 128 and 129 of the Act, the Minister may disclose to the International Narcotics Control Board other information that is obtained under the Act if the disclosure is necessary to enable Canada to fulfill its international obligations in relation to cannabis.

• Marginal note:Former statute

  (2) The Minister may also disclose to the International Narcotics Control Board any information relating to cannabis that was obtained under the Controlled Drugs and Substances Act before the day on which these Regulations come into force if the disclosure is necessary to enable Canada to fulfill its international obligations in relation to cannabis.

Marginal note:Competent authorities

252 The Minister may, for the purposes of the administration or enforcement of the Act or these Regulations or if it is necessary to enable Canada to fulfill its international obligations in relation to cannabis, disclose to a competent authority

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

• (b) information relating to an activity authorized by

  • (i) an import or export permit, or

  • (ii) a licence held by a person that has applied for or that holds an import or export permit;

• (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 a licence that they hold or held; and

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

PART 13Test Kits

Marginal note:Exemption — Division 2 of Part 1 of Act

253 The cannabis that is contained in a test kit that meets the requirements of paragraphs 255(a) and (b) is exempt from Subdivisions A to D of Division 2 of Part 1 of the Act.

Marginal note:Non-application

254 Part 5 and section 137 do not apply to the cannabis that is contained in a test kit.

Marginal note:Sale, importation and exportation

255 A person is authorized to sell, import or export a test kit if

• (a) a registration number has been issued for the test kit and the number has not been cancelled;

• (b) the following information is included on the label that is applied to the test kit:

  • (i) the registration number, and

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

    • (A) the name and address of the manufacturer or assembler or, if applicable, the name and address of the person for which the test kit was manufactured or assembled further to a custom order, and

    • (B) its brand name; and

• (c) the test kit is sold, imported or exported for a medical, laboratory, industrial, educational, law administration or enforcement or research purpose.

Marginal note:Individual — possession and distribution

256 An individual is authorized to conduct the following activities, in relation to one or more test kits that contain a total amount of cannabis that, as determined in accordance with subsection 2(4) of the Act, is equivalent to more than the amount the individual may possess under the Act, if the registration number is included on the label of each test kit

• (a) possess it in a public place; and

• (b) distribute it for a medical, laboratory, industrial, educational, law administration or enforcement or research purpose.

Marginal note:Organization — possession and distribution

257 An organization is authorized to conduct the following activities if the label of a test kit includes its registration number:

• (a) possess the test kit; and

• (b) distribute the test kit for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Marginal note:Application for registration number

• 258 (1) The manufacturer or assembler of a test kit or, if the test kit is manufactured or assembled further to a custom order, the person for which the test kit was manufactured or assembled, may apply for a registration number for the test kit by submitting an application to the Minister containing the following information:

  • (a) the brand name of the test kit;

  • (b) particulars of the design and construction of the test kit;

  • (c) a statement of the proposed use of the test kit;

  • (d) a detailed description of the cannabis contained in the test kit, including

    • (i) the class of cannabis set out in column 1 of Schedule 3 to the Act, and

    • (ii) the quantity of cannabis;

  • (e) if applicable, a detailed description of every other substance contained in the test kit, including

    • (i) the name of each substance,

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

    • (iii) the quantity of each substance; and

  • (f) the directions for use of the test kit.

• Marginal note:Signature and declaration

  (2) An application for the registration of a test kit must

  • (a) be signed and dated by an individual authorized by the applicant for that purpose; and

  • (b) include a declaration, signed and dated by that individual, indicating that all the information provided in support of the application is correct and complete to the best of their knowledge.

Marginal note:Additional information

259 The Minister may, on receiving an application referred to in section 258, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.

Marginal note:Issuance of a registration number

• 260 (1) Subject to subsection (2), the Minister must, after examining the information and documents required under sections 258 and 259, issue a registration number for the test kit to the applicant if the applicant demonstrates that the test kit is designed to be used solely for a medical, laboratory, industrial, educational, law administration or enforcement or research purpose.

• Marginal note:Refusal

  (2) The Minister must refuse to issue a registration number if he or she has reasonable grounds to believe that

  • (a) the test kit is likely to create a risk to public health or safety, including the risk of cannabis being diverted to an illicit market or activity, because

    • (i) the quantity of cannabis in the test kit is too high, or

    • (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption or administration of the cannabis; or

  • (b) the test kit is likely to be used for a purpose other than any of those set out in subsection (1).

Marginal note:Cancellation

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

  • (a) the Minister receives a notice from the holder of the registration number stating that it has ceased all authorized activities referred to in section 255, 256 or 257 with respect to the test kit;

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

    • (i) the test kit is likely to create a risk to public health or safety, including the risk of cannabis being diverted to an illicit market or activity, because

      • (A) the quantity of cannabis in the test kit is too high, or

      • (B) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption or administration of the cannabis, or

    • (ii) the test kit is likely to be used for a purpose other than any of those set out in subsection 260(1); or

  • (c) the test kit is a medical device and is no longer authorized for sale in Canada under the Medical Devices Regulations.

• Marginal note:Effect of cancellation

  (2) When a registration number issued for a test kit is cancelled, the cancelled registration number

  • (a) must not be displayed on the label of any test kit manufactured or assembled further to a custom order after the cancellation; and

  • (b) in the case of a cancellation under paragraph (1)(a), must remain on the label of any existing test kit until all of the test kits with that registration number are disposed of.

Marginal note:Refusal or cancellation

262 If the Minister proposes to refuse to issue or to cancel a registration number, the Minister must

• (a) send a notice to the applicant or to the holder of the registration number that sets out the reasons for the refusal or cancellation; and

• (b) give the applicant or holder an opportunity to be heard in respect of the refusal or cancellation.