Cannabis Regulations (SOR/2018-144)

Marginal note:Voluntary recall

• 247 (1) A holder of a licence must, before commencing a voluntary recall of a cannabis product that has been sold or distributed in Canada, provide the Minister with a document that contains the following information:

  • (a) a description of the cannabis product, including the brand name;

  • (b) the number of each lot or batch of the cannabis product to be recalled, together with, if known, the number of any lot or batch of cannabis that was used to make the cannabis product;

  • (c) if known, the name and address of each person that

    • (i) produced or imported into Canada the cannabis that is, or is contained in, the cannabis product,

    • (ii) packaged or labelled the cannabis referred to in subparagraph (i) before it became, or became part of, the cannabis product,

    • (iii) in the case of a cannabis accessory that is a cannabis product, produced or imported into Canada the cannabis accessory or any component of it, or

    • (iv) packaged or labelled the cannabis product;

  • (d) the reasons for commencing the recall;

  • (e) if the cannabis that is, or is contained in, the cannabis product was produced or imported into Canada by the holder, the quantity of cannabis that was produced or imported;

  • (f) the quantity of the cannabis product that was sold or distributed by the holder in Canada;

  • (g) if applicable, the quantity of the cannabis product that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;

  • (h) the number of persons to which the holder sold or distributed the cannabis product in Canada;

  • (i) the period during which the holder sold or distributed the cannabis product in Canada;

  • (j) the time and manner in which the recall is to be carried out, including

    • (i) the expected date for the commencement of the recall,

    • (ii) how and when the Minister will be informed of the progress of the recall, and

    • (iii) the date by which the recall is expected to be completed;

  • (k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and

  • (l) contact information for a representative who will be responsible for the recall.

• Marginal note:Recall — exported cannabis

  (2) A holder of a licence must, before commencing a voluntary recall of cannabis that has been exported from Canada, provide the Minister with a document that contains the following information:

  • (a) a description of the cannabis, including, if applicable, the brand name;

  • (b) the number of each lot or batch of the cannabis;

  • (c) if known, the name and address of each person that

    • (i) produced or imported into Canada the cannabis, and, if applicable, packaged or labelled it, and

    • (ii) in the case where the cannabis is contained in a cannabis accessory, produced or imported into Canada the cannabis accessory or any component of it;

  • (d) the reasons for commencing the recall;

  • (e) if applicable, the quantity of the cannabis that was produced or imported into Canada by the holder;

  • (f) the quantity of the cannabis that was sold or distributed by the holder in foreign countries;

  • (g) if applicable, the quantity of the cannabis that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;

  • (h) the number of persons to which the holder sold or distributed the cannabis in foreign countries;

  • (i) the period during which the holder sold or distributed the cannabis in foreign countries;

  • (j) the time and manner in which the recall is to be carried out, including

    • (i) the expected date for the commencement of the recall,

    • (ii) how and when the Minister will be informed of the progress of the recall, and

    • (iii) the date by which the recall is expected to be completed;

  • (k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and

  • (l) contact information for a representative who will be responsible for the recall.

• Marginal note:Risk evaluation

  (3) The holder must, within 72 hours after providing the Minister with the document referred to in subsection (1) or (2), provide the Minister with a document that contains an evaluation of the risk associated with the problem or potential problem that underlies the recall.

• Marginal note:Report

  (4) The holder must, within 30 days after the day on which the recall is completed, provide the Minister with a written report that sets out the results of the recall and the measures taken to prevent a recurrence of the problem.

• Marginal note:Extension

  (5) Despite subsection (4), the Minister may extend the period for providing the report — to a maximum of 90 days after the day on which the recall is completed — if, for reasons beyond the holder’s control, it is not feasible to provide it within the 30-day period.

• Marginal note:Retention periods

  (6) The holder must retain

  • (a) a copy of the documents that they provide to the Minister under subsections (1) and (3) for at least two years after the day on which their last sale or distribution of any cannabis product that is the subject of the recall takes place;

  • (b) a copy of the documents that they provide to the Minister under subsections (2) and (3) for at least two years after the day on which their last export of any of the cannabis that is the subject of the recall takes place; and

  • (c) a copy of the report that they provide to the Minister under subsection (4) for at least two years after the day on which the recall is completed.

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.