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Benzodiazepines and Other Targeted Substances Regulations (SOR/2000-217)

Regulations are current to 2020-01-08 and last amended on 2019-12-09. Previous Versions

Test Kits

Marginal note:Authorized activities

 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:

  • (a) a registration number has been issued for the test kit under section 6 or subsection 10(2) and has not been cancelled under subsection 9(1);

  • (b) the test kit is labelled with

    • (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 the test kit is manufactured or assembled in accordance with a custom order, the name and address of the person for whom the test kit was manufactured or assembled, and

      • (B) its brand name; and

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

  • SOR/2010-223, s. 3(F)
  • SOR/2018-69, s. 78(E)
  • SOR/2019-170, s. 2

Marginal note:Application for registration number

  •  (1) The manufacturer or assembler of a test kit or, if the test kit is manufactured or assembled in accordance with a custom order, the person for whom the test kit was manufactured or assembled, may obtain a registration number for the test kit by submitting to the Minister an application containing

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

    • (b) a detailed description of the design and construction of the test kit;

    • (c) a detailed description of the targeted substance and other substances, if any, contained in the test kit, including

      • (i) the specified name of the targeted substance and the name of any other substance,

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

      • (iii) the quantity of the substance;

    • (d) a description of the proposed use of the test kit; and

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

  • 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.

  • SOR/2019-170, s. 2

Marginal note:Issuance of registration number

 Subject to section 7, on completion of the review of the application for a registration number, the Minister must issue 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.

  • SOR/2019-170, s. 2

Marginal note:Refusal of registration number

  •  (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 of the targeted substance in the test kit being diverted to an illicit market or use, because

      • (i) the total amount of the targeted substance 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 the consumption of the targeted substance in the test kit by a person or animal or the administration of that substance to a person or animal; or

    • (b) the test kit is likely to be used for a purpose other than one referred to in section 6.

  • Marginal note:Notice

    (2) Before refusing to issue a registration number, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

  • SOR/2019-170, s. 2

Marginal note:Labelling — non-application

 The symbol required by subparagraph C.01.004(1)(b)(iv) of the Food and Drug Regulations does not need to appear on the label of a test kit if the label displays the registration number that has been issued for the test kit under section 6 or subsection 10(2).

  • SOR/2019-170, s. 2

Marginal note:Cancellation of registration number

  •  (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 they have ceased to conduct all activities with respect to the test kit;

    • (b) the test kit is a medical device and is no longer approved for sale in Canada under the Medical Devices Regulations;

    • (c) one of the circumstances referred to in subparagraph 7(1)(a)(i) or (ii) exists; or

    • (d) the Minister has reasonable grounds to believe that the test kit is being used for a purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that the test kit poses a risk to public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use.

  • Marginal note:Effect of cancellation

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

    • (a) must not be displayed on the label of any test kit manufactured or assembled 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.

  • SOR/2019-170, s. 2

Marginal note:Application for new number

  •  (1) The following persons may, after a period of 90 days following the cancellation of the registration number of a test kit, obtain a new registration number by submitting to the Minister an application that is supported by proof that the circumstances that gave rise to the cancellation have been corrected:

    • (a) the manufacturer or assembler of the test kit; or

    • (b) if the test kit is manufactured or assembled in accordance with a custom order, the person for whom the test kit was manufactured or assembled.

  • Marginal note:New number

    (2) On completion of the review of the application, the Minister must issue a new registration number for the test kit unless a condition referred to in any of paragraphs 9(1)(b) to (d) applies.

  • SOR/2010-223, s. 4
  • SOR/2019-170, s. 2

Marginal note:Notice to Minister

 The holder of a registration number for a test kit must inform the Minister in writing, within 30 days after the occurrence, if they have

  • (a) ceased to conduct all activities authorized by section 4 with respect to the test kit;

  • (b) transferred the manufacturing or assembly of the test kit to another person;

  • (c) increased the quantity of targeted substance in the test kit;

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

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

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

  • SOR/2019-170, s. 2
 
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