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

Regulations are current to 2019-07-01 and last amended on 2018-10-17. Previous Versions

PART 4Hospitals (continued)

Marginal note:Information

 The person in charge of a hospital must record, or cause to be recorded, the following information:

  • (a) the brand name or, if the targeted substance does not have a brand name, the specified name, the quantity of any targeted substance received by the hospital and the date on which it was received;

  • (b) the name and address of the licensed dealer, pharmacist or other hospital that sold or provided the targeted substance;

  • (c) the name and quantity of the targeted substance sold, provided, administered, sent, delivered or transported, the name and address of the recipient and the date of the transaction; and

  • (d) the name and address of any out-patient to whom a targeted substance is sold or provided under section 64.

  • SOR/2010-223, s. 30

Marginal note:Closure

 If a targeted substance is stored in a hospital or the pharmacy department of a hospital and the hospital or department closes, the person in charge of the hospital must, not later than 10 days after the day of the closure, inform the Minister of the date of closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved.

  • SOR/2010-223, s. 31(E)

PART 5Individuals

Marginal note:Importation — Canadian residents

  •  (1) An individual who is a resident of Canada may, at the time of the individual’s return to Canada from a foreign country, import a targeted substance that is in their possession at the time of entry if

    • (a) the substance has been obtained under a prescription and is labelled with the information set out in paragraphs 51(2)(a) to (g);

    • (b) the individual is importing the substance

      • (i) for their own use,

      • (ii) for the use of a person for whom the individual is responsible and who is travelling with them, or

      • (iii) for the use of an animal for which the individual is responsible and which is travelling with them;

    • (c) the substance is imported to meet the medical needs of the individual or animal for whose benefit it is prescribed;

    • (d) the substance is declared to a customs office at the port of entry into Canada at the time of import; and

    • (e) the quantity being imported does not exceed the lesser of

      • (i) a single course of treatment, and

      • (ii) a 90-day supply, based on the usual daily dose.

  • Marginal note:Importation — foreign residents

    (2) An individual who is a resident of a foreign country may, at the time that the individual enters Canada, import a targeted substance that is in their possession at the time of entry if

    • (a) the requirements set out in paragraphs (1)(a) to (d) are met; and

    • (b) the quantity imported is the least of

      • (i) the content of the container,

      • (ii) a 90-day supply, based on the usual daily dose, and

      • (iii) the usual daily dose multiplied by the number of days that the individual will stay in Canada.

Marginal note:Export

 An individual may, at the time of their departure from Canada, export a targeted substance that is in their possession at the time of departure if

  • (a) the substance has been obtained under a prescription and is labelled with the information set out in paragraphs 51(2)(a) to (g);

  • (b) the individual is exporting the substance

    • (i) for their own use,

    • (ii) for the use of a person for whom the individual is responsible and who is travelling with them, or

    • (iii) for the use of an animal for which the individual is responsible and which is travelling with them;

  • (c) the substance is required to meet the medical needs of the individual or animal for whose benefit it is prescribed; and

  • (d) the quantity exported does not exceed the lesser of

    • (i) a single course of treatment, and

    • (ii) a 90-day supply, based on the usual daily dose.

PART 6Test Kits

Marginal note:Authorization

  •  (1) A person may sell, provide, send, deliver, transport, import or export a test kit if

    • (a) a registration number has been issued for the test kit under subsections 72(1) or 75(2) and the number has not been cancelled under section 74;

    • (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 maker or assembler or, in the case where the test kit is made or assembled pursuant to a custom order, the name and address of the person for whom the test kit was custom made or assembled, and

        • (B) its brand name; and

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

  • Marginal note:Individual

    (2) An individual who does not hold a dealer’s licence may possess a test kit that contains a targeted substance set out in Part 2 of Schedule 1 if the test kit is labelled with its registration number.

  • SOR/2010-223, s. 32

Marginal note:Application for a registration number

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

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

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

    • (b.1) a statement of the proposed use of the test kit;

    • (c) a detailed description of the targeted substance contained in the test kit, including

      • (i) the specified name for the substance,

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

      • (iii) the quantity of the substance;

    • (d) a detailed description of each 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

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

  • Marginal note:Statement by signatory

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

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

    • (b) indicate that all the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

  • SOR/2010-223, ss. 33, 42(E)

Marginal note:Issuance of a registration number

  •  (1) Subject to subsection (2), the Minister must, after examining the information and documents required under sections 11 and 71, 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 the Minister has reasonable grounds to believe that

    • (a) the test kit poses a risk to security, 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 consumption of the targeted substance in the test kit by a human or animal or the administration of that substance to a human or animal; or

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

  • SOR/2010-223, ss. 34, 43(F)
 
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