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

Regulations are current to 2019-06-20 and last amended on 2018-10-17. Previous Versions

PART 6Test Kits (continued)

Marginal note:Effect of the registration number

 The requirement in subparagraph C.01.004(1)(b)(iv) of the Food and Drug Regulations that a symbol be displayed on the label of a targeted substance does not apply to a test kit if a registration number has been issued under subsection 72(1) or 75(2) for that test kit and the number is displayed on the label.

  • SOR/2010-223, s. 35(E)

Marginal note:Cancellation

  •  (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 activities referred to in section 70 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; or

    • (c) there exists a reason set out in paragraph 72(2)(a).

  • Marginal note:Non-compulsory compensation

    (2) The Minister may cancel the registration number of a test kit if the Minister determines 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, after considering the nature and extent of that other purpose, concludes that it 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.

  • Marginal note:Effect of cancellation

    (3) 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 made 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/2010-223, s. 36

Marginal note:Application for a new number

  •  (1) If a registration number issued for a test kit has been cancelled under subsection 74(1) or (2), the maker or assembler of the test kit or, where the test kit is made or assembled pursuant to a custom order, the person for whom the test kit was custom made or assembled

    • (a) may, after a period of 90 days following the cancellation, apply to the Minister for the issuance of a new registration number; and

    • (b) must, in support of the application, provide the Minister with proof that the circumstance that gave rise to the cancellation has been corrected.

  • Marginal note:New number

    (2) The Minister, after examining the application and supporting proof referred to in subsection (1), must issue a new registration number for the test kit unless there exists a circumstance set out in paragraph 74(1)(b) or (c) or subsection 74(2).

Marginal note:Notice to the Minister

 The holder of a registration number for a test kit issued under subsection 72(1) or 75(2) must inform the Minister in writing, within 30 days after the event, if they have

  • (a) ceased all activities referred to in section 70 with respect to the test kit;

  • (b) transferred the making 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 a new adulterating or denaturing agent.

PART 7Targeted Substances in Transit or Transhipment

Marginal note:Application

  •  (1) If a targeted substance is being shipped from a country of export to a foreign country by a route that requires it to be in transit through Canada or to be transhipped in Canada, the exporter in the country of export or an agent or mandatary in Canada of that exporter must apply to the Minister for a permit for transit or transhipment by providing the following information:

    • (a) the name, address and telephone number of the exporter in the country of export;

    • (b) the name, address and telephone number of the person who will be responsible for the targeted substance while it is in Canada;

    • (c) with respect to the targeted substance for which the permit is requested,

      • (i) its specified name,

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

      • (iii) if applicable, its brand name,

      • (iv) the quantity,

      • (v) in the case of a raw material, its purity, and

      • (vi) if applicable, its anhydrous content;

    • (d) the expected date of transit or transhipment in Canada;

    • (e) the name of the Canadian port of entry and exit;

    • (f) each mode of transportation that is to be used in Canada for the targeted substance; and

    • (g) in the case of a transhipment, the address, if applicable, of every place in Canada at which the targeted substance will be stored during the transhipment and the expected duration of each storage.

  • Marginal note:Supporting documentation

    (2) An application referred to in subsection (1) must be accompanied by

    • (a) a copy of the export permit issued by a competent authority in the country of export; and

    • (b) a copy of the import permit issued by a competent authority in the country of final destination.

  • Marginal note:Statement by signatory

    (3) An application referred to in subsection (1) must

    • (a) be signed by a person who is authorized for that purpose by the exporter, including an agent or mandatary in Canada of that exporter; and

    • (b) state 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. 37(E), 42(E)
  • SOR/2018-69, s. 78(E)

Marginal note:Permit for transit or transhipment

  •  (1) Subject to subsection (2), after examining the information and documents required under sections 11 and 77, the Minister must issue a permit for transit or transhipment that contains the following information:

    • (a) the name, address and telephone number of the exporter in the country of export;

    • (b) the name, address and telephone number of the person who is responsible for the targeted substance while it is in Canada;

    • (c) the specified name, quantity, purity and strength per unit of the targeted substance;

    • (d) the countries of export and final destination and the numbers and expiry dates of the export and import permits issued by a competent authority in each of those countries;

    • (e) the expected date of the transit or transhipment in Canada;

    • (f) the names of the Canadian ports of entry and exit;

    • (g) each mode of transportation that is to be used for the targeted substance while in Canada;

    • (h) in the case of a transhipment, the address, if applicable, of every place in Canada at which the targeted substance may be stored during the transhipment and the duration of each storage; and

    • (i) the dates of issuance and expiry of the permit.

  • Marginal note:Refusal to issue a permit

    (2) The Minister must refuse to issue a permit for transit or transhipment if the Minister has reasonable grounds to believe that

    • (a) the issuance of the permit

      • (i) would not be in conformity with an international obligation,

      • (ii) would be in contravention of the Act, the regulations, another Act of Parliament, or a law of the country of export, of the country of final destination or of a country of transit or transhipment, or

      • (iii) would likely create a risk to security, public health or safety, including the risk of the targeted substance being diverted to an illicit market or use; or

    • (b) the import permit issued by a competent authority in the country of final destination has expired or has been suspended or revoked.

  • SOR/2010-223, ss. 38(E), 43(F)
 
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