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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2019-06-20 and last amended on 2015-06-13. Previous Versions

Test Kits Containing Restricted Drugs

 Any person may sell, possess or otherwise deal in a test kit that contains a restricted drug if

  • (a) a registration number has been issued for the test kit pursuant to section J.01.033.3;

  • (b) the test kit bears, on its external surface,

    • (i) the name of the producer, maker or assembler,

    • (ii) the trade name or trademark, and

    • (iii) the registration number issued therefor pursuant to section J.01.033.3;

  • (c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

  • (d) the registration number has not been cancelled pursuant to section J.01.033.4.

  • SOR/2004-238, s. 41
  • 2014, c. 20, s. 366(E)

 The manufacturer of a test kit that contains a restricted drug may apply for a registration number therefor by submitting to the Minister an application containing

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

  • (b) a detailed description of the restricted drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

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

  • (d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.

  • SOR/2018-69, s. 70

 Where, on application under section J.01.033.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

  • (a) contains a restricted drug and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

  • (b) contains such small quantities or concentrations of any restricted drug as to have no significant drug abuse potential,

the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters “TK”.

  • SOR/81-21, ss. 3, 4
  • SOR/86-91, s. 4(F)

 The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister’s opinion,

  • (a) it is necessary to cancel the registration number in the interest of public health; or

  • (b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

Prescribed Manner of Notice of Application for an Order of Restoration

  •  (1) For the purpose of subsection 24(1) of the Controlled Drugs and Substances Act, notice of application for an order of restoration shall be given in writing to the Attorney General by registered mail.

  • (2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application is to be made to the magistrate and shall specify

    • (a) the magistrate to whom the application is to be made;

    • (b) the time and place where the application is to be heard;

    • (c) the restricted drug or other thing in respect of which the application is to be made; and

    • (d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the restricted drug or other thing referred to in paragraph (c).

  • SOR/97-228, s. 24

 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Controlled Drugs and Substances Act, the member or person is, in respect of that conduct, exempt from the application of this Part.

  • SOR/97-228, s. 25
 
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