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

Regulations are current to 2022-07-13 and last amended on 2022-03-02. Previous Versions

PART JRestricted Drugs (continued)

Possession (continued)

 [Repealed, SOR/2019-171, s. 22]

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 J.01.007 and has not been cancelled under section J.01.008;

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

    • (i) the name of the manufacturer,

    • (ii) the trade name or trademark, and

    • (iii) the registration number; and

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

Marginal note:Application for registration number

  •  (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing

    • (a) a detailed description 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; and

    • (c) a description of the proposed 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 or document

    (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.

Marginal note:Issuance of registration number

 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 and that it contains

  • (a) a restricted drug and an adulterating or denaturing agent that are combined in such a manner and in such a quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential; or

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

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

 [Repealed, SOR/2019-171, s. 22]

Marginal note:Cancellation of registration number

 The Minister must cancel the registration number for a test kit if

  • (a) the test kit is removed from the market by the manufacturer;

  • (b) the Minister has reasonable grounds to believe that the test kit is used or is likely to be used for any purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; or

  • (c) the Minister has reasonable grounds to believe that the cancellation is necessary to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use.

Licensed Dealers

Authorized Activities

Marginal note:General

  •  (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

  • Marginal note:Qualified person in charge present

    (2) A licensed dealer may conduct an activity in relation to a restricted drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

  • Marginal note:Permit — import and export

    (3) A licensed dealer must obtain a permit to import or export a restricted drug.

  • Marginal note:Possession for export

    (4) A licensed dealer may possess a restricted drug for the purpose of exporting it if they have obtained it in accordance with this Part.

Dealer’s Licences

Preliminary Requirements

Marginal note:Eligible persons

 The following persons may apply for a dealer’s licence:

  • (a) an individual who ordinarily resides in Canada;

  • (b) a corporation that has its head office in Canada or operates a branch office in Canada; or

  • (c) the holder of a position that includes responsibility for restricted drugs on behalf of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

Marginal note:Senior person in charge

 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to restricted drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Marginal note:Qualified person in charge

  •  (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to restricted drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

  • Marginal note:Alternate qualified person in charge

    (2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

  • Marginal note:Qualifications

    (3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:

    • (a) they work at the site specified in the dealer’s licence;

    • (b) they

      • (i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,

      • (ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or

      • (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold

        • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or

        • (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;

    • (c) they have sufficient knowledge of and experience with the use and handling of the restricted drugs specified in the dealer’s licence to properly carry out their duties; and

    • (d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

  • Marginal note:Exception

    (4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if

    • (a) no other individual working at the site meets those requirements;

    • (b) those requirements are not necessary for the activities specified in the licence; and

    • (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

 
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