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

Regulations are current to 2022-09-22 and last amended on 2019-12-09. Previous Versions

Test Kits (continued)

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.

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.

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).

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.

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.

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.

Licensed Dealers

Authorized Activities

Marginal note:General

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

  • Marginal note:Qualified person in charge present

    (2) A licensed dealer may conduct an activity in relation to a targeted substance 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 in order to import or export a targeted substance.

  • Marginal note:Possession for export

    (4) A licensed dealer may possess a targeted substance for the purpose of exporting it if they have obtained it in accordance with these Regulations.

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 targeted substances 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 targeted substances 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 targeted substances that are specified in the licence application and for ensuring that those activities comply with these Regulations. 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 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 targeted substances 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 these Regulations 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.

Marginal note:Ineligibility

 An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,

  • (a) in respect of a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act, the individual

    • (i) was convicted as an adult, or

    • (ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or

  • (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act,

    • (i) the individual was convicted as an adult, or

    • (ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence.

Issuance of Licence

Marginal note:Application

  •  (1) A person who intends to conduct an activity referred to in section 12 must obtain a dealer’s licence for each site at which they intend to conduct activities by submitting an application to the Minister that contains the following information:

    • (a) if the licence is requested by

      • (i) an individual, the individual’s name,

      • (ii) a corporation, its corporate name and any other name registered with a province under which it intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself, and

      • (iii) the holder of a position described in paragraph 13(c), the applicant’s name and the title of the position;

    • (b) the municipal address, telephone number and, if applicable, the email address of the proposed site and, if different from the municipal address, its mailing address;

    • (c) the name, date of birth, telephone number and email address of the proposed senior person in charge;

    • (d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge,

      • (i) their name, date of birth, telephone number and email address,

      • (ii) the title of their position at the site,

      • (iii) the name and title of the position of their immediate supervisor at the site,

      • (iv) if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and

      • (v) their education, training and work experience that are relevant to their duties;

    • (e) the activities that are to be conducted and the targeted substances in respect of which each of the activities is to be conducted;

    • (f) if the licence is requested to manufacture or assemble a product or compound that contains a targeted substance, other than a test kit, a list that includes, for each product or compound,

      • (i) the brand name of the product or the name of the compound,

      • (ii) the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any,

      • (iii) the specified name of the targeted substance in the product or compound,

      • (iv) the strength per unit of the targeted substance in it, the number of units per package and the number of packages,

      • (v) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer, and

      • (vi) if the applicant’s name appears on the label of the product or compound, a copy of the inner label, as defined in section A.01.010 of the Food and Drug Regulations;

    • (g) if the licence is requested in order to produce a targeted substance other than a product or compound that contains a targeted substance,

      • (i) the specified name of the targeted substance,

      • (ii) the quantity that the applicant expects to produce under their licence and the period during which that quantity would be produced, and

      • (iii) if it is to be produced for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer;

    • (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the specified name of the targeted substance for which the activity is to be conducted and the purpose of the activity;

    • (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and

    • (j) a detailed description of the method for recording information that the applicant proposes to use for the purpose of section 40.

  • Marginal note:Documents

    (2) An application for a dealer’s licence must be accompanied by the following documents:

    • (a) if the applicant is a corporation, a copy of

      • (i) the certificate of incorporation or other constituting instrument, and

      • (ii) any document filed with the province in which its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself;

    • (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section 16;

    • (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 16(a)(i) or received a sentence as specified in subparagraph 16(a)(ii);

    • (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 16(b)(i) or received a sentence as specified in subparagraph 16(b)(ii);

    • (e) a declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 15(3)(c) and (d); and

    • (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph 15(3)(b)(i), either

      • (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph 15(3)(b)(ii) or (iii), or

      • (ii) a detailed description of the education, training and work experience that is required under paragraph 15(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.

  • Marginal note:Signature and attestation

    (3) The application must

    • (a) be signed and dated by the proposed senior person in charge; and

    • (b) include an attestation by that person that

      • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

      • (ii) they have the authority to bind the applicant.

  • Marginal note:Additional information and documents

    (4) 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.

 
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