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

Regulations are current to 2020-01-16 and last amended on 2015-06-13. Previous Versions

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

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 controlled 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 controlled 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.

  • SOR/2004-238, s. 4
  • SOR/2019-171, s. 1

 [Repealed, SOR/2004-238, s. 4]

Marginal note:Validity

 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section G.02.027 or G.02.028.

  • SOR/2019-171, s. 1

Marginal note:Refusal

  •  (1) The Minister must refuse to issue a dealer’s licence if

    • (a) the applicant may not apply for a licence under section G.02.002;

    • (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened

      • (i) a provision of the Act, the Cannabis Act or their regulations, or

      • (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;

    • (c) during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii);

    • (d) an activity for which the licence is requested would contravene an international obligation;

    • (e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

    • (f) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required under section G.02.071;

    • (g) the applicant has not complied with the requirements of subsection G.02.006(4) or the information and documents that they have provided are not sufficient to complete the review of the licence application;

    • (h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;

    • (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or

    • (j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

  • Marginal note:Exceptions

    (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (h) if the applicant meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use:

    • (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

    • (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

  • Marginal note:Notice

    (3) Before refusing to issue a licence, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

  • SOR/2019-171, s. 1

Marginal note:Application

  •  (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections G.02.006(1) and (2).

  • Marginal note:Signature and attestation

    (2) The application must

    • (a) be signed and dated by the senior person in charge of the site specified in the application; 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 licensed dealer.

  • Marginal note:Additional information and documents

    (3) The licensed dealer 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.

  • SOR/2019-171, s. 1

Marginal note:Renewal

  •  (1) Subject to section G.02.013, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in section G.02.007.

  • Marginal note:Terms and conditions

    (2) When renewing a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

    • (a) ensure that an international obligation is respected;

    • (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or

    • (c) reduce a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

  • SOR/2004-238, s. 5
  • SOR/2010-222, s. 7
  • SOR/2019-171, s. 1

 [Repealed, SOR/2019-171, s. 1]

 
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