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

Regulations are current to 2019-06-20 and last amended on 2018-05-17. Previous Versions

  •  (1) To have its dealer’s licence amended, a licensed dealer shall submit to the Minister

    • (a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section J.01.007 that are relevant to the proposed amendment; and

    • (b) the original dealer’s licence.

  • (2) An application for amendment must

    • (a) be signed by the individual in charge of the premises to which the amended dealer’s licence would apply; and

    • (b) be accompanied by a statement signed by the individual in charge indicating that

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

      • (ii) the individual in charge has the authority to bind the applicant.

  • (3) Subject to section J.01.007.3, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application and may add any conditions to be met by the licensed dealer to

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

    • (b) provide for the security level referred to in paragraph J.01.007.2(f) or the new level required as a result of the amendment being implemented; or

    • (c) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use.

  • SOR/2004-238, s. 33
  • SOR/2010-222, ss. 28(F), 35(F)
  • SOR/2014-260, ss. 11, 16(F)
  •  (1) A licensed dealer shall

    • (a) obtain the Minister’s approval before making any of the following changes, namely,

      • (i) a change relating to the security at the premises referred to in the dealer’s licence, or

      • (ii) the replacement or the addition of

        • (A) an individual in charge of the premises to which the dealer’s licence applies,

        • (B) a qualified person in charge and, if applicable, an alternate qualified person in charge at the premises to which the dealer’s licence applies, and

        • (C) an individual authorized to place an order for a restricted drug on behalf of the licensed dealer;

    • (b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in

      • (i) the application for a dealer’s licence under section J.01.007,

      • (ii) the application to renew a dealer’s licence under section J.01.007.4, or

      • (iii) the request for approval under paragraph (a); and

    • (c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in

      • (i) the application for a dealer’s licence under section J.01.007,

      • (ii) the application to renew a dealer’s licence under section J.01.007.4, or

      • (iii) the request for approval under paragraph (a).

  • (2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person:

    • (a) in the case of the replacement of the individual in charge of the premises to which the dealer’s licence applies,

      • (i) the information specified in paragraph J.01.007(1)(c), and

      • (ii) the declarations specified in paragraph J.01.007(3)(a) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c);

    • (b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer’s licence applies,

      • (i) the information specified in paragraph J.01.007(1)(d), and

      • (ii) the documents specified in paragraphs J.01.007(3)(a), (d) and (e) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c); and

    • (c) in the case of the replacement or addition of an individual who is authorized to place an order for a restricted drug on behalf of the licensed dealer, the individual’s name and gender.

  • SOR/2004-238, s. 33
  • SOR/2014-260, s. 14(F)

 The Minister shall revoke a dealer’s licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.

  • SOR/2004-238, s. 33
  • SOR/2014-260, s. 15(F)
  •  (1) Subject to subsection (2), the Minister shall revoke a dealer’s licence in accordance with section J.01.007.91 if

    • (a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;

    • (b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part;

    • (c) the licensed dealer is no longer an eligible person under section J.01.003.1;

    • (d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises, has been convicted, as an adult, within the previous 10 years, of

      • (i) a designated drug offence,

      • (ii) a designated criminal offence, or

      • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or

    • (e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use.

  • (2) Unless it is necessary to do so to protect public health, safety, or security, including preventing a restricted drug from being diverted to an illicit market or use, the Minister shall not revoke a dealer’s licence under paragraph (1)(a) or (b) if the licensed dealer

    • (a) has no history of non-compliance with the Act and the regulations made or continued under it; and

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

  • SOR/2004-238, s. 33
  • SOR/2010-222, ss. 29, 35(F)
  • SOR/2014-260, ss. 14(F), 15(F)
 
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