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

Regulations are current to 2016-04-03 and last amended on 2016-02-09. Previous Versions

  •  (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).

 The Minister shall suspend a dealer’s licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a restricted drug from being diverted to an illicit market or use.

  • SOR/2004-238, s. 33;
  • SOR/2010-222, s. 35(F).
  •  (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer’s licence under this Part, the Minister shall

    • (a) send a notice to the applicant or to the licensed dealer, together with a written report that sets out the reasons for the proposed refusal or revocation; and

    • (b) give the applicant or the licensed dealer an opportunity to be heard in respect of the proposed refusal or revocation.

  • (2) The suspension of a licence under this Part takes effect as soon as the Minister notifies the licensed dealer of the decision to suspend and provides a written report that sets out the reasons for the suspension.

  • (3) A person who receives a notice of suspension referred to in subsection (2) may, in the 10 days following the receipt of the notice, provide the Minister with reasons why the suspension of the licence is unfounded.

  • SOR/2004-238, s. 33;
  • SOR/2014-260, s. 12.

 [Repealed, SOR/2004-238, s. 33]

 The Minister may impose such restrictions and conditions on a licensed dealer as he deems necessary for the control of a restricted drug.

 A licensed dealer may at any time make an application to the Minister to amend his licence in order to become a licensed dealer in respect of a restricted drug other than a restricted drug specified in his licence or to change the terms or conditions of his licence.

 A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the restricted drugs specified in their dealer’s licence.

  • SOR/2004-238, s. 34.

 The Minister shall revoke a permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.

  • SOR/2004-238, s. 34;
  • SOR/2010-222, s. 30.
  •  (1) Subject to subsection (2), the Minister shall revoke a permit by taking the same measures as those set out in subsection J.01.007.91(1) if

    • (a) any of paragraphs J.01.007.8(1)(a) to (e) applies with respect to the dealer’s licence as it pertains to the restricted drug to be imported or exported; or

    • (b) the import or export permit was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application.

  • (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 permit under paragraph J.01.007.8(1)(a) or (b) or J.01.012.1(1)(b) if the holder meets the conditions set out in paragraphs J.01.007.8(2)(a) and (b).

  • (3) The Minister may revoke a permit if the holder

    • (a) fails to comply with the Minister’s decision to suspend the permit under section J.01.012.2; or

    • (b) fails to rectify the situation giving rise to the suspension within the period referred to in subsection J.01.012.2(3).

  • SOR/2010-222, s. 30;
  • SOR/2014-260, s. 13.
 
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