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

Regulations are current to 2016-02-03 and last amended on 2015-06-13. Previous Versions

 The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

  • SOR/2004-238, s. 33.

 Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under sections J.01.007 and J.01.007.1, issue a dealer’s licence that contains

  • (a) the licence number;

  • (b) the name of the licensed dealer or the title of the position they hold, or, if the licensed dealer is a corporation, its corporate name;

  • (c) a list of the activities that are permitted;

  • (d) the address of the premises at which the licensed dealer may carry on the permitted activities;

  • (e) the name of the restricted drug for which the activities are permitted;

  • (f) the security level at the premises, determined in accordance with the Security Directive;

  • (g) the effective date of the licence;

  • (h) the expiry date of the licence, which may not be later than three years after its effective date;

  • (i) any conditions to be met by the licensed dealer to

    • (i) ensure that an international obligation is respected,

    • (ii) provide the security level referred to in paragraph (f), or

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

  • (j) in the case of a producer of a restricted drug, the quantity of the restricted drug that may be produced under the licence and the period during which that quantity may be produced; and

  • (k) in the case of the maker or assembler of a product or compound that contains a restricted drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:

    • (i) the licence number,

    • (ii) the name, number or identifying mark, if any, of each product or compound,

    • (iii) the restricted drug in each product or compound,

    • (iv) the strength per unit of the restricted drug in each product or compound, and

    • (v) the quantity or package sizes of each product or compound.

  • SOR/2004-238, s. 33;
  • SOR/2010-222, ss. 26, 35(F);
  • SOR/2014-260, s. 10.
  •  (1) The Minister shall refuse to issue, renew or amend a dealer’s licence if

    • (a) the applicant is not eligible under section J.01.003.1;

    • (b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section J.01.025;

    • (c) false or misleading information or false or falsified documents were submitted in or with the application;

    • (d) an activity for which the licence is requested would not be in compliance with an international obligation;

    • (e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;

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

    • (g) the applicant is in contravention of or has contravened during the preceding 10 years

      • (i) a provision of the Act or any regulations made or continued under the Act, or

      • (ii) a term or condition of another dealer’s licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act;

    • (h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a restricted drug being diverted to an illicit market or use;

    • (i) the individual in charge of the premises, the proposed qualified person in charge or, if applicable, the alternate proposed qualified person in charge has been convicted, as an adult, within the preceding 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);

    • (j) the proposed method referred to in paragraph J.01.007(1)(j) is not capable of recording the applicant’s restricted drug transactions as required under section J.01.023 or permitting the Minister to audit the applicant’s activities with respect to restricted drugs in a timely manner; or

    • (k) the additional information required under section J.01.007.1 has not been provided or is insufficient to process 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 refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant

    • (a) does not have a history of non compliance with the Act or any regulation 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. 27, 35(F).
  •  (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister

    • (a) the information required under paragraphs J.01.007(1)(a) to (k); and

    • (b) the following documents, namely,

      • (i) the documents referred to in paragraphs J.01.007(3)(a) and (d) and, subject to subsection J.01.007(5), the document specified in paragraph J.01.007(3)(b),

      • (ii) if applicable and if not previously submitted in respect of the dealer’s licence that is being renewed, the document referred to in paragraph J.01.007(3)(e), and

      • (iii) the original dealer’s licence that is to be renewed.

  • (2) An application for renewal must

    • (a) be signed by the individual in charge of the premises to which the renewed 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 information and documents required under subsections (1) and (2) and section J.01.007.1, issue a renewed dealer’s licence that contains the information specified in paragraphs J.01.007.2(a) to (k).

  • SOR/2004-238, s. 33;
  • SOR/2014-260, s. 16(F).
  •  (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).
 
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