Fees in Respect of Drugs and Medical Devices Regulations (SOR/2011-79)

Regulations are current to 2013-11-02 and last amended on 2013-06-07. Previous Versions

Division 3Fees for the Examination of Dealer’s Licence Applications

Interpretation

Marginal note:Definitions
  •  (1) The following definitions apply in this Division.

    “controlled drug”

    « drogue contrôlée »

    “controlled drug” has the same meaning as in subsection G.01.001(1) of the Food and Drug Regulations.

    “dealer’s licence”

    « licence de distributeur autorisé »

    “dealer’s licence” means

    “health care facility”

    « établissement de santé »

    “health care facility” means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities.

    “narcotic”

    « stupéfiant »

    “narcotic” has the same meaning as in section 2 of the Narcotic Control Regulations.

  • Marginal note:Words and expressions

    (2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Controlled Drugs and Substances Act, Part G of the Food and Drug Regulations or the Narcotic Control Regulations.

Application

Marginal note:Non-application

 This Division does not apply to

  • (a) any publicly funded health care facility;

  • (b) any branch or agency of the Government of Canada or of the government of a province; or

  • (c) any person or organization engaged only in scientific investigation.

Fees

Marginal note:Fee — Dealer’s licence
  •  (1) The fee payable by an applicant for the examination of an application for either a dealer’s licence or the renewal of a dealer’s licence is $4,510 for each of the premises at which activities are to be conducted under the licence.

  • Marginal note:Remission

    (2) Subject to section 32 and subsection 33(2), if the fee is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under a dealer’s licence during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides with their application a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

  • Marginal note:Timing of payment

    (3) Subject to subsection (4), the fee is payable at the time of submitting the application for a dealer’s licence or for the renewal of a dealer’s licence under section 9 or 9.5 of the Narcotic Control Regulations or section G.02.003 or G.02.003.4 of the Food and Drug Regulations.

  • Marginal note:First year of activities

    (4) If the applicant has not completed their first calendar year of conducting activities under the licence, the payment of the fee is deferred until the end of that year.