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

Regulations are current to 2017-10-13 and last amended on 2013-12-19. Previous Versions

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.

Marginal note:Remission — dealer’s licence and establishment licence

 Remission is granted of an amount equal to the difference between the total of the fees payable under subsections 17(1) and 31(1) and an amount equal to 1% of the applicant’s actual gross revenue referred to in paragraph (a) if

  • (a) the total of the fees payable under those subsections is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under their dealer’s licence during the previous calendar year;

  • (b) the dealer’s licence and the establishment licence were issued to the same holder and are related to the same activities conducted at the same premises;

  • (c) remission has not been granted under subsection 17(2) nor under subsection 31(2); and

  • (d) the applicant has provided the statement referred to in subsection 31(2).

Marginal note:Audited sales records
  •  (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 31(2) is not adequate to determine the applicant’s actual gross revenue referred to in that subsection, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the applicant to provide sales records that have been audited by a qualified independent auditor.

  • Marginal note:Omission

    (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the applicant has not provided the Minister with them, the difference between the fee payable under subsection 31(1) and the amount already paid is immediately payable.

  • Marginal note:Difference payable

    (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 31, the difference between those amounts is immediately payable.

  • Marginal note:Difference remitted

    (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 31, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

DIVISION 4Fees for Right to Sell Drugs

Interpretation

Marginal note:Words and expressions

 The words and expressions used in this Division have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.

Fee

Marginal note:Annual fee
  •  (1) The annual fee that is payable by a manufacturer for the right to sell a drug for which a drug identification number has been assigned under section C.01.014.2 of the Food and Drug Regulations is $1,020.

  • Marginal note:Remission — actual gross revenue

    (2) Subject to subsection 36(2), if the fee is greater than an amount equal to 1.5% of the actual gross revenue from the sale of the drug in Canada during the previous calendar year, remission is granted of the difference between those amounts if the manufacturer provides with the notification referred to in subsection (3) a statement signed by the individual responsible for the manufacturer’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 the manufacturer furnishes the notification under section C.01.014.5 of the Food and Drug Regulations.

  • Marginal note:First year of activities

    (4) If the manufacturer has not completed its first calendar year of selling the drug, the payment of the fee is deferred until the end of that year.

Marginal note:Audited sales records
  •  (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 35(2) is not adequate to determine the actual gross revenue from the sale of the drug in Canada during the previous calendar year, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the manufacturer to provide sales records that have been audited by a qualified independent auditor.

  • Marginal note:Omission

    (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the manufacturer has not provided the Minister with them, the difference between the fee payable under subsection 35(1) and the amount already paid is immediately payable.

  • Marginal note:Difference payable

    (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 35, the difference between those amounts is immediately payable.

  • Marginal note:Difference remitted

    (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 35, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

PART 3Medical Device Fees

DIVISION 1Interpretation

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

    actual gross revenue

    actual gross revenue means the amount earned by a manufacturer during the fee verification period from sales in Canada of a medical device that is the subject of a licence application that is referred to in section 39, 40 or 41. (recettes brutes réelles)

    annual gross revenue

    annual gross revenue means

    • (a) in section 48, the amount earned by a manufacturer during a calendar year from sales in Canada of a medical device in respect of which the manufacturer holds a licence; and

    • (b) in sections 51 and 52, the amount earned by an establishment during a calendar year from sales in Canada of medical devices. (recettes brutes annuelles)

    anticipated gross revenue

    anticipated gross revenue means the amount that a manufacturer expects to earn during the fee verification period from sales in Canada of the medical device that is the subject of a licence application that is referred to in section 39, 40 or 41. (recettes brutes prévues)

    fee verification period

    fee verification period, in respect of a medical device that is the subject of a licence application, means

    • (a) for an application that is referred to in section 39 or 40, the period beginning on the day on which the medical device is first sold in Canada under the licence and ending two years after that day; and

    • (b) for an application that is referred to in section 41, the period beginning on the day on which the licence is amended and ending two years after that day. (période de vérification du prix à payer)

  • Definition of licence

    (2) In this Division and Divisions 2 and 3, licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations.

  • Marginal note:Words and expressions

    (3) Unless the context otherwise requires, all other words and expressions used in this Part have the meanings assigned to them by the Food and Drugs Act or the Medical Devices Regulations.

  • SOR/2013-121, s. 4.
 
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