Fees in Respect of Dealer’s Licences Regulations

Marginal note:Remission — anticipated gross revenue

• 44 (1) Subject to subsection (4) and subsection 46(2), remission is granted of the amount by which the fee payable under section 39, 40 or 41, as applicable, exceeds 2.5% of the actual gross revenue from a medical device if that revenue is $100,000 or less and if

  • (a) the manufacturer provides with their licence application

    • (i) a statement signed by the individual responsible for the manufacturer’s financial affairs indicating that the anticipated gross revenue is $100,000 or less and certifying that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of that anticipated gross revenue,

    • (ii) information establishing that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of the anticipated gross revenue, and

    • (iii) the amount of $50 for processing the remission, except in the case of the remission of a fee payable under section 39; and

  • (b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister determines that the actual gross revenue will be $100,000 or less and that the fee payable under section 39, 40 or 41, as applicable, is likely to be greater than an amount equal to 2.5% of the actual gross revenue.

• Marginal note:Amounts payable

  (2) The fee is then payable as follows:

  • (a) an amount equal to 2.5% of the anticipated gross revenue is payable in accordance with section 39 or 42, as applicable; and

  • (b) the amount, if any, by which the lesser of the fee referred to in section 39, 40 or 41, as applicable, and 2.5% of the actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

• Marginal note:Sales records

  (3) Within 60 days after the end of the fee verification period, the manufacturer must provide the Minister with sales records in regard to the sales of the medical device in Canada during the fee verification period, prepared in accordance with generally accepted accounting principles, and a document signed by the individual responsible for the manufacturer’s financial affairs certifying that they were so prepared.

• Marginal note:Omission

  (4) If, within 60 days after the end of the fee verification period, the manufacturer has not provided the Minister with the sales records, the difference between the fee referred to in section 39, 40 or 41, as applicable, and the amount already paid is immediately payable.