Fees in Respect of Dealer’s Licences Regulations

Marginal note:Annual fee

• 35 (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.