Fees in Respect of Dealer’s Licences Regulations

Marginal note:Definitions

• 37 (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.