Marginal note:Audited sales records

• 36. (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

• 37. (1) The following definitions apply in this Part.

  “actual gross revenue”

  « recettes brutes réelles »

  “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.

  “annual gross revenue”

  « recettes brutes annuelles »

  “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.

  “anticipated gross revenue”

  « recettes brutes prévues »

  “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.

  “fee verification period”

  « période de vérification du prix à payer »

  “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.

• 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.