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

Marginal note:Remission — actual gross revenue

12. If the amount already paid is greater than 10% of the actual gross revenue of the person referred to in section 6, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Marginal note:Audited sales records

• 13. (1) If the Minister determines, on the basis of any information available to the Minister, that the records provided in accordance with subsection 11(3) are not adequate to determine the actual gross revenue of the person referred to in section 6, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the person 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 person has not provided the Minister with them, the difference between the fee payable under section 6 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 10% of the person’s actual gross revenue, the amount by which the lesser of the fee payable under section 6 and 10% of the person’s actual gross revenue exceeds the amount paid is immediately payable.

• Marginal note:Difference remitted

  (4) If the audited sales records establish that the amount already paid is greater than 10% of the person’s actual gross revenue, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Marginal note:Remission

14. Remission is granted to the person referred to in section 6 of the amount of the fee referred to in that section in respect of a drug if the manufacturer has received an authorization under section 21.04 of the Patent Act.

Marginal note:Definitions

• 15. (1) The following definitions apply in this Division.

  “activity”

  « activité »

  “activity” means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations.

  “category”

  « catégorie »

  “category” means a category of drugs set out in Table II to section C.01A.008 of the Food and Drug Regulations.

  “drug”

  « drogue »

  “drug” has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations.

  “establishment licence”

  « licence d’établissement »

  “establishment licence” means a licence issued under section C.01A.008 of the Food and Drug Regulations.

  “health care facility”

  « établissement de santé »

  “health care facility” means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities.

• Marginal note:Words and expressions

  (2) Unless the context otherwise requires, all other 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.