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

Regulations are current to 2013-11-02 and last amended on 2013-06-07. Previous Versions

Marginal note:Deferred payment — notice of compliance

  • 10. (1) If the person referred to in section 6 submits an application for authorization under section C.07.003 of the Food and Drug Regulations at the same time that it files the submission or supplement or makes the application for a drug identification number, the payment of the fee is deferred until the issuance of a notice of compliance under section C.08.004 of those Regulations or the issuance of a document setting out the drug identification number assigned for the drug under section C.01.014.2 of those Regulations.

  • Marginal note:Later date

    (2) If the person is also entitled to a deferral under section 9, the payment of the fee is deferred until the later date.

  • SOR/2013-121, s. 2(F).
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Remission

Marginal note:Remission — anticipated gross revenue

  • 11. (1) Subject to subsection (4) and subsection 13(2), remission is granted of the amount by which the fee payable under section 6 exceeds 10% of the actual gross revenue of a person referred to in that section if

    • (a) the person provides with their submission, supplement or application

      • (i) a statement signed by the individual responsible for the person’s financial affairs indicating the person’s anticipated gross revenue and certifying that the fee payable under section 6 is greater than an amount equal to 10% of that anticipated gross revenue,

      • (ii) information establishing that the fee payable under section 6 is greater than an amount equal to 10% of the person’s anticipated gross revenue, and

      • (iii) the amount of $500 for processing the remission; 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 fee payable under section 6 is likely to be greater than an amount equal to 10% of the person’s actual gross revenue.

  • Marginal note:Amounts payable

    (2) The fee is then payable as follows:

    • (a) an amount equal to 10% of the person’s anticipated gross revenue is payable in accordance with subsection 7(2); and

    • (b) the amount, if any, by which the lesser of the fee payable under section 6 and 10% of the person’s 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 person must provide the Minister with sales records in regard to the sales of the drug 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 person’s financial affairs certifying that the records were so prepared.

  • Marginal note:Omission

    (4) If, within 60 days after the end of the fee verification period, the person has not provided the Minister with the records referred to in subsection (3), the difference between the fee payable under section 6 and the amount already paid is immediately payable.

  • SOR/2013-121, s. 3(E).
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