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Marginal note:Remission — anticipated gross revenue

• 44 (1) Subject to subsection (4) and subsection 46(2), remission is granted of the amount by which the fee payable under section 39, 40 or 41, as applicable, exceeds 2.5% of the actual gross revenue from the medical device in question if that revenue is $100,000 or less and if

  • (a) the manufacturer provides with their licence application

    • (i) a statement signed by the individual responsible for the manufacturer’s financial affairs indicating that the anticipated gross revenue is $100,000 or less and certifying that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of that anticipated gross revenue,

    • (ii) information establishing that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of the anticipated gross revenue, 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 actual gross revenue will be $100,000 or less and that the fee payable under section 39, 40 or 41, as applicable, is likely to be greater than an amount equal to 2.5% of the actual gross revenue.

• Marginal note:Amounts payable

  (2) The fee is then payable as follows:

  • (a) an amount equal to 2.5% of the anticipated gross revenue is payable in accordance with section 39 or 42, as applicable; and

  • (b) the amount, if any, by which the lesser of the fee referred to in section 39, 40 or 41, as applicable, and 2.5% of the 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:Omission

  (4) If, within 60 days after the end of the fee verification period, the manufacturer has not provided the Minister with the sales records, the difference between the fee referred to in section 39, 40 or 41, as applicable, and the amount already paid is immediately payable.

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Marginal note:Activity

• 28 (1) If an application to amend an establishment licence seeks to add an activity at a building, the fee for the examination of the application for each building at which the activity is to be added is,

  • [...]

  • (d) if the amendment seeks to authorize the holder to distribute drugs (other than drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form) as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations but not to fabricate, package/label or import drugs, the basic fee set out in item 1, column 2, of Schedule 4; and

  • (e) if the amendment seeks to authorize the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, to distribute drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form as a distributor referred to in paragraph C.01A.003(b) of those Regulations, to wholesale drugs or to conduct more than one of those activities, but not to fabricate, package/label or import drugs or to distribute drugs (other than drugs that are listed in Schedule C to that Act and that are in dosage form) as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 23.

• (2) Subject to subsection (3), if an application to amend an establishment licence seeks to add a category in respect of an activity that is authorized by the licence at a building, the fee for the examination of the application for each building at which the category is to be added is,

  • [...]

  • (d) if the amendment seeks to authorize the holder to distribute a drug (other than a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form) of an additional category as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the basic fee set out in item 1, column 2, of Schedule 4;

  • (e) if the amendment seeks to authorize the holder to distribute a drug of an additional category as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, to distribute a drug that is listed in Schedule C to the Food and Drugs Act and that is in dosage form as a distributor referred to in paragraph C.01A.003(b) of those Regulations or to wholesale a drug of an additional category, the basic fee set out in section 23; and

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Marginal note:Licence authorizing distribution or wholesaling

23 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including distributing drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, distributing drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form as a distributor referred to in paragraph C.01A.003(b) of those Regulations or wholesaling drugs but not including fabricating, packaging/labelling or importing drugs or distributing drugs (other than drugs that are listed in Schedule C to the Food and Drugs Act and that are in dosage form) as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the fee is a basic fee of $3,870.

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Marginal note:Definitions

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

  controlled drug

  controlled drug  has the same meaning as in subsection G.01.001(1) of the Food and Drug Regulations. (drogue contrôlée)

  drug

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

  narcotic

  narcotic  has the same meaning as in section 2 of the Narcotic Control Regulations. (stupéfiant)

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