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Marginal note:Amendment to add activity

• 17 (1) If an establishment licence is amended to add an activity at a site, the fee payable for the amendment to the licence is, for each site at which the activity is added,

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  • (d) if the amendment authorizes the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, but the amended licence does not authorize the holder to fabricate, package/label or import drugs, the basic fee set out in column 2 of item 1 of Schedule 3; and

  • (e) if the amendment authorizes the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, or to wholesale drugs or to carry out both activities, but the amended licence does not authorize the holder to fabricate, package/label or import drugs or distribute drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 9.

• (2) Subject to subsection (3), if an establishment licence is amended to add a category of drugs for an activity that is authorized by the licence at a site, the fee payable for the amendment to the licence is, for each site at which the category of drugs is added for the authorized activity,

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  • (d) if the amendment authorizes the holder to distribute an additional category of drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the basic fee set out in column 2 of item 1 of Schedule 3;

  • (e) if the amendment authorizes the holder to distribute an additional category of drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, or to wholesale an additional category of drugs, the basic fee set out in section 9; and

Marginal note:Fee for reinstated licence

• 20 (1) Subject to subsection (2), if an establishment licence has been suspended by the Minister of Health in respect of any or all matters indicated in subsection C.01A.008(2) of the Food and Drug Regulations, the fee payable for a reinstated licence is

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  • (d) if it authorizes the holder to carry out one or more activities, including distributing drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, but not including fabricating, packaging/labelling or importing drugs, for each site in respect of which the matter is reinstated, the basic fee set out in column 2 of item 1 of Schedule 3;

  • (e) if it authorizes the holder to carry out one or more activities, including distributing drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations or wholesaling drugs but not including fabricating, packaging/labelling or importing drugs or distributing drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, for each site in respect of which the matter is reinstated, the basic fee set out in section 9; and

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Marginal note:Remission

• 11 (1) Subject to subsection 13(2), if the total of the fees payable under sections 3 to 10 of these Regulations and the fee payable under section 3 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations is greater than an amount equal to 1.5% of the applicant’s actual gross revenue from the sale, testing and packaging/labelling of drugs, as well as controlled drugs and narcotics not in dosage form, for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides, with their application for the annual review of their licence, a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

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Marginal note:Licence authorizing distribution or wholesaling

9 The fee that is payable for each site at which one or more activities is authorized by the establishment licence, including distributing drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations or wholesaling drugs but not including fabricating, packaging/labelling or importing drugs or distributing drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, is a basic fee of $1,500.

Marginal note:Definitions

• 1 (1) The definitions in this subsection apply in these Regulations.

  drug

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

• Marginal note:Other words and expressions

  (2) Unless the context otherwise requires, all other words and expressions used in these Regulations have the meanings assigned to them by the Food and Drugs Act, the Food and Drug Regulations, the Controlled Drugs and Substances Act or the Narcotic Control Regulations, as the case may be.