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

Regulations are current to 2017-11-20 and last amended on 2013-12-19. Previous Versions

Marginal note:Licence authorizing importation

 If one or more activities, including importing drugs but not including fabricating or packaging/labelling drugs, are referred to in the application for an establishment licence, the fee for the examination of that application is

  • (a) for each building at which those activities are to be conducted, the basic fee, set out in item 1, column 2, of Schedule 4, and any of the following fees that are applicable:

    • (i) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2, column 2, of Schedule 4,

    • (ii) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3, column 2, of Schedule 4; and

  • (b) for each fabricator outside Canada of drugs that are to be imported, except if the importer provides a certificate from a Canadian inspector indicating that the fabricator’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 of Part C of the Food and Drug Regulations, the sum of the following fees that are applicable:

    • (i) the fee set out in item 4, column 2, of Schedule 4,

    • (ii) if the licence is in respect of more than one dosage form class, for each additional dosage form class, the fee set out in item 5, column 2, of Schedule 4.

Marginal note:Licence authorizing distribution

 For the examination of an application for an establishment licence for each building at which 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 — are to be conducted, the fee is the basic fee, set out in item 1, column 2, of Schedule 4, and any of the following fees that are applicable:

  • (a) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2, column 2, of Schedule 4;

  • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3, column 2, of Schedule 4.

Marginal note:Licence authorizing distribution or wholesaling

 For the examination of an application for an establishment licence for each building at which 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 — are to be conducted, the fee is a basic fee of $3,870.

Marginal note:Licence authorizing testing

 For the examination of an application for an establishment licence for each building at which only the testing of drugs is to be conducted, the fee is a basic fee of $2,580.

Marginal note:Drug analysis fee

 In addition to the fees referred to in sections 19 to 22, if the application for an establishment licence seeks to 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 the Food and Drug Regulations, the fee is the highest fee set out in column 2 of Schedule 5 that corresponds to the drugs described in column 1

  • (a) in respect of which the licence is requested; and

  • (b) for which the holder has obtained a drug identification number, except in the case of an importer.

Marginal note:Audited sales records
  •  (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 17(2) is not adequate to determine the applicant’s actual gross revenue referred to in that subsection, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the applicant 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 applicant has not provided the Minister with them, the difference between the fee payable under subsection 17(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 17, 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 17, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

Licence Amendment

Marginal note:Sterile dosage forms

 If the application to amend an establishment licence authorizing the holder to conduct one or more activities including fabricating drugs seeks to authorize the holder to fabricate drugs in sterile dosage forms for the first time at a building, the fee for the examination of the application is the basic fee set out in item 1, column 2, of Schedule 2 for each building referred to in the application.

Marginal note:Activity
  •  (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,

    • (a) if the amendment seeks to authorize the holder to fabricate drugs, the basic fee set out in item 1, column 2, of Schedule 2;

    • (b) if the amendment seeks to authorize the holder to package/label drugs but not to fabricate drugs, the basic fee set out in item 1, column 2, of Schedule 3;

    • (c) if the amendment seeks to authorize the holder to import drugs but not to fabricate or package/label drugs, the basic fee set out in item 1, column 2, of Schedule 4;

    • (d) if the amendment seeks to authorize the holder to distribute drugs 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, or to wholesale drugs or to conduct both of those activities, but not to fabricate, package/label or import drugs or to distribute drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 23.

  • Marginal note:Category

    (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,

    • (a) if the amendment seeks to authorize the holder to fabricate a drug of an additional category, the basic fee set out in item 1, column 2, of Schedule 2;

    • (b) if the amendment seeks to authorize the holder to package/label a drug of an additional category, the basic fee set out in item 1, column 2, of Schedule 3;

    • (c) if the amendment seeks to authorize the holder to import a drug of an additional category, the basic fee set out in item 1, column 2, of Schedule 4;

    • (d) 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(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 or to wholesale a drug of an additional category, the basic fee set out in section 23; and

    • (f) if the amendment seeks to authorize the holder to test a drug of an additional category, the basic fee set out in section 24.

  • Marginal note:Included categories

    (3) If an application to amend an establishment licence seeks to add a category in respect of more than one activity referred to in paragraphs (2)(a) to (f), the fee payable under subsection (2) for the examination of the application is the highest applicable fee for those activities.

DIVISION 3Fees for the Examination of Dealer’s Licence Applications

Interpretation

Marginal note:Definitions
  •  (1) The following definitions apply in this Division.

    controlled drug

    controlled drug[Repealed, SOR/2013-122, s. 21]

    dealer’s licence

    dealer’s licence means

    health care facility

    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. (établissement de santé)

    narcotic

    narcotic[Repealed, SOR/2013-122, s. 21]

  • 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 Controlled Drugs and Substances Act, Part G of the Food and Drug Regulations or the Narcotic Control Regulations.

  • SOR/2013-122, s. 21.
 
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