Interpretation

Marginal note:Definitions

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

  activity

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

  category

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

  drug

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

  establishment licence

  establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)

  site

  site means

  • (a) a building specified in an establishment licence and located more than one kilometre from any other building specified in the licence; or

  • (b) more than one building specified in an establishment licence, all of which are located within one kilometre of each other. (site)

• 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.

Application

Marginal note:Non-application

2 These Regulations do not apply to a public hospital or a public health institution with respect to sales of drugs to

• (a) its patients or those of another public hospital or public health institution; or

• (b) another public hospital or public health institution.

Fees

Marginal note:Amount payable

3 The fee that is payable for an establishment licence is the sum of the fees referred to in sections 4 to 10, as applicable.

Marginal note:Licence authorizing fabrication

• 4 (1) The fee payable for each site at which one or more activities is authorized by the establishment licence including the fabrication of drugs is the basic fee, set out in column 2 of item 1 of Schedule 1, together with each of the following fees that are applicable:

  • (a) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 1, for each additional category;

  • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 1; and

  • (c) if the licence is in respect of sterile dosage forms, the fee set out in column 2 of item 4 of Schedule 1.

• Marginal note:Importing

  (2) Despite section 6, if importing is authorized by the establishment licence at a site referred to in subsection (1), the fee referred to in paragraph 6(b) is also payable.

Marginal note:Licence authorizing packaging/labelling

• 5 (1) The fee that is payable for each site at which one or more activities is authorized by the establishment licence, including packaging/labelling drugs but not including fabricating drugs, is the basic fee, set out in column 2 of item 1 of Schedule 2, together with each of the following fees that are applicable:

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

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

• Marginal note:Importing

  (2) Despite section 6, if importing is authorized by the establishment licence at a site referred to in subsection (1), the fee referred to in paragraph 6(b) is also payable.

Marginal note:Licence authorizing importation

6 The fee that is payable for one or more activities authorized by the establishment licence, including importing drugs but not including fabricating or packaging/labelling drugs, is

• (a) for each site where those activities are so authorized, the basic fee, set out in column 2 of item 1 of Schedule 3, together with each of the following fees that are applicable:

  • (i) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 3, for each additional category, and

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

• (b) for each fabricator outside Canada of drugs that are imported, except where 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 is provided by the importer, the sum of the following fees that are applicable:

  • (i) the fee set out in column 2 of item 4 of Schedule 3, and

  • (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 column 2 of item 5 of Schedule 3.

Marginal note:Licence authorizing distribution

7 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(b) of the Food and Drug Regulations but not including fabricating, packaging/labelling or importing drugs, is the basic fee, set out in column 2 of item 1 of Schedule 3, together with each of the following fees that are applicable:

• (a) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 3, for each additional category; and

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

Marginal note:Drug analysis fee

8 In addition to the fees referred to in sections 4 to 7, the fee that is payable, if an establishment licence authorizes the holder to fabricate, package/label, import or distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, is for any of those activities, the highest fee set out in column 2 of Schedule 4 that corresponds to drugs described in column 1 of that Schedule

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

• (b) except in the case of an importer, for which the holder of the licence has obtained an identification number (DIN) or a numbered certificate of registration (GP).

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:Licence authorizing testing

10 The fee that is payable for each site at which only the testing of drugs is authorized by the establishment licence is a basic fee of $1,000.

Marginal note:Time of payment

11 The fees determined in accordance with sections 3 to 10 and subsection 13(2) are payable on the day on which the relevant establishment licence is issued.

Fee Reduction

Marginal note:Application

• 12 (1) A person who satisfies the conditions set out in section 13 or 14 may apply to the Minister of Health for a reduction in the total of the following fees, as applicable:

  • (a) the fees payable under sections 3 to 10; and

  • (b) the fee payable under section 3, 4 or 5 of the Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations.

• Marginal note:Time limit for submission of application

  (2) An application for a fee reduction shall be submitted together with an application for an establishment licence.

Marginal note:Reduction granted — revenue in previous fiscal year

• 13 (1) The Minister of Health shall grant an application for a fee reduction if the total fee payable pursuant to subsection 12(1) is more than 1.5 per cent of the applicant’s gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form, for the applicant’s previous fiscal year, based on financial records provided by the applicant and prepared in accordance with generally accepted accounting principles.

• Marginal note:Fees

  (2) If the Minister of Health grants an application for a fee reduction pursuant to subsection (1), the total fee payable by the applicant is an amount equal to 1.5 per cent of the applicant’s gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form, for the applicant’s previous fiscal year.

Marginal note:Reduction granted — no revenue in previous fiscal year

• 14 (1) Despite subsection 13(1) and subject to subsection (2), where an applicant does not have any revenue referred to in subsection 13(1) for the applicant’s previous fiscal year, the Minister of Health shall grant an application for a fee reduction after the time limit referred to in subsection (2) if the total fee payable pursuant to subsection 12(1) is more than 1.5 per cent of the applicant’s gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form, for the applicant’s fiscal year in which the application is made.

• Marginal note:Financial records

  (2) The revenue for the applicant’s fiscal year in which the application for a fee reduction is made shall be based on financial records prepared in accordance with generally accepted accounting principles and provided by the applicant within 90 days after the end of that fiscal year.

• Marginal note:Fees

  (3) Subject to subsection (4), the fee payable by an applicant is an amount equal to the sum of the following:

  • (a) any of following amounts as applicable, payable on submission of the application for a fee reduction:

    • (i) for an establishment licence authorizing one or more activities, including the fabrication of drugs, $6,000,

    • (ii) for an establishment licence authorizing one or more activities, including packaging/labelling drugs but not including fabricating drugs, $4,000,

    • (iii) for an establishment licence authorizing one or more activities, including importing drugs but not including fabricating or packaging/labelling drugs, $2,500,

    • (iv) for an establishment licence authorizing 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, $2,500,

    • (v) for an establishment licence authorizing 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, $750, and

    • (vi) for an establishment licence authorizing only the testing of drugs, $500, and

  • (b) an amount equal to the difference between the following, payable within 90 days after the end of the applicant’s fiscal year in which the application is made,

    • (i) 1.5 per cent of the applicant’s gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form, for the applicant’s fiscal year in which the application is made, and

    • (ii) the applicable amount set out in paragraph (a).

• Marginal note:Remission

  (4) If the amount paid by an applicant in accordance with paragraph (3)(a) is greater than the amount payable under paragraph (3)(b), the Minister of Health shall grant a remission to the applicant of an amount equal to the difference between those amounts.

• Marginal note:Where application refused

  (5) If the Minister of Health refuses to grant an application for a fee reduction pursuant to subsection (1) because the applicant fails to provide financial records within the period referred to in subsection (2) or because the total fee payable pursuant to subsection 12(1) is not more than 1.5 per cent of the applicant’s gross revenue from the sales, testing and packaging/labelling of drugs, as well as narcotics and controlled drugs not in dosage form, for the applicant’s fiscal year in which the application is made, the fee payable by the applicant is an amount equal to the difference between

  • (a) the sum of the fees referred to in subsection 12(1), as applicable, and

  • (b) the amount paid by the applicant pursuant to paragraph (3)(a).

• Marginal note:Time of payment

  (6) The fee referred to in subsection (5) is payable upon the expiry of the 90 day period referred to in subsection (2).

Marginal note:Audited statements

• 15 (1) If the Minister of Health determines that, on the basis of any information available to that Minister, the financial records provided in accordance with subsection 13(1) or 14(2) might not be adequate for the purpose of determining the gross revenue referred to in any of those subsections, the Minister may require the applicant to submit financial records that have been audited by a qualified independent auditor.

• Marginal note:Discrepancy in financial records

  (2) If there is a discrepancy between the applicant’s financial records referred to in subsection 13(1) or 14(2) and the financial records submitted in accordance with subsection (1), the latter shall be used for the purpose of determining the fee payable.

Licence Amendments

Marginal note:Amendment to add sterile dosage forms

16 If an establishment licence authorizing the holder to carry out one or more activities including fabricating drugs is amended to authorize sterile dosage forms of drugs for the first time at a site, the fee payable for each site at which those forms are so authorized is the basic fee set out in column 2 of item 1 of Schedule 1.

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,

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

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

  • (c) if the amendment authorizes the holder to import drugs but the amended licence does not authorize the holder to fabricate or package/label drugs, the basic fee set out in column 2 of item 1 of Schedule 3;

  • (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.

• Marginal note:Amendment to add category

  (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,

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

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

  • (c) if the amendment authorizes the holder to import an additional category of drugs, the basic fee set out in column 2 of item 1 of Schedule 3;

  • (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

  • (f) if the amendment authorizes the holder to test an additional category of drugs, the basic fee set out in section 10.

• Marginal note:Included categories

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

Marginal note:Fee exemption

18 If a fee reduction has been granted under sections 12 to 15 in respect of an establishment licence, no fee is payable under sections 16 or 17 for the amendment of the establishment licence.

Marginal note:Time of payment

19 The fees determined in accordance with sections 16 and 17 are payable on the day on which the amended licence is issued.

Suspended Licences

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

  • (a) if it authorizes the holder to carry out one or more activities, including fabricating 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 1;

  • (b) if it authorizes the holder to carry out one or more activities, including packaging/labelling drugs but not including fabricating 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 2;

  • (c) if it authorizes the holder to carry out one or more activities, including importing drugs but not including fabricating or packaging/labelling 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;

  • (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

  • (f) if it authorizes the holder only to test drugs, for each site in respect of which the matter is reinstated, the basic fee set out in section 10.

• Marginal note:Fee reduction

  (2) If a fee reduction has been granted under sections 12 to 15, the fee payable for a reinstated establishment licence is the lesser of

  • (a) the fee determined in accordance with sections 12 to 15, and

  • (b) the fee determined in accordance with subsection (1).

• Marginal note:Time of payment

  (3) The fee determined in accordance with this section is payable on the day on which the establishment licence is reinstated.

Transitional Provisions

Marginal note:Licence issued before coming into force

21 Despite section 11, the fees determined in accordance with sections 3 to 10 and subsection 13(2) are payable on January 1, 1998, if an establishment licence is issued before that date.

Marginal note:Application for a reduction

• 22 (1) Despite subsection 12(2), if an application for an establishment licence is submitted before January 1, 1998, an application for a fee reduction may be submitted no later than 60 days after the day of the coming into force of these Regulations.

• Marginal note:Remission

  (2) If a person has paid the total fee referred to in subsection 12(1) at the time an application for a fee reduction is submitted within the period referred to in subsection (1), the Minister of Health shall grant a remission to the applicant of an amount equal to the difference between

  • (a) in the case of an application under section 13, an amount equal to the difference between

    • (i) the sum of the fees paid pursuant to subsection 12(1), and

    • (ii) the total fee payable pursuant to subsection 13(2); and

  • (b) in the case of an application under section 14, an amount equal to the difference between

    • (i) the sum of the fees paid pursuant to subsection 12(1), and

    • (ii) the sum of the fees payable pursuant to paragraph 14(3)(a).

Coming into Force

Marginal note:Coming into force

23 These Regulations come into force on January 1, 1998.