Interpretation

Marginal note:Definitions

1 The definitions in this section apply in these Regulations.

controlled drug

drogue contrôlée

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

dealer’s licence for controlled drugs

licence de distributeur autorisé de drogues contrôlées

dealer’s licence for controlled drugs means a licence issued pursuant to section G.02.003 of the Food and Drug Regulations. (licence de distributeur autorisé de drogues contrôlées)

dealer’s licence for narcotics

licence de distributeur autorisé de stupéfiants

dealer’s licence for narcotics means a licence issued under subsection 9(1) of the Narcotic Control Regulations. (licence de distributeur autorisé de stupéfiants)

narcotic

stupéfiant 

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

package/label

emballer-étiqueter

package/label means to put a controlled drug or narcotic in its immediate container or to affix the inner or outer label to the controlled drug or narcotic. (emballer-étiqueter)

sell

vente

sell includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration. (vente)

site

site

site means

• (a) a building specified in a dealer’s licence for controlled drugs or a dealer’s licence for narcotics and located more than one kilometre from any other building specified in the licence; or

• (b) more than one building specified in a dealer’s licence for controlled drugs or a dealer’s licence for narcotics, all of which are located within one kilometre of each other. (site)

Application

Marginal note:Non-application

2 These Regulations do not apply to

• (a) a public hospital or a public health institution with respect to the sale of controlled drugs or narcotics to its patients or those of another public hospital or public health institution or to another public hospital or public health institution;

• (b) any branch or agency of the Government of Canada or of the government of a province; or

• (c) any person or organization engaged only in scientific investigation.

Fees

Marginal note:Dealer’s licence for controlled drugs

3 Subject to section 5, the fee that is payable for a dealer’s licence for controlled drugs is $1,750 for each site at which the licensed activities are performed.

Marginal note:Dealer’s licence for narcotics

4 Subject to section 5, the fee that is payable for a dealer’s licence for narcotics is $1,750 for each site at which the licensed activities are performed.

Marginal note:Maximum fee

5 The maximum fee payable for both a licence under section 3 and a licence under section 4 is $1,750 for each site at which the licensed activities are performed.

Marginal note:Time of payment

6 The fees referred to in sections 3 to 5 and subsection 8(2) are payable on the day on which the relevant licences are issued.

Fee Reduction

Marginal note:Application

• 7 (1) Any person who satisfies the conditions set out in sections 8 and 9 may apply to the Minister of Health for a reduction in the total fee payable pursuant to section 3, 4 or 5.

• Marginal note:Time limit for submission of application

  (2) An application for a fee reduction shall be submitted together with an application for a dealer’s licence for controlled drugs or a dealer’s licence for narcotics.

Marginal note:Reduction granted — revenue in previous fiscal year

• 8 (1) The Minister of Health shall grant an application for a fee reduction if the total fee payable is more than 1.5 per cent of the applicant’s gross revenue from the sale, testing and packaging/labelling of controlled drugs and narcotics 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 sale, testing and packaging/labelling of controlled drugs and narcotics for the applicant’s previous fiscal year.

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

• 9 (1) Despite subsection 8(1) and subject to subsection (2), where an applicant does not have any revenue referred to in subsection 8(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 is more than 1.5 per cent of the applicant’s gross revenue from the sale, testing and packaging/labelling of controlled drugs and narcotics 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 referred to in subsection (1) is the total of:

  • (a) $875, payable on submission of the application for a fee reduction, 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 sales, testing and packaging/labelling of controlled drugs and narcotics for the applicant’s fiscal year in which the application is made, and

    • (ii) the 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 section 3, 4 or 5 is not more than 1.5 per cent of the applicant’s gross revenue from the sale, testing and packaging/labelling of controlled drugs and narcotics 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 total fee payable pursuant to section 3, 4 or 5, 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 in subsection (2).

Marginal note:Audited statements

• 10 (1) If the Minister of Health determines that, on the basis of any information available to the Minister, the financial records provided in accordance with subsection 8(1) or 9(2) might not be adequate for the purpose of determining the applicant’s 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 8(1) or 9(2) and the financial records submitted in accordance with subsection (1), the latter shall be used for the purpose of determining the fee payable.

Marginal note:Exception

11 Any person who is required to hold an establishment licence pursuant to section C.01A.004 of the Food and Drug Regulations shall not be entitled to a fee reduction under sections 7 to 9.

Transitional Provisions

Marginal note:Licence issued before coming into force

12 Despite section 6, the fees determined in accordance with sections 3 to 5 and subsection 8(2) are payable on January 1, 1998, if the relevant licences are issued before that date.

Marginal note:Application for a reduction

• 13 (1) Despite subsection 7(2), if an application for a dealer’s licence for controlled drugs or a dealer’s licence for narcotics 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 section 3, 4 or 5 at the time an application for a fee reduction is submitted and the application is submitted within the period referred to in subsection (1), the Minister of Health shall grant a remission to the person of an amount equal to the difference between

  • (a) in the case of an application under section 8, an amount equal to the difference between:

    • (i) the total fee paid pursuant to section 3, 4 or 5, and

    • (ii) the total fee payable pursuant to subsection 8(2), and

  • (b) in the case of an application under section 9, an amount equal to the difference between the following:

    • (i) the total fee paid pursuant to section 3, 4 or 5, and

    • (ii) the fee payable pursuant to paragraph 9(3)(a).

Coming into Force

Marginal note:Coming into force

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