Interpretation

Marginal note:Definitions

1 The definitions in this section apply in these Regulations.

controlled drug

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

dealer’s licence

dealer’s licence means

• (a) a licence issued under section G.02.007 of the Food and Drug Regulations; or

• (b) a licence issued under section 10.1 of the Narcotic Control Regulations. (licence de distributeur autorisé)

dealer’s licence for controlled drugs

dealer’s licence for controlled drugs[Repealed, SOR/2011-83, s. 2]

dealer’s licence for narcotics

dealer’s licence for narcotics[Repealed, SOR/2011-83, s. 2]

narcotic

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

package/label

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

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 means

• (a) a building specified in a dealer’s licence 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, all of which are located within one kilometre of each other. (site)

Application

Marginal note:Application

1.1 These Regulations apply only to applicants for dealer’s licences that relate only to controlled drugs for veterinary use or to narcotics for veterinary use.

Marginal note:Non-application

2 These Regulations do not apply to

• (a) [Repealed, SOR/2011-83, s. 4]

• (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

• 3 (1) The fee for a dealer’s licence is $1,750 for each site at which the licensed activities are to be conducted.

• Marginal note:First year of activities

  (2) If the applicant has not completed their first calendar year of conducting activities under the licence, the fee for a dealer’s licence is $875 for each site at which the licensed activities are to be conducted.

Marginal note:Remission

• 4 (1) Subject to subsection 6(2), if the fee is greater than an amount equal to 1.5% of the applicant’s actual gross revenue from the sale, testing and packaging/labelling of controlled drugs and narcotics for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides with their application for the renewal of their dealer’s licence a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

• Marginal note:Statement — first year of activities

  (2) If the applicant has not completed their first calendar year of conducting activities under a dealer’s licence, the applicant must provide the statement within 90 days after the day on which that year ends in order to be eligible for the remission.

Marginal note:Timing of payment

• 5 (1) Subject to subsection (2), the fee is payable on the day on which the dealer’s licence is issued.

• Marginal note:Timing of deferred payment

  (2) In the case of an applicant referred to in subsection 4(2), the fee is payable on the expiry of the 90-day period if the renewed dealer’s licence is issued.

Marginal note:Audited sales records

• 6 (1) If the Minister of Health determines, on the basis of any information available to the Minister, that the statement provided under subsection 4(1) is not adequate to determine the 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 the applicant fails to provide the Minister with the audited sales records within 90 days after the day on which the Minister requested those records, the difference between the fee 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, 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, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

Marginal note:Exception

7 An applicant for a dealer’s licence is not entitled to a remission under subsection 4(1) if, in order to conduct an activity referred to in the application, the applicant must also hold an establishment licence under Division 1A of Part C of the Food and Drug Regulations.

8 [Repealed, SOR/2011-83, s. 5]

9 [Repealed, SOR/2011-83, s. 5]

10 [Repealed, SOR/2011-83, s. 5]

11 [Repealed, SOR/2011-83, s. 5]

12 [Repealed, SOR/2018-69, s. 85]

13 [Repealed, SOR/2018-69, s. 85]

Coming into Force

Marginal note:Coming into force

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