His Excellency the Governor General in Council, on the recommendation of the Minister of Health and the Treasury Board, pursuant to paragraph 19.1(a) a of the Financial Administration Act and, considering that it is in the public interest to remit certain debts, pursuant to subsection 23(2.1) b of that Act, hereby makes the annexed Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations (1056). S.C. 1991, c. 24, s. 6 S.C. 1991, c. 24, s. 7(2)
Interpretation
The definitions in this section apply in these Regulations.
controlled drug has the same meaning as in section G.01.001 of the Food and Drug Regulations. (drogue contrôlée)
dealer’s licence means
a licence issued under section G.02.007 of the Food and Drug Regulations; or
a licence issued under section 10.1 of the Narcotic Control Regulations. (licence de distributeur autorisé)
dealer’s licence for controlled drugs[Repealed, SOR/2011-83, s. 2]
dealer’s licence for narcotics[Repealed, SOR/2011-83, s. 2]
narcotic has the same meaning as in section 2 of the Narcotic Control Regulations. (stupéfiant)
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 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 means
a building specified in a dealer’s licence and located more than one kilometre from any other building specified in the licence; or
more than one building specified in a dealer’s licence, all of which are located within one kilometre of each other. (site)
Application
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.
These Regulations do not apply to
[Repealed]
any branch or agency of the Government of Canada or of the government of a province; or
any person or organization engaged only in scientific investigation.
Fees
The fee for a dealer’s licence or its renewal is $1,750 for each site at which the licensed activities are to be conducted.
If the applicant has not completed their first calendar year of conducting activities under a dealer’s licence, the fee for the licence or its renewal is $875 for each site at which the licensed activities are to be conducted.
Subject to subsection 5(2), remission is granted to an applicant in respect of their dealer’s licence or its renewal if
the fee payable 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;
the applicant provides a statement to the Minister of Health signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue
if the applicant has not completed a calendar year following the issuance of their first licence, within one month after the end of that year, and
in any other case, if applicable, with the application for the renewal.
The amount of the remission is equal to the difference between the fee payable for the licence and the amount calculated in accordance with paragraph (1)(a).
If the Minister of Health determines, on the basis of any available information, that the statement provided under paragraph 4(1)(b) is not sufficient to determine the actual gross revenue, the Minister must require, in writing, the applicant to provide additional information that is necessary to make that determination, within 90 days after the day on which the request is made.
Remission is not granted if
the applicant fails to provide the additional information within the period specified; or
the Minister determines that the additional information, provided within the period specified, is not sufficient to determine the actual gross revenue.
In the case of an applicant referred to in subsection 3(2), the fee is payable on issuance of the notice
once the statement referred to in subparagraph 4(1)(b)(i) is provided; and
in any other case, during the second month after the end of the calendar year following the issuance of the first licence.
If additional information is required under subsection 5(1), the fee is payable on issuance of the notice once the licence has been issued or renewed
after the Minister has assessed any additional information, if the applicant has provided it; or
after the expiry of the period set out in subsection 5(1), if the applicant has not provided the information.
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.
[Repealed]
[Repealed]
[Repealed]
[Repealed]
[Repealed]
[Repealed]
Coming into Force
These Regulations come into force on January 1, 1998.