ARCHIVED — Regulations Amending the Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations (1056)

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Vol. 145, No. 8 — April 13, 2011

Registration

SOR/2011-83 March 25, 2011

FINANCIAL ADMINISTRATION ACT

P.C. 2011-445 March 25, 2011

His Excellency the Governor General in Council, on the recommendation of the Treasury Board and the Minister of Health, pursuant to section 19.1 (see footnote a) of the Financial Administration Act (see footnote b) and, considering that it is otherwise in the public interest, subsection 23(2.1) (see footnote c) of that Act, hereby makes the annexed Regulations Amending the Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations (1056).

REGULATIONS AMENDING THE LICENSED DEALERS FOR CONTROLLED DRUGS AND NARCOTICS FEES REGULATIONS (1056)

AMENDMENTS

1. The title of the Licensed Dealers for Co n trolled Drugs and Narcotics Fees Regulations (1056) (see footnote 1) is replaced by the following:

LICENSED DEALERS FOR CONTROLLED DRUGS AND NARCOTICS (VETERINARY USE) FEES REGULATIONS

2. (1) The definitions “dealer’s licence for controlled drugs” and “dealer’s licence for narcotics” in section 1 of the Regulations are repealed.

(2) Section 1 of the Regulations is amended by adding the following in alphabetical order:

“dealer’s licence”
« licence de distributeur autorisé »

“dealer’s licence” means

  1. (a) a licence issued under section G.02.003.2 of the Food and Drug Regulations; or
  2. (b) a licence issued under section 9.2 of the Narcotic Control Regulations.

3. The Regulations are amended by adding the following before section 2:

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.

4. Paragraph 2(a) of the Regulations is repealed.

5. Sections 3 to 11 of the Regulations are replaced by the following:

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.

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.

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 licence a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

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.

Timing of payment

5. (1) Subject to subsection (2), the fee is payable on the day on which the relevant licence is issued.

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.

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.

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.

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.

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.

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.

COMING INTO FORCE

6. These Regulations come into force on April 1, 2011, but if they are registered after that day, they come into force on the day on which they are registered.

N.B. The Regulatory Impact Analysis Statement for these Regulations appears, following SOR/2011-79, Fees in Respect of Drugs and Medical Devices Regulations.

Footnote a
S.C. 1991, c. 24, s. 6

Footnote b
R.S., c. F-11

Footnote c
S.C. 1991, c. 24, s. 7(2)

Footnote 1
SOR/98-5