Vol. 145, No. 8 — April 13, 2011
SOR/2011-84 March 25, 2011
FINANCIAL ADMINISTRATION ACT
ARCHIVED — Regulations Amending the Establishment Licensing Fees Regulations (1056)
P.C. 2011-446 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 Establishment Licensing Fees Regulations (1056).
REGULATIONS AMENDING THE ESTABLISHMENT LICENSING FEES REGULATIONS (1056)
1. The title of the Establishment Licensing Fees Regulations (1056) (see footnote 1) is replaced by the following:
ESTABLISHMENT LICENSING FEES (VETERINARY DRUGS) REGULATIONS
2. Section 2 of the Regulations is replaced by the following:
2. These Regulations apply only to establishment licences for activities that relate to drugs for veterinary use only.
3. Sections 11 to 15 of the Regulations are replaced by the following:
11. (1) Subject to subsection 13(2), if the total of the fees payable under sections 3 to 10 of these Regulations and the fee payable under section 3 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations is greater than an amount equal to 1.5% of the applicant’s actual gross revenue from the sale, testing and packaging/labelling of drugs, as well as controlled drugs and narcotics not in dosage form, for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides, with their application for the annual review 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 the licence, the applicant shall 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
12. (1) Subject to subsection (2), the fee is payable on the day on which the establishment licence is issued or the application for the annual review of the licence is submitted.
Timing of deferred payment
(2) In the case of an applicant referred to in subsection 11(2), the fee for an application for the annual review of their licence is payable upon the expiry of the 90–day period.
13. (1) If the Minister determines that, on the basis of any information available to the Minister, the statement provided under subsection 11(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.
(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.
(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.
(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.
4. Section 18 of the Regulations is replaced by the following:
18. If a remission has been granted under section 11 or 13, no fee is payable under section 16 or 17 for the amendment of the establishment licence.
5. Subsection 20(2) of the Regulations is replaced by the following:
(2) If a remission has been granted under section 11 or 13, the fee payable for a reinstated establishment licence is the lesser of
- (a) the fee determined in accordance with section 11 or 13, and
- (b) the fee determined in accordance with subsection (1).
6. Items 1 to 4 of Schedule 4 to the Regulations are repealed.
7. Items 6 to 11 of Schedule 4 to the Regulations are repealed.
COMING INTO FORCE
8. 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.
S.C. 1991, c. 24, s. 6
R.S., c. F-11
S.C. 1991, c. 24, s. 7(2)