SOR/2011-7920113

25

20204

3

FINANCIAL ADMINISTRATION ACTFees in Respect of Dealer’s Licences RegulationsP.C.2011-44120113

25

Whereas the requirements of section 4 of the User Fees Acta have been complied with in respect of the fees fixed in the annexed Regulations;Therefore His Excellency the Governor General in Council, on the recommendation of the Treasury Board and the Minister of Health, pursuant to subsection 19(1)b and section 19.1b of the Financial Administration Actc and, considering that it is otherwise in the public interest, subsection 23(2.1)d of that Act, hereby makes the annexed Fees in Respect of Drugs and Medical Devices Regulations.aS.C. 2004, c. 6bS.C. 1991, c. 24, s. 6cR.S., c. F-11dS.C. 1991, c. 24, s. 7(2)

1[Repealed, SOR/2019-134, s. 2]

Purpose — fees2(1)The purpose of these Regulations is to prescribe the fees for the examination of an application for, or the renewal of, a dealer’s licence under Part G of the Food and Drug Regulations or under the Narcotic Control Regulations.Purpose — remission(2)The purpose of these Regulations is also to remit, in whole or in part, certain of those fees.SOR/2019-134, s. 4

3[Repealed, SOR/2019-134, s. 5]

Adjustment of fees4Every fee set out in these Regulations is to be increased annually by 2%, rounded up to the nearest dollar, beginning on April 1, 2012.

5[Repealed, SOR/2019-134, s. 7]

6[Repealed, SOR/2019-134, s. 7]

6.1[Repealed, SOR/2019-134, s. 7]

7[Repealed, SOR/2019-134, s. 7]

8[Repealed, SOR/2019-134, s. 7]

9[Repealed, SOR/2019-134, s. 7]

10[Repealed, SOR/2019-134, s. 7]

11[Repealed, SOR/2019-134, s. 7]

12[Repealed, SOR/2019-134, s. 7]

13[Repealed, SOR/2019-134, s. 7]

14[Repealed, SOR/2019-134, s. 7]

15[Repealed, SOR/2019-134, s. 7]

16[Repealed, SOR/2019-134, s. 7]

17[Repealed, SOR/2019-134, s. 7]

18[Repealed, SOR/2019-134, s. 7]

19[Repealed, SOR/2019-134, s. 7]

20[Repealed, SOR/2019-134, s. 7]

21[Repealed, SOR/2019-134, s. 7]

22[Repealed, SOR/2019-134, s. 7]

22.1[Repealed, SOR/2019-134, s. 7]

23[Repealed, SOR/2019-134, s. 7]

24[Repealed, SOR/2019-134, s. 7]

25[Repealed, SOR/2019-134, s. 7]

25.1[Repealed, SOR/2019-134, s. 7]

26[Repealed, SOR/2019-134, s. 7]

27[Repealed, SOR/2019-134, s. 7]

28[Repealed, SOR/2019-134, s. 7]

Definitions29(1)The following definitions apply in sections 30, 31 and 33.controlled drug[Repealed, SOR/2013-122, s. 21]dealer’s licence means(a)a licence issued under section G.02.007 of the Food and Drug Regulations; or(b)a licence issued under section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)health care facility means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (établissement de santé)narcotic[Repealed, SOR/2013-122, s. 21]Words and expressions(2)Unless the context otherwise requires, all other words and expressions used in sections 30, 31 and 33 have the meaning assigned to them by the Controlled Drugs and Substances Act, Part G of the Food and Drug Regulations or the Narcotic Control Regulations.SOR/2013-122, s. 21SOR/2019-134, s. 9SOR/2019-172, s. 3

Non-application — applicants30(1)These Regulations do not apply to(a)any publicly funded health care facility;(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.Non-application — drug for veterinary use only(2)These Regulations do not apply to a drug that is for veterinary use only.SOR/2019-134, s. 11

Fee — Dealer’s licence31(1)The fee payable by an applicant for the examination of an application for either a dealer’s licence or the renewal of a dealer’s licence is $4,510 for each of the premises at which activities are to be conducted under the licence.Remission(2)Subject to subsection 33(2), if the fee is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under a dealer’s licence during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides with their application a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.Timing of payment(3)Subject to subsection (4), the fee is payable at the time of submitting the application for a dealer’s licence or for the renewal of a dealer’s licence under section 10 or 11 of the Narcotic Control Regulations or section G.02.006 or G.02.010 of the Food and Drug Regulations.First year of activities(4)If the applicant has not completed their first calendar year of conducting activities under the licence, the payment of the fee is deferred until the end of that year.SOR/2019-134, s. 13SOR/2019-172, s. 4

32[Repealed, SOR/2019-134, s. 14]

Audited sales records33(1)If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 31(2) is not adequate to determine the applicant’s 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, within 60 days after the day of the Minister’s request for the audited sales records, the applicant has not provided the Minister with them, the difference between the fee payable under subsection 31(1) 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 under section 31, 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 under section 31, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

34[Repealed, SOR/2019-134, s. 15]

35[Repealed, SOR/2019-134, s. 15]

35.1[Repealed, SOR/2019-134, s. 15]

36[Repealed, SOR/2019-134, s. 15]

37[Repealed, SOR/2019-134, s. 15]

38[Repealed, SOR/2019-134, s. 15]

39[Repealed, SOR/2019-134, s. 15]

40[Repealed, SOR/2019-134, s. 15]

41[Repealed, SOR/2019-134, s. 15]

42[Repealed, SOR/2019-134, s. 15]

43[Repealed, SOR/2019-134, s. 15]

44[Repealed, SOR/2019-134, s. 15]

45[Repealed, SOR/2019-134, s. 15]

46[Repealed, SOR/2019-134, s. 15]

47[Repealed, SOR/2019-134, s. 15]

48[Repealed, SOR/2019-134, s. 15]

49[Repealed, SOR/2019-134, s. 15]

50[Repealed, SOR/2019-134, s. 15]

51[Repealed, SOR/2019-134, s. 15]

52[Repealed, SOR/2019-134, s. 15]

53[Repealed, SOR/2019-134, s. 15]

Repeals

54[Repeal]

55[Repeal]

Coming into Force

Registration56These 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.

SCHEDULE 1[Repealed, SOR/2019-134, s. 16]SCHEDULE 2[Repealed, SOR/2019-134, s. 16]SCHEDULE 3[Repealed, SOR/2019-134, s. 16]SCHEDULE 4[Repealed, SOR/2019-134, s. 16]SCHEDULE 5[Repealed, SOR/2019-134, s. 16]SCHEDULE 6[Repealed, SOR/2019-134, s. 16]SCHEDULE 7[Repealed, SOR/2019-134, s. 16]RELATED PROVISIONS — SOR/2019-134, s. 20

20The Fees in Respect of Drugs and Medical Devices Regulations, as they read immediately before the day on which the Regulations Amending and Repealing Certain Regulations Made Under the Financial Administration Act come into force, continue to apply in respect of(a)a fee whose payment is deferred under subsection 9(1), section 10 or subsection 17(4), 35(4), 43(1), 48(3) or 51(4) of the Fees in Respect of Drugs and Medical Devices Regulations to a day that is on or after that day; and(b)a remission referred to in section 11, subsection 17(2), section 44 or subsection 51(2) of the Fees in Respect of Drugs and Medical Devices Regulations.