Fees in Respect of Drugs and Medical Devices Order: SOR/2019-124

Canada Gazette, Part II, Volume 153, Number 11

Registration

SOR/2019-124 May 8, 2019

FOOD AND DRUGS ACT

Whereas, pursuant to section 30.62 footnote a of the Food and Drugs Act footnote b, the Minister of Health has consulted with any persons that the Minister considers to be interested in the matter;

Therefore, the Minister of Health, pursuant to subsections 30.61(1)footnote a and 30.63(1)footnote a of the Food and Drugs Act footnote b, makes the annexed Fees in Respect of Drugs and Medical Devices Order.

Ottawa, May 3, 2019

Ginette C. Petitpas Taylor
Minister of Health

TABLE OF PROVISIONS

Fees in Respect of Drugs and Medical Devices Order

PART 1

General

Interpretation

1 Definitions

Purpose

2 Purpose — fees

Non-application

3 Non-application

Annual Adjustment of Fees

4 Adjustment of fees

Requests for Information — Remissions for Small Businesses

5 Information on request

Performance Standard and Remission

6 Remission — performance standard

PART 2

Drugs

DIVISION 1

Fees for Examination of a Submission — Drugs for Human Use

Interpretation

7 Definition of submission

Non-application

8 Non-application

Fees and Remissions

9 Fee for examination

10 Fee and timing of payment — preliminary examination

11 Fee and timing of payment — no preliminary examination

12 Fee — filing in previous fiscal year

13 Deferred payment — notice of compliance

14 Remission — urgent public health need

15 Remission — General Council Decision

16 Remission — small business

17 Remission — first submission by small business

18 Fee or difference payable

DIVISION 2

Fees for Examination of a Submission — Drugs for Veterinary Use Only

Interpretation

19 Definition of submission

Application

20 Application

Fees and Remissions

21 Fee for examination

22 Fee and timing of payment — preliminary examination

23 Fee and timing of payment — no preliminary examination

24 Fee — filing in previous fiscal year

25 Remission — small business

26 Remission — first submission by small business

27 Fee or difference payable

DIVISION 3

Fees for Examination of an Application for an Establishment Licence — Drugs

Interpretation

28 Definitions

Fees and Remission

29 Fee for examination

30 Timing of payment

31 Reinstatement

32 Interpretation

33 Fee — licence authorizing sterile fabrication

34 Fee — licence authorizing importation

35 Fee — licence authorizing non-sterile fabrication

36 Fee — licence authorizing distribution

37 Fee — licence authorizing wholesaling

38 Fee — licence authorizing packaging/labelling

39 Fee — licence authorizing testing

40 Fee — application for licence — building outside Canada

41 Fee — amendment — licence authorizing sterile fabrication

42 Fee — amendment — licence authorizing importation

43 Fee — amendment — licence authorizing non-sterile fabrication

44 Fee — amendment — licence authorizing distribution

45 Fee — amendment — licence authorizing wholesaling

46 Fee — amendment — licence authorizing packaging/labelling

47 Fee — amendment — licence authorizing testing

48 Prorated fee

49 Remission — small business

50 Difference payable

DIVISION 4

Fees for Right to Sell Drugs for Human Use

Non-application

51 Non-application

Fees and Remission

52 Annual fee

53 Remission — small business

54 Difference payable

DIVISION 5

Fees for Right to Sell Drugs for Veterinary Use Only

Application

55 Application

Fees and Remission

56 Annual fee

57 Remission — small business

58 Difference payable

PART 3

Medical Devices

DIVISION 1

Fees for Examination of an Application for a Medical Device Licence

Interpretation

59 Definition of licence

Fees and Remissions

60 Fee for examination

61 Reinstatement

62 Fee and timing of payment — preliminary examination

63 Fee and timing of payment — no preliminary examination

64 Fee — filing in previous fiscal year

65 Remission — General Council Decision

66 Remission — small business

67 Remission — first application by small business

68 Fee or difference payable

DIVISION 2

Fees for Examination of an Application for an Establishment Licence — Medical Devices

Interpretation

69 Definition of establishment licence

Application

70 Applicable classes

Fee and Remission

71 Fee for examination

72 Timing of payment

73 Reinstatement

74 Remission — small business

75 Difference payable

DIVISION 3

Fees for Right to Sell Licensed Class II, III or IV Medical Devices

Interpretation

76 Definition of licence

Fees and Remission

77 Annual fee

78 Timing of payment

79 Remission — small business

80 Difference payable

Coming into Force

81 SOR/96-143

SCHEDULE 1

SCHEDULE 2

SCHEDULE 3

SCHEDULE 4

SCHEDULE 5

SCHEDULE 6

Interpretation

1 Definition of disinfectant

SCHEDULE 7

SCHEDULE 8

Interpretation

1 Definition of private label medical device

Fees in Respect of Drugs and Medical Devices Order

PART 1

General

Interpretation

Definitions

1 (1) The following definitions apply in this Order.

entity has the meaning assigned by the definition organization in section 2 of the Criminal Code. (entité)

fiscal year means

performance standard means the document entitled Performance Standards for the Fees in Respect of Drugs and Medical Devices Order, published by the Government of Canada, dated November 22, 2018. (norme de rendement)

small business means a person in respect of which either of the following criteria applies:

Other words and expressions

(2) Unless the context otherwise requires, other words and expressions used in this Order have the meanings assigned to them by the Food and Drug Regulations or the Medical Devices Regulations, as the case may be.

Affiliation

(3) For the purposes of this Order,

Subsidiary entity

(4) For the purposes of this Order, an entity is a subsidiary of another entity if it is controlled by that other entity.

Control

(5) For the purposes of this Order,

Deemed affiliation

(6) For the purposes of this Order, if it may reasonably be considered that one of the main reasons for the separate existence of two or more corporations is so that one of them meets the applicable conditions for a remission of a fee fixed under this Order for which only small businesses are eligible, the two or more corporations are deemed to be affiliated with each other.

Purpose

Purpose — fees

2 (1) The purpose of this Order is to fix the fees for the following:

Purpose — remission

(2) The purpose of this Order is also to remit, in whole or in part, certain of those fees.

Non-application

Non-application

3 (1) This Order does not apply in respect of

Definition of publicly funded health care institution

(2) For the purposes of subsection (1), publicly funded health care institution means an institution that is funded by the Government of Canada or the government of a province and that is

Annual Adjustment of Fees

Adjustment of fees

4 (1) Beginning on April 1, 2021, every fee set out in this Order is to be adjusted in each fiscal year on April 1 by the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year and rounded up to the nearest dollar.

Formula

(2) In the case of a fee that is payable under any of Divisions 1 to 5 of Part 2 or Division 1 of Part 3 in a fiscal year that is not set out in the applicable schedule, the amount of the fee is to be calculated, on April 1 of the fiscal year, in accordance with the following formula and rounded up to the nearest dollar:

Fee = A + (A × B)

where

Requests for Information — Remissions for Small Businesses

Information on request

5 If the Minister determines, in respect of a person that provided information under any of the following provisions, that additional information is necessary to demonstrate that the person met the definition small business in subsection 1(1) in the applicable fiscal year, the Minister may request that the person provide him or her with additional information within 60 days after the day on which the request is made:

Performance Standard and Remission

Remission — performance standard

6 (1) If the Minister determines that the performance standard has not been met in relation to a fee that is payable under this Order, remission is granted to the person that must pay the fee

Exceptions

(2) Subsection (1) does not apply to a fee for the examination of

PART 2

Drugs

DIVISION 1

Fees for Examination of a Submission — Drugs for Human Use

Interpretation

Definition of submission

7 In this Division, submission means any of the following:

Non-application

Non-application

8 This Division does not apply to drugs for veterinary use only.

Fees and Remissions

Fee for examination

9 (1) Subject to paragraph 10(b) and section 12, the fee for the examination of a submission is, in respect of the applicable submission class set out in column 1 of Schedule 1 and described in column 2, as follows:

Fee paid by person that files submission

(2) The fee is payable by the person that files the submission.

Fee and timing of payment — preliminary examination

10 If a preliminary examination is conducted in respect of a submission,

Fee and timing of payment — no preliminary examination

11 If a preliminary examination is not conducted in respect of a submission, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 9(2) stating that the submission has been received.

Fee — filing in previous fiscal year

12 For the purposes of subsection 9(1), if the Minister issues a notice referred to in section 10 or 11 in the fiscal year that follows the fiscal year in which the submission was filed, the fee that is payable is the fee that was payable in the fiscal year in which the submission was filed.

Deferred payment — notice of compliance

13 Despite sections 10 and 11, if the person referred to in subsection 9(2) files an application for authorization under section C.07.003 of the Food and Drug Regulations at the same time that the person files the submission, payment of the fee is deferred until the issuance to the person of a notice of compliance under section C.08.004 of those Regulations or of a document setting out the drug identification number assigned for the drug under subsection C.01.014.2(1) of those Regulations.

Remission — urgent public health need

14 Remission is granted to a person referred to in subsection 9(2) that files a new drug submission under section C.08.002 of the Food and Drug Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations of the amount of the fee that is payable under subsection 9(1) if, as of the day on which the person filed the new drug submission or application,

Remission — General Council Decision

15 Remission is granted to the person referred to in subsection 9(2) of the amount of the fee that is payable under subsection 9(1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the drug.

Remission — small business

16 Subject to section 18, remission is granted to the person referred to in subsection 9(2) of an amount equal to 50% of the fee that is payable under subsection 9(1) if the person provides with their submission, in a form established by the Minister,

Remission — first submission by small business

17 Subject to section 18, remission is granted to the person referred to in subsection 9(2) of an amount equal to the fee that is payable under subsection 9(1) if the following conditions are met:

Fee or difference payable

18 If the Minister requests under section 5 that the person referred to in subsection 9(2) provide additional information, the fee — or the difference between the fee payable under subsection 9(1) and the amount already paid, as the case may be — is immediately payable if

DIVISION 2

Fees for Examination of a Submission — Drugs for Veterinary Use Only

Interpretation

Definition of submission

19 In this Division, submission means any of the following:

Application

Application

20 This Division applies to drugs for veterinary use only.

Fees and Remissions

Fee for examination

21 (1) Subject to paragraph 22(b) and section 24, the fee that is payable in respect of a submission that is of a type set out in column 1 of Schedule 2, for the examination of each component set out in column 2 that is included in the submission, is as follows:

Fee paid by person that files submission

(2) The fee is payable by the person that files the submission.

Fee and timing of payment — preliminary examination

22 If a preliminary examination is conducted in respect of a submission,

Fee and timing of payment — no preliminary examination

23 If a preliminary examination is not conducted in respect of a submission, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 21(2) stating that the submission has been received.

Fee — filing in previous fiscal year

24 For the purposes of subsection 21(1), if the Minister issues a notice referred to in section 22 or 23 in the fiscal year that follows the fiscal year in which the submission was filed, the fee that is payable is the fee that was payable in the fiscal year in which the submission was filed.

Remission — small business

25 Subject to section 27, remission is granted to the person referred to in subsection 21(2) of an amount equal to 50% of the fee that is payable under subsection 21(1) if the person provides with their submission, in a form established by the Minister,

Remission — first submission by small business

26 Subject to section 27, remission is granted to the person referred to in subsection 21(2) of an amount equal to the fee that is payable under subsection 21(1) if the following conditions are met:

Fee or difference payable

27 If the Minister requests under section 5 that the person referred to in subsection 21(2) provide additional information, the fee — or the difference between the fee payable under subsection 21(1) and the amount already paid, as the case may be — is immediately payable if

DIVISION 3

Fees for Examination of an Application for an Establishment Licence — Drugs

Interpretation

Definitions

28 The following definitions apply in this Division.

activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations. (activité)

drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations. (drogue)

establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)

Fees and Remission

Fee for examination

29 (1) Subject to section 48, the fee for the examination of an application for an establishment licence or for the annual review of an establishment licence is the sum of the applicable fees referred to in sections 33 to 40 and the fee payable for the examination of an application to amend an establishment licence to add a building is the sum of the applicable fees referred to in sections 41 to 47.

Fee paid by person that files application

(2) The fee is payable by the person that files the application.

Timing of payment

30 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 29(2) stating that the application has been accepted for further examination.

Reinstatement

31 Every provision of this Division that applies to an application for an establishment licence also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.

Interpretation

32 In sections 33 to 39, a reference to the examination of an application for an establishment licence includes an examination of an application for the annual review of an establishment licence.

Fee — licence authorizing sterile fabrication

33 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including fabricating drugs in sterile dosage form, the fee is as follows:

Fee — licence authorizing importation

34 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including importing drugs — but not fabricating drugs in sterile dosage form — the fee is as follows:

Fee — licence authorizing non-sterile fabrication

35 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including fabricating drugs that are not in sterile dosage form — but not fabricating drugs in sterile dosage form or importing drugs — the fee is as follows:

Fee — licence authorizing distribution

36 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including distributing drugs — but not fabricating drugs in sterile dosage form, importing drugs or fabricating drugs that are not in sterile dosage form — the fee is as follows:

Fee — licence authorizing wholesaling

37 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including wholesaling drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form or distributing drugs — the fee is as follows:

Fee — licence authorizing packaging/labelling

38 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including packaging/labelling drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form, distributing drugs or wholesaling drugs — the fee is as follows:

Fee — licence authorizing testing

39 For the examination of an application for an establishment licence for each building at which one or more activities are to be conducted, including testing drugs — but not fabricating drugs in sterile dosage form, importing drugs, fabricating drugs that are not in sterile dosage form, distributing drugs, wholesaling drugs or packaging/labelling drugs — the fee is as follows:

Fee — application for licence — building outside Canada

40 (1) For the examination of an application for an establishment licence referred to in section 33 or 34, the fee for each building located outside Canada that is listed on the application is

Fee — application for annual review — building outside Canada

(2) For the examination of an application for the annual review of an establishment licence referred to in section 33 or 34, the fee for each building located outside Canada that is listed on the establishment licence is the applicable fee set out in paragraph (1)(a) or (b).

Fee — amendment — licence authorizing sterile fabrication

41 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to fabricate drugs in sterile dosage form at that building, the fee for the examination of the application for each building to be added is as follows:

Fee — amendment — licence authorizing importation

42 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to import drugs — but not to fabricate drugs in sterile dosage form — at that building, the fee for the examination of the application for each building to be added is as follows:

Fee — amendment — licence authorizing non-sterile fabrication

43 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to fabricate drugs that are not in sterile dosage form — but not to fabricate drugs in sterile dosage form or import drugs — at that building, the fee for the examination of the application for each building to be added is as follows:

Fee — amendment — licence authorizing distribution

44 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to distribute drugs — but not to fabricate drugs in sterile dosage form, import drugs or fabricate drugs that are not in sterile dosage form — at that building, the fee for the examination of the application for each building to be added is as follows:

Fee — amendment — licence authorizing wholesaling

45 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to wholesale drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form or distribute drugs — at that building, the fee for the examination of the application for each building to be added is as follows:

Fee — amendment — licence authorizing packaging/labelling

46 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to package/label drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form, distribute drugs or wholesale drugs — at that building, the fee for the examination of the application for each building to be added is as follows:

Fee — amendment — licence authorizing testing

47 If an application to amend an establishment licence seeks to add a building and the amendment seeks to authorize the holder to test drugs — but not to fabricate drugs in sterile dosage form, import drugs, fabricate drugs that are not in sterile dosage form, distribute drugs, wholesale drugs or package/label drugs — at that building, the fee for the examination of the application for each building to be added is as follows:

Prorated fee

48 The fee that is payable under subsection 29(1) is reduced by the percentage set out in column 1 of Schedule 5 if the person referred to in subsection 29(2) files, in the period set out in column 2,

Remission — small business

49 Subject to section 50, remission is granted to the person referred to in subsection 29(2) of an amount equal to 25% of the fee that is payable under subsection 29(1) if the person provides with their application, in a form established by the Minister,

Difference payable

50 If the Minister requests under section 5 that the person referred to in subsection 29(2) provide additional information, the difference between the fee payable under subsection 29(1) and the amount already paid is immediately payable if

DIVISION 4

Fees for Right to Sell Drugs for Human Use

Non-application

Non-application

51 This Division does not apply to drugs for veterinary use only.

Fees and Remission

Annual fee

52 (1) The annual fee that is payable for the right to sell a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations is, in respect of the type of drug set out in column 1 of Schedule 6, as follows:

Fee payable by person after first sale

(2) The fee is payable by the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug if the person has sold the drug following the issuance of the document.

Timing of payment

(3) The fee is payable on October 1.

Non-application — interruption of sale

(4) Subject to subsection (5), subsection (1) does not apply to the person if they notified the Minister in accordance with section C.01.014.71 of the Food and Drug Regulations in the 12 months preceding October 1.

Resumption of sale

(5) Subsection (4) ceases to apply on the day on which the person notifies the Minister in accordance with section C.01.014.72 of the Food and Drug Regulations.

Remission — small business

53 Subject to section 54, remission is granted to the person referred to in subsection 52(2) of an amount equal to 25% of the fee that is payable under subsection 52(1) if the person provides with the notification provided under subsection C.01.014.5(1) of the Food and Drug Regulations, in a form established by the Minister,

Difference payable

54 If the Minister requests under section 5 that the person referred to in subsection 52(2) provide additional information, the difference between the fee payable under subsection 52(1) and the amount already paid is immediately payable if

DIVISION 5

Fees for Right to Sell Drugs for Veterinary Use Only

Application

Application

55 This Division applies to drug for veterinary use only.

Fees and Remission

Annual fee

56 (1) The annual fee that is payable for the right to sell a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations is as follows:

Fee payable by person after first sale

(2) The fee is payable by the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug if the person has sold the drug following the issuance of the document.

Timing of payment

(3) The fee is payable on October 1.

Non-application — interruption of sale

(4) Subject to subsection (5), subsection (1) does not apply to the person if they notified the Minister in accordance with section C.01.014.71 of the Food and Drug Regulations in the 12 months preceding October 1.

Resumption of sale

(5) Subsection (4) ceases to apply on the day on which the person notifies the Minister in accordance with section C.01.014.72 of the Food and Drug Regulations.

Remission — small business

57 Subject to section 58, remission is granted to the person referred to in subsection 56(2) of an amount equal to 25% of the fee that is payable under subsection 56(1) if the person provides with the notification provided under subsection C.01.014.5(1) of the Food and Drug Regulations, in a form established by the Minister,

Difference payable

58 If the Minister requests under section 5 that the person referred to in subsection 56(2) provide additional information, the difference between the fee payable under subsection 56(1) and the amount already paid is immediately payable if

PART 3

Medical Devices

DIVISION 1

Fees for Examination of an Application for a Medical Device Licence

Interpretation

Definition of licence

59 In this Division, licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations.

Fees and Remissions

Fee for examination

60 (1) Subject to paragraph 62(b) and section 64, the fee for the examination of an application for a licence that is filed under section 32 of the Medical Devices Regulations or for the examination of an application for a licence amendment that is filed under section 34 of those Regulations is, in respect of the applicable category set out in column 1 of Schedule 8 and described in column 2, as follows:

Fee payable by person that files application

(2) The fee is payable by the person that files the application.

Reinstatement

61 Every provision of this Division that applies to an application for a licence for a Class II, III or IV medical device filed under section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.

Fee and timing of payment — preliminary examination

62 If a preliminary examination is conducted in respect of an application,

Fee and timing of payment — no preliminary examination

63 If a preliminary examination is not conducted in respect of an application, the fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 60(2) stating that the application has been received.

Fee — filing in previous fiscal year

64 For the purposes of subsection 60(1), if the Minister issues a notice referred to in section 62 or 63 in the fiscal year that follows the fiscal year in which the application was filed, the fee that is payable is the fee that was payable in the fiscal year in which the application was filed.

Remission — General Council Decision

65 Remission is granted to the person referred to in subsection 60(2) of an amount equal to the fee that is payable under subsection 60(1) if the person has received an authorization under section 21.04 of the Patent Act in respect of the medical device.

Remission — small business

66 Subject to section 68, remission is granted to the person referred to in subsection 60(2) of an amount equal to 50% of the fee that is payable under subsection 60(1) if the person provides with their application, in a form established by the Minister,

Remission — first application by small business

67 Subject to section 68, remission is granted to the person referred to in subsection 60(2) of an amount equal to the fee that is payable under subsection 60(1) if the following conditions are met:

Fee or difference payable

68 If the Minister requests under section 5 that the person referred to in subsection 60(2) provide additional information, the fee — or the difference between the fee payable under subsection 60(1) and the amount already paid, as the case may be — is immediately payable if

DIVISION 2

Fees for Examination of an Application for an Establishment Licence — Medical Devices

Interpretation

Definition of establishment licence

69 In this Division, establishment licence means a licence issued under section 46 of the Medical Devices Regulations.

Application

Applicable classes

70 This Division applies to persons that import or sell medical devices that are subject to the Medical Devices Regulations, other than persons that import or sell only medical devices that are subject to Part 2 or 3 of those Regulations.

Fee and Remission

Fee for examination

71 (1) The fee that is payable for the examination of an application for an establishment licence filed under section 45 of the Medical Devices Regulations or for the annual review of such a licence filed under section 46.1 of those Regulations is $4,590.

Fee paid by person that files application

(2) The fee is payable by the person that files the application.

Timing of payment

72 The fee is payable on the issuance by the Minister of a notice to the person referred to in subsection 71(2) stating that the application has been accepted for further examination.

Reinstatement

73 Every provision of this Division that applies to an application for an establishment licence also applies to a request to have such a licence reinstated following the correction of the situation that gave rise to its suspension.

Remission — small business

74 Subject to section 75, remission is granted to the person referred to in subsection 71(2) of an amount equal to 25% of the fee that is payable under subsection 71(1) if the person provides with their application, in a form established by the Minister,

Difference payable

75 If the Minister requests under section 5 that the person referred to in subsection 71(2) provide additional information, the difference between the fee payable under subsection 71(1) and the amount already paid is immediately payable if

DIVISION 3

Fees for Right to Sell Licensed Class II, III or IV Medical Devices

Interpretation

Definition of licence

76 In this Division, licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations.

Fees and Remission

Annual fee

77 (1) The annual fee that is payable for the right to sell a licensed Class II, III or IV medical device is $381.

Fee payable by holder — licence not suspended

(2) The fee is payable by the person that holds the licence for the Class II, III or IV medical device if the licence is not suspended under section 40 or 41 of the Medical Devices Regulations.

Timing of payment

78 The fee is payable on December 20.

Remission — small business

79 Subject to section 80, remission is granted to the person referred to in subsection 77(2) of an amount equal to 25% of the fee that is payable under subsection 77(1) if the person provides with the statement provided under subsection 43(1) of the Medical Devices Regulations, in a form established by the Minister,

Difference payable

80 If the Minister requests under section 5 that the person referred to in subsection 77(2) provide additional information, the difference between the fee payable under subsection 77(1) and the amount already paid is immediately payable if

Coming into Force

SOR/96-143

81 This Order comes into force on the day on which the Veterinary Drug Evaluation Fees Regulations are repealed but if it is registered after that day, it comes into force on the day on which it is registered.

SCHEDULE 1

(Section 9)

Fees for Examination of a Submission — Drugs for Human Use

Item

Column 1



Submission Class

Column 2



Description

Column 3

Fee ($)
Fiscal Year
2020-2021

Column 4

Fee ($)
Fiscal Year
2021-2022

Column 5

Fee ($)
Fiscal Year
2022-2023

Column 6

Fee ($)
Fiscal Year
2023-2024

1

New active substance

Submissions in support of a drug, other than a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph

400,288

437,884

475,481

513,077

2

Clinical or non-clinical data and chemistry and manufacturing data

Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance

204,197

224,691

245,185

265,678

3

Clinical or non-clinical data only

Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance

90,864

95,987

101,110

106,232

4

Comparative studies

Submissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance

53,836

55,848

57,859

59,870

5

Chemistry and manufacturing data only

Submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance

27,587

30,670

33,752

36,835

6

Clinical or non-clinical data only, in support of safety updates to the labelling

Submissions based only on clinical or non-clinical data, in support of safety updates to the labelling materials for a new drug that does not include a new active substance

19,442

19,442

19,442

19,442

7

Labelling only

Submissions, other than those described in item 8, 11 or 12, of labelling material, that include data in support of the following: brand name assessment, standardized or published test methods, in vitro or in vivo photostability or applications for a drug identification number in support of changes to brand names of non-prescription drugs (but not including examination of other supporting clinical or non-clinical data, comparative data, or chemistry and manufacturing data)

3,816

4,328

4,841

5,353

8

Labelling only (generic drugs)

Submissions in support of a change to the labelling to be consistent with the Canadian reference product that do not include any additional labelling updates requiring a labelling assessment

2,010

2,010

2,010

2,010

9

Administrative submission

Submissions in support of a change in the manufacturer’s name or brand name, including the following: changes in ownership of the drug, request for an additional brand name or changes resulting from a licensing agreement being entered into by two manufacturers that do not require an assessment of labelling material or brand name (e.g., post-authorization label changes filed by licensees to remain identical to licensor’s drug and post-authorization chemistry and manufacturing updates for drugs listed in Schedule C or D of the Food and Drugs Act)

432

540

676

845

10

Disinfectant — full review

Submissions, other than those described in item 11, that include data in support of a disinfectant

5,712

7,140

8,925

11,157

11

Labelling only (disinfectants)

Submissions in support of changes to the labelling of disinfectants that do not require supporting data, submissions in support of safety updates for disinfectants that are new drugs or submissions in support of a change in the manufacturer’s name or brand name that requires a review of labelling material due to deviations from the previously authorized labelling or drug

2,507

2,507

2,507

2,507

12

Drug identification number application — labelling standards

Applications, including those that pertain to changes to brand names for non-prescription drugs, that include an attestation of compliance with a labelling standard or Category IV Monograph for a drug and that do not include clinical or non-clinical data or chemistry and manufacturing data

1,616

1,616

1,616

1,616

SCHEDULE 2

(Section 21)

Fees for Examination of a Submission — Drugs for Veterinary Use Only

Item

Column 1


Type of Submission

Column 2



Component

Column 3

Fee ($)
Fiscal Year
2020-2021

Column 4

Fee ($)
Fiscal Year
2021-2022

Column 5

Fee ($)
Fiscal Year
2022-2023

Column 6

Fee ($)
Fiscal Year
2023-2024

Column 7

Fee ($)
Fiscal Year
2024-2025

Column 8

Fee ($)
Fiscal Year
2025-2026

Column 9

Fee ($)
Fiscal Year
2026-2027

1

Application for drug identification number

Information, other than that referred to in item 2, to support an application for a drug identification number, including the submission of labelling material for a second review, if required

918

1,148

1,436

1,714

1,959

2,204

2,448

2

Application for drug identification number

Published references or other data

638

798

998

1,191

1,361

1,532

1,701

3

Application for drug identification number

Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug table 2 note 1

320

400

500

596

681

765

850

4

Notification — veterinary health product

Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product

486

486

486

486

486

486

486

5

New drug submission

Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species (in the case of an antiparasitic drug, several indications in one food animal species)

20,375

25,469

31,837

38,033

43,467

48,900

54,333

6

New drug submission

Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species

12,342

15,428

19,286

23,039

26,331

29,622

32,913

7

New drug submission

Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species

29,631

37,040

46,300

55,312

63,214

71,116

79,017

8

New drug submission

Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species

40,125

50,157

62,697

74,899

85,599

96,299

106,998

9

New drug submission

Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration

3,698

4,623

5,779

6,903

7,889

8,876

9,861

10

New drug submission

Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength

612

765

957

1,143

1,306

1,469

1,632

11

New drug submission

For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species

27,783

34,729

43,412

51,861

59,270

66,678

74,086

12

New drug submission

For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species

37,040

46,300

57,875

69,140

79,017

88,893

98,770

13

New drug submission

For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration

3,698

4,623

5,779

6,903

7,889

8,876

9,861

14

New drug submission

For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species

18,513

23,142

28,928

34,558

39,495

44,432

49,368

15

New drug submission

Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug

6,171

7,715

9,644

11,520

13,166

14,811

16,456

16

New drug submission

Chemistry and manufacturing data to support one strength of a single dosage form

6,171

7,715

9,644

11,520

13,166

14,811

16,456

17

New drug submission

Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 16

3,086

3,858

4,823

5,760

6,584

7,407

8,229

18

New drug submission

Documentation to support a change of manufacturer table 2 note 2

320

400

500

596

681

765

850

19

Supplement to a new drug submission

Efficacy data to support an additional indication in one animal species

16,053

20,067

25,084

29,965

34,246

38,527

42,807

20

Supplement to a new drug submission

Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species

12,342

15,428

19,286

23,039

26,331

29,622

32,913

21

Supplement to a new drug submission

Efficacy and safety data (in the intended species) to support an indication in another animal species

20,375

25,469

31,837

38,033

43,467

48,900

54,333

22

Supplement to a new drug submission

Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species

29,631

37,040

46,300

55,312

63,214

71,116

79,017

23

Supplement to a new drug submission

Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species

40,125

50,157

62,697

74,899

85,599

96,299

106,998

24

Supplement to a new drug submission

Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species

9,869

12,336

15,421

18,422

21,053

23,685

26,316

25

Supplement to a new drug submission

Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration

3,698

4,623

5,779

6,903

7,889

8,876

9,861

26

Supplement to a new drug submission

Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength

612

765

957

1,143

1,306

1,469

1,632

27

Supplement to a new drug submission

For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species

3,698

4,623

5,779

6,903

7,889

8,876

9,861

28

Supplement to a new drug submission

For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species

18,513

23,142

28,928

34,558

39,495

44,432

49,368

29

Supplement to a new drug submission

For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period

9,257

11,571

14,464

17,279

19,748

22,216

24,684

30

Supplement to a new drug submission

For the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required

7,409

9,261

11,576

13,829

15,804

17,780

19,755

31

Supplement to a new drug submission

Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process

6,171

7,715

9,644

11,520

13,166

14,811

16,456

32

Supplement to a new drug submission

Chemistry and manufacturing data to support a change in formulation or dosage form

3,086

3,858

4,823

5,760

6,584

7,407

8,229

33

Supplement to a new drug submission

Chemistry and manufacturing data to support a change in the packaging or sterilization process

2,462

3,078

3,848

4,595

5,250

5,906

6,562

34

Supplement to a new drug submission

Chemistry and manufacturing data to support an extension of the expiry date

1,850

2,313

2,891

3,452

3,945

4,437

4,930

35

Supplement to a new drug submission

Chemistry and manufacturing data to support the concurrent use of two drugs

1,850

2,313

2,891

3,452

3,945

4,437

4,930

36

Supplement to a new drug submission

Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form

612

765

957

1,143

1,306

1,469

1,632

37

Supplement to a new drug submission

Documentation to support a change to the brand name of a drug table 2 note 3

320

400

500

596

681

765

850

38

Abbreviated new drug submission or supplement to an abbreviated new drug submission

Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form

3,698

4,623

5,779

6,903

7,889

8,876

9,861

39

Abbreviated new drug submission or supplement to an abbreviated new drug submission

For food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product

3,698

4,623

5,779

6,903

7,889

8,876

9,861

40

Abbreviated new drug submission or supplement to an abbreviated new drug submission

Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug

6,171

7,715

9,644

11,520

13,166

14,811

16,456

41

Abbreviated new drug submission or supplement to an abbreviated new drug submission

Chemistry and manufacturing data to support a single dosage form

6,171

7,715

9,644

11,520

13,166

14,811

16,456

42

Abbreviated new drug submission or supplement to an abbreviated new drug submission

Documentation to support

  • (a) a change of manufacturer, in the case of an abbreviated new drug submission; or
  • (b) a change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission table 2 note 4

320

400

500

596

681

765

850

43

Preclinical submission

Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species

6,171

7,715

9,644

11,520

13,166

14,811

16,456

44

Preclinical submission

Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated

4,935

6,169

7,712

9,211

10,527

11,843

13,158

45

Preclinical submission

For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species

18,513

23,142

28,928

34,558

39,495

44,432

49,368

46

Preclinical submission

For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species

27,783

34,729

43,412

51,861

59,270

66,678

74,086

47

Preclinical submission

For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species

37,040

46,300

57,875

69,140

79,017

88,893

98,770

48

Preclinical submission

For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species

9,257

11,571

14,464

17,279

19,748

22,216

24,684

49

Preclinical submission

Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient

6,171

7,715

9,644

11,520

13,166

14,811

16,456

50

Preclinical submission

Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient

3,086

3,858

4,823

5,760

6,584

7,407

8,229

51

Sale of new drug for emergency treatment

Information and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal

51

51

51

51

51

51

51

52

Sale of new drug for emergency treatment

Information and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal

102

102

102

102

102

102

102

53

Experimental studies certificate

Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal

980

980

980

980

980

980

980

54

Experimental studies certificate

Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal

490

490

490

490

490

490

490

55

Experimental studies certificate

Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal

2,958

2,958

2,958

2,958

2,958

2,958

2,958

56

Experimental studies certificate

Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal

490

490

490

490

490

490

490

57

Notifiable change

Information and material to support an application for a notifiable change

1,658

2,073

2,591

3,095

3,537

3,978

4,420

58

Protocol

A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate

1,658

2,073

2,591

3,095

3,537

3,978

4,420

Table 2 note(s)

Table 2 Note 1

This item applies only to an application for a drug identification number that does not include either of the components set out in items 1 and 2.

Return to table 2 note 1 referrer

Table 2 Note 2

This item applies only to a new drug submission that does not include any of the components set out in items 5 to 17.

Return to table 2 note 2 referrer

Table 2 Note 3

This item applies only to a supplement to a new drug submission that does not include any of the components set out in items 19 to 36.

Return to table 2 note 3 referrer

Table 2 Note 4

This item applies only to an abbreviated new drug submission or a supplement to an abbreviated new drug submission that does not include any of the components set out in items 38 to 41.

Return to table 2 note 4 referrer

SCHEDULE 3

(Sections 33 to 39 and 41 to 47)

Fees for Examination of an Application for an Establishment Licence — Drugs for Human Use

Item

Column 1



Activity

Column 2

Fee ($)
Fiscal Year
2020-2021

Column 3

Fee ($)
Fiscal Year
2021-2022

Column 4

Fee ($)
Fiscal Year
2022-2023

Column 5

Fee ($)
Fiscal Year
2023-2024

1

Fabrication — sterile dosage form

41,626

41,730

41,834

41,937

2

Importation

27,359

29,033

30,707

32,380

3

Fabrication — non-sterile dosage form

27,000

28,364

29,727

31,091

4

Distribution

12,560

13,882

15,205

16,527

5

Wholesaling

4,937

6,171

7,715

9,644

6

Packaging/labelling

6,061

6,061

6,061

6,061

7

Testing

2,560

3,200

4,001

5,002

SCHEDULE 4

(Sections 33 to 39 and 41 to 47)

Fees for Examination of an Application for an Establishment Licence — Drugs for Veterinary Use Only

Item

Column 1



Activity

Column 2

Fee ($)
Fiscal Year
2020-2021

Column 3

Fee ($)
Fiscal Year
2021-2022

Column 4

Fee ($)
Fiscal Year
2022-2023

Column 5

Fee ($)
Fiscal Year
2023-2024

Column 6

Fee ($)
Fiscal Year
2024-2025

Column 7

Fee ($)
Fiscal Year
2025-2026

Column 8

Fee ($)
Fiscal Year
2026-2027

1

Fabrication — sterile dosage form

40,198

40,487

40,777

41,068

41,357

41,647

41,937

2

Importation

10,715

13,393

16,742

20,927

26,158

32,380

32,380

3

Fabrication — non-sterile dosage form

8,782

10,978

13,722

17,152

21,440

26,800

31,091

4

Distribution

4,835

6,043

7,555

9,443

11,803

14,754

16,527

5

Wholesaling

1,933

2,416

3,020

3,774

4,718

5,898

7,372

6

Packaging/labelling

6,061

6,061

6,061

6,061

6,061

6,061

6,061

7

Testing

1,315

1,644

2,055

2,569

3,210

4,013

5,002

SCHEDULE 5

(Section 48)

Fee Reduction — Application for an Establishment Licence — Drugs

Item

Column 1

Percentage of Fee Reduction

Column 2

Filing Period

1

25%

July 1 to September 30

2

50%

October 1 to December 31

3

75%

January 1 to March 31

Note: The fee payable under subsection 30(1) of this Order is not reduced if an application is filed on or after April 1 and up to and including June 30.

SCHEDULE 6

(Section 52)

Fees for Right to Sell Drugs for Human Use

Interpretation

Definition of disinfectant

1 In this Schedule, disinfectant has the meaning assigned by the definition antimicrobial agent in subsection C.01A.001(1) of the Food and Drug Regulations.

Item

Column 1



Type of Drug

Column 2

Fee ($)
Fiscal Year
2020-2021

Column 3

Fee ($)
Fiscal Year
2021-2022

Column 4

Fee ($)
Fiscal Year
2022-2023

Column 5

Fee ($)
Fiscal Year
2023-2024

1

Disinfectant

1,285

1,344

1,403

1,462

2

Non-prescription drug

1,623

2,022

2,421

2,820

3

Drug other than one referred to in item 1 or 2

1,836

2,754

4,080

4,679

SCHEDULE 7

(Section 56)

Fees for Right to Sell Drugs for Veterinary Use Only

Item

Column 1
Fee ($)
Fiscal Year
2020-2021

Column 2
Fee ($)
Fiscal Year
2021-2022

Column 3
Fee ($)
Fiscal Year
2022-2023

Column 4
Fee ($)
Fiscal Year
2023-2024

1

312

367

422

477

SCHEDULE 8

(Section 60)

Fees for Examination of an Application for a Medical Device Licence

Interpretation

Definition of private label medical device

1 In this Schedule, private label medical device means a medical device that is identical in every respect to a medical device in respect of which a licence has been issued, except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that the other manufacturer is proposing to sell under its own name or under a trademark, design, trade-name or other name or mark owned or controlled by it.

Item

Column 1



Category

Column 2



Description

Column 3

Fee ($)
Fiscal Year
2020-2021

Column 4

Fee ($)
Fiscal Year
2021-2022

Column 5

Fee ($)
Fiscal Year
2022-2023

Column 6

Fee ($)
Fiscal Year
2023-2024

1

Applications for Class II licence

Applications for Class II medical device licence other than those referred to in item 10

450

478

505

533

2

Applications for Class II licence amendment

Applications for amendment of Class II medical device licence other than those referred to in item 10

272

272

272

272

3

Applications for Class III licence

Applications for Class III medical device licence other than those referred to in item 4 or 10

7,477

8,912

10,347

11,783

4

Applications for Class III licence (near patient)

Applications for Class III medical device licence for a near patient in vitro diagnostic device

12,851

16,064

20,081

25,102

5

Applications for Class III licence amendment — changes in manufacturing

Applications for amendment of Class III medical device licence — changes in manufacturing process, facility or equipment or manufacturing quality control procedures

1,903

2,379

2,974

3,717

6

Applications for Class III licence amendment — significant changes not related to manufacturing

Applications for amendment of Class III medical device licence — significant changes other than those referred to in item 5

6,608

7,558

8,508

9,458

7

Applications for Class IV licence

Applications for Class IV medical device licence other than those referred to in item 10

24,345

24,748

25,151

25,554

8

Applications for Class IV licence amendment — changes in manufacturing

Applications for amendment of Class IV medical device licence — changes referred to in paragraph 34(a) of the Medical Devices Regulations that relate to manufacturing

1,903

2,379

2,974

3,717

9

Applications for Class IV licence amendment — significant changes not related to manufacturing

Applications for amendment of Class IV medical device licence — any other changes referred to in paragraph 34(a) or (b) of the Medical Devices Regulations

8,057

9,983

11,752

13,521

10

Applications for Class II, III or Class IV licence or licence amendment — private label medical device

Applications for Class II, III or IV medical device licence or applications for amendment of such a licence — private label medical device

147

147

147

147

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

Health Canada (the Department) has responsibility in Canada to regulate the safety, efficacy and quality of health products. The Department charges fees for certain services and activities related to the regulation of health products (including pharmaceutical and biologic drugs, medical devices and veterinary drugs) under the Financial Administration Act (FAA). These fees apply to activities such as pre-market regulatory review, the ongoing surveillance of products once they are on the market, and the review of establishment licences.

Health Canada last updated its fees relating to human drugs and medical devices in 2011. Fees for veterinary drugs were enacted in stages between 1995 and 1998 and have not been updated since their inception. Prior to the Food and Drugs Act (FDA) amendments in 2017, fees relating to therapeutic products that were enacted under the FDA could only be changed through a regulation made by the Governor in Council and had to meet the requirements found under the former User Fees Act. This process took several years, which resulted in Health Canada’s fees for services and activities related to drugs (human and veterinary) and medical devices not being up to date with evolving regulatory costs. As a consequence, Health Canada’s fees in relation to drugs and medical devices no longer reflect current costs to the Department, nor are they well aligned with fees charged by regulatory partners.

Background

Amendments to the FDA were made through the Budget Implementation Act, 2017, No. 1 (BIA 1), and gave the Minister of Health (the Minister) authority under subsection 30.61(1) of the FDA to fix, by order, fees for services, regulatory processes or approvals, products, rights and privileges provided under the FDA. It also gave the Minister authority to remit those fees, to adjust them and to withhold or withdraw services for the non-payment of fees. Furthermore, amendments to the FDA exempt those fees from the requirements of the Service Fees Act (formerly the User Fees Act).

These authorities provide the Minister with levers to set or update fees efficiently. By being able to fix fees by ministerial order under the FDA, the Minister has the flexibility to set and adjust fees in a timely way so that they better reflect actual costs. A modernized cost recovery regime will ensure that industry pays an appropriate share of the costs associated with regulating health products in Canada, while alleviating some of the costs of regulatory services for taxpayers.

In order to implement the new fee regime, several of the current fee regulations under the FAA will be repealed, while some will be amended in part, by way of the Regulations Amending and Repealing Certain Regulations Made under the Financial Administration Act. The Fees in Respect of Drugs and Medical Devices Regulations under the FAA will in large part be repealed, as well as amended. The Veterinary Drug Evaluation Fees Regulations, the Establishment Licensing Fees (Veterinary Drugs) Regulations and the Authority to Sell Veterinary Drugs Fees Regulations will be repealed. Transitional provisions will also be made so that fee deferrals and remissions pending at the time of the repeal will be allowed to continue.

Objective

The Fees in Respect of Drugs and Medical Devices Order (the ministerial order) will revise the fee structure and cost recovery framework for drugs and medical devices. A modernized cost recovery framework supports effective and responsive service delivery, a fair and consistent approach to program funding, while at the same time alleviating the costs of regulatory services on Canadian taxpayers.

Description

The ministerial order will fix fees in relation to human drugs, veterinary drugs and medical devices for pre- and post-market activities under the Food and Drug Regulations (FDR) and under the Medical Devices Regulations (MDR), in respect of

Fee setting

All fees described below have been fixed based on the costs of delivering the regulatory service or program.

Pre-market evaluation and review fees
Establishment licence fees
Fees for right to sell

Exemptions

The following will be exempt from the payment of fees:

Annual fee adjustment

Every fee payable under the ministerial order will be adjusted annually on April 1st, beginning on April 1, 2021, by the consumer price index (CPI). To further clarify, all the fees set out in the ministerial order, including those in the schedules, will change over time as cumulative CPI adjustments are made to the fees in each fiscal year.

Mitigation measures

In order to qualify for mitigation measures for small businesses, a person (company or individual) must meet one of two criteria:

For small businesses that can demonstrate one of the above criteria for their last completed fiscal year, the ministerial order establishes the following mitigation measures:

Where a small business does not have a completed previous fiscal year, it must demonstrate that it meets one of the above-mentioned criteria in its current/first fiscal year (taking into account the number of employees or annual gross revenues of any affiliates in their last completed fiscal year).

A remission will also be possible for the full amount of the fee payable for the examination of a new drug submission or for the examination of an application for a drug identification number if the submission or application relates to a drug that may be imported under subsection C.10.001(2) of the Food and Drug Regulations for an urgent public health need. The remission will be granted if the drug, which must have a comparable dosage form, also has the same medicinal ingredient, strength and route of administration as the drug that may be imported under subsection C.10.001(2). No such drug, however, must already be approved for sale or have a drug identification number assigned to it.

The current remission granted to human drug or device manufacturers who have received an authorization in relation to a General Council Decision under section 21.04 of the Patent Act (i.e. Canada Access to Medicine Regime) is continued under this ministerial order.

With regard to the drug establishment licence fees, new applicants and applicants for amendments to add a new building to a DEL will have their fees prorated for a portion of the Government of Canada fiscal year in which they apply.

Performance standards and remission

All Health Canada fees will have appropriate performance standards that reflect the Department’s ability to deliver its service(s) within a set time frame. These standards will be used to assess performance for the purpose of calculating the performance standard remissions and will be outlined in detail in a document entitled Performance Standards for the Fees in Respect of Drugs and Medical Devices Order. This document was published by the Government of Canada and dated November 22, 2018. In a case where an applicable performance standard has not been met, the Minister will be required to remit 25% of the applicable fee. Performance standards are incorporated by reference into the ministerial order using the authorities under the Statutory Instruments Act.

Health Canada joint and parallel reviews with other regulatory agencies will be exempt from the application of the performance standard remissions. Medical device combination reviews where the medical device includes a drug component and a decision has been made to issue or amend (or refuse to issue or amend) a medical device licence will also be exempt from the application of performance standard remissions.

Remissions for missed performance standards will also apply in a case where the person has already received a small business remission. For example, in cases where a company receives a remission of 50% as a result of a small business remission, the performance standard remission would be 25% of the remaining 50% of the fee payable.

Coming into force

The ministerial order will come into force on the day on which the Veterinary Drug Evaluation Fees Regulations are repealed, unless it is registered at a later date. The repeal of those Regulations comes into force on April 1, 2020.

Rationale

The ministerial order is aligned with the Government’s recent commitments on fees in Budget 2017. Establishing a new cost recovery framework ensures fairness for Canadian taxpayers by supporting a better balance between tax-based funding and fees where there is a private benefit. Revenues from fees assist Health Canada to continue to meet its internationally aligned performance standards, in turn supporting timely access to drugs and medical devices, thus benefiting consumers and industry.

In the spirit of regulatory cooperation, the new cost recovery framework aims to align with the rules of Canada’s key trading partners to the greatest extent possible. A modern and internationally comparable cost recovery system will alleviate pressure on a strained system and support Health Canada in maintaining performance standards in a manner that is fair to taxpayers. Some comparable regulators in the G-20 currently charge 100% of regulatory costs to industry, while Health Canada only charges 43%. Fee setting via a ministerial order should help Health Canada keep up to date on adjusting fees to reflect regulatory costs.

Accountability principles are preserved under the new fee regime. The FDA requires that the Minister consult stakeholders prior to fixing fees. Under the FDA, a fee fixed for a service may not exceed the cost to Government of providing the service. The new fee regime maintains a financial accountability for missed performance standards by remitting fees under the new authorities. The new cost recovery regime also continues to include fee mitigation measures and introduces an annual adjustment of fees in accordance with the consumer price index.

Cost-benefit analysis

The Canadian market

Canada is the ninth-largest market for drugs footnote 1 and the eighth-largest market for medical devices footnote 2 in the world, representing just over 2.4% footnote 3 of a global market worth approximately US$1 trillion in 2017. footnote 4 In 2015, the Canadian market was estimated to be worth US$24.3 billion footnote 5 ($6.2 billion in medical devices, footnote 6 $3 billion in over the counter medicines, $10.8 billion in prescription patented medicines, and $4.3 billion in generic prescription medicines footnote 7).

The vast majority of drugs and medical devices sold in Canada are imported from other countries. For instance, Canadian-manufactured generic pharmaceuticals make up just 20.4% of the Canadian market, while Canadian manufactured brand name and innovator pharmaceuticals make up only 8.8% of the Canadian market. footnote 8 Similarly, the Canadian-manufactured medical devices make up just 20% of the Canadian market. footnote 9

A report published by the Patented Medicines Price Review Board (PMPRB) indicates that Canada is generally the fifth market (following the United States, Sweden, Germany and the United Kingdom) in which new active substances (NASs) are launched.

The fee model

The Government of Canada provides services and regulatory activities that benefit a specific group above the benefit that the general taxpayer receives. One of the key principles behind cost recovery is that, in such cases, the group receiving the additional benefit is expected to pay at least a portion of the costs of these services and activities in the form of fees.

Costs

Price elasticity and passing costs to consumers

The impact of the increase in fees on the price paid by both public and private payers is directly tied to price elasticity. For NASs, the prices of which are set by the PMPRB, it is likely that the regulatory costs will be absorbed by the industry. In the case of generics and biosimilar drugs, regulatory costs are more likely to be passed on to consumers depending on the level of competition in the product category.

However, in both cases, there are externalities that need to be accounted for. For patented medicines, regulatory changes to the PMPRB framework are designed to protect Canadians from excessive prices for patented medicines. Meanwhile, in the case of generics, a new five-year agreement announced by the Pan-Canadian Pharmaceutical Alliance and the Canadian Generic Pharmaceutical Association came into effect on April 1, 2018. The Agreement should facilitate price reductions of nearly 70 of the most commonly prescribed drugs by between 25% and 40%. Price caps such as the two examples above may limit industry’s ability to pass increased regulatory costs onto payers leaving industry more likely to absorb these costs.

For medical devices, there is no one body that sets prices and it is likely that regulatory costs would be passed on to payers when the likelihood of product substitution is low, but absorbed by industry when the likelihood of product substitution is high.

Decision not to market in Canada

It is conceivable that there may be situations in which the fees could undermine the commercial viability of a product. In such instances, industry may decide not to market the product in Canada. As a result, Canadians may be denied access to that product.

The likelihood of this scenario is lessened by the limited price sensitivity of some medical devices and human drugs, which have more unique characteristics than most traditional consumer goods. footnote 10

Another reason the increase in fees may not influence the decision to market in Canada is that the Canadian market is expected to remain lucrative given the rising demand in the near to mid future due to aging populations. Consequently, despite an increase in fees, the margins on new products should continue to be competitive vis-à-vis global markets.

Indeed, despite Canada’s current lower fees and competitive performance standards, industry rarely launches products in Canada first. As noted, industry comes to Canada fifth, on average, which is most likely related to the way pricing is currently set by the PMPRB, and due to corporate limitations to launch products in multiple jurisdictions simultaneously. footnote 11

Health Canada maintains various mechanisms to ensure that products may still be brought into the country if there is a need. These mechanisms are the Special Access Programme and certain provisions in the Food and Drug Regulations that permit the importation of drugs when necessary to meet an urgent public health need.

Overall, it is expected that in the vast majority of cases, the increase in fees would not affect the availability of products on the Canadian market.

Benefits

Reduced burn rates and opportunity costs

Research and development costs for new patented medicines are high. Citing a Tufts University study and subsequent updates, footnote 12 Innovation, Science and Economic Development Canada indicated that research and development (R&D) costs per drug averaged US$1.4 billion over a 12–13 year period. footnote 13

Full costing (amortization of research failures and opportunity cost of capital) raised the average costs to an estimated US$2.6 billion. However, these figures for the cost and length of development are controversial and have often been disputed. In fact, their actual value may be as much as 80% lower. footnote 14, footnote 15

According to the fourth in a series of comprehensive compound-based analyses of the costs of new drug development, the estimated total out-of-pocket and capitalized R&D costs per new drug were $1.4 billion and $2.6 billion in 2013 U.S. dollars, respectively. Examining R&D costs over the entire product and development life cycle increased the out-of-pocket cost per approved drug to $1.9 billion, and the capitalized cost, to $2.9 billion. When compared to the results of the previous study in the series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation.

The costs of developing generics are less contentious. The Canadian Generic Pharmaceutical Association suggests that bringing a generic product to the Canadian market costs somewhere in the range of $3.5 million and takes three to six years. This includes the costs for bio-equivalence studies, development and regulatory approval.

This new modernized cost recovery regime helps support Health Canada’s ability to produce timelier regulatory decisions. Timelier regulatory decisions are expected to benefit industry in terms of reduced burn rate (the rate at which a company spends money in excess of income) and lower opportunity cost (the benefit that a company could have received had it pursued another option). For example, the sooner a therapeutic product manufacturer receives a negative regulatory decision, the sooner the manufacturer can decide to terminate or change its approach to product development, thereby allowing it to cut its losses and redeploy its resources earlier. Alternatively, if the regulatory decision proves to be favourable, the manufacturer can bring that product to market and generate revenues earlier.

As an example, the PMPRB reports that of 210 NASs brought to Canada between 2009 and 2014, sales at the individual drug level of the top 30 NASs exceeded $250 million per year, while the sales at the low end represented drug sales worth $25 million. footnote 16 More timely regulatory decisions would allow the market authorization holders of these products to access the market sooner and recoup their development and regulatory costs earlier.

Prior to the ministerial order, Health Canada was only required to meet its approval timelines on a cumulative average basis. That is to say, the average of all of Health Canada’s approvals in a given category was required to meet the performance standard. If Health Canada failed to meet this requirement, fees were reduced for the subsequent year. Under the ministerial order, Health Canada is required to meet its standards in each case or apply a fee remission to the affected company.

Consultation

In April 2017, Health Canada communicated its intent to update fees and began its engagement process with stakeholders. Industry associations from various sectors were engaged. These sectors included medical devices, disinfectants, generic drugs, biosimilar drugs, innovator/biological drugs, over-the-counter (non-prescription) drugs, radiopharmaceutical drugs and veterinary drugs. A number of individual companies were also engaged.

Health Canada also undertook a number of stakeholder engagement events. These events included the following:

A report including stakeholder feedback received throughout the consultations and the responses from Health Canada will be published on the Health Canada website.

Fee proposal — October 11, 2017

On October 21, 2017, Health Canada published a notice of intent to consult in the Canada Gazette, Part I, on Health Canada’s Fee Proposal for Drugs and Medical Devices and informed all licence and drug identification holders of the consultations. In addition, Health Canada posted its fee proposal on the Department’s website on October 11, 2017. At the time, a costing companion document was also made available by the Department.

Industry associations from the following sectors were engaged: medical devices, disinfectants, generic drugs, biosimilar drugs, innovator/biological drugs, over-the-counter (non-prescription) drugs, radiopharmaceutical drugs and veterinary drugs. Stakeholders actively participated in the consultation process.

The main concerns raised during the consultation process and summarized below included the magnitude of the fee increases, the lack of staggered implementation and the proposed approach to small business:

Revised fee proposal — May 24, 2018

The input received by stakeholders during this consultation process was instrumental to the development of a revised fee proposal. The revised fee proposal included the following measures to address stakeholder concerns:

Spring 2018 feedback process

The revised fee proposal was published on Health Canada’s website on May 24, 2018. Health Canada held a WebEx for stakeholders on June 1, 2018. In addition, stakeholders were also invited to submit feedback on the revised proposal from May 24, 2018, to June 14, 2018.

In the May 2018 revised proposal, the same DEL fees were applied to both human and veterinary drug establishments. However, some of these fee increases were perceived as too large by veterinary stakeholders since veterinary drugs were not part of the previous cost recovery fee update in 2011. This view was compounded by concerns regarding additional regulatory requirements on industry to conform to the new Regulations Amending the Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance).

In response to industry concerns, targeted reductions and an extension of the phase-in period from four to seven years have been granted for DEL fees through the ministerial order for establishments that only deal with veterinary products.

“One-for-One” Rule

This ministerial order is not expected to introduce a new administrative burden on business.

Small business lens

Health Canada’s approach to fee mitigation is focused on facilitating Canadians’ access to products in order to help them maintain and improve their health. Companies that meet the definition of a small business under the ministerial order qualify for significant fee remissions and will pay between 25% and 50% less than other companies. All “first-time” pre-market evaluation submissions or applications by small businesses will qualify for a full remission of their evaluation fees.

Additional mitigation measures being proposed include an exemption from the application of the ministerial order for all publicly funded health care institutions, and a remission of fees for submissions concerning drugs that may be imported for an urgent public health need, as well as for quarterly pro-rated DEL fees for new applicants.

Implementation, enforcement and service standards

A communication strategy will include notices to stakeholders regarding the revised fees, as well as updated guidance documents for stakeholders and posting on Health Canada’s website. Revised fees will be posted in the fall of each year, reflecting adjusted fees based on the consumer price index.

With respect to enforcement, if a person fails to pay a fee, then the fee payable will become a debt owing to the Crown, which would be collected in accordance with standard practices. The Minister also has the authority to withhold or withdraw a service or a right or privilege from any person who fails to pay the fixed fee. Regarding small business remissions, the Minister will have the ability to request additional information to assess whether the company qualified as a small business at the time of filing their submission or other required material. Where the additional information is not provided within 60 days, or the Minister determines that the person did not qualify as a small business at the time of their filing, the applicable fee has to be paid in full, with interest from the date of the initial filing.

With respect to performance standards, Health Canada has consulted both fee-paying and non–fee-paying stakeholders. For each fee, Health Canada has identified a performance standard that reflects the level of service that can be expected.

Performance standards will not only be the expected level of service, but will become a service commitment, with remission consequences applied if standards are missed. Public performance reporting on performance standards, remissions, costs and revenues will continue through the appropriate mechanisms as directed by the Treasury Board Secretariat.

Contact

Bruno Rodrigue
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower A, Suite 14, Ground Floor
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca