Health Canada Fees Report Fiscal Year 2024-25

Table of contents

Minister's message

On behalf of Health Canada, I am pleased to present the Department's fees report for the 2024-25 fiscal year.

As part of its mandate to help keep people in Canada safe and healthy, Health Canada assesses the safety, efficacy and quality of health products. To minimize costs to Canadian taxpayers, the Department charges fees to the submitting company. Fees are charged for drugs and medical devices, pesticides, hazardous materials, radiation protection and cannabis.

This report covers fee amounts, service standards, performance results, revenues and remissions. Other notable work from this past fiscal year includes:

Health Canada will continue to work with industry partners to ensure its fee structures are current, relevant and are determined in an open and transparent manner. By collaborating and making evidence-based decisions, we will continue to help ensure that people in Canada have access to safe and effective health products.

The Honourable Marjorie Michel, P.C. M.P.
Minister of Health

About this report

This report, which is tabled under section 20 of the Service Fees Act, the Low-Materiality Fees Regulations, and subsection 4.2.9 of the Treasury Board Directive on Charging and Special Financial Authorities, contains information about the fees Health Canada had the authority to charge in fiscal year 2024-25.

The report covers fees that are subject to the Service Fees Act and exempted from the Service Fees Act.

For reporting purposes, fees are categorized by fee-setting mechanism. There are three mechanisms:

  1. Act, regulation or fees notice
    The authority to set these fees is delegated to a department, minister or Governor in Council pursuant to an act of Parliament.
  2. Contract
    Ministers have the authority to enter into contracts, which are usually negotiated between the minister and an individual or organization, and which cover fees and other terms and conditions. In some cases, that authority may also be provided by an act of Parliament.
  3. Market rate or auction
    The authority to set these fees comes from an act of Parliament or a regulation, and the minister, department or Governor in Council has no control in determining the fee amount.

For fees set by act, regulation or fees notice, the report provides totals for fee groupings, as well as detailed information for each fee. Health Canada did not have fees set by contract, market rate or auction.

Fees charged by Health Canada under the Access to Information Act are not subject to the Service Fees Act, and are not included in this report. Information on Health Canada's access to information fees can be found in our annual report to Parliament on the administration of the Access to Information Act.

Remissions

In 2024-25, Health Canada was subject to the requirements to issue remissions under section 7 of the Service Fees Act and subsection 4.2.4 of the Treasury Board Directive on Charging and Special Financial Authorities to remit a fee, in whole or in part, to a fee payer when a service standard was not met. Health Canada's remission policy and procedures, pursuant to the Service Fees Act, are on the following web page: Remissions for missed service standards

In 2024-25, Health Canada also issued remissions under its enabling legislation. These remissions may have been for reasons other than not meeting a service standard.

The authority to remit is delegated in the Food and Drugs Act, 30.63(1) and is detailed in the Fees in Respect of Drugs and Medical Devices Order.

The other sections of this report provide detailed amounts on Health Canada's remissions for 2024-25.

Overall totals, by fee setting mechanism

The following table presents the total revenue, cost and remissions for all fees that Health Canada had the authority to charge in 2024-25, by fee-setting mechanism.

Overall totals for 2024-25, by fee-setting mechanism

Fee-setting mechanism Revenue ($) Cost ($) Remissions ($)
Fees set by act, regulation or fees notice 317,406,120 672,793,375 1,871,415

Totals, by fee grouping, for fees set by act, regulation or fees notice

A fee grouping is a set of fees relating to a single business line, directorate or program that a department had the authority to set for those activities.

This section presents, for each fee grouping, the total revenue, cost and remissions for all fees that Health Canada had the authority to set in 2024-25 that are set by any of the following:

The revenue collections reported below may include: fees from previous years due to the timing of payments and lower fees due to mitigation measures (as per the relevant regulations).

Fees for Examination of a Submission - Drugs for Human Use: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
98,261,696 195,549,161 1,744,484

Certificate of Supplementary Protection Application Fees: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
103,560 157,599 0

Master File Fees: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
988,040 1,415,414 0

Fees for Right to Sell Drugs - Human: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
55,397,982 86,493,302 0

Drug Establishment Licensing Fees - Human: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
32,487,974 41,679,022 0

Certificate of Pharmaceutical Product Fee: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
242,509 725,311 0

Fees for Examination of a Submission - Drugs for Veterinary Use Only: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
1,529,523 13,659,963 0

Fees for Right to Sell Drugs - Vet: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
468,394 1,841,542 0

Drug Establishment Licensing Fees - Vet: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
1,641,965 2,799,674 0

Drug Establishment Licensing Fees - Dealer's Licences: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
486,778 4,641,479 11,370

Fees for Examination of Medical Device Licence Applications: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
12,638,651 31,121,589 2,591

Fees for Right to Sell Licenced Class II, III, or IV Medical Devices: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
13,946,715 35,032,207 0

Medical Devices Establishment Licensing Fees: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
13,397,431 16,062,172 0

Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
5,280,347 60,760,497 111,913

Annual Charge (for a registered Pest Control Product): totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
10,284,768 38,684,631 0

Fees Charged for Filing a Claim for Exemption under the Hazardous Materials Information Review Act: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
428,092 3,000,316 1,057

Cannabis Fees: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
61,582,371 127,674,704 0

National Dosimetry Products and Services Fees: totals for 2024-25

Revenue ($) Cost ($) Remissions ($)
8,239,324 11,494,792 0

Details on each fee set by act, regulation or fees notice

This section provides detailed information on each fee that Health Canada had the authority to charge in 2024-25 and that was set by any of the following:

The total of the revenue collections by fee grouping below may not equal the revenues reported in the "Totals, by fee grouping, for fees set by act, regulation or fees notice" section due to small discrepancies in the reports used.

Fees for Examination of a Submission — Drugs for Human Use

Before a drug is authorized for sale in Canada, Health Canada reviews it to assess its safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, biologics, disinfectants and sanitizers with disinfectant claims.

Fee

New Active Substance

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

300 calendar days to complete Review 1

Performance result

90.7% (39/43 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: New Active Substance

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
New Active Substance 590,346 22,891,247 601,391 April 1, 2026 616,593

Fee

Clinical or non-clinical data and chemistry and manufacturing data

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Clinical or non-clinical data and chemistry and manufacturing data

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Clinical or non-clinical data and chemistry and manufacturing data 305,690 20,092,904 439,209 April 1, 2026 319,282

Fee

Clinical or non-clinical data only

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Clinical or non-clinical data only

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Clinical or non-clinical data only 122,232 14,593,923 263,430 April 1, 2026 127,668

Fee

Comparative studies

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Comparative studies

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Comparative studies 68,889 11,655,021 73,449 April 1, 2026 71,953

Fee

Chemistry and manufacturing data only

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Chemistry and manufacturing data only

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Chemistry and manufacturing data only 42,384 16,742,891 335,271 April 1, 2026 44,269

Fee

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

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

120 calendar days to complete Review 1

Performance result

99.5% (217/218 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Clinical or non-clinical data only, in support of safety upgrades to the labelling

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Clinical or non-clinical data only, in support of safety upgrades to the labelling 22,372 5,075,649 0 April 1, 2026 23,368

Fee

Labelling only

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

120 calendar days to complete Review 1

Performance result

99.4% (655/659 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Labelling only

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Labelling only 6,161 3,744,919 6,769 April 1, 2026 6,436

Fee

Labelling only (generic drugs)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

120 calendar days to complete Review 1

Performance result

100% (221/221 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Labelling only (generic drugs)

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Labelling only (generic drugs) 2,315 436,077 0 April 1, 2026 2,419

Fee

Administrative submission

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

45 calendar days to review

Performance result

98.7% (597/605 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Administrative submission

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Administrative submission 975 537,836 1,166 April 1, 2026 1,020

Fee

Disinfectant - full review

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Disinfectant - full review

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Disinfectant - full review 12,839 198,093 21,520 April 1, 2026 13,411

Fee

Labelling only (disinfectants)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

90 calendar days to complete Review 1

Performance result

68.2% (15/22 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Labelling only (disinfectants)

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Labelling only (disinfectants) 2,886 45,212 691 April 1, 2026 3,015

Fee

Drug identification number application - labelling standards

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 calendar days to complete Review 1

Performance result

96.8% (122/126 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Drug identification number application - labelling standards

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Drug identification number application - labelling standards 1,861 208,672 1,589 April 1, 2026 1,945

Certificate of Supplementary Protection Application Fees

In agreeing to provisionally apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs.

Fee

Certificate of Supplementary Protection Application Fees

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 days for the first eligibility decision

Performance result

100% (16/16 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Certificate of Supplementary Protection Application Fees

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Certificate of Supplementary Protection Application Fees 10,356 103,560 This fee was not subject to remissions April 1, 2026 10,776

Master File Fees

A Master File (MF) is a reference that provides information about specific processes or components used in the manufacturing, processing, or packaging of a drug. The MF is a useful vehicle for providing information to Health Canada, where that information is confidential business information (CBI) and is not available to the manufacturer of the dosage form or to the sponsors of a drug submission, DIN (Drug identification Number) application or clinical trial application (CTA).

Fee

Fee-setting authority

Year fee-setting authority was introduced

1996

Last year fee-setting authority was amended

2017

Service standard

30 calendar days

Performance result

100% (2,245/2,245 issued within 30 calendar days)

Application of Low-Materiality Fees Regulations

Not subject to section 17 of the Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

New Master Files (file registration)

1,379

326,116

This fee was not subject to remissions

April 1, 2026

1,436

Drug Master Files – letter of access

196

255,613

April 1, 2026

204

Drug Master Files - Update

599

432,584

April 1, 2026

624

Fees for Right to Sell Drugs – Human Use

Health Canada monitors human drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to maintain and sell human drugs in Canada.

Fee

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

20 calendar days to update the Drug Product Database following receipt of a complete Annual Notification Package

Performance result

100% (1,098/1,098 human and veterinary completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Human drugs - Disinfectant (item 1)

1,684

1,510,155

0

April 1, 2026

1,760

Human drugs - Non-prescription (item 2)

3,246

7,921,878

0

April 1, 2026

3,391

Human drugs - Prescription (drug other than one referred to in item 1 or 2)

5,385

45,965,950

0

April 1, 2026

5,626

Drug Establishment Licensing Fees – Human Use

Any person in Canada must obtain a Drug Establishment Licence (DEL) if they are engaged in any of the six regulated activities (fabricate, import, distribute, wholesale, package/label, and test) with respect to human drugs. A fee is charged for the examination of a DEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The DEL fee is calculated on a per-site basis, therefore, the fee amount varies by application. A DEL fee is charged for the application for a new DEL, an annual licence review of a DEL, certain amendments to a DEL, or reinstatement of a suspended DEL.

Fee

Human Drug Establishment Licence Fees

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

250 calendar days to issue/ renew license

Performance result

100% (791/791) of licences issued (human and veterinary) within 250 calendar days

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Fabrication - Sterile dosage form

48,255

2,138,201

0

April 1, 2026

50,401

Importation

37,259

12,209,699

0

April 1, 2026

38,916

Fabrication - non-sterile dosage form

35,774

2,237,165

0

April 1, 2026

37,365

Distribution

19,017

918,856

0

April 1, 2026

19,864

Wholesaling

11,098

1,339,544

0

April 1, 2026

11,592

Packaging/labelling

6,975

598,860

0

April 1, 2026

7,286

Testing

5,757

326,466

0

April 1, 2026

6,014

Building outside Canada (each)

1,059

13,044,476

0

April 1, 2026

1,107

Certificate of Pharmaceutical Product Fee

A certificate issued establishing the status of the pharmaceutical, biological, radiopharmaceutical or veterinary product listed and the Good Manufacturing Practice status of the fabricator of the product.

Fee

Certificate of Pharmaceutical Product

Fee-setting authority

Year fee-setting authority was introduced

1996

Last year fee-setting authority was amended

2012

Service standard

25 business days to issue certificate

Performance result

94.8% (2,409/2,541 of certificates issued within 25 business days)

Application of Low-Materiality Fees Regulations

Not subject to section 17 of the Service Fees Act: Certificate of Pharmaceutical Product

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Certificate of Pharmaceutical Product 100 242,509 This fee was not subject to remissions April 1, 2026 105

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

Before a veterinary drug is authorized for sale in Canada, Health Canada reviews it to assess its efficacy and safety in the intended species as well as human safety. Fees are calculated on a component basis.

Fee

Drug Identification Number (Schedule 2 items 1 to 3)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

120 calendar days to complete Review 1

Performance result

100% (18/18 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

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

2,257

4,514

0

April 1, 2026

2,946

2) Published references or other data

1,569

0

0

April 1, 2026

2,047

3) 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

786

393

0

April 1, 2026

1,025

Fee

Notification - veterinary health product (Schedule 2 item 4)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

30 calendar days to process notification

Performance result

100% (634/634 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
4) 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 562 172,824 0 April 1, 2026 588

Fee

New drug submission (Schedule 2 items 5 to 18)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

5) 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.)

50,015

417,030

0

April 1, 2026

65,297

6) 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

30,298

30,298

0

April 1, 2026

39,557

7) 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, dosage form and two indications in one animal species

72,735

0

0

April 1, 2026

94,961

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

98,491

0

0

April 1, 2026

128,589

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

9,079

0

0

April 1, 2026

11,855

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

1,505

0

0

April 1, 2026

1,964

11) 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

68,199

68,199

0

April 1, 2026

89,035

12) 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

90,918

90,918

0

April 1, 2026

118,700

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

9,079

4,540

0

April 1, 2026

11,855

14) 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

45,446

0

0

April 1, 2026

59,332

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

15,150

128,775

0

April 1, 2026

19,780

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

15,150

141,472

0

April 1, 2026

19,780

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

7,578

37,890

0

April 1, 2026

9,893

18) Documentation to support a change of manufacturer

786

786

0

April 1, 2026

1,025

Fee

Supplement to a new drug submission (Schedule 2 items 19 to 37)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

19) Efficacy data to support an additional indication in one animal species

39,406

78,812

0

April 1, 2026

51,445

20) 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

30,298

146,584

0

April 1, 2026

39,557

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

50,015

0

0

April 1, 2026

65,297

22) 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.

72,735

0

0

April 1, 2026

94,961

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

98,491

0

0

April 1, 2026

128,589

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

24,225

0

0

April 1, 2026

31,628

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

9,079

0

0

April 1, 2026

11,855

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

1,505

1,261

0

April 1, 2026

1,964

27) 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

9,079

0

0

April 1, 2026

11,855

28) 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

45,446

0

0

April 1, 2026

59,332

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

22,724

0

0

April 1, 2026

29,667

30) 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

18,187

0

0

April 1, 2026

23,744

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

15,150

0

0

April 1, 2026

19,780

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

7,578

6,350

0

April 1, 2026

9,893

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

6,043

6,043

0

April 1, 2026

7,888

34) Chemistry and manufacturing data to support an extension of the expiry dating

4,541

0

0

April 1, 2026

5,930

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

4,541

0

0

April 1, 2026

5,930

36) Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms

1,505

0

0

April 1, 2026

1,964

37) Documentation to support a change to the name of a manufacturer or the brand name of a drug

786

0

0

April 1, 2026

1,025

Fee

Abbreviated new drug submission (Schedule 2 items 38 to 42)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

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

9,079

16,689

0

April 1, 2026

11,855

39) For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product

9,079

0

0

April 1, 2026

11,855

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

15,150

63,269

0

April 1, 2026

19,780

41) Chemistry and manufacturing data to support a single dosage form

15,150

85,994

0

April 1, 2026

19,780

42) Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission

786

1,572

0

April 1, 2026

1,025

Fee

Supplement to an abbreviated new drug submission (Schedule 2 items 38 to 42)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

Performance result

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

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

9,079

16,689

0

April 1, 2026

11,855

39) For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product

9,079

0

0

April 1, 2026

11,855

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

15,150

63,269

0

April 1, 2026

19,780

41) Chemistry and manufacturing data to support a single dosage form

15,150

85,994

0

April 1, 2026

19,780

42) Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission

786

1,572

0

April 1, 2026

1,025

Fee

Preclinical submission (Schedule 2 items 43 to 50)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 calendar days to complete Review 1

Performance result

Not applicable - no applications received

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

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

15,150

0

0

April 1, 2026

19,780

44) 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

12,114

0

0

April 1, 2026

15,816

45) 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

45,446

0

0

April 1, 2026

59,332

46) 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

68,199

0

0

April 1, 2026

89,035

47) 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

90,918

0

0

April 1, 2026

118,700

48) 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

22,724

0

0

April 1, 2026

29,667

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

15,150

0

0

April 1, 2026

19,780

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

7,578

0

0

April 1, 2026

9,893

Fee

Sale of new drug for emergency treatment (Schedule 2 items 51 and 52)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

2 business days to review application

Performance result

100% (630/630 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

51) Information to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal

60

25,551

0

April 1, 2026

64

52) Information to support the sale of a drug to be used in the emergency treatment of a food-producing animal

120

9,615

0

April 1, 2026

127

Fee

Experimental studies certificate (Schedule 2 items 53 to 56)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 calendar days to review application

Performance result

100% (100/100 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

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

1,130

15,465

0

April 1, 2026

1,181

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

566

1,131

0

April 1, 2026

592

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

3,406

11,921

0

April 1, 2026

3,558

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

566

566

0

April 1, 2026

592

Fee

Notifiable change (Schedule 2 item 57)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

90 calendar days to review application

Performance result

100% (41/41 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
57) Information and material to support an application for Notifiable Change 4,072 101,200 0 April 1, 2026 5,316

Fee

Protocol (Schedule 2 item 58)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

90 calendar days to review package

Performance result

Not applicable - no applications received

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
58) 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 4,072 0 0 April 1, 2026 5,316

Fees for Right to Sell Drugs – Veterinary Use

Health Canada monitors veterinary drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to maintain veterinary drugs in Canada.

Fee

Veterinary Drugs

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

20 calendar days to update the Drug Product Database following receipt of a complete Annual Notification Package

Performance result

100% (1,098/1,098 human and veterinary completed within the service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Veterinary Drugs

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Veterinary Drugs 552 468,394 0 April 1, 2026 577

Drug Establishment Licensing Fees – Veterinary Use

Any person in Canada must obtain a Drug Establishment Licence (DEL) if they are engaged in any of the six regulated activities (fabricate, import, distribute, wholesale, package/label, and test) with respect to veterinary drugs. A fee is charged for the examination of a DEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The DEL fee is calculated on a per-site basis, therefore, the fee amount varies by application. A DEL fee is charged for the application for a new DEL, an annual licence review of a DEL, certain amendments to a DEL, or reinstatement of a suspended DEL.

Fee

Veterinary Drug Establishment Licence Fees

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

250 calendar days to issue/ renew license

Performance result

100% (791/791) of licences issued (human and veterinary) within 250 calendar days

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Fabrication - Sterile dosage form

47,588

0

0

April 1, 2026

50,401

Importation

30,099

629,120

0

April 1, 2026

38,916

Fabrication - non-sterile dosage form

24,671

61,441

0

April 1, 2026

37,365

Distribution

13,583

48,778

0

April 1, 2026

19,864

Wholesaling

5,431

73,210

0

April 1, 2026

8,864

Packaging/labelling

6,975

0

0

April 1, 2026

7,286

Testing

3,695

2,771

0

April 1, 2026

6,014

Building outside Canada (each)

1,059

825,585

0

April 1, 2026

1,107

Drug Establishment Licensing Fees - Dealer's Licences

Fees for the examination of a new dealer's licence application (Human Drugs), a new dealer's licence (Veterinary Drugs) or the renewal of a dealer's licence; issued under the Narcotic Control Regulations and Part G of the Food and Drug Regulations. There is no fee associated with the application for a new or renewal of a controlled substances licence issued under the Benzodiazepines and Other Targeted Substances Regulations and Part J of the Food and Drug Regulations.

Fee

Fee-setting authority

Financial Administration Act (FAA)

Year fee-setting authority was introduced

1998

Last year fee-setting authority was amended

Service standard:

Performance result

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Dealer's Licence Fees - Human Drugs 5,841.00 476,782 11,143 April 1, 2026 6,078.00
Dealer's Licence Fees - Veterinary Drugs 2,098.99 8,080 228 April 1, 2026 2,192.31
Dealer's Licence Fees - Veterinary Drugs – First Year 1,049.50 1,916 0 April 1, 2026 1,096.16

Fees for Examination of an Application for a Medical Device Licence

The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types of medical devices are exempt from medical device licensing and therefore no fees apply: Class I medical devices; custom-made medical devices; medical devices for special access; and medical devices for investigational testing involving human subjects.

Fee

Applications for Class II licence

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

15 calendar days to review

Performance result

99.3% (1,528/1,539 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class II licence

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class II licence 615 847,004 1,384 April 1, 2026 643

Fee

Applications for Class II licence amendment

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

15 calendar days to review

Performance result

99.2% (1,344/1,355 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class II licence amendment

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class II licence amendment 316 394,014 546 April 1, 2026 331

Fee

Applications for Class III licence

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 calendar days to complete Review 1

Performance result

99.7% (302/303 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class III licence

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class III licence 13,559 3,503,741 0 April 1, 2026 14,163

Fee

Applications for Class III licence (near patient)

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 calendar days to complete Review 1

Performance result

100% (12/12 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class III licence (near patient)

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class III licence (near patient) 28,884 315,619 0 April 1, 2026 30,169

Fee

Applications for Class III licence amendment - changes in manufacturing

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 calendar days to complete Review 1

Performance result

100% (28/28 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class III licence amendment - changes in manufacturing

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class III licence amendment - changes in manufacturing 4,279 73,035 0 April 1, 2026 4,470

Fee

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

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

60 calendar days to complete Review 1

Performance result

100% (353/353 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class III licence amendment - significant changes not related to manufacturing

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class III licence amendment - significant changes not related to manufacturing 10,884 3,720,579 533 April 1, 2026 11,369

Fee

Applications for Class IV licence

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

75 calendar days to complete Review 1

Performance result

100% (58/58 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class IV licence

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class IV licence 29,405 1,610,428 0 April 1, 2026 30,713

Fee

Applications for Class IV licence amendment - changes in manufacturing

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

75 calendar days to complete Review 1

Performance result

100% (38/38 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class IV licence amendment - changes in manufacturing

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class IV licence amendment - changes in manufacturing 4,279 148,606 0 April 1, 2026 4,470

Fee

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

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

75 calendar days to complete Review 1

Performance result

100% (109/109 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class IV licence amendment – significant changes not related to manufacturing

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class IV licence amendment - significant changes not related to manufacturing 15,558 1,815,719 0 April 1, 2026 16,251

Fee

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

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

15 calendar days to review

Performance result

99.3% (573/577 completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Applications for Class II, III or IV licence or licence amendment - private label medical device

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications for Class II, III or IV licence or licence amendment - private label medical device 171 74,502 128 April 1, 2026 179

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

Health Canada monitors medical devices on the Canadian market through post-market surveillance and compliance and enforcement activities. There is an annual fee for the right to sell a Class II, III, IV medical device.

Fee

Medical Device Right to Sell

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

20 days to update Medical Device Licence Listing database following receipt of a complete Annual Notification Package

Performance result

100% (34,833/34,833 were completed within service standard)

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Medical Device Right to Sell

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Medical Device Right to Sell 440 13,946,715 0 April 1, 2026 460

Medical Device Establishment Licensing Fees

A Medical Device Establishment Licence (MDEL) is required for the activities of importing or selling medical devices for human use in Canada with exceptionsFootnote 1. A fee is charged for the examination of an MDEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The MDEL fee is a flat fee. The same fee is charged for an application for a new MDEL, an annual licence review of an MDEL, and the reinstatement of a suspended MDEL.

Fee

Medical Device Establishment Licensing Fees

Fee-setting authority

Year fee-setting authority was introduced

2017

Last year fee-setting authority was amended

2025

Service standard

120 calendar days to issue/ renew licence

Performance result

100% (2,956/2,956) of licenses issued within 120 calendar days

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Application for new licence and annual review of licence

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Application for new licence and annual review of licence 5,283 13,397,431 0 April 1, 2026 5,519

Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product

No person shall manufacture, possess, handle, store, transport, import, distribute or use a pest control product that is not registered under the Pest Control Products Act, except as otherwise authorized under the Act or unless specifically exempted by the Pest Control Products Regulations. Fees for applications to register or to amend the registration of a pest control product are payable by component submitted. The fee payable is the sum of the fees for the submitted components in addition to the basic processing fee.

The following table reflects the total 2024-25 fee revenue by individual fee.

Fee 2024-25 total fee revenue ($)

Processing

1,427,720

Applications not Mentioned in Schedules

242,146

Renewal

99,519

Schedule 1: Fees for Applications to Register, or to Amend the Registration of, a Pest Control Product Other Than a Semiochemical or Microbial Agent

Product Chemistry – active ingredient

798,565

Product Chemistry – end-use product or manufacturing concentrate

396,346

Toxicology data accompanying an application to register a pest control product that contains a new active ingredient

142,566

Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains a registered active ingredient

42,737

Toxicology data-acute toxicity studies

169,555

Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient

30,219

Exposure data accompanying an application to register a pest control product –or to amend the registration of a pest control product –that contains a registered active ingredient, when a new risk assessment is necessary

40,287

Exposure data-other

81,344

Metabolism data

97,806

Residue data

332,117

Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

73,710

Environmental fate data accompanying an application to register a pest control product,or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

19,008

Environmental fate data-other

39,276

Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

92,067

Environmental toxicology data accompanying an application to register a pest control product,or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

0

Environmental toxicology data-other

14,012

Value and effectiveness data for a pest control product

164,321

Identification of compensable data

510,418

Schedule 2: Fees for Applications in Respect of a Pest Control Product that is a Semiochemical or Microbial Agent

Registration of a new active ingredient – food use

11,225

Registration of a new active ingredient – non-food use

3,056

Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data

3,262

Amendment of registration – data required, label changes

9,098

Amendment of registration – data required, other

11,210

Amendment of registration – no data required

3,019

Registration of new active ingredient

0

Amendment of registration

616

Schedule 3: Fees for Other Applications in Respect of a Pest Control Product

Research authorization – major crops, other than research authorizations set out in paragraphs (c) and (d)

220,386

Research authorization – minor use crops, other than research authorizations set out in paragraphs (c) and (d)

13,280

Research authorization – microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations

14,000

Research authorization – greenhouse crops and non-agricultural uses

6,689

Research notifications

3,942

Registration of active ingredient to be used in pest control product manufactured only for export

0

Amendment to Registration of active ingredient to be used in pest control product manufactured only for export

2,612

Specification of maximum residue limit for a previously unexamined pest control product

141,293

Specification of maximum residue limit for an unregistered use of a previously examined pest control product

36,035

Fee

Category A Component Based - 655 days of Review (Conventional Chemicals and Import Maximum Residue Limits)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

655 calendar days of Review

Performance result

78% (7/9 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

0

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product that contains a new active ingredient

87,082

April 1, 2026

90,601

Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains a registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data - acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient

20,103

April 1, 2026

20,917

Exposure data accompanying an application to register a pest control product -or to amend the registration of a pest control product -that contains a registered active ingredient, when a new risk assessment is necessary

6,618

April 1, 2026

6,887

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

49,035

April 1, 2026

51,017

Environmental fate data accompanying an application to register a pest control product,or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

27,154

April 1, 2026

28,252

Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

42,824

April 1, 2026

44,555

Environmental toxicology data accompanying an application to register a pest control product,or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

27,215

April 1, 2026

28,316

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Specification of maximum residue limit for a previously unexamined pest control product

144,119

April 1, 2026

149,943

Specification of maximum residue limit for an unregistered use of a previously examined pest control product

18,196

April 1, 2026

18,932

Processing

1,306

April 1, 2026

1,360

Fee

Category A Component Based - 555 days (Reduced risk, other biopesticides, non-conventionals, non-straight-chain lepidopteran pheromone)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

555 calendar days of Review

Performance result

77% (10/13 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

4,793

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product that contains a new active ingredient

87,082

April 1, 2026

90,601

Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data - acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient

20,103

April 1, 2026

20,917

Exposure data accompanying an application to register a pest control product - or to amend the registration of a pest control product - that contains a registered active ingredient, when a new risk assessment is necessary

6,618

April 1, 2026

6,887

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

49,035

April 1, 2026

51,017

Environmental fate data accompanying an application to register a pest control product, or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

27,154

April 1, 2026

28,252

Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

42,824

April 1, 2026

44,555

Environmental toxicology data accompanying an application to register a pest control product, or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

27,215

April 1, 2026

28,316

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Registration of a new active ingredient - food use

8,315

April 1, 2026

8,652

Registration of a new active ingredient - non-food use

4,990

April 1, 2026

5,192

Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data

3,328

April 1, 2026

3,463

Processing

1,306

April 1, 2026

1,360

Fee

Category A Component Based - 470 days of Review (Microbials including User Requested Minor Use Registration (URMUR), and URMUR for conventional chemical, reduced risk, other biopesticides, non-conventionals, non-straight-chain lepidopteran pheromone)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

470 calendar days of Review

Performance result

75% (6/8 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Product Chemistry - active ingredient 5,601 See the total fee revenue table 876 April 1, 2026 5,829
Product Chemistry - end-use product or manufacturing concentrate 3,120 April 1, 2026 3,247
Toxicology data accompanying an application to register a pest control product that contains a new active ingredient 87,082 April 1, 2026 90,601
Toxicology data accompanying an application to register a pest control product - or to amend a pest control product -that contains an registered active ingredient 18,186 April 1, 2026 18,921
Toxicology data - acute toxicity studies 3,397 April 1, 2026 3,535
Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient 20,103 April 1, 2026 20,917
Exposure data accompanying an application to register a pest control product - or to amend the registration of a pest control product -that contains a registered active ingredient, when a new risk assessment is necessary 6,618 April 1, 2026 6,887
Metabolism data 33,250 April 1, 2026 34,594
Residue data 18,196 April 1, 2026 18,932
Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient 49,035 April 1, 2026 51,017
Environmental fate data accompanying an application to register a pest control product, or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary 27,154 April 1, 2026 28,252
Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient 42,824 April 1, 2026 44,555
Environmental toxicology data accompanying an application to register a pest control product, or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary 27,215 April 1, 2026 28,316
Value and effectiveness data for a pest control product 1,045 April 1, 2026 1,088
Registration of a new active ingredient - food use 8,315 April 1, 2026 8,652
Registration of a new active ingredient - non-food use 4,990 April 1, 2026 5,192
Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data 3,328 April 1, 2026 3,463
Processing 1,306 April 1, 2026 1,360

Fee

Category A Component Based - 285 days of Review (Straight-chain lepidopteran pheromones, including User Requested Minor Use Registration)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

285 calendar days of Review

Performance result

N/A (0 applications completed in 2024-25)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Registration of new active ingredient

669

See the total fee revenue table

0

April 1, 2026

697

Amendment of registration

337

April 1, 2026

351

Fee

Category A Component Based - Submissions with atypical timelines and joint reviews

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

Variable as per Management of Submission Policy Appendix I, table 1

Performance result

40% (2/5 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

0

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product that contains a new active ingredient

87,082

April 1, 2026

90,601

Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data - acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient

20,103

April 1, 2026

20,917

Exposure data accompanying an application to register a pest control product - or to amend the registration of a pest control product - that contains a registered active ingredient, when a new risk assessment is necessary

6,618

April 1, 2026

6,887

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

49,035

April 1, 2026

51,017

Environmental fate data accompanying an application to register a pest control product, or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

27,154

April 1, 2026

28,252

Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient

42,824

April 1, 2026

44,555

Environmental toxicology data accompanying an application to register a pest control product,or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary

27,215

April 1, 2026

28,316

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Registration of a new active ingredient - food use

8,315

April 1, 2026

8,652

Registration of a new active ingredient - non-food use

4,990

April 1, 2026

5,192

Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data

3,328

April 1, 2026

3,463

Registration of new active ingredient

669

April 1, 2026

697

Amendment of registration

337

April 1, 2026

351

Specification of maximum residue limit for a previously unexamined pest control product

144,119

April 1, 2026

149,943

Specification of maximum residue limit for an unregistered use of a previously examined pest control product

18,196

April 1, 2026

18,932

Processing

1,306

April 1, 2026

1,360

Fee

Category B Component Based - 425 days of Review (Conventional Chemicals including emergency use and New Import Maximum Residue Limits for previously assessed active ingredient)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

425 calendar days of Review

Performance result

91% (144/159 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

11,582

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data - acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data - other

5,993

April 1, 2026

6,236

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environmental fate data - other

13,266

April 1, 2026

13,803

Environmental toxicology data - other

2,836

April 1, 2026

2,951

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Specification of maximum residue limit for an unregistered use of a previously examined pest control product

18,196

April 1, 2026

18,932

Processing

1,306

April 1, 2026

1,360

Fee

Category B Component Based - 360 days of Review (Reduced risk, other biopesticides, non-conventionals, non-straight chain lepidopteran pheromone including emergency use)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

360 calendar days of Review

Performance result

75% (21/28 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

1,367

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data - acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data - other

5,993

April 1, 2026

6,236

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environmental fate data - other

13,266

April 1, 2026

13,803

Environmental toxicology data - other

2,836

April 1, 2026

2,951

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Amendment of registration - data required, label changes

1,665

April 1, 2026

1,733

Amendment of registration - data required, other

1,335

April 1, 2026

1,390

Processing

1,306

April 1, 2026

1,360

Fee

Category B Component Based - 240 days of Review (Microbials and straight chain lepidopteran pheromones including emergency use)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

240 calendar days of Review

Performance result

82% (14/17 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Amendment of registration - data required, label changes

1,665

See the total fee revenue table

1,136

April 1, 2026

1,733

Amendment of registration - data required, other

1,335

April 1, 2026

1,390

Amendment of registration

337

April 1, 2026

351

Fee

Category B Component Based - 158 days of Review (Streamlined; application rate changes, tank mixes, new pests or changes to level of control)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

158 calendar days of Review

Performance result

100% (117/117 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Value and effectiveness data for a pest control product

1,045

See the total fee revenue table

0

April 1, 2026

1,088

Amendment of registration - data required, label changes

1,665

April 1, 2026

1,733

Amendment of registration - no data required, other

337

April 1, 2026

351

Processing

1,306

April 1, 2026

1,360

Fee

Category B Component Based - Submissions with atypical timelines and joint reviews

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

Variable as per Management of Submission Policy Appendix I, table 2

Performance result

58% (7/12 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

0

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data-acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data-other

5,993

April 1, 2026

6,236

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environmental fate data - other

13,266

April 1, 2026

13,803

Environmental toxicology data - other

2,836

April 1, 2026

2,951

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Amendment of registration - data required, label changes

1,665

April 1, 2026

1,733

Amendment of registration - data required, other

1,335

April 1, 2026

1,390

Amendment of registration - no data required

337

April 1, 2026

351

Amendment of registration

337

April 1, 2026

351

Specification of maximum residue limit for an unregistered use of a previously examined pest control product

18,196

April 1, 2026

18,932

Processing

1,306

April 1, 2026

1,360

Fee

Category C Component Based - 240 days of Review (New/Changes to Product Labels, Addition of Approved Minor Use, Similar Product)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

240 calendar days of Review

Performance result

61% (449/734 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Amendment of registration - no data required

337

See the total fee revenue table

58,979

April 1, 2026

351

Amendment of registration

337

April 1, 2026

351

Processing

1,306

April 1, 2026

1,360

Fee

Category C Component Based - 180 days of Review (New/Changes to TGAI, ISP, MA or EP Product Chemistry, Administrative Changes, Administrative Re-instatement)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

180 calendar days of Review

Performance result

85% (63/74 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Amendment of registration - no data required

337

See the total fee revenue table

1,268

April 1, 2026

351

Amendment of registration

337

April 1, 2026

351

Processing

1,306

April 1, 2026

1,360

Fee

Category C Component Based - Submissions with atypical timelines and joint reviews

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

Variable as per Management of Submission Policy Appendix I, table 3

Performance result

N/A (0 applications completed in 2024-25)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Amendment of registration - no data required

337

See the total fee revenue table

0

April 1, 2026

351

Amendment of registration

337

April 1, 2026

351

Processing

1,306

April 1, 2026

1,360

Fee

Category D Component Based - 285 days of Review (Registration Renewal)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

285 calendar days of Review (The number of days from the issuance of the renewal notice to March 15 of the following year)

Performance result

100% (1,053/1,053 applications met the service standard)

Application of Low-Materiality Fees Regulations

Low-materiality ($51-$151) : Registration Renewal

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Registration Renewal 94 See the total fee revenue table 0 April 1, 2026 98

Fee

Category D Component Based – 46 Days of Review (Registration/Amendment to Registration of active ingredient to be used in pest control product manufactured only for export)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

46 calendar days of Review

Performance result

N/A (0 applications completed in 2024-25)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Registration of active ingredient to be used in pest control product manufactured only for export

8,994

See the total fee revenue table

0

April 1, 2026

9,358

Amendment to Registration of active ingredient to be used in pest control product manufactured only for export

1,306

April 1, 2026

1,360

Fee

Category D Component Based - 42 days of Review (Master Copies)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

42 calendar days of Review

Performance result

97% (111/114 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Processing 1,306 See the total fee revenue table 223 April 1, 2026 1,360

Fee

Category D Component Based - 10 days of Review (Private Labels)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

10 calendar days of Review

Performance result

100% (4/4 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Processing 1,306 See the total fee revenue table 0 April 1, 2026 1,360

Fee

Category E Component Based - 159 days of Review (Research Authorizations for New Technical Grade Active Ingredients)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

159 calendar days of Review

Performance result

50% (9/18 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Research authorization - major crops, other than research authorizations set out in paragraphs (c) and (d)

5,838

See the total fee revenue table

6,844

April 1, 2026

6,075

Research authorization - minor use crops, other than research authorizations set out in paragraphs (c) and (d)

5,838

April 1, 2026

6,075

Research authorization - microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations

1,401

April 1, 2026

1,459

Research authorization - greenhouse crops and non-agricultural uses

1,401

April 1, 2026

1,459

Fee

Category E Component Based - 69 days of Review (Research Authorizations for New Uses of Registered Active Ingredients)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

69 calendar days of Review

Performance result

81% (35/43 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Research authorization - major crops, other than research authorizations set out in paragraphs (c) and (d)

5,838

See the total fee revenue table

7,645

April 1, 2026

6,075

Research authorization - minor use crops, other than research authorizations set out in paragraphs (c) and (d)

5,838

April 1, 2026

6,075

Research authorization - microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations

1,401

April 1, 2026

1,459

Research authorization - greenhouse crops and non-agricultural uses

1,401

April 1, 2026

1,459

Fee

Category E Component Based - 30 days of Review (Research Notification for Research Carried out in Canada)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

30 calendar days of Review

Performance result

94% (16/17 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Research notifications 288 See the total fee revenue table 72 April 1, 2026 300

Fee

Category F Component Based - 45 days of Review (Registration and amendments to registered pest control products via notification)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

45 calendar days of Review

Performance result

91% (772/846 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Applications not mentioned in schedules 288 See the total fee revenue table 2,363 April 1, 2026 300

Fee

Category L Component Based - 425 days of Review (Equivalency and data compensation assessment of end-use product and manufacturing concentrate with partial data package - conventional chemical)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

425 calendar days of Review

Performance result

92% (79/86 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

4,461

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data-acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data - other

5,993

April 1, 2026

6,236

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environmental fate data - other

13,266

April 1, 2026

13,803

Environmental toxicology data - other

2,836

April 1, 2026

2,951

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Identification of compensable data

2,487

April 1, 2026

2,588

Processing

1,306

April 1, 2026

1,360

Fee

Category L Component Based - 365 days of Review (Equivalency and data compensation assessment of active ingredient, end-use product and manufacturing concentrate with no data)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

365 calendar days of Review

Performance result

87% (97/111 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

10,304

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Identification of compensable data

2,487

April 1, 2026

2,588

Processing

1,306

April 1, 2026

1,360

Fee

Category L Component Based – 360 days of Review (Equivalency and data compensation assessment of end-use product and manufacturing concentrate with partial data package - reduced risk, other biopesticides, non-conventionals, non-straight chain lepidopteran pheromone)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

360 calendar days of Review

Performance result

100% (2/2 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

0

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data-acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data - other

5,993

April 1, 2026

6,236

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environmental fate data - other

13,266

April 1, 2026

13,803

Environmental toxicology data - other

2,836

April 1, 2026

2,951

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Identification of compensable data

2,487

April 1, 2026

2,588

Amendment of registration - data required, label changes

1,665

April 1, 2026

1,733

Amendment of registration - data required, other

1,335

April 1, 2026

1,390

Processing

1,306

April 1, 2026

1,360

Fee

Category L Component Based 240 days of Review (Equivalency and data compensation assessment of end-use product and manufacturing concentrate with partial data package - microbials and straight chain lepidopteran pheromone)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

240 calendar days of Review

Performance result

N/A (0 applications completed in 2024-25)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Identification of compensable data

2,487

See the total fee revenue table

0

April 1, 2026

2,588

Amendment of registration - data required, label changes

1,665

April 1, 2026

1,733

Amendment of registration - data required, other

1,335

April 1, 2026

1,390

Amendment of registration

337

April 1, 2026

351

Processing

1,306

April 1, 2026

1,360

Fee

Category L Component Based – Applications with atypical timelines (Tailgaters, renegotiated timelines, synchronized timelines, coordination with Re-Evaluation)

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

Variable as per Management of Submission Policy Appendix I, table 7

Performance result

100% (3/3 applications met the service standard)

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Product Chemistry - active ingredient

5,601

See the total fee revenue table

0

April 1, 2026

5,829

Product Chemistry - end-use product or manufacturing concentrate

3,120

April 1, 2026

3,247

Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient

18,186

April 1, 2026

18,921

Toxicology data-acute toxicity studies

3,397

April 1, 2026

3,535

Exposure data - other

5,993

April 1, 2026

6,236

Metabolism data

33,250

April 1, 2026

34,594

Residue data

18,196

April 1, 2026

18,932

Environmental fate data - other

13,266

April 1, 2026

13,803

Environmental toxicology data - other

2,836

April 1, 2026

2,951

Value and effectiveness data for a pest control product

1,045

April 1, 2026

1,088

Identification of compensable data

2,487

April 1, 2026

2,588

Amendment of registration - data required, label changes

1,665

April 1, 2026

1,733

Amendment of registration - data required, other

1,335

April 1, 2026

1,390

Amendment of registration

337

April 1, 2026

351

Processing

1,306

April 1, 2026

1,360

Annual Charge (for a registered Pest Control Product)

A registrant must pay each year, in respect of every pest control product that is registered in their name on April 1 of the year, an annual charge. All registered products including technical grade active ingredients (TGAI), import for manufacturing and export program (IMEPs), private label products and master copies must pay the annual charge.

Fee

Annual Charge

Fee-setting authority

Year fee-setting authority was introduced

2002

Last year fee-setting authority was amended

2024

Service standard

Invoice is issued by April 30th 2024 or within 30 days of submitting a completed form (if after April 30th)

Performance result

100% of invoices were issued on time

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Annual Charge The lesser of $4,317.93 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $119.93 10,284,768 0 April 1, 2026 The lesser of $4,509.90 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $125.26

Fees Charged for Filing a Claim for Exemption under the Hazardous Materials Information Review Act

When a supplier or employer wants to be exempt from having to disclose confidential business information (CBI), such as the chemical identity of one or more trade-secret hazardous ingredients, they must file a claim for exemption with Health Canada.

Fee

Note: A 50% fee reduction is available for small businesses that meet certain criteria

Fee-setting authority:

Year fee-setting authority was introduced

1988

Last year fee-setting authority was amended

2020

Service standard

Up to 15 claims – 10 business days

Between 16 and 25 claims – 15 business days

26+ claims – 20 business days

Performance result

99% of claims (original and refiled) were registered within the service standard

Application of Low-Materiality Fees Regulations

Material (>$151): All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Original Claim (up to 15)

2,158.97

400,530

1,057

April 1, 2026

2,254.95

Original Claim (between 16-25)

479.78

April 1, 2026

501.11

Original Claim (26+)

239.88

April 1, 2026

250.55

Refiled Claims (up to 15)

1,727.18

27,562

0

April 1, 2026

1,803.96

Refiled Claims (between 16-25)

383.82

April 1, 2026

400.88

Refiled Claims (26+)

191.91

April 1, 2026

200.44

Cannabis Fees

Fees are charged for the following transactional activities: application screening, security clearances, and import/export permits. In addition, an Annual Regulatory Fee is charged which covers costs associated with a range of regulatory activities including regulatory inspections, compliance and enforcement, program management and oversight. These activities are carried out by Health Canada, the Canada Border Services Agency, the Public Health Agency of Canada and Public Safety Canada to support the objectives of the Cannabis Act with respect to the legislation and regulations of cannabis.

Fee

Licence Application Screening Fees

Fee-setting authority

Year fee-setting authority was introduced

2018

Last year fee-setting authority was amended

2024

Service standard

Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of new licence applications. The standard excludes time spent awaiting additional information from applicants.

Performance result

The non-binding administrative standard was met 93% of the time.

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Licence Application Screening Fee - Licence for micro-cultivation

1,969

231,953

This fee was not subject to remissions

April 1, 2026

2,058

Licence Application Screening Fee - Licence for standard cultivation

3,933

April 1, 2026

4,109

Licence Application Screening Fee - Licence for a nursery

1,969

April 1, 2026

2,058

Licence Application Screening Fee - Licence for micro-processing

1,969

April 1, 2026

2,058

Licence Application Screening Fee - Licence for standard processing

3,933

April 1, 2026

4,109

Licence Application Screening Fee - Licence for sale for medical purposes

3,933

April 1, 2026

4,109

Fee

Application for a Security Clearance

Fee-setting authority

Year fee-setting authority was introduced

2018

Last year fee-setting authority was amended

2024

Service standard

No administrative service standard for this fee as outlined during the 2018 consultation on the Proposed Approach to Cost Recovery for the Regulation of Cannabis and the subsequent Regulatory Impact Analysis Statement for the Cannabis Fees Order.

Performance result

Not applicable

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Application for a Security Clearance

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Application for a Security Clearance 1,987 2,037,876 This fee was not subject to remissions April 1, 2026 2,076

Fee

Application for Import or Export Permit

Fee-setting authority

Year fee-setting authority was introduced

2018

Last year fee-setting authority was amended

2024

Service standard

Health Canada commits to a non-binding administrative service standard of 30 business days from the date that payment is received for the application to the issuance or rejection of the permit. The standard excludes time spent awaiting additional information from applicants.

Performance result

The non-binding administrative standard was met 99.9% of the time

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: Application for Import or Export Permit

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)
Application for Import or Export Permit 734 2,564,639 This fee was not subject to remissions April 1, 2026 767

Fee

Annual Regulatory Fee

Fee-setting authority

Year fee-setting authority was introduced

2018

Last year fee-setting authority was amended

2024

Service standard

No administrative service standard for this fee as outlined during the 2018 consultation on the Proposed Approach to Cost Recovery for the Regulation of Cannabis and the subsequent Regulatory Impact Analysis Statement for the Cannabis Fees Order.

Performance result

Not applicable

Application of Low-Materiality Fees Regulations

Not subject to Service Fees Act: All fees listed below

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Annual fee - Licence for micro-cultivation

as per Cannabis Fees Order

56,747,903

This fee was not subject to remissions

Exempt

as per Cannabis Fees Order

Annual fee - Licence for standard cultivation

Annual fee - Licence for a nursery

Annual fee - Licence for micro-processing

Annual fee - Licence for standard processing

Annual fee - Licence for sale for medical purposes

National Dosimetry Products and Services Fees

National Dosimetry Services (NDS) provides radiation monitoring services to Canadians who are exposed to radiation in their work environment. NDS provides commercial dosimetry services to over 100,000 individuals working in over 12,500 organizations and operates on a cost-recovery basis. There are a number of components to NDS that are billed on a regular basis. These fees include the annual support fee, the shipping and handling fee and the processing fee. Other fees are billed depending on whether additional services are requested or if a dosimeter is overdue, late, lost or damaged.

Fee

National Dosimetry Products and Services Fees

Fee-setting authority

Year fee-setting authority was introduced

2004

Last year fee-setting authority was amended

2024

Service standard

Provide timely, responsive and reliable dosimetry services:

  1. Exposures reported to the National Dose Registry within 45 calendar days of receipt - Canadian Nuclear Safety Commission (CNSC) regulatory standard;
  2. Dosimeters shipped 10-15 business days prior to exchange date with clients;
  3. Dose results for whole body and extremity services reported to clients within internal service standards of 10- 20 business days, depending on the dosimetry service;
  4. Client account information updated within two business days;
  5. Client voice mails responded to within two business days; and
  6. Client emails responded to within two business days.

Performance result

  1. 100% compliance within the 45 calendar day regulatory (CNSC) standard;
  2. Shipped 98% of dosimeters within 10-15 business days prior to exchange date;
  3. 97% reported within internal standard of 10-20 business days, depending on the dosimetry service.
  4. 96% completed within two business days;
  5. 95% addressed within two business days; and
  6. 95% addressed within two business days.

Application of Low-Materiality Fees Regulations

Not subject to section 17 of the Service Fees Act

Fee 2024-25 fee amount ($) 2024-25 total fee revenue ($) 2024-25 total remissions issued for the fee ($) Fee adjustment date in 2026-27 2026-27 fee amount ($)

Annual support

98.75

Not available

This fee was not subject to remissions

April 1, 2026

103.10

Annual support - multi-group discount (5+ groups)

65.00

Not available

67.90

Shipping and handling (per shipment)

14.50

Not available

14.50

Processing fees (per dosimeter)

6.00 to 17.50

Not available

6.30 to 18.30

Ad hoc dosimeter request - add-on (per shipment)

75.00

Not available

75.00

Priority processing request (per request)

110.00

Not available

110.00

Pregnancy service (semi-monthly)

375.00

Not available

375.00

Electronic personal dosimeter rental (per 9 months)

322.50

Not available

322.50

Electronic personal dosimeter rental with beta module (per 9 months)

375.00

Not available

375.00

Specialized consultation (per hour)

125.00

Not available

125.00

Customized reporting (per hour)

70.00

Not available

70.00

NDR dose modifications (per hour)

75.00

Not available

75.00

Reprinting reports (per report)

25.00

Not available

25.00

Overdue dosimeter (three months after wearing period ends)

48.50

Not available

48.50

Late dosimeter (six months after wearing period ends)

48.50

Not available

48.50

Lost/damaged dosimeter

80.00

Not available

80.00

Damaged electronic personal dosimeter

430.00

Not available

430.00

Credit upon returning overdue dosimeter

24.00

Not available

24.00

Credit upon returning late or lost dosimeter

40.00

Not available

40.00

Footnotes

Footnote 1

As per the Medical Devices Regulations, an MDEL is not required for: a retailer, a health care facility, a manufacturer of Class II, III or IV medical devices who only sells either medical devices for which they hold a valid licence, or medical devices subject to Parts 2 and 3 of the Regulations, a manufacturer of a Class I medical device who imports or distributes solely through a licensed establishment, a person solely selling medical devices subject to Parts 2 and 3 of the Regulations, or a dispenser.

Return to footnote 1 referrer

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2025-11-07