2023-2024 Report on Fees
Table of contents
- Ministers' message
- About this report
- Remissions
- Overall totals, by fee setting mechanism.
- Totals, by fee grouping, for fees set by act, regulation or fees notice
- Details on each fee set by act, regulation or fees notice
- Fees for Examination of a Submission - Drugs for Human Use
- Certificate of Supplementary Protection Application Fees
- Master File Fees
- Fees for Right to Sell Drugs - Human Use
- Drug Establishment Licensing Fees - Human Use
- Certificate of Pharmaceutical Product Fee
- Fees for Examination of a Submission - Drugs for Veterinary Use Only
- Fees for Right to Sell Drugs - Veterinary Use
- Drug Establishment Licensing Fees - Veterinary Use
- Drug Establishment Licensing Fees - Dealer's Licences
- Fees for Examination of an Application for a Medical Device Licence
- Fees for Right to Sell a Licensed Class II, III or IV Medical Device
- Medical Device Establishment Licensing Fees
- Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product
- Annual Charge (for a registered Pest Control Product)
- Fees Charged for Filing a Claim for Exemption under the Hazardous Materials Information Review Act
- Cannabis Fees
- National Dosimetry Products and Services Fees
Ministers' message
On behalf of Health Canada, we are pleased to present the department's fees report for the 2023-2024 fiscal year. The report includes information on fee amounts, service standards, performance results, revenues and remissions.
Health Canada helps people in Canada maintain and improve their health. We currently charge fees in the areas of drugs and medical devices, pesticides, hazardous materials, radiation protection and cannabis. To ensure transparency and accountability, we actively consult and engage with relevant industry stakeholders on the setting of fees.
This past fiscal year, we published a pre-consultation on the proposed update to the pesticides annual charge fee. Proposed amendments to the Regulations Amending the Pest Control Products Fees and Charges Regulations (Annual Charge) include revising the annual charge that is payable for each registered pest control product. Publication in the Canada Gazette, Part I, on the amended regulations is expected this fiscal year.
In March 2024, we consulted on a revised proposal for fees for natural health products. The proposal involves cost recovery to allow Health Canada to recover some of the costs of reviewing applications for natural health products and conducting oversight activities.
National Dosimetry Services (NDS) provides radiation monitoring services to individuals who are exposed to radiation in their work environment. NDS amended the fees that are payable as of April 1, 2024, to better align revenues with expenses.
In August 2024, we began consultations on the proposed cost recovery for tobacco products. We propose to introduce an annual charge to designated tobacco product manufacturers (including importers).
Finally, the new Biocides Regulations were registered on May 31, 2024, placing disinfectants and surface sanitizers under a single regulatory framework to simplify the market authorization process. These regulations, along with the associated fees under the Order Amending Fees in Respect of Drugs and Medical Devices Order, will come into force on May 31, 2025.
Health Canada will continue to work to ensure its fee structure is current and relevant and that any modifications are presented in an open and transparent manner. By collaborating and making evidence-based decisions, we will continue to advance mandate priorities to help keep people in Canada healthy and safe.
The Honourable Mark Holland, P.C. M.P.
Minister of Health
The Honourable Ya'ara Saks, P.C. M.P.
Minister of Mental Health and Addictions and Associate 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 2023-24.
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:
- 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.
- 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.
- 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 2023–24, 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 2023-24, 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 2023–24.
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 2023–24, by fee-setting mechanism.
| Fee-setting mechanism | Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|---|
| Fees set by act, regulation or fees notice | 307,041,206 | 645,454,467 | 700,065 |
Totals, by fee grouping, for fees set by act, regulation or fees notice
A fee grouping is a set of fees relating to a single business line, directorate or program that a department had the authority to set for those activities.
This section presents, for each fee grouping, the total revenue, cost and remissions for all fees that Health Canada had the authority to set in 2023-24 that are set by any of the following:
- act
- regulation
- fees notice
The revenue collections reported below may include: discontinued fees as of April 1, 2020; fees from previous years due to the timing of payments; and lower fees due to mitigation measures (as per the relevant regulations).
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 92,420,710 | 184,089,984 | 600,511 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 182,739 | 203,977 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 937,033 | 991,078 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 52,461,480 | 86,488,971 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 31,568,898 | 43,120,101 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 283,961 | 1,130,860 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 1,394,708 | 12,420,190 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 451,553 | 2,228,558 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 1,739,476 | 3,248,509 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 536,794 | 8,607,908 | 19,679 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 10,519,248 | 32,462,740 | 15,812 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 13,749,187 | 36,239,858 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 14,075,685 | 14,085,252 | 6,959 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 6,271,360 | 60,864,504 | 48,094 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 10,816,609 | 35,584,837 | 0 |
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 391,820 | 2,941,111 | 9,010 |
| Revenue ($) | Cost ($)Footnote 1 | Remissions ($) |
|---|---|---|
| 61,572,772 | 109,970,240 | 0 |
|
||
| Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|
| 7,667,173 | 10,775,789 | 0 |
Details on each fee set by act, regulation or fees notice
This section provides detailed information on each fee that Health Canada had the authority to set in 2023-24 and that was set by any of the following:
- act
- regulation
- fees notice
The total of the revenue collections by fee grouping below may not equal the revenues reported in the "Totals, by fee grouping, for fees set by act, regulation or fees notice" section due to the following:
- Effective April 1, 2020, some fees were repealed from the Financial Administration Act and set under the authority of the Food and Drugs Act. In some instances, new fees were introduced and some fees were discontinued. Revenues collected after March 31, 2020 for discontinued fees are not included below; and
- A report was developed in the financial system to allow the reporting of revenue collections at the individual fee level, however, small discrepancies may exist.
Fees for Examination of a Submission - Drugs for Human Use
Before a drug is authorized for sale in Canada, Health Canada reviews it to assess its safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, biologics, disinfectants and sanitizers with disinfectant claims.
Fee
New Active Substance
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
300 calendar days to complete Review 1
Performance result
97.7% (42/43 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: New Active Substance
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| New Active Substance | 565,465 | 22,554,351 | 122,667 | April 1, 2025 | 606,286 |
Fee
Clinical or non-clinical data and chemistry and manufacturing data
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1
- For drugs under Division 8 of the Food and Drug Regulations: 300 calendar days to complete Review 1
Performance result
- 210 calendar days – N/A (0 completed in 2023-24)
- 300 calendar days – 98% (49/50 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Clinical or non-clinical data and chemistry and manufacturing data
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Clinical or non-clinical data and chemistry and manufacturing data | 292,806 | 14,154,197 | 10,149 | April 1, 2025 | 313,944 |
Fee
Clinical or non-clinical data only
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1
- For drugs under Division 8 of the Food and Drug Regulations: 300 calendar days to complete Review 1
Performance result
- 210 calendar days – 100% (1/1 completed within service standard)
- 300 calendar days – 98.4% (123/125 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Clinical or non-clinical data only
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Clinical or non-clinical data only | 117,080 | 16,892,385 | 52,170 | April 1, 2025 | 125,533 |
Fee
Comparative studies
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1
- For drugs under Division 8 of the Food and Drug Regulations: 180 calendar days to complete Review 1
Performance result
- 210 calendar days – 66.7% (2/3 completed within service standard)
- 180 calendar days – 98.1% (157/160 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Comparative studies
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Comparative studies | 65,985 | 11,540,316 | 102,328 | April 1, 2025 | 70,750 |
Fee
Chemistry and manufacturing data only
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1
- For drugs under Division 8 of the Food and Drug Regulations: 180 calendar days to complete Review 1
Performance result
- 210 calendar days – 97.4% (37/38 completed within service standard)
- 180 calendar days - 96.1% (318/331 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Chemistry and manufacturing data only
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Chemistry and manufacturing data only | 40,597 | 14,934,545 | 162,646 | April 1, 2025 | 43,529 |
Fee
Clinical or non-clinical data only, in support of safety upgrades to the labelling
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
120 calendar days to complete Review 1
Performance result
98.9% (281/284 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Clinical or non-clinical data only, in support of safety upgrades to the labelling
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Clinical or non-clinical data only, in support of safety upgrades to the labelling | 21,429 | 5,513,384 | 15,389 | April 1, 2025 | 22,977 |
Fee
Labelling only
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
120 calendar days to complete Review 1
Performance result
99.8% (926/928 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Labelling only
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Labelling only | 5,901 | 4,910,200 | 10,183 | April 1, 2025 | 6,328 |
Fee
Labelling only (generic drugs)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
120 calendar days to complete Review 1
Performance result
99.4% (174/175 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Labelling only (generic drugs)
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Labelling only (generic drugs) | 2,217 | 489,657 | 554 | April 1, 2025 | 2,378 |
Fee
Administrative submission
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
45 calendar days to review
Performance result
97.2% (631/649 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Administrative submission
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Administrative submission | 933 | 576,312 | 4,432 | April 1, 2025 | 1,002 |
Fee
Disinfectant - full review
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- For drugs under Division 1 of the Food and Drug Regulations: 210 calendar days to complete Review 1
- For drugs under Division 8 of the Food and Drug Regulations: 300 calendar days to complete Review 1
Performance result
- 210 calendar days – 66.1% (41/62 completed within service standard)
- 300 calendar days - 100% (1/1 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Disinfectant - full review
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Disinfectant - full review | 12,297 | 500,916 | 93,014 | April 1, 2025 | 13,186 |
Fee
Labelling only (disinfectants)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
90 calendar days to complete Review 1
Performance result
88.0% (22/25 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Labelling only (disinfectants)
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Labelling only (disinfectants) | 2,764 | 34,405 | 20,411 | April 1, 2025 | 2,964 |
Fee
Drug identification number application - labelling standards
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
60 calendar days to complete Review 1
Performance result
91.0% (122/134 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Drug identification number application - labelling standards
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Drug identification number application - labelling standards | 1,782 | 199,936 | 6,569 | April 1, 2025 | 1,912 |
Certificate of Supplementary Protection Application Fees
In agreeing to provisionally apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs.
Fee
Certificate of Supplementary Protection Application Fees
Fee-setting authority
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2023
Service standard
60 days for the first eligibility decision
Performance result
100% (15/15 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Certificate of Supplementary Protection Application Fees
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Certificate of Supplementary Protection Application Fees | 10,152 | 182,736 | This fee was not subject to remissions | April 1, 2025 | 10,564 |
Master File Fees
A Master File (MF) is a reference that provides information about specific processes or components used in the manufacturing, processing, or packaging of a drug. The MF is a useful vehicle for providing information to Health Canada, where that information is confidential business information (CBI) and is not available to the manufacturer of the dosage form or to the sponsors of a drug submission, DIN (Drug identification Number) application or clinical trial application (CTA).
Fee
- New Master Files (file registration)
- Drug Master Files - letter of access
- Drug Master Files - Update
Fee-setting authority
- Minister's Authority
- Fees notice published in Canada Gazette
Year fee-setting authority was introduced
1996
Last year fee-setting authority was amended
2017
Service standard
30 calendar days
Performance result
99.9% (1,480/1,482 issued within 30 calendar days)
Application of Low-Materiality Fees Regulations
Not subject to section 17 of the Service Fees Act: All fees listed below
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| New Master Files (file registration) | 1,351 | 289,667 | This fee was not subject to remissions | April 1, 2025 | 1,407 |
| Drug Master Files – letter of access | 192 | 253,371 | April 1, 2025 | 200 | |
| Drug Master Files - Update | 587 | 424,975 | April 1, 2025 | 611 |
Fees for Right to Sell Drugs - Human Use
Health Canada monitors human drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to maintain and sell human drugs in Canada.
Fee
- Human drugs - Disinfectant (item 1)
- Human drugs - Non-prescription (item 2)
- Human drugs - Prescription (drug other than one referred to in item 1 or 2)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
20 calendar days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result
100% (1,117/1,117 human and veterinary completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Human drugs - Disinfectant (item 1) | 1,613 | 1,534,385 | 0 | April 1, 2025 | 1,730 |
| Human drugs - Non-prescription (item 2) | 3,109 | 7,075,289 | 0 | April 1, 2025 | 3,334 |
| Human drugs - Prescription (drug other than one referred to in item 1 or 2) | 5,158 | 43,911,062 | 0 | April 1, 2025 | 5,531 |
Drug Establishment Licensing Fees - Human Use
Any person in Canada must obtain a Drug Establishment Licence (DEL) if they are engaged in any of the six regulated activities (fabricate, import, distribute, wholesale, package/label, and test) with respect to human drugs. A fee is charged for the examination of a DEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The DEL fee is calculated on a per-site basis, therefore, the fee amount varies by application. A DEL fee is charged for the application for a new DEL, an annual licence review of a DEL, certain amendments to a DEL, or reinstatement of a suspended DEL.
Fee
Human Drug Establishment Licence Fees
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
250 calendar days to issue/ renew license
Performance result
100% (755/755) of licences issued (human and veterinary) within 250 calendar days
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Fabrication - Sterile dosage form | 46,221 | 1,950,641 | 0 | April 1, 2025 | 49,558 |
| Importation | 35,688 | 12,315,622 | 0 | April 1, 2025 | 38,265 |
| Fabrication - non-sterile dosage form | 34,266 | 2,193,763 | 0 | April 1, 2025 | 36,740 |
| Distribution | 18,215 | 827,276 | 0 | April 1, 2025 | 19,531 |
| Wholesaling | 10,630 | 1,476,753 | 0 | April 1, 2025 | 11,398 |
| Packaging/labelling | 6,681 | 752,096 | 0 | April 1, 2025 | 7,164 |
| Testing | 5,514 | 317,673 | 0 | April 1, 2025 | 5,913 |
| Building outside Canada (each) | 1,014 | 12,301,074 | 0 | April 1, 2025 | 1,088 |
Certificate of Pharmaceutical Product Fee
A certificate issued establishing the status of the pharmaceutical, biological, radiopharmaceutical or veterinary product listed and the Good Manufacturing Practice status of the fabricator of the product.
Fee
Certificate of Pharmaceutical Product
Fee-setting authority
- Minister's Authority
- Fees notice published in Canada Gazette
Year fee-setting authority was introduced
1996
Last year fee-setting authority was amended
2012
Service standard
25 business days to issue certificate
Performance result
91.7% (2,469 / 2,693 of certificates issued within 25 business days)
Application of Low-Materiality Fees Regulations
Not subject to section 17 of the Service Fees Act: Certificate of Pharmaceutical Product
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Certificate of Pharmaceutical Product | 98 | 283,961 | This fee was not subject to remissions | April 1, 2025 | 102 |
Fees for Examination of a Submission - Drugs for Veterinary Use Only
Before a veterinary drug is authorized for sale in Canada, Health Canada reviews it to assess its efficacy and safety in the intended species as well as human safety. Fees are calculated on a component basis.
Fee
Drug Identification Number (Schedule 2 items 1 to 3)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
120 calendar days to complete Review 1
Performance result
100% (25/25 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 1) Information, other than that referred to in item 2, to support an application for a number, including the submission of labelling material for a second review, if required | 1,891 | 19,856 | 0 | April 1, 2025 | 2,606 |
| 2) Published references or other data | 1,314 | 3,942 | 0 | April 1, 2025 | 1,812 |
| 3) Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug | 658 | 5,922 | 0 | April 1, 2025 | 906 |
Fee
Notification - veterinary health product (Schedule 2 item 4)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
30 calendar days to process notification
Performance result
100% (585/585 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 4) Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product | 538 | 154,332 | 0 | April 1, 2025 | 578 |
Fee
New drug submission (Schedule 2 items 5 to 18)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- 300 calendar days to complete Review 1 (items 5 to 17)
- 90 calendar days to complete Review 1 (item 18)
Performance result
- 300 calendar days - 100% (6/6 completed within service standard)
- 90 calendar days - 100% (2/2 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023-24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 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.) | 41,917 | 150,098 | 0 | April 1, 2025 | 57,787 |
| 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 | 25,392 | 0 | 0 | April 1, 2025 | 35,006 |
| 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 | 60,961 | 121,922 | 0 | April 1, 2025 | 84,038 |
| 8) Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 82,548 | 0 | 0 | April 1, 2025 | 113,795 |
| 9) Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration | 7,610 | 0 | 0 | April 1, 2025 | 10,491 |
| 10) Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength | 1,261 | 0 | 0 | April 1, 2025 | 1,739 |
| 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 | 57,158 | 57,158 | 0 | April 1, 2025 | 78,793 |
| 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 | 76,201 | 14,525 | 0 | April 1, 2025 | 105,044 |
| 13) For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration | 7,610 | 4,614 | 0 | April 1, 2025 | 10,491 |
| 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 | 38,088 | 38,088 | 0 | April 1, 2025 | 52,506 |
| 15) Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 12,697 | 53,491 | 0 | April 1, 2025 | 17,505 |
| 16) Chemistry and manufacturing data to support one strength of a single dosage form | 12,697 | 60,908 | 0 | April 1, 2025 | 17,505 |
| 17) Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 16 | 6,350 | 19,050 | 0 | April 1, 2025 | 8,756 |
| 18) Documentation to support a change of manufacturer | 658 | 1,974 | 0 | April 1, 2025 | 906 |
Fee
Supplement to a new drug submission (Schedule 2 items 19 to 37)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- 240 calendar days to complete Review 1 (items 19 to 36)
- 90 calendar days to complete Review 1 (item 37)
Performance result
- 240 calendar days - 100% (25/25 completed within service standard)
- 90 calendar days - N/A (0 completed in 2023-24)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 19) Efficacy data to support an additional indication in one animal species | 33,026 | 99,078 | 0 | April 1, 2025 | 45,528 |
| 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 | 25,392 | 76,176 | 0 | April 1, 2025 | 35,006 |
| 21) Efficacy and safety data (in the intended species) to support an indication in another animal species | 41,917 | 41,917 | 0 | April 1, 2025 | 57,787 |
| 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. | 60,961 | 0 | 0 | April 1, 2025 | 84,038 |
| 23) Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 82,548 | 0 | 0 | April 1, 2025 | 113,795 |
| 24) Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species | 20,305 | 0 | 0 | April 1, 2025 | 27,990 |
| 25) Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration | 7,610 | 0 | 0 | April 1, 2025 | 10,491 |
| 26) Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength | 1,261 | 0 | 0 | April 1, 2025 | 1,739 |
| 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 | 7,610 | 0 | 0 | April 1, 2025 | 10,491 |
| 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 | 38,088 | 0 | 0 | April 1, 2025 | 52,506 |
| 29) For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period | 19,044 | 0 | 0 | April 1, 2025 | 26,254 |
| 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 | 15,243 | 0 | 0 | April 1, 2025 | 21,013 |
| 31) Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process | 12,697 | 67,950 | 0 | April 1, 2025 | 17,505 |
| 32) Chemistry and manufacturing data to support a change in formulation or dosage form | 6,350 | 19,050 | 0 | April 1, 2025 | 8,756 |
| 33) Chemistry and manufacturing data to support a change in packaging or in the sterilization process | 5,065 | 9,037 | 0 | April 1, 2025 | 6,982 |
| 34) Chemistry and manufacturing data to support an extension of the expiry dating | 3,807 | 0 | 0 | April 1, 2025 | 5,246 |
| 35) Chemistry and manufacturing data to support the concurrent use of two drugs | 3,807 | 0 | 0 | April 1, 2025 | 5,246 |
| 36) Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms | 1,261 | 1,261 | 0 | April 1, 2025 | 1,739 |
| 37) Documentation to support a change to the name of a manufacturer or the brand name of a drug | 658 | 0 | 0 | April 1, 2025 | 906 |
Fee
Abbreviated new drug submission (Schedule 2 items 38 to 42)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- 300 calendar days to complete Review (items 38 to 41)
- 90 calendar days to complete Review 1 (item 42)
Performance result
- 300 calendar days - 100% (5/5 completed within service standard)
- 90 calendar days – 100% (6/6 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 38) Comparative (pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form | 7,610 | 15,217 | 0 | April 1, 2025 | 10,491 |
| 39) For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product | 7,610 | 0 | 0 | April 1, 2025 | 10,491 |
| 40) Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 12,697 | 41,690 | 0 | April 1, 2025 | 17,505 |
| 41) Chemistry and manufacturing data to support a single dosage form | 12,697 | 67,084 | 0 | April 1, 2025 | 17,505 |
| 42) Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission | 658 | 5,025 | 0 | April 1, 2025 | 906 |
Fee
Supplement to an abbreviated new drug submission (Schedule 2 items 38 to 42)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
- 240 calendar days to complete Review 1 (items 38 to 41)
- 90 calendar days to complete Review 1 (item 42)
Performance result
- 240 calendar days - 100% (7/7 completed within service standard)
- 90 calendar days - 100% (4/4 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 38) Comparative (pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form | 7,610 | 15,217 | 0 | April 1, 2025 | 10,491 |
| 39) For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product | 7,610 | 0 | 0 | April 1, 2025 | 10,491 |
| 40) Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 12,697 | 41,690 | 0 | April 1, 2025 | 17,505 |
| 41) Chemistry and manufacturing data to support a single dosage form | 12,697 | 67,084 | 0 | April 1, 2025 | 17,505 |
| 42) Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission | 658 | 5,025 | 0 | April 1, 2025 | 906 |
Fee
Preclinical submission (Schedule 2 items 43 to 50)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
60 calendar days to complete Review 1
Performance result
Not applicable - no applications received
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 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 | 12,697 | 0 | 0 | April 1, 2025 | 17,505 |
| 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 | 10,153 | 0 | 0 | April 1, 2025 | 13,997 |
| 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 | 38,088 | 0 | 0 | April 1, 2025 | 52,506 |
| 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 | 57,158 | 0 | 0 | April 1, 2025 | 78,793 |
| 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 | 76,201 | 0 | 0 | April 1, 2025 | 105,044 |
| 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 | 19,045 | 0 | 0 | April 1, 2025 | 26,254 |
| 49) Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient | 12,697 | 0 | 0 | April 1, 2025 | 17,505 |
| 50) Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient | 6,350 | 0 | 0 | April 1, 2025 | 8,756 |
Fee
Sale of new drug for emergency treatment (Schedule 2 items 51 and 52)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
2 business days to review application
Performance result
100% (494/494 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 51) Information to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal | 57 | 14,481 | 0 | April 1, 2025 | 62 |
| 52) Information to support the sale of a drug to be used in the emergency treatment of a food-producing animal | 114 | 6,483 | 0 | April 1, 2025 | 124 |
Fee
Experimental studies certificate (Schedule 2 items 53 to 56)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
60 calendar days to review application
Performance result
100% (114/114 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 53) Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal | 1,082 | 19,948 | 0 | April 1, 2025 | 1,161 |
| 54) Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal | 542 | 1,897 | 0 | April 1, 2025 | 582 |
| 55) Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal | 3,262 | 14,575 | 0 | April 1, 2025 | 3,498 |
| 56) Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal | 542 | 507 | 0 | April 1, 2025 | 582 |
Fee
Notifiable change (Schedule 2 item 57)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
90 calendar days to review application
Performance result
100% (69/69 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 57) Information and material to support an application for Notifiable Change | 3,413 | 71,932 | 0 | April 1, 2025 | 4,705 |
Fee
Protocol (Schedule 2 item 58)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
90 calendar days to review package
Performance result
100% (2/2 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| 58) A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate | 3,413 | 3,413 | 0 | April 1, 2025 | 4,705 |
Fees for Right to Sell Drugs - Veterinary Use
Health Canada monitors veterinary drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to maintain veterinary drugs in Canada.
Fee
Veterinary Drugs
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
20 calendar days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result
100% (1,117/1,117 human and veterinary completed within the service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Veterinary Drugs
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Veterinary Drugs | 528 | 451,554 | 0 | April 1, 2025 | 567 |
Drug Establishment Licensing Fees - Veterinary Use
Any person in Canada must obtain a Drug Establishment Licence (DEL) if they are engaged in any of the six regulated activities (fabricate, import, distribute, wholesale, package/label, and test) with respect to veterinary drugs. A fee is charged for the examination of a DEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The DEL fee is calculated on a per-site basis, therefore, the fee amount varies by application. A DEL fee is charged for the application for a new DEL, an annual licence review of a DEL, certain amendments to a DEL, or reinstatement of a suspended DEL.
Fee
Veterinary Drug Establishment Licence Fees
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
250 calendar days to issue/ renew license
Performance result
100% (755/755) of licences issued (human and veterinary) within 250 calendar days
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Fabrication - Sterile dosage form | 45,262 | 0 | 0 | April 1, 2025 | 49,215 |
| Importation | 23,066 | 593,498 | 0 | April 1, 2025 | 38,265 |
| Fabrication - non-sterile dosage form | 18,905 | 60,202 | 0 | April 1, 2025 | 31,671 |
| Distribution | 10,409 | 27,309 | 0 | April 1, 2025 | 17,437 |
| Wholesaling | 4,161 | 53,468 | 0 | April 1, 2025 | 6,973 |
| Packaging/labelling | 6,681 | 0 | 0 | April 1, 2025 | 7,164 |
| Testing | 2,833 | 3,716 | 0 | April 1, 2025 | 4,744 |
| Building outside Canada (each) | 1,014 | 1,001,208 | 0 | April 1, 2025 | 1,088 |
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
- Dealer's Licence Fees - Human Drugs
- Dealer's Licence Fees - Veterinary Drugs
Fee-setting authority
Financial Administration Act (FAA)
- Human Drugs: Fees in Respect of a Dealer's Licences Regulations (SOR/2011-79)
- Veterinary Drugs: Licenced Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations (SOR/98-5)
Year fee-setting authority was introduced
1998
Last year fee-setting authority was amended
- Human Drugs: 2020
- Veterinary Drugs: 2022
Service standard:
- 270 Calendar days to issue a decision on an application for a new dealer's licence for controlled substances, from the receipt of a complete application
- 90 Calendar days to issue a decision on an application to renew a dealer's licence for controlled substances, from the receipt of a complete application
Performance result
- New: 61.7% (50/81) of applications were processed within the service standard
- Renew: 99.2% (122/123) of applications were processed within the service standard
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Dealer's Licence Fees - Human Drugs | 5,726.00 | 522,530 | 19,679 | April 1, 2025 | 5,958.00 |
| Dealer's Licence Fees - Veterinary Drugs | 2,010.53 | 11,423 | 0 | April 1, 2025 | 2,155.66 |
| Dealer's Licence Fees - Veterinary Drugs – First Year | 1,005.27 | 2,841 | 0 | April 1, 2025 | 1,077.84 |
Fees for Examination of an Application for a Medical Device Licence
The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types of medical devices are exempt from medical device licensing and therefore no fees apply: Class I medical devices; custom-made medical devices; medical devices for special access; and medical devices for investigational testing involving human subjects.
Fee
Applications for Class II licence
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
15 calendar days to review
Performance result
98.9% (1,558/1,575 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class II licence
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class II licence | 589 | 862,577 | 1,750 | April 1, 2025 | 632 |
Fee
Applications for Class II licence amendment
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
15 calendar days to review
Performance result
98.8% (1,195/1,210 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class II licence amendment
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class II licence amendment | 302 | 336,528 | 972 | April 1, 2025 | 325 |
Fee
Applications for Class III licence
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
60 calendar days to complete Review 1
Performance result
99.6% (248/249 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class III licence
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class III licence | 12,987 | 2,818,461 | 0 | April 1, 2025 | 13,926 |
Fee
Applications for Class III licence (near patient)
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
60 calendar days to complete Review 1
Performance result
100% (17/17 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class III licence (near patient)
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class III licence (near patient) | 27,666 | 293,869 | 0 | April 1, 2025 | 29,664 |
Fee
Applications for Class III licence amendment - changes in manufacturing
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
60 calendar days to complete Review 1
Performance result
100% (23/23 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class III licence amendment - changes in manufacturing
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class III licence amendment - changes in manufacturing | 4,098 | 73,015 | 0 | April 1, 2025 | 4,395 |
Fee
Applications for Class III licence amendment - significant changes not related to manufacturing
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
60 calendar days to complete Review 1
Performance result
99.4% (332/334 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class III licence amendment - significant changes not related to manufacturing
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class III licence amendment - significant changes not related to manufacturing | 10,425 | 3,355,118 | 6,276 | April 1, 2025 | 11,178 |
Fee
Applications for Class IV licence
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
75 calendar days to complete Review 1
Performance result
100% (46/46 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class IV licence
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class IV licence | 28,165 | 1,136,235 | 6,489 | April 1, 2025 | 30,199 |
Fee
Applications for Class IV licence amendment - changes in manufacturing
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
75 calendar days to complete Review 1
Performance result
100% (41/41 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class IV licence amendment - changes in manufacturing
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class IV licence amendment - changes in manufacturing | 4,098 | 175,887 | 0 | April 1, 2025 | 4,395 |
Fee
Applications for Class IV licence amendment - significant changes not related to manufacturing
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
75 calendar days to complete Review 1
Performance result
100% (94/94 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class IV licence amendment – significant changes not related to manufacturing
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class IV licence amendment - significant changes not related to manufacturing | 14,902 | 1,506,655 | 0 | April 1, 2025 | 15,979 |
Fee
Applications for Class II, III or IV licence or licence amendment - private label medical device
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
15 calendar days to review
Performance result
98.7% (591/599 completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Applications for Class II, III or IV licence or licence amendment - private label medical device
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications for Class II, III or IV licence or licence amendment - private label medical device | 163 | 73,883 | 326 | April 1, 2025 | 176 |
Fees for Right to Sell a Licensed Class II, III or IV Medical Device
Health Canada monitors medical devices on the Canadian market through post-market surveillance and compliance and enforcement activities. There is an annual fee for the right to sell a Class II, III, IV medical device.
Fee
Medical Device Right to Sell
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
20 days to update Medical Device Licence Listing database following receipt of a complete Annual Notification Package
Performance result
100% (34,749/34,749 were completed within service standard)
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Medical Device Right to Sell
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Medical Device Right to Sell | 421 | 13,749,184 | 0 | April 1, 2025 | 452 |
Medical Device Establishment Licensing Fees
A Medical Device Establishment Licence (MDEL) is required for the activities of importing or selling medical devices for human use in Canada with exceptions. A fee is charged for the examination of an MDEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The MDEL fee is a flat fee. The same fee is charged for an application for a new MDEL, an annual licence review of an MDEL, and the reinstatement of a suspended MDEL.
Fee
Medical Device Establishment Licensing Fees
Fee-setting authority
- Food and Drugs Act (FDA), 30.61(1)
- Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Year fee-setting authority was introduced
2017
Last year fee-setting authority was amended
2024
Service standard
120 calendar days to issue/ renew licence
Performance result
99.95% (3,714 / 3,716) of licenses issued within 120 calendar days
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Application for new licence and annual review of licence
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Application for new licence and annual review of licence | 5,060 | 14,075,685 | 6,959 | April 1, 2025 | 5,426 |
Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product
No person shall manufacture, possess, handle, store, transport, import, distribute or use a pest control product that is not registered under the Pest Control Products Act, except as otherwise authorized under the Act or unless specifically exempted by the Pest Control Products Regulations. Fees for applications to register or to amend the registration of a pest control product are payable by component submitted. The fee payable is the sum of the fees for the submitted components in addition to the basic processing fee.
The following table reflects the total 2023-24 fee revenue by individual fee.
| Fee | 2023-24 total fee revenue ($) |
|---|---|
| Processing | 2,644,916 |
| Applications not Mentioned in Schedules | 235,246 |
| Renewal | 103,322 |
| 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 | 713,202 |
| Product Chemistry – end-use product or manufacturing concentrate | 299,043 |
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 232,123 |
| Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains a registered active ingredient | 62,905 |
| Toxicology data-acute toxicity studies | 151,312 |
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 16,959 |
| 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 | 27,264 |
| Exposure data-other | 65,630 |
| Metabolism data | 167,313 |
| Residue data | 327,012 |
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 48,524 |
| 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 | 62,008 |
| Environmental fate data-other | 55,272 |
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 176,348 |
| 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 | 62,147 |
| Environmental toxicology data-other | 9,822 |
| Value and effectiveness data for a pest control product | 302,339 |
| Identification of compensable data | 350,293 |
| 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 | 8,151 |
| Registration of a new active ingredient – non-food use | 0 |
| Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data | 6,524 |
| Amendment of registration – data required, label changes | 20,854 |
| Amendment of registration – data required, other | 3,924 |
| Amendment of registration – no data required | 7,297 |
| Registration of new active ingredient | 0 |
| Amendment of registration | 0 |
| 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) | 249,883 |
| Research authorization – minor use crops, other than research authorizations set out in paragraphs (c) and (d) | 11,446 |
| Research authorization – microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations | 27,943 |
| Research authorization – greenhouse crops and non-agricultural uses | 15,103 |
| Research notifications | 2,532 |
| 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 | 0 |
| Specification of maximum residue limit for a previously unexamined pest control product | 0 |
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 67,069 |
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
2018
Service standard
655 calendar days of Review
Performance result
80% (24/30 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 0 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 85,374 | April 1, 2025 | 88,824 | ||
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains a registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data - acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 19,708 | April 1, 2025 | 20,506 | ||
| 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 | 6,488 | April 1, 2025 | 6,751 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 48,073 | April 1, 2025 | 50,016 | ||
| 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 | 26,621 | April 1, 2025 | 27,698 | ||
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 41,984 | April 1, 2025 | 43,681 | ||
| 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 | 26,681 | April 1, 2025 | 27,760 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Specification of maximum residue limit for a previously unexamined pest control product | 141,293 | April 1, 2025 | 147,002 | ||
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 17,839 | April 1, 2025 | 18,560 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
555 calendar days of Review
Performance result
100% (10/10 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 0 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 85,374 | April 1, 2025 | 88,824 | ||
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data - acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 19,708 | April 1, 2025 | 20,506 | ||
| 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 | 6,488 | April 1, 2025 | 6,751 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 48,073 | April 1, 2025 | 50,016 | ||
| 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 | 26,621 | April 1, 2025 | 27,698 | ||
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 41,984 | April 1, 2025 | 43,681 | ||
| 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 | 26,681 | April 1, 2025 | 27,760 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Registration of a new active ingredient - food use | 8,151 | April 1, 2025 | 8,482 | ||
| Registration of a new active ingredient - non-food use | 4,892 | April 1, 2025 | 5,090 | ||
| Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data | 3,262 | April 1, 2025 | 3,395 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
470 calendar days of Review
Performance result
0% (0/3 applications met the service standard)
Application of Low-Materiality Fees RegulationsMaterial (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 0 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 85,374 | April 1, 2025 | 88,824 | ||
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product -that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data - acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 19,708 | April 1, 2025 | 20,506 | ||
| 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 | 6,488 | April 1, 2025 | 6,751 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 48,073 | April 1, 2025 | 50,016 | ||
| 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 | 26,621 | April 1, 2025 | 27,698 | ||
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 41,984 | April 1, 2025 | 43,681 | ||
| 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 | 26,681 | April 1, 2025 | 27,760 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Registration of a new active ingredient - food use | 8,151 | April 1, 2025 | 8,482 | ||
| Registration of a new active ingredient - non-food use | 4,892 | April 1, 2025 | 5,090 | ||
| Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data | 3,262 | April 1, 2025 | 3,395 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
285 calendar days of Review
Performance result
N/A (0 applications completed in 2023-24)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Registration of new active ingredient | 655 | See the total fee revenue table | 0 | April 1, 2025 | 683 |
| Amendment of registration | 330 | April 1, 2025 | 344 |
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
2018
Service standard
Variable as per Management of Submission Policy Appendix I, table 1
Performance result
54% (7/13 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 0 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 85,374 | April 1, 2025 | 88,824 | ||
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data - acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 19,708 | April 1, 2025 | 20,506 | ||
| 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 | 6,488 | April 1, 2025 | 6,751 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 48,073 | April 1, 2025 | 50,016 | ||
| 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 | 26,621 | April 1, 2025 | 27,698 | ||
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 41,984 | April 1, 2025 | 43,681 | ||
| 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 | 26,681 | April 1, 2025 | 27,760 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Registration of a new active ingredient - food use | 8,151 | April 1, 2025 | 8,482 | ||
| Registration of a new active ingredient - non-food use | 4,892 | April 1, 2025 | 5,090 | ||
| Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data | 3,262 | April 1, 2025 | 3,395 | ||
| Registration of new active ingredient | 655 | April 1, 2025 | 683 | ||
| Amendment of registration | 330 | April 1, 2025 | 344 | ||
| Specification of maximum residue limit for a previously unexamined pest control product | 141,293 | April 1, 2025 | 147,002 | ||
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 17,839 | April 1, 2025 | 18,560 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
425 calendar days of Review
Performance result
90% (177/197 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 15,475 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data - acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data - other | 5,875 | April 1, 2025 | 6,113 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environmental fate data - other | 13,005 | April 1, 2025 | 13,532 | ||
| Environmental toxicology data - other | 2,780 | April 1, 2025 | 2,893 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 17,839 | April 1, 2025 | 18,560 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
360 calendar days of Review
Performance result
60% (9/15 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 8,896 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data - acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data - other | 5,875 | April 1, 2025 | 6,113 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environmental fate data - other | 13,005 | April 1, 2025 | 13,532 | ||
| Environmental toxicology data - other | 2,780 | April 1, 2025 | 2,893 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Amendment of registration - data required, label changes | 1,632 | April 1, 2025 | 1,699 | ||
| Amendment of registration - data required, other | 1,308 | April 1, 2025 | 1,362 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
240 calendar days of Review
Performance result
69% (9/13 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Amendment of registration - data required, label changes | 1,632 | See the total fee revenue table | 0 | April 1, 2025 | 1,699 |
| Amendment of registration - data required, other | 1,308 | April 1, 2025 | 1,362 | ||
| Amendment of registration | 330 | April 1, 2025 | 344 |
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
2018
Service standard
158 calendar days of Review
Performance result
100% (167/167 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Value and effectiveness data for a pest control product | 1,024 | See the total fee revenue table | 0 | April 1, 2025 | 1,066 |
| Amendment of registration - data required, label changes | 1,632 | April 1, 2025 | 1,699 | ||
| Amendment of registration - no data required, other | 330 | April 1, 2025 | 344 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
Variable as per Management of Submission Policy Appendix I, table 2
Performance result
100% (11/11 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 0 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data-acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data-other | 5,875 | April 1, 2025 | 6,113 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environmental fate data - other | 13,005 | April 1, 2025 | 13,532 | ||
| Environmental toxicology data - other | 2,780 | April 1, 2025 | 2,893 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Amendment of registration - data required, label changes | 1,632 | April 1, 2025 | 1,699 | ||
| Amendment of registration - data required, other | 1,308 | April 1, 2025 | 1,362 | ||
| Amendment of registration - no data required | 330 | April 1, 2025 | 344 | ||
| Amendment of registration | 330 | April 1, 2025 | 344 | ||
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 17,839 | April 1, 2025 | 18,560 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
240 calendar days of Review
Performance result
85% (495/581 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Amendment of registration - no data required | 330 | See the total fee revenue table | 5,160 | April 1, 2025 | 344 |
| Amendment of registration | 330 | April 1, 2025 | 344 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
180 calendar days of Review
Performance result
99% (253/255 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Amendment of registration - no data required | 330 | See the total fee revenue table | 0 | April 1, 2025 | 344 |
| Amendment of registration | 330 | April 1, 2025 | 344 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
Variable as per Management of Submission Policy Appendix I, table 3
Performance result
N/A (0 applications completed in 2023-24)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Amendment of registration - no data required | 330 | See the total fee revenue table | 0 | April 1, 2025 | 344 |
| Amendment of registration | 330 | April 1, 2025 | 344 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
Fee
Category D Component Based - 284 days of Review (Registration Renewal)
Fee-setting authority
Year fee-setting authority was introduced
2002
Last year fee-setting authority was amended
2018
Service standard
284 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% (1,075/1,075 applications met the service standard)
Application of Low-Materiality Fees Regulations
Low-materiality ($51-$151) : Registration Renewal
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Registration Renewal | 92 | See the total fee revenue table | 0 | April 1, 2025 | 96 |
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
2018
Service standard
46 calendar days of Review
Performance result
N/A (0 applications completed in 2023-24)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Registration of active ingredient to be used in pest control product manufactured only for export | 8,817 | See the total fee revenue table | 0 | April 1, 2025 | 9,174 |
| Amendment to Registration of active ingredient to be used in pest control product manufactured only for export | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
42 calendar days of Review
Performance result
98% (87/89 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Processing | 1,280 | See the total fee revenue table | 0 | April 1, 2025 | 1,333 |
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
2018
Service standard
10 calendar days of Review
Performance result
100% (3/3 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Processing | 1,280 | See the total fee revenue table | 0 | April 1, 2025 | 1,333 |
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
2018
Service standard
159 calendar days of Review
Performance result
87% (20/23 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Research authorization - major crops, other than research authorizations set out in paragraphs (c) and (d) | 5,723 | See the total fee revenue table | 5,922 | April 1, 2025 | 5,955 |
| Research authorization - minor use crops, other than research authorizations set out in paragraphs (c) and (d) | 5,723 | April 1, 2025 | 5,955 | ||
| Research authorization - microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations | 1,373 | April 1, 2025 | 1,430 | ||
| Research authorization - greenhouse crops and non-agricultural uses | 1,373 | April 1, 2025 | 1,430 |
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
2018
Service standard
69 calendar days of Review
Performance result
88% (45/51 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Research authorization - major crops, other than research authorizations set out in paragraphs (c) and (d) | 5,723 | See the total fee revenue table | 8,427 | April 1, 2025 | 5,955 |
| Research authorization - minor use crops, other than research authorizations set out in paragraphs (c) and (d) | 5,723 | April 1, 2025 | 5,955 | ||
| Research authorization - microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations | 1,373 | April 1, 2025 | 1,430 | ||
| Research authorization - greenhouse crops and non-agricultural uses | 1,373 | April 1, 2025 | 1,430 |
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
2018
Service standard
30 calendar days of Review
Performance result
100% (12/12 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Research notifications | 282 | See the total fee revenue table | 0 | April 1, 2025 | 294 |
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
2018
Service standard
45 calendar days of Review
Performance result
95% (614/646 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Applications not mentioned in schedules | 282 | See the total fee revenue table | 326 | April 1, 2025 | 294 |
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
2018
Service standard
425 calendar days of Review
Performance result
91% (51/56 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 782 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data-acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data - other | 5,875 | April 1, 2025 | 6,113 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environmental fate data - other | 13,005 | April 1, 2025 | 13,532 | ||
| Environmental toxicology data - other | 2,780 | April 1, 2025 | 2,893 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Identification of compensable data | 2,438 | April 1, 2025 | 2,537 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
365 calendar days of Review
Performance result
92% (84/91 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 3,106 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Identification of compensable data | 2,438 | April 1, 2025 | 2,537 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
360 calendar days of Review
Performance result
100% (3/3 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 0 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data-acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data - other | 5,875 | April 1, 2025 | 6,113 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environmental fate data - other | 13,005 | April 1, 2025 | 13,532 | ||
| Environmental toxicology data - other | 2,780 | April 1, 2025 | 2,893 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Identification of compensable data | 2,438 | April 1, 2025 | 2,537 | ||
| Amendment of registration - data required, label changes | 1,632 | April 1, 2025 | 1,699 | ||
| Amendment of registration - data required, other | 1,308 | April 1, 2025 | 1,362 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
240 calendar days of Review
Performance result
N/A (0 applications completed in 2023-24)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Identification of compensable data | 2,438 | See the total fee revenue table | 0 | April 1, 2025 | 2,537 |
| Amendment of registration - data required, label changes | 1,632 | April 1, 2025 | 1,699 | ||
| Amendment of registration - data required, other | 1,308 | April 1, 2025 | 1,362 | ||
| Amendment of registration | 330 | April 1, 2025 | 344 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
Variable as per Management of Submission Policy Appendix I, table 7
Performance result
100% (1/1 applications met the service standard)
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,491 | See the total fee revenue table | 0 | April 1, 2025 | 5,714 |
| Product Chemistry - end-use product or manufacturing concentrate | 3,058 | April 1, 2025 | 3,183 | ||
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient | 17,829 | April 1, 2025 | 18,550 | ||
| Toxicology data-acute toxicity studies | 3,330 | April 1, 2025 | 3,465 | ||
| Exposure data - other | 5,875 | April 1, 2025 | 6,113 | ||
| Metabolism data | 32,598 | April 1, 2025 | 33,915 | ||
| Residue data | 17,839 | April 1, 2025 | 18,560 | ||
| Environmental fate data - other | 13,005 | April 1, 2025 | 13,532 | ||
| Environmental toxicology data - other | 2,780 | April 1, 2025 | 2,893 | ||
| Value and effectiveness data for a pest control product | 1,024 | April 1, 2025 | 1,066 | ||
| Identification of compensable data | 2,438 | April 1, 2025 | 2,537 | ||
| Amendment of registration - data required, label changes | 1,632 | April 1, 2025 | 1,699 | ||
| Amendment of registration - data required, other | 1,308 | April 1, 2025 | 1,362 | ||
| Amendment of registration | 330 | April 1, 2025 | 344 | ||
| Processing | 1,280 | April 1, 2025 | 1,333 |
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
2018
Service standard
Invoice is issued by April 30th 2023 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 (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Annual Charge | The lesser of $4,135.95 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $114.88 | 10,816,609 | 0 | April 1, 2025 | The lesser of $4,434.51 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $123.17 |
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
- Original Claims
- Refiled Claims
Note: A 50% fee reduction is available for small businesses that meet certain criteria
Fee-setting authority:
- Hazardous Materials Information Review Act, 48(2)
- Hazardous Materials Information Review Regulations (SOR/88-456)
Year fee-setting authority was introduced
1988
Last year fee-setting authority was amended
2020
Service standard
Seven calendar days from the date of the receipt of a complete application, for the issuance of a registry number
Performance result
90% of claims (original and refiled) were registered within the service standard of seven calendar days
Note: In-year process changes have resulted in the need to review the current service standard
Application of Low-Materiality Fees Regulations
Material (>$151): All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Original Claim (up to 15) | 2,067.98 | 380,766 | 9,010 | April 1, 2025 | 2,217.26 |
| Original Claim (between 16-25) | 459.56 | April 1, 2025 | 492.73 | ||
| Original Claim (26+) | 229.78 | April 1, 2025 | 246.36 | ||
| Refiled Claims (up to 15) | 1,654.39 | 11,054 | 0 | April 1, 2025 | 1,773.81 |
| Refiled Claims (between 16-25) | 367.64 | April 1, 2025 | 394.18 | ||
| Refiled Claims (26+) | 183.82 | April 1, 2025 | 197.09 |
Cannabis Fees
Fees are charged for the following transactional activities: application screening, security clearances, and import/export permits. In addition, an Annual Regulatory Fee is charged which covers costs associated with a range of regulatory activities including regulatory inspections, compliance and enforcement, program management and oversight. These activities are carried out by Health Canada, the Canada Border Services Agency, the Public Health Agency of Canada and Public Safety Canada to support the objectives of the Cannabis Act with respect to the legislation and regulations of cannabis.
Fee
Licence Application Screening Fees
Fee-setting authority
- Cannabis Act, 142(1)
- Cannabis Fees Order (SOR/2018-198)
Year fee-setting authority was introduced
2018
Last year fee-setting authority was amended
2020
Service standard
Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of new licence applications. The standard excludes time spent awaiting additional information from applicants.
Performance result
The non-binding administrative standard was met 95.3% of the time.
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Licence Application Screening Fee - Licence for micro-cultivation | 1,886 | 295,410 | This fee was not subject to remissions | April 1, 2025 | 2,023 |
| Licence Application Screening Fee - Licence for standard cultivation | 3,767 | April 1, 2025 | 4,040 | ||
| Licence Application Screening Fee - Licence for a nursery | 1,886 | April 1, 2025 | 2,023 | ||
| Licence Application Screening Fee - Licence for micro-processing | 1,886 | April 1, 2025 | 2,023 | ||
| Licence Application Screening Fee - Licence for standard processing | 3,767 | April 1, 2025 | 4,040 | ||
| Licence Application Screening Fee - Licence for sale for medical purposes | 3,767 | April 1, 2025 | 4,040 |
Fee
Application for a Security Clearance
Fee-setting authority
- Cannabis Act, 142(1)
- Cannabis Fees Order (SOR/2018-198)
Year fee-setting authority was introduced
2018
Last year fee-setting authority was amended
2020
Service standard
No administrative service standard for this fee as outlined during the 2018 consultation on the Proposed Approach to Cost Recovery for the Regulation of Cannabis and the subsequent Regulatory Impact Analysis Statement for the Cannabis Fees Order.
Performance result
Not applicable
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Application for a Security Clearance
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Application for a Security Clearance | 1,903 | 1,964,125 | This fee was not subject to remissions | April 1, 2025 | 2,041 |
Fee
Application for Import or Export Permit
Fee-setting authority
- Cannabis Act, 142(1)
- Cannabis Fees Order (SOR/2018-198)
Year fee-setting authority was introduced
2018
Last year fee-setting authority was amended
2020
Service standard
Health Canada commits to a non-binding administrative service standard of 30 business days from the date that payment is received for the application to the issuance or rejection of the permit. The standard excludes time spent awaiting additional information from applicants.
Performance result
The non-binding administrative standard was met 99.8% of the time
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: Application for Import or Export Permit
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Application for Import or Export Permit | 703 | 1,563,854 | This fee was not subject to remissions | April 1, 2025 | 754 |
Fee
Annual Regulatory Fee
Fee-setting authority
- Cannabis Act, 142(1)
- Cannabis Fees Order (SOR/2018-198)
Year fee-setting authority was introduced
2018
Last year fee-setting authority was amended
2020
Service standard
No administrative service standard for this fee as outlined during the 2018 consultation on the Proposed Approach to Cost Recovery for the Regulation of Cannabis and the subsequent Regulatory Impact Analysis Statement for the Cannabis Fees Order.
Performance result
Not applicable
Application of Low-Materiality Fees Regulations
Not subject to Service Fees Act: All fees listed below
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Annual fee - Licence for micro-cultivation | as per Cannabis Fees Order | 57,749,383 | 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
- Minister's Authority
- Fees notice published in Canada Gazette
Year fee-setting authority was introduced
2004
Last year fee-setting authority was amended
2024
Service standard
Provide timely, responsive and reliable dosimetry services:
- Exposures reported to the National Dose Registry within 45 calendar days of receipt - Canadian Nuclear Safety Commission (CNSC) regulatory standard;
- Dosimeters shipped 10-15 business days prior to exchange date with clients;
- 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;
- Client account information updated within two business days;
- Client voice mails responded to within one business day; and
- Client emails responded to within two business days.
Performance result
- 100% compliance within the 45 calendar day regulatory (CNSC) standard;
- Shipped 94% of dosimeters within 10-15 business days prior to exchange date;
- 91% reported within internal standard of 10-20 business days, depending on the dosimetry service.
- 92% completed within two business days;
- 97% addressed within one business day; and
- 95% addressed within two business days.
Application of Low-Materiality Fees Regulations
Not subject to section 17 of the Service Fees Act
| Fee | 2023–24 fee amount ($) | 2023-24 total fee revenue ($) | 2023-24 total remissions issued for the fee ($) | Fee adjustment date in 2025-26 | 2025-26 fee amount ($) |
|---|---|---|---|---|---|
| Annual support | 85.00 | Not available | This fee was not subject to remissions | April 1, 2025 | 101.40 |
| Annual support - multi-group discount (5+ groups) | 50.00 | Not available | 66.80 | ||
| Shipping and handling (per shipment) | 14.50 | Not available | 14.50 | ||
| Processing fees (per dosimeter) | 5.50 to 17.50 | Not available | 6.20 to 18.00 | ||
| Ad hoc dosimeter request - add-on (per shipment) | 65.00 | Not available | 75.00 | ||
| Priority processing request (per request) | 95.00 | Not available | 110.00 | ||
| Pregnancy service (semi-monthly) | 375.00 | Not available | 375.00 | ||
| Electronic personal dosimeter rental (per year) | 415.00 | Not available | N/A | ||
| Electronic personal dosimeter rental (per 9 months) | N/A | Not available | 322.50 | ||
| Electronic personal dosimeter rental with beta module (per 9 months) | N/A | Not available | 375.00 | ||
| Specialized consultation (per hour) | 125.00 | Not available | 125.00 | ||
| Customized reporting (per hour) | 60.00 | Not available | 70.00 | ||
| NDR dose modifications (per hour) | 60.00 | Not available | 75.00 | ||
| Reprinting reports (per report) | 10.00 | Not available | 25.00 | ||
| Overdue dosimeter (three months after wearing period ends) | 55.00 | Not available | 48.50 | ||
| Late dosimeter (six months after wearing period ends) | 55.00 | Not available | 48.50 | ||
| Lost/damaged dosimeter | 82.50 | Not available | 80.00 | ||
| Damaged electronic personal dosimeter | 415.00 | Not available | 430.00 | ||
| Credit upon returning overdue dosimeter | 28.75 | Not available | 24.00 | ||
| Credit upon returning late or lost dosimeter | 57.50 | Not available | 40.00 |
Page details
- Date modified: