2019-2020 Report on Fees
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(3.7 MB, 123 pages)
Organization: Health Canada
ISBN: 2562-3346
Cat.: H1-9/35E-PDF
Table of contents
- Minister's 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 Right to Sell Drugs
- Fees for Right to Sell a Licenced Class II, III or IV Medical Device
- Fees for Examination of a Submission - Drugs for Human Use
- Certificate of Supplementary Protection Application Fees
- Fees for Examination of an Application for a Medical Device Licence
- Fees for Examination of a Submission - Drugs for Veterinary Use Only
- Drug Establishment Licensing Fees
- Drug Establishment Licensing Fees - Dealer's Licences
- 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
- Master File Fees
- Certificate of Pharmaceutical Product Fee
Minister's message
On behalf of Health Canada, I am pleased to present our report on fees for fiscal year 2019-20, my organization's third annual report under the Service Fees Act.
The Service Fees Act provides a modern legislative framework that enables cost-effective delivery of services and, through better reporting to Parliament, improves transparency and oversight.
This year's report includes the revision of the fees with respect to drugs and medical devices. Effective April 1, 2020, where indicated, fees were repealed from the Financial Administration Act and set under the authority of the Food and Drugs Act.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.
Cannabis fees were introduced on October 17, 2018 in support of the legalization, strict regulation and restriction on access to cannabis under the Cannabis Act. This year's report is the first time a full year of collections related to cannabis fees is reported. The amount recovered is expected to increase year over year as the legal industry grows, matures and stabilizes. By 2021-22, Health Canada aims to recover as much as 100 percent of annual regulatory costs.
I welcome the increased transparency and oversight that the Service Fees Act's reporting regime embodies, and I am fully committed to transitioning my department to this modern framework. I will continue to advance my key mandate priorities through collaboration and evidence-based decision-making that will maintain and improve the health and safety of all Canadians.
The Honourable Patty Hajdu,
Minister of Health
About this report
This report, which is tabled under section 20 of the Service Fees Act and section 4.2.8 of the Directive on Charging and Special Financial Authorities, contains information about the fees that Health Canada had the authority to set in 2019-20.
Government of Canada departments may set fees for services, licences, permits, products, the use of facilities; for other authorizations of rights or privileges; or to recover, in whole or in part, costs incurred in relation to a regulatory scheme.
For reporting purposes, fees must be categorized under the following three fee setting mechanisms:
- Act, regulation or fees notice
- An act of Parliament delegates the fee setting authority to a department, minister or Governor in Council.
- 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 or both
- The authority to set these fees is pursuant to an act of Parliament or regulation, and the minister, department or Governor in Council has no control over the fee amount.
This report contains information about all fees that are under Health Canada's authority, including any that are collected by another department.
The information covers fees that are subject to the Service Fees Act and fees that are exempted from the Service Fees Act.
For fees set by contract, fees set by market-rate, auction or both, the report provides totals only. For fees set by act, regulation or fees notice, it provides totals for fee groupings, as well as detailed information for each fee.
Although the fees that Health Canada charges under the Access to Information Act are subject to the Service Fees Act, they are not included in this report. Information on Health Canada's access to information fees for 2019-20 can be found in our access to information report, which is posted on our website.
Remissions
A remission is a partial or full return of a fee to a fee payer who paid for a service.
Under the Service Fees Act, departments must develop policies for determining whether a service standard has been met and for determining how much of a fee will be remitted to a fee payer if a service standard is not met. This requirement will not take effect until April 1, 2021, therefore this report does not include remissions issued under the Service Fees Act.
Under the Cannabis Act, the Minister may, by order, remit all or part of any fee fixed by the Minister under subsection 142(1) of the Cannabis Act. During 2019-20 the Minister of Health, pursuant to subsection 144(1) of the Cannabis Act, via the Cannabis for Medical Purposes Remission Order, remitted fees paid by certain stakeholders due to an oversight with how the Cannabis Fees Order was worded, which resulted in some otherwise eligible licence holders not qualifying for the exemption in the year they were first licenced to sell cannabis for medical purposes. Going forward, this oversight was corrected via the Order Amending the Cannabis Fees Order (Exemptions - Sale for Medical Purposes).
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 set in 2019-20, by fee setting mechanism.
| Fee setting mechanism | Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|---|
| Fees set by contract Tablenote * | 0 | 0 | Remissions do not apply to fees set by contract. |
| Fees set by market-rate, auction or both | 0 | 0 | Remissions do not apply to fees set by market base, auction or both. |
| Fees set by act, regulation or fees notice | 178,300,057 | 529,140,037 | 69,000 |
| Total | 178,300,057 | 529,140,037 | 69,000 |
Tablenotes
|
|||
Totals, by fee grouping, for fees set by act, regulation or fees notice
The following tables present, for each fee grouping, the total revenue, cost and remissions for all fees that Health Canada had the authority to set in 2019-20 that are set by any of the following:
- act
- regulation
- fees notice
A fee grouping is a grouping of all the fees that a department has the authority to set for activities relating to a single business line, directorate or program.
| Fee grouping | Fees for Right to Sell Drugs | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 12,376,389 | 85,021,505 | 0 |
| Fee grouping | Fees for Right to Sell Licenced Class II, III, or IV Medical Devices | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 8,559,329 | 26,802,633 | 0 |
| Fee grouping | Fees for Examination of a Submission - Drugs for Human Use | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 50,939,645 | 129,446,836 | 0 |
| Fee grouping | Certificate of Supplementary Protection Application Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 149,832 | 420,333 | 0 |
| Fee grouping | Fees for Examination of Medical Device Licence Applications | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 5,613,398 | 23,779,103 | 0 |
| Fee grouping | Fees for Examination of a Submission - Drugs for Veterinary Use Only | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 817,043 | 10,109,721 | 0 |
| Fee grouping | Drug Establishment Licensing Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 16,925,045 | 33,852,458 | 0 |
| Fee grouping | Drug Establishment Licensing Fees - Dealer's Licences | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 1,140,548 | 4,032,761 | 0 |
| Fee grouping | Medical Devices Establishment Licensing Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 9,455,621 | 12,264,929 | 0 |
| Fee grouping | Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 4,632,274 | 43,284,542 | 0 |
| Fee grouping | Annual Charge (for a registered Pest Control Product) | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 8,654,696 | 33,817,537 | 0 |
| Fee grouping | Fees Charged for Filing a Claim for Exemption under the Hazardous Materials Information Review Act | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 511,379 | 5,496,990 | 0 |
| Fee grouping | Cannabis Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($)Tablenote 1 |
| 50,446,556 | 110,242,063 | 69,000 |
Tablenotes
|
||
The following fees are set under the Ministerial Authority to Enter into a Contract. Health Canada strives to recover 100% of costs for these services, however since the fees were last set increases to costs have been incurred.
| Fee grouping | National Dosimetry Products and Services Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 6,957,396 | 8,444,108 | 0 |
| Fee grouping | Master File Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 857,352 | 1,832,626 | 0 |
| Fee grouping | Certificate of Pharmaceutical Product Fee | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 263,554 | 291,892 | 0 |
Details on each fee set by act, regulation or fees notice
This section provides detailed information on each fee that Health Canada had the authority to set in 2019-20 and that was set by any of the following:
- act
- regulation
- fees notice
In most cases, the Department does not currently report that revenues are collected at the individual fee level. Health Canada is in the process of implementing changes to the financial system to allow for the reporting of lower level fees in the future.
Fees for Right to Sell Drugs
Health Canada monitors human and veterinary drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to maintain and sell human and veterinary drugs in Canada.
Fee: Human Drugs
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2011
Service standard: 120 days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result: 100% completed on time
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 1,200
2019-20 total fee revenue ($): 12,376,389
Fee adjustment date: Not applicable, fee discontinued as of April 1, 2020
Adjusted fee amount in 2021-22 ($): Not applicable, fee discontinued as of April 1, 2020
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:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 20 days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result: Not applicable, new fee as of April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Human drugs - Disinfectant (item 1) | Not applicable, new fee as of April 1, 2020 | Not applicable, new fee as of April 1, 2020 | April 1, 2021 | 1,342 |
| Human drugs - Non-prescription (item 2) | April 1, 2021 | 2,018 | ||
| Human drugs - Prescription (drug other than one referred to in item 1 or 2) | April 1, 2021 | 2,749 |
Fee: Veterinary Drugs
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- 120 days to update the Drug Product Database following receipt of a complete Annual Notification Package
- * As of April 1, 2020 will be 20 days
Performance result: 100% completed on time
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 255.50
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 367
Fees for Right to Sell a Licenced 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 (if annual gross revenue medical device sales is less than $20,000)
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Year fee-setting authority was introduced: 1999
Last year fee-setting authority was amended: 2011
Service standard: 20 days from deadline for receipt of annual notification to update the Medical Devices Licence Listing database
Performance result: 96% completed on time
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 65
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: Not applicable, fee discontinued as of April 1, 2020
Adjusted fee amount in 2021-22 ($): Not applicable, fee discontinued as of April 1, 2020
Fee: Medical Device Right to Sell
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1999
Last year fee-setting authority was amended: 2019
Service standard: 20 days from deadline for receipt of annual notification to update the Medical Devices Licence Listing (MDALL) database
Performance result: 96% completed on time
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 391
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 381
Fees for Examination of a Submission - Drugs for Human Use
Before a drug is authorized for sale in Canada, Health Canada reviews it to assess its safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, biologics, disinfectants and sanitizers with disinfectant claims.
Fee: New Active Substance
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard: New Drug Submission (NDS) - 300 Days
Performance result: NDS - Pharmaceuticals (267 Days) Biologics (281 Days)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 355,579
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 437,009
Fee: Clinical or non-clinical data and chemistry and manufacturing data
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- New Drug Submission (NDS) - 300 Days
- Supplement to a New Drug Submission (SNDS) - 300 Days
- Drug Identification Number Application (DIN A) - 210 Days
Performance result:
- NDS - Pharmaceuticals (276 Days) Biologics (274 Days)
- SNDS - Pharmaceuticals (300 Days) Biologics (273 Days)
- DIN A - Pharmaceuticals (207 Days) Biologics (209 Days)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 180,101
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 224,242
Fee: Clinical or non-clinical data only
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- New Drug Submission (NDS) - 300 Days
- Supplement to a New Drug Submission (SNDS) - 300 Days
- Drug Identification Number Application (DIN A) - 210 Days
Performance result:
- NDS - Pharmaceuticals (n/a) Biologics (n/a)
- SNDS - Pharmaceuticals (252 Days) Biologics (266 Days)
- DIN A - Pharmaceuticals (n/a)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 84,059
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 95,796
Fee: Comparative studies
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- Abbreviated New Drug Submission (ANDS) - 180 Days
- New Drug Submission (NDS) - 180 Days
- Supplement to an Abbreviated New Drug Submission (SANDS) - 180 Days
- Supplement to a New Drug Submission (SNDS) - 180 Days
- Drug Identification Number Application (DIN A) - Pharmaceutical - 210 Days
Performance result:
- ANDS - Pharmaceuticals (168 Days) Biologics (n/a)
- NDS - Pharmaceuticals (n/a) Biologics (179 Days)
- SANDS - Pharmaceuticals (161 Days)
- SNDS - Pharmaceuticals (176 Days) Biologics (180 Days)
- DIN A - Pharmaceuticals (n/a) Biologics (n/a)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 50,808
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 55,737
Fee: Chemistry and manufacturing data only
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- Abbreviated New Drug Submission (ANDS) - 180 Days
- New Drug Submission (NDS) - 180 Days
- Supplement to an Abbreviated New Drug Submission (SANDS) - 180 Days
- Supplement to a New Drug Submission (SNDS) - 180 Days
- Drug Identification Number Application (DIN A) - 210 Days
Performance result:
- ANDS - Pharmaceuticals (170 Days) Biologics (178 Days)
- NDS - Pharmaceuticals (n/a)
- SANDS - Pharmaceuticals (147 Days) Biologics (n/a)
- SNDS - Pharmaceuticals (158 Days) Biologics (148 Days)
- DIN A - Pharmaceuticals (183 Days) Biologics (n/a)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 24,023
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 30,609
Fee: Clinical or non-clinical data only, in support of safety upgrades to the labelling
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 120 Days
Performance result: Not applicable as new fee as of April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): Not applicable as new fee as of April 1, 2020
2019-20 total fee revenue ($): Not applicable as new fee as of April 1, 2020
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 19,404
Fee: Published data only
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2011
Service standard:
- Supplement to a new Drug Submission (SNDS) - 300 Days
- Supplement to an Abbreviated New Drug Submission (SANDS) - 300 Days
- Drug Identification Number Application (DIN A) - 210 Days
Performance result:
- SNDS - Pharmaceuticals (282 Days) Biologics (297 Days)
- SANDS - Pharmaceuticals (n/a)
- DIN A - Pharmaceuticals (n/a)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 19,921
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: Not applicable, fee discontinued as of April 1, 2020
Adjusted fee amount in 2021-22 ($): Not applicable, fee discontinued as of April 1, 2020
Fee: Switch from prescription to non-prescription status
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2011
Service standard:
- New Drug Submission (NDS) - 180 Days
- Supplement to a New Drug Submission (SNDS) - 180 Days
Performance result:
- NDS Pharmaceuticals (n/a)
- SNDS - Pharmaceuticals (n/a)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 48,370
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: Not applicable, fee discontinued as of April 1, 2020
Adjusted fee amount in 2021-22 ($): Not applicable, fee discontinued as of April 1, 2020
Fee: Labelling only
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- New Drug Submission (NDS) - 60 Days
- Supplement to a New Drug Submission (SNDS) - 60 Days
- Abbreviated New Drug Submission (ANDS) - 60 Days
- Supplement to an Abrreviated New Drug Submission (SANDS) - 60 Days
- Drug Identification Number Application (DIN A) - 180 Days
- * As of April 2020 will be 120 Days for all types
Performance result:
- NDS - Pharmaceuticals (54 Days) Biologics (59 Days)
- SNDS - Pharmaceuticals (50 Days) Biologics (54 Days)
- ANDS - Pharmaceuticals (39 Days)
- SANDS - Pharmaceuticals (38 Days)
- DIN A - Pharmaceuticals (153 Days) Biologics (179 Days)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 3,238
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 4,320
Fee: Labelling only (generic drugs)
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 120 Days
Performance result: Not applicable as new fee as of April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): Not applicable, new fee as of April 1, 2020
2019-20 total fee revenue ($): Not applicable, new fee as of April 1, 2020
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 2,006
Fee: Administrative submission
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- Abbreviated New Drug Submisson (ANDS) - 45 Days
- New Drug Submission (NDS) - 45 Days
- Supplement to a New Drug Submission (SNDS) - 45 Days
- Supplement to an Abbreviated New Drug Submission (SANDS) - 45 Days
- Drug Identification Number Application (DIN) - 45 Days
- Drug Identification Number Application - Disinfectant (DIN Disinfectant) - 45 Days
- Drug Identification Number Application - Category (DIN Category IV) - 45 Days
Performance result:
- ANDS - Pharmaceuticals (22 days)
- NDS - Pharmaceuticals (29 Days) Biologics (44 Days)
- SNDS - Pharmaceuticals (17 Days)
- SANDS - Pharmaceuticals (17 Days)
- DIN - Pharmaceuticals (31 Days) Biologics (43 Days)
- DIN Disinfectant - Pharmaceuticals (32 Days)
- DIN Category IV - Pharmaceuticals (38 Days)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 338
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 539
Fee: Disinfectant - full review
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- New Drug Submission (NDS) - 300 Days
- Supplement to a New Drug Submission (SNDS) - 300 Days
- Drug Identification Number Application (Disinfectant 210) (DIN D 210) - 210 Days
- Drug Identification Number Application (Disinfectant 180) (DIN D 180) - 180 Days
Performance result:
- NDS - Pharmaceuticals (300 Days)
- SNDS - Pharmaceuticals (n/a)
- DIN D 210 - Pharmaceuticals (204 Days)
- DIN D 180 - Pharmaceuticals (146 Days)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 4,480
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 7,126
Fee: Labelling only (disinfectants)
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 90 days
Performance result: Not applicable as new fee as of April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): Not applicable, new fee as of April 1, 2020
2019-20 total fee revenue ($): Not applicable, new fee as of April 1, 2020
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 2,502
Fee: Drug identification number application - labelling standards
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1995
Last year fee-setting authority was amended: 2019
Service standard:
- Drug Identification Number Application (DIN A) - 45 Days
- Drug Identification Number Application - Disinifectant (DIN D) - 45 Days
- Drug Identification Number Application - Category IV (DIN F) - 45 Days
- * As of April 2020 it will be 60 Days for all types
Performance result:
- DIN A - Pharmaceuticals (40 Days)
- DIN D - Pharmaceuticals (38 Days)
- DIN F - Pharmaceuticals (36 Days)
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 1,797
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 1,613
Certificate of Supplementary Protection Application Fees
In agreeing to provisionally apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs.
Fee: Certificate of Supplementary Protection Application Fees
Fee-setting authority:
Year fee-setting authority was introduced: 2017
Last year fee-setting authority was amended: Not applicable
Service standard: 60 days for the first eligibility decision
Performance result: 100% issued within 60 days
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 9,376
2019-20 total fee revenue ($): 149,832
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 9,756
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; medical devices for investigational testing involving human subjects.
Fee: Applications for Class II licence
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 15 Days to complete Review 1
Performance result: 9 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 414
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 478
Fee: Applications for Class II licence amendment
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 15 Days to complete Review 1
Performance result: Not applicable, new fee as of April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): Not applicable, new fee as of April 1, 2020
2019-20 total fee revenue ($): Not applicable, new fee as of April 1, 2020
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 272
Fee: Applications for Class III licence
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 60 Days to complete Review 1
Performance result: 45 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 5,922
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 8,895
Fee: Applications for Class III licence (near patient)
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 60 Days to complete Review 1
Performance result: Not applicable
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 10,079
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 16,032
Fee: Applications for Class III licence amendment - changes in manufacturing
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 60 Days to complete Review 1
Performance result: 41 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 1,492
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 2,375
Fee: Applications for Class III licence amendment - significant changes not related to manufacturing
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 60 Days to complete Review 1
Performance result: 44 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 5,546
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 7,543
Fee: Applications for Class IV licence
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 75 Days to complete Review 1
Performance result: 64 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 13,770
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 24,699
Fee: Class IV - Licence Application (Devices that contain Human - Animal Tissue)
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2011
Service standard: 75 Days to complete Review 1
Performance result: 68 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 12,846
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: Not applicable, fee discontinued as of April 1, 2020
Adjusted fee amount in 2021-22 ($): Not applicable, fee discontinued as of April 1, 2020
Fee: Class IV - Licence Application (Near patient In Vitro Diagnostic Device)
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2011
Service standard: 75 Days to complete Review 1
Performance result: Not applicable
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 23,473
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: Not applicable, fee discontinued as of April 1, 2020
Adjusted fee amount in 2021-22 ($): Not applicable, fee discontinued as of April 1, 2020
Fee: Applicatons for Class IV licence amendment - changes in manufacturing
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 75 Days to complete Review 1
Performance result: 41 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 1,492
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 2,375
Fee: Applicatons for Class IV licence amendment - significange changes not related to manufacturing
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
As at April 1, 2020:
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2019
Service standard: 75 Days to complete Review 1
Performance result: 54 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 6,319
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 9,964
Fee: Applications for Class II, III or IV licence or licence amendment - private label medical device
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 15 days to complete Review 1
Performance result: Not applicable, new fee as of April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): Not applicable, new fee as of April 1, 2020
2019-20 total fee revenue ($): Not applicable, new fee as of April 1, 2020
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 147
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 it efficacy and safety in the intended species as well as human safety. Fees are calculated on a component basis.
Fee: Drug Identification Number
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 120 Days to complete Review 1
Performance result: 78 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Information, other than that referred to in item 2, to support an application for a number, including the submission of labelling material for a second review, if required | 735.84 | Not available at this time | April 1, 2021 | 1,146 |
| Published references or other data | 511 | Not available at this time | April 1, 2021 | 797 |
| Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug | 255.50 | Not available at this time | April 1, 2021 | 400 |
Fee: Notification - veterinary health product
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 30 Days to process notification
Performance result: Not applicable, as this is a new fee as of April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
Fee: Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product
2019-20 fee amount ($): Not applicable, as this is a new fee as of April 1, 2020
2019-20 total fee revenue ($): Not applicable, as this is a new fee as of April 1, 2020
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 486
Fee: New drug submission
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard:
- 300 Days to complete Review 1 (other than Administrative New Drug Submission (NDS))
- 90 Days to complete review for Administrative New Drug Submission (NDS)
Performance result:
- 194 Days to complete Review 1 (other than Administrative NDS)
- 28 Days to complete review for Administrative NDS
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| 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.) | 16,331.56 | Not available at this time | April 1, 2021 | 25,419 |
| 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 | 9,892.96 | Not available at this time | April 1, 2021 | 15,398 |
| 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 | 23,751.28 | Not available at this time | April 1, 2021 | 36,966 |
| Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 32,162.34 | Not available at this time | April 1, 2021 | 50,057 |
| Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength | 490.56 | Not available at this time | April 1, 2021 | 764 |
| 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 | 22,269.38 | Not available at this time | April 1, 2021 | 34,660 |
| 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 | 29,689.10 | Not available at this time | April 1, 2021 | 46,208 |
| For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| 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 | 14,839.44 | Not available at this time | April 1, 2021 | 23,096 |
| Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| Chemistry and manufacturing data to support one strength of a single dosage form | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as the above item | 2,473.24 | Not available at this time | April 1, 2021 | 3,851 |
| Documentation to support a change of manufacturer | 255.50 | Not available at this time | April 1, 2021 | 400 |
Fee: Supplement to a new drug submission
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 240 Days to complete Review 1
Performance result: 147 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Efficacy data to support an additional indication in one animal species | 12,866.98 | Not available at this time | April 1, 2021 | 20,027 |
| 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 | 9,892.96 | Not available at this time | April 1, 2021 | 15,398 |
| Efficacy and safety data (in the intended species) to support an indication in another animal species | 16,331.56 | Not available at this time | April 1, 2021 | 25,419 |
| 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. | 23,751.28 | Not available at this time | April 1, 2021 | 36,966 |
| Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 32,162.34 | Not available at this time | April 1, 2021 | 50,057 |
| Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species | 7,910.28 | Not available at this time | April 1, 2021 | 12,312 |
| Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength | 490.56 | Not available at this time | April 1, 2021 | 764 |
| 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 | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| 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 | 14,839.44 | Not available at this time | April 1, 2021 | 23,096 |
| For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period | 7,419.72 | Not available at this time | April 1, 2021 | 11,548 |
| 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 | 5,937.82 | Not available at this time | April 1, 2021 | 9,243 |
| Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| Chemistry and manufacturing data to support a change in formulation or dosage form | 2,473.24 | Not available at this time | April 1, 2021 | 3,851 |
| Chemistry and manufacturing data to support a change in packaging or in the sterilization process | 1,972.46 | Not available at this time | April 1, 2021 | 3,072 |
| Chemistry and manufacturing data to support an extension of the expiry dating | 1,481.90 | Not available at this time | April 1, 2021 | 2,309 |
| Chemistry and manufacturing data to support the concurrent use of two drugs | 1,481.90 | Not available at this time | April 1, 2021 | 2,309 |
| Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms | 490.56 | Not available at this time | April 1, 2021 | 764 |
| Documentation to support a change to the name of a manufacturer or the brand name of a drug | 255.50 | Not available at this time | April 1, 2021 | 400 |
Fee: Abbreviated new drug submission
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 300 Days to complete Review 1
Performance result: 270 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Comparative (pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form. | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product. | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug. | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| Chemistry and manufacturing data to support a single dosage form. | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission. | 255.50 | Not available at this time | April 1, 2021 | 400 |
Fee: Supplement to an abbreviated new drug submission
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 240 Days to complete Review 1
Performance result: 180 Days to complete Review 1
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Comparative (pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form. | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| 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. | 2,963.80 | Not available at this time | April 1, 2021 | 4,614 |
| Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug. | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| Chemistry and manufacturing data to support a single dosage form. | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| 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. | 255.50 | Not available at this time | April 1, 2021 | 400 |
Fee: Preclinical new drug submission
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 60 days to review application
Performance result: n/a for 2019-20
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Efficacy and safety (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 | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| 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 | 3,955.14 | Not available at this time | April 1, 2021 | 6,157 |
| 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 | 14,839.44 | Not available at this time | April 1, 2021 | 23,096 |
| 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 | 22,269.38 | Not available at this time | April 1, 2021 | 34,660 |
| 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 | 29,689.10 | Not available at this time | April 1, 2021 | 46,208 |
| 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 | 7,419.72 | Not available at this time | April 1, 2021 | 11,548 |
| Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient | 4,946.48 | Not available at this time | April 1, 2021 | 7,700 |
| Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient | 2,473.24 | Not available at this time | April 1, 2021 | 3,851 |
Fee: Sale of new drug for emergency treatment
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 2 business days to review application
Performance result: <2 business days to review application
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Information to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal | 51.10 | Not available at this time | April 1, 2021 | 51 |
| Information to support the sale of a drug to be used in the emergency treatment of a food-producing animal | 102.20 | Not available at this time | April 1, 2021 | 102 |
Fee: Experimental studies certificate
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 60 Days to review application
Performance result: 37 Days to review application
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal | 981.12 | Not available at this time | April 1, 2021 | 979 |
| Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal | 490.56 | Not available at this time | April 1, 2021 | 490 |
| Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal | 2,963.80 | Not available at this time | April 1, 2021 | 2,953 |
| Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal | 490.56 | Not available at this time | April 1, 2021 | 490 |
Fee: Notifiable change
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard: 90 Days to review application for Notifiable Changes
Performance result: 64 Days to review application for Notifiable Changes
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
Fee: Information and material to support an application for Notifiable Change
2019-20 fee amount ($): 1,300
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 2,069
Fee: Protocol
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2019
Service standard:
- 60 Days to review package
- * Modified to 90 Days as of April 1, 2020
Performance result: 60 days to review package
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
Fee: 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
2019-20 fee amount ($): 1,300
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 2,069
Drug Establishment Licensing Fees
Any person in Canada must obtain a Drug Establishment Licence (DEL) if they are engaged in any of the six regulated activities (fabricate, import, distribute, wholesale, package/label, and test) with respect to human and/or veterinary drugs. A fee is charged for the examination of a DEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The DEL fee is calculated on a component basis; therefore, the fee amount varies by application. A DEL fee is charged for the application for a new DEL, an annual licence review of a DEL, certain amendments to a DEL, reinstatement of a suspended DEL, or re-activation of a cancelled or withdrawn DEL.
As of April 1, 2020, a more simplified DEL fee regime was introduced, as indicated in the tables below.
Fee: Human Drug Establishment Licence Fees
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: 2011
Service standard: 250 Calendar days to issue/ renew license
Performance result: 96% of licenses issued (human and veterinary) within 250 calendar days
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Fabrication - Basic Fee | 18,107 | Not available | Not applicable, fee discontinued as of April 1, 2020 | Not applicable, fee discontinued as of April 1, 2020 |
| Fabrication - Each Additional Category | 4,538 | Not available | ||
| Dosage Form Classes: | N/A | N/A | ||
| Fabrication - Two classes | 9,061 | Not available | ||
| Fabrication - Three classes | 18,107 | Not available | ||
| Fabrication - Four classes | 22,642 | Not available | ||
| Fabrication - Five classes | 27,162 | Not available | ||
| Fabrication - Six classes | 31,686 | Not available | ||
| Fabrication - Each additional class | 1,819 | Not available | ||
| Fabrication - Sterile dosage forms | 9,061 | Not available | ||
| Packaging/labelling - Basic Fee | 12,107 | Not available | ||
| Packaging/labelling - Each Additional Category | 3,026 | Not available | ||
| Packaging/labelling - Two classes | 6,039 | Not available | ||
| Packaging/labelling - Three or more classes | 9,061 | Not available | ||
| Importation/Distribution - Basic Fee | 7,551 | Not available | ||
| Importation/Distribution - Each Additional Category | 1,891 | Not available | ||
| Importation/Distribution - Two classes | 3,778 | Not available | ||
| Importation/Distribution - Three or more classes | 7,551 | Not available | ||
| Importation/Distribution - Each fabricator | 1,819 | Not available | ||
| Importation/Distribution - Each additional dosage form class for each fabricator | 917 | Not available | ||
| Distribution and Wholesaling Fee | 4,538 | Not available | ||
| Testing - Testing Fee | 3,026 | Not available | ||
| Drug Analysis Component - Vaccines | 30,174 | Not available | ||
| Drug Analysis Component - Schedule D Drugs which are not vaccines or whole blood and its components | 12,073 | Not available | ||
| Drug Analysis Component - Drugs for human use that are prescription drugs, controlled drugs or narcotics | 9,061 | Not available | ||
| Drug Analysis Component - Drugs for human use, not included in any other item, for which a drug identification number has been assigned | 4,538 | Not available |
Fee: Human Drug Establishment Licence Fees
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 250 Calendar days to issue/ renew license
Performance result: No performance result is available, since the new fees were introduced on April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Fabrication - Sterile dosage form | Not applicable, as these are new fees as of April 1, 2020 | Not applicable, as these are new fees as of April 1, 2020 | April 1, 2021 | 41,647 |
| Importation | 28,975 | |||
| Fabrication - non-sterile dosage form | 28,308 | |||
| Distribution | 13,855 | |||
| Wholesaling | 6,159 | |||
| Packaging/labelling | 6,049 | |||
| Testing | 3,194 | |||
| Building outside Canada (each) | 917 |
Fee: Veterinary Drug Establishment Licence Fees
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Establishment Licensing Fees (Veterinary Drugs) Regulations
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended: Not applicable
Service standard: 250 Calendar days to issue/ renew license
Performance result: 96% of licenses issued (human and veterinary) within 250 calendar days
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Fabrication - Basic Fee | 6,132 | Not available | Not applicable, fees discontinued as of April 1, 2020 | Not applicable, fees discontinued as of April 1, 2020 |
| Fabrication - Each Additional Category | 1,533 | Not available | ||
| Dosage Form Classes: | N/A | N/A | ||
| Fabrication - Two classes | 3,066 | Not available | ||
| Fabrication - Three classes | 6,132 | Not available | ||
| Fabrication - Four classes | 7,665 | Not available | ||
| Fabrication - Five classes | 9,198 | Not available | ||
| Fabrication - Six classes | 10,731 | Not available | ||
| Fabrication - Each additional class | 613.20 | Not available | ||
| Fabrication - Sterile dosage forms | 3,066 | Not available | ||
| Packaging/labelling - Basic Fee | 4,088 | Not available | ||
| Packaging/labelling - Each Additional Category | 1,022 | Not available | ||
| Packaging/labelling - Two classes | 2,044 | Not available | ||
| Packaging/labelling - Three or more classes | 3,066 | Not available | ||
| Importation/Distribution - Basic Fee | 2,555 | Not available | ||
| Importation/Distribution - Each Additional Category | 638.75 | Not available | ||
| Importation/Distribution - Two classes | 1,277.50 | Not available | ||
| Importation/Distribution - Three or more classes | 2,555 | Not available | ||
| Importation/Distribution - Each fabricator | 613.20 | Not available | ||
| Importation/Distribution - Each additional dosage form class for each fabricator | 306.60 | Not available | ||
| Distribution and Wholesaling Fee | 1,533 | Not available | ||
| Testing - Testing Fee | 1,022 | Not available | ||
| Drug Analysis Component - Drug Identification Numbers for Veterinary Use | 255.50 | Not available |
Fee: Veterinary Drug Establishment Licence Fees
Fee-setting authority:
As at April 1, 2020:
Year fee-setting authority was introduced: 2019
Last year fee-setting authority was amended: Not applicable
Service standard: 250 Calendar days to issue/ renew license
Performance result: No performance result is available, since the new fees were introduced on April 1, 2020
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Fabrication - Sterile dosage form | Not applicable, as these are new fees as of April 1, 2020 | Not applicable, as these are new fees as of April 1, 2020 | April 1, 2021 | 40,407 |
| Importation | 13,367 | |||
| Fabrication - non-sterile dosage form | 10,957 | |||
| Distribution | 6,031 | |||
| Wholesaling | 2,412 | |||
| Packaging/labelling | 6,049 | |||
| Testing | 1,641 | |||
| Building outside Canada (each) | 917 |
Drug Establishment Licensing Fees - Dealer's Licences
Fees for the examination of an application for a new dealer's licence 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:
Human Drugs:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations (until March 21, 2019)
- Fees in Respect of a Dealer's Licences Regulations (beginning April 1, 2020)
Veterinary Drugs:
- Financial Administration Act (FAA)
- Licenced Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations
Year fee-setting authority was introduced: 1998
Last year fee-setting authority was amended:
- Human Drugs: 2011
- Veterinary Drugs: Not applicable
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: 94% of applications were processed within the service standard
- Renew: 100% of applications were processed within the service standard
Application of Low-Materiality Fees Regulations: Material (>$151)
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Dealer's Licence Fees - Human Drugs | 5,288 | 1,121,826 | April 1, 2021 | 5,502 |
| Dealer's Licence Fees - Veterinary Drugs | 1,788.50 | 18,722 | April 1, 2021 | 1,820.62 |
Medical Device Establishment Licensing Fees
A Medical Device Establishment Licence (MDEL) is required for the activities of importing or selling medical devices for human use in Canada with exceptionsFootnote 1. A fee is charged for the examination of an MDEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The MDEL fee is a flat fee. The same fee is charged for an application for a new MDEL, an annual licence review of an MDEL, and the reinstatement of a suspended MDEL.
Fee: Application for new licence and annual review of licence
Fee-setting authority:
- Financial Administration Act (FAA)
- ARCHIVED - Fees in Respect of Drugs and Medical Devices Regulations
Beginning April 1, 2020:
Year fee-setting authority was introduced: 2000
Last year fee-setting authority was amended: 2019
Service standard: 120 Calendar days to issue/ renew licence
Performance result: 100% of licenses issued within 120 calendar days
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 8,438
2019-20 total fee revenue ($): 9,455,621
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 4,581
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.
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 655 days of Review
Performance result: 100% (5/5 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 78,871 | Not available at this time | April 1, 2021 | 82,058 |
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data - acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 18,205 | Not available at this time | April 1, 2021 | 18,942 |
| 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 | 5,992 | Not available at this time | April 1, 2021 | 6,235 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 44,410 | Not available at this time | April 1, 2021 | 46,205 |
| 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 | 24,593 | Not available at this time | April 1, 2021 | 25,587 |
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 38,784 | Not available at this time | April 1, 2021 | 40,352 |
| 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 | 24,648 | Not available at this time | April 1, 2021 | 25,644 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Specification of maximum residue limit for a previously unexamined pest control product | 130,531 | Not available at this time | April 1, 2021 | 135,805 |
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 555 days of Review
Performance result: 82% (14/17 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 78,871 | Not available at this time | April 1, 2021 | 82,058 |
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data - acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 18,205 | Not available at this time | April 1, 2021 | 18,942 |
| 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 | 5,992 | Not available at this time | April 1, 2021 | 6,235 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 44,410 | Not available at this time | April 1, 2021 | 46,205 |
| 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 | 24,593 | Not available at this time | April 1, 2021 | 25,587 |
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 38,784 | Not available at this time | April 1, 2021 | 40,352 |
| 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 | 24,648 | Not available at this time | April 1, 2021 | 25,644 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Registration of a new active ingredient - food use | 7,529 | Not available at this time | April 1, 2021 | 7,834 |
| Registration of a new active ingredient - non-food use | 4,517 | Not available at this time | April 1, 2021 | 4,701 |
| Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data | 3,012 | Not available at this time | April 1, 2021 | 3,135 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 470 days of Review
Performance result: N/A (0 applications completed in 2019-20)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 78,871 | Not available at this time | April 1, 2021 | 82,058 |
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product -that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data - acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 18,205 | Not available at this time | April 1, 2021 | 18,942 |
| 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 | 5,992 | Not available at this time | April 1, 2021 | 6,235 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 44,410 | Not available at this time | April 1, 2021 | 46,205 |
| 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 | 24,593 | Not available at this time | April 1, 2021 | 25,587 |
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 38,784 | Not available at this time | April 1, 2021 | 40,352 |
| 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 | 24,648 | Not available at this time | April 1, 2021 | 25,644 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Registration of a new active ingredient - food use | 7,529 | Not available at this time | April 1, 2021 | 7,834 |
| Registration of a new active ingredient - non-food use | 4,517 | Not available at this time | April 1, 2021 | 4,701 |
| Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data | 3,012 | Not available at this time | April 1, 2021 | 3,135 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 285 days of Review
Performance result: N/A (0 applications completed in 2019-20)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Registration of new active ingredient | 603 | Not available at this time | April 1, 2021 | 629 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
Fee: Category A Component Based - Submissions with atypical timelines and joint reviews
Fee-setting authority:
Year fee-setting authority was introduced: 1997
Last year fee-setting authority was amended: 2017
Service standard: Variable as per Management of Submission Policy Appendix I, table 1
Performance result: 73% (8/11 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product that contains a new active ingredient | 78,871 | Not available at this time | April 1, 2021 | 82,058 |
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data - acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient | 18,205 | Not available at this time | April 1, 2021 | 18,942 |
| 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 | 5,992 | Not available at this time | April 1, 2021 | 6,235 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 44,410 | Not available at this time | April 1, 2021 | 46,205 |
| 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 | 24,593 | Not available at this time | April 1, 2021 | 25,587 |
| Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient | 38,784 | Not available at this time | April 1, 2021 | 40,352 |
| 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 | 24,648 | Not available at this time | April 1, 2021 | 25,644 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Registration of a new active ingredient - food use | 7,529 | Not available at this time | April 1, 2021 | 7,834 |
| Registration of a new active ingredient - non-food use | 4,517 | Not available at this time | April 1, 2021 | 4,701 |
| Amendment of registration - new risk assessment necessary - environmental fate data, environmental toxicity data or exposure data | 3,012 | Not available at this time | April 1, 2021 | 3,135 |
| Registration of new active ingredient | 603 | Not available at this time | April 1, 2021 | 629 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
| Specification of maximum residue limit for a previously unexamined pest control product | 130,531 | Not available at this time | April 1, 2021 | 135,805 |
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 425 days of Review
Performance result: 86% (201/233 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data - acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data - other | 5,426 | Not available at this time | April 1, 2021 | 5,646 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environmental fate data - other | 12,013 | Not available at this time | April 1, 2021 | 12,500 |
| Environmental toxicology data - other | 2,566 | Not available at this time | April 1, 2021 | 2,671 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 360 days of Review
Performance result: 100% (5/5 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data - acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data - other | 5,426 | Not available at this time | April 1, 2021 | 5,646 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environmental fate data - other | 12,013 | Not available at this time | April 1, 2021 | 12,500 |
| Environmental toxicology data - other | 2,566 | Not available at this time | April 1, 2021 | 2,671 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Amendment of registration - data required, label changes | 1,506 | Not available at this time | April 1, 2021 | 1,568 |
| Amendment of registration - data required, other | 1,206 | Not available at this time | April 1, 2021 | 1,256 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 240 days of Review
Performance result: 89% (16/18 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Amendment of registration - data required, label changes | 1,506 | Not available at this time | April 1, 2021 | 1,568 |
| Amendment of registration - data required, other | 1,206 | Not available at this time | April 1, 2021 | 1,256 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 158 days of Review
Performance result: 88% (35/40 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Amendment of registration - data required, label changes | 1,506 | Not available at this time | April 1, 2021 | 1,568 |
| Amendment of registration - no data required, other | 302 | Not available at this time | April 1, 2021 | 316 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
Fee: Category B Component Based - Submissions with atypical timelines and joint reviews
Fee-setting authority:
Year fee-setting authority was introduced: 1997
Last year fee-setting authority was amended: 2017
Service standard: Variable as per Management of Submission Policy Appendix I, table 2
Performance result: N/A (0 applications completed in 2019-20)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product - or to amend a pest control product - that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data-acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data-other | 5,426 | Not available at this time | April 1, 2021 | 5,646 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environmental fate data - other | 12,013 | Not available at this time | April 1, 2021 | 12,500 |
| Environmental toxicology data - other | 2,566 | Not available at this time | April 1, 2021 | 2,671 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Amendment of registration - data required, label changes | 1,506 | Not available at this time | April 1, 2021 | 1,568 |
| Amendment of registration - data required, other | 1,206 | Not available at this time | April 1, 2021 | 1,256 |
| Amendment of registration - no data required | 302 | Not available at this time | April 1, 2021 | 316 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
| Specification of maximum residue limit for an unregistered use of a previously examined pest control product | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 240 days of Review
Performance result: 97% (680/701 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Amendment of registration - no data required | 302 | Not available at this time | April 1, 2021 | 316 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 180 days of Review
Performance result: 99% (122/123 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Amendment of registration - no data required | 302 | Not available at this time | April 1, 2021 | 316 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
Fee: Category C Component Based - Submissions with atypical timelines and joint reviews
Fee-setting authority:
Year fee-setting authority was introduced: 1997
Last year fee-setting authority was amended: 2017
Service standard: Variable as per Management of Submission Policy Appendix I, table 3
Performance result: 0% (0/1 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Amendment of registration - no data required | 302 | Not available at this time | April 1, 2021 | 316 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
Fee: Category D Component Based - 247 days of Review (Registration Renewal)
Fee-setting authority:
Year fee-setting authority was introduced: 1997
Last year fee-setting authority was amended: 2017
Service standard: 247 days of Review
Performance result: 100% (970/970 applications met the service standard)
Application of Low-Materiality Fees Regulations: Low-materiality ($51-$151)
2019-20 fee amount ($): 84
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 88
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 46 days of Review
Performance result: 33% (1/3 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Registration of active ingredient to be used in pest control product manufactured only for export | 8,144 | Not available at this time | April 1, 2021 | 8,474 |
| Amendment to Registration of active ingredient to be used in pest control product manufactured only for export | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
Fee: Category D Component Based - 42 days of Review (Master Copies)
Fee-setting authority
Year fee-setting authority was introduced: 1997
Last year fee-setting authority was amended: 2017
Service standard: 42 days of Review
Performance result: 100% (61/61 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
2019-20 fee amount ($): 1,180
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 1,229
Fee: Category D Component Based - 10 days of Review (Private Labels)
Fee-setting authority
Year fee-setting authority was introduced: 1997
Last year fee-setting authority was amended: 2017
Service standard: 10 days of Review
Performance result: 100% (5/5 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
Fee: Processing
2019-20 fee amount ($): 1,180
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 1,229
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 159 days of Review
Performance result: 69% (20/29 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Research authorization - major crops, other than research authorizations set out in paragraphs (c) and (d) | 5,286 | Not available at this time | April 1, 2021 | 5,500 |
| Research authorization - minor use crops, other than research authorizations set out in paragraphs (c) and (d) | 5,286 | Not available at this time | April 1, 2021 | 5,500 |
| Research authorization - microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations | 1,267 | Not available at this time | April 1, 2021 | 1,319 |
| Research authorization - greenhouse crops and non-agricultural uses | 1,267 | Not available at this time | April 1, 2021 | 1,319 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 69 days of Review
Performance result: 79% (37/47 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Research authorization - major crops, other than research authorizations set out in paragraphs (c) and (d) | 5,286 | Not available at this time | April 1, 2021 | 5,500 |
| Research authorization - minor use crops, other than research authorizations set out in paragraphs (c) and (d) | 5,286 | Not available at this time | April 1, 2021 | 5,500 |
| Research authorization - microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations | 1,267 | Not available at this time | April 1, 2021 | 1,319 |
| Research authorization - greenhouse crops and non-agricultural uses | 1,267 | Not available at this time | April 1, 2021 | 1,319 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 30 days of Review
Performance result: 93% (27/29 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
Fee: Research notifications
2019-20 fee amount ($): 258
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 270
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 45 days of Review
Performance result: 98% (926/945 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
Fee: Applications not mentioned in schedules
2019-20 fee amount ($): 258
2019-20 total fee revenue ($): Not available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 270
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 425 days of Review
Performance result: 76% (34/45 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data-acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data - other | 5,426 | Not available at this time | April 1, 2021 | 5,646 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environmental fate data - other | 12,013 | Not available at this time | April 1, 2021 | 12,500 |
| Environmental toxicology data - other | 2,566 | Not available at this time | April 1, 2021 | 2,671 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Identification of compensable data | 2,251 | Not available at this time | April 1, 2021 | 2,343 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 365 days of Review
Performance result: 90% (76/84 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Identification of compensable data | 2,251 | Not available at this time | April 1, 2021 | 2,343 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 360 days of Review
Performance result: 100% (1/1 applications met the service standard)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data-acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data - other | 5,426 | Not available at this time | April 1, 2021 | 5,646 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environmental fate data - other | 12,013 | Not available at this time | April 1, 2021 | 12,500 |
| Environmental toxicology data - other | 2,566 | Not available at this time | April 1, 2021 | 2,671 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Identification of compensable data | 2,251 | Not available at this time | April 1, 2021 | 2,343 |
| Amendment of registration - data required, label changes | 1,506 | Not available at this time | April 1, 2021 | 1,568 |
| Amendment of registration - data required, other | 1,206 | Not available at this time | April 1, 2021 | 1,256 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 240 days of Review
Performance result: N/A (0 applications completed in 2019-20)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Identification of compensable data | 2,251 | Not available at this time | April 1, 2021 | 2,343 |
| Amendment of registration - data required, label changes | 1,506 | Not available at this time | April 1, 2021 | 1,568 |
| Amendment of registration - data required, other | 1,206 | Not available at this time | April 1, 2021 | 1,256 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: Variable as per Management of Submission Policy Appendix I, table 7
Performance result: N/A (0 applications completed in 2019-20)
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Product Chemistry - active ingredient | 5,071 | Not available at this time | April 1, 2021 | 5,277 |
| Product Chemistry - end-use product or manufacturing concentrate | 2,824 | Not available at this time | April 1, 2021 | 2,939 |
| Toxicology data accompanying an application to register a pest control product -or to amend a pest control product -that contains an registered active ingredient | 16,470 | Not available at this time | April 1, 2021 | 17,136 |
| Toxicology data-acute toxicity studies | 3,075 | Not available at this time | April 1, 2021 | 3,200 |
| Exposure data - other | 5,426 | Not available at this time | April 1, 2021 | 5,646 |
| Metabolism data | 30,113 | Not available at this time | April 1, 2021 | 31,331 |
| Residue data | 16,479 | Not available at this time | April 1, 2021 | 17,146 |
| Environmental fate data - other | 12,013 | Not available at this time | April 1, 2021 | 12,500 |
| Environmental toxicology data - other | 2,566 | Not available at this time | April 1, 2021 | 2,671 |
| Value and effectiveness data for a pest control product | 944 | Not available at this time | April 1, 2021 | 983 |
| Identification of compensable data | 2,251 | Not available at this time | April 1, 2021 | 2,343 |
| Amendment of registration - data required, label changes | 1,506 | Not available at this time | April 1, 2021 | 1,568 |
| Amendment of registration - data required, other | 1,206 | Not available at this time | April 1, 2021 | 1,256 |
| Amendment of registration | 302 | Not available at this time | April 1, 2021 | 316 |
| Processing | 1,180 | Not available at this time | April 1, 2021 | 1,229 |
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: 1997
Last year fee-setting authority was amended: 2017
Service standard: 100% of all invoices were issued by April 30, 2019
Performance result: 100%
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
2019-20 fee amount ($): The lesser of $3,679.20 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $100
2019-20 total fee revenue ($): 8,654,696
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): The lesser of $3,745.27 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $100
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:
Year fee-setting authority was introduced: 1988
Last year fee-setting authority was amended: 2002
Service standard: Seven calendar days from the date of the receipt of a complete application, for the issuance of a registry number
Performance result: 99.5% of claims (original and refiled) were registered within the service standard of seven days
Application of Low-Materiality Fees Regulations: Material (>$151): All fees
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Original Claim (up to 15) | 1,839.60 | Not available at this time | April 1, 2021 | 1,872.64 |
| Original Claim (between 16-25) | 408.80 | April 1, 2021 | 416.14 | |
| Original Claim (26+) | 204.40 | April 1, 2021 | 208.07 | |
| Refiled Claims (up to 15) | 1,471.68 | Not available at this time | April 1, 2021 | 1,498.11 |
| Refiled Claims (between 16-25) | 327.04 | April 1, 2021 | 332.91 | |
| Refiled Claims (26+) | 163.52 | April 1, 2021 | 166.46 |
Cannabis Fees
Fees are charged for the following transactional activities: application screening, security clearances, and import/export permits. In addition, an Annual Regulatory Fee is charged which covers costs associated with a range of regulatory activities including regulatory inspections, compliance and enforcement, program management and oversight. These activities are carried out by Health Canada, the Canada Border Services Agency, the Public Health Agency of Canada and Public Safety Canada to support the objectives of the Cannabis Act with respect to the legislation and regulations of cannabis.
Fee: Licence Application Screening Fees
Fee-setting authority:
Year fee-setting authority was introduced: 2018
Last year fee-setting authority was amended: Not Applicable
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 78% of the time.
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Licence Application Screening Fee - Licence for micro-cultivation | 1,675 | No data available at this time | April 1, 2021 | 1,706 |
| Licence Application Screening Fee - Licence for standard cultivation | 3,350 | No data available at this time | April 1, 2021 | 3,411 |
| Licence Application Screening Fee - Licence for a nursery | 1,675 | No data available at this time | April 1, 2021 | 1,706 |
| Licence Application Screening Fee - Licence for micro-processing | 1,675 | No data available at this time | April 1, 2021 | 1,706 |
| Licence Application Screening Fee - Licence for standard processing | 3,350 | No data available at this time | April 1, 2021 | 3,411 |
| Licence Application Screening Fee - Licence for sale for medical purposes | 3,350 | No data available at this time | April 1, 2021 | 3,411 |
Fee: Application for a security Clearance
Fee-setting authority:
Year fee-setting authority was introduced: 2018
Last year fee-setting authority was amended: Not Applicable
Service standard: No administrative service standard for this fee as outlined during the 2018 consultation on the Proposed Approach to Cost Recovery for the Regulation of Cannabis and the subsequent Regulatory Impact Analysis Statement for the Cannabis Fees Order.
Performance result: Not applicable
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 1,691
2019-20 total fee revenue ($): No data available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 1,722
Fee: Application for import or export permit
Fee-setting authority:
Year fee-setting authority was introduced: 2018
Last year fee-setting authority was amended: Not Applicable
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 82.46% of the time.
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
2019-20 fee amount ($): 624
2019-20 total fee revenue ($): No data available at this time
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 636
Fee: Annual Regulatory Fee
Fee-setting authority:
Year fee-setting authority was introduced: 2018
Last year fee-setting authority was amended: Not Applicable
Service standard: No administrative service standard for this fee as outlined during the 2018 consultation on the Proposed Approach to Cost Recovery for the Regulation of Cannabis and the subsequent Regulatory Impact Analysis Statement for the Cannabis Fees Order.
Performance result: Not applicable
Application of Low-Materiality Fees Regulations: Not subject to Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| Annual fee - Licence for micro-cultivation | as per Cannabis Fees Order | No data available at this time | 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 will be 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: Ministerial Authority to enter into Contract
Year fee-setting authority was introduced: 2004
Last year fee-setting authority was amended: 2017
Service standard: Provide timely, responsive and reliable dosimetry services:
- Exposures reported to the National Dose Registry within 45 calendar days of receipt (a regulatory standard set by the Canadian Nuclear Safety Commission (CNSC));
- Dosimeters shipped 10 to 13 working days prior to exchange date with clients;
- Dose results for whole body and extremity services reported to clients within internal service standards of 20 to 30 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 with the 45 day regulatory (CNSC) standard;
- Shipped out 99.97% of dosimeters 10 to 13 working days prior to exchange date;
- 99.7% reported within the 20 to 30 business day internal standard, depending on the dosimetry service;
- 97% completed within two business days;
- 94% being addressed within one business day; and
- 93% addressed within two business days.
Application of Low-Materiality Fees Regulations: Not subject to section 17 of the Service Fees Act
| N/A | Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|---|
| Core Fees: | Annual support | 80.00 | Not available at this time | April 1, 2021 | 82.50 |
| Annual support - multi-group discount (5+ groups) | 50.00 | Not available at this time | n/a | 50.00 | |
| Shipping and handling (per shipment) | 14.50 | Not available at this time | n/a | 14.50 | |
| Processing fees (per dosimeter) | 5.00 to 17.50 | Not available at this time | April 1, 2021 | 5.25 to 17.50 | |
| Additional Fees: | Ad hoc dosimeter request - add-on (per shipment) | 65.00 | Not available at this time | n/a | 65.00 |
| Priority processing request (per request) | 95.00 | Not available at this time | n/a | 95.00 | |
| Pregnancy service (semi-monthly) | 375.00 | Not available at this time | n/a | 375.00 | |
| Electronic personal dosimeter rental (per year) | 415.00 | Not available at this time | n/a | 415.00 | |
| Specialized consultation (per hour) | 125.00 | Not available at this time | n/a | 125.00 | |
| Customized reporting (per hour) | 60.00 | Not available at this time | n/a | 60.00 | |
| NDR dose modifications (per hour) | 60.00 | Not available at this time | n/a | 60.00 | |
| Reprinting reports (per report) | 10.00 | Not available at this time | n/a | 10.00 | |
| Overdue dosimeter (three months after wearing period ends) | 55.00 | Not available at this time | n/a | 55.00 | |
| Late dosimeter (six months after wearing period ends) | 55.00 | Not available at this time | n/a | 55.00 | |
| Lost/damaged dosimeter | 82.50 | Not available at this time | n/a | 82.50 | |
| Damaged electronic personal dosimeter | 415.00 | Not available at this time | n/a | 415.00 | |
| Credit upon returning overdue dosimeter | 28.75 | Not available at this time | n/a | 28.75 | |
| Credit upon returning late or lost dosimeter | 57.50 | Not available at this time | n/a | 57.50 |
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: Ministerial Authority to enter into Contract
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: 2017
Service standard: 30 calendar days
Performance result: 99.86% issued within 30 calendar days
Application of Low-Materiality Fees Regulations: Not subject to section 17 of the Service Fees Act
| Fee | 2019-20 fee amount ($) | 2019-20 total fee revenue ($) | Fee adjustment date | Adjusted fee amount in 2021-22 ($) |
|---|---|---|---|---|
| New Master Files (file registration) | 1,248 | Not available at this time | April 1, 2021 | 1,298 |
| Drug Master Files – letter of access | 176 | Not available at this time | April 1, 2021 | 184 |
| Drug Master Files - Update | 541 | Not available at this time | April 1, 2021 | 563 |
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: Ministerial Authority to enter into Contract
Year fee-setting authority was introduced: 1996
Last year fee-setting authority was amended: Not applicable
Service standard: 10 calendar days to issue certificate
Performance result: 87% of certificates issued within 10 calendar days
Application of Low-Materiality Fees Regulations: Not subject to section 17 of the Service Fees Act
2019-20 fee amount ($): 90
2019-20 total fee revenue ($): 263,554
Fee adjustment date: April 1, 2021
Adjusted fee amount in 2021-22 ($): 94
Footnotes
- Footnote 1
-
As per the Medical Devices Regulations, an MDEL is not required for: a retailer, a health care facility, a manufacturer of Class II, III or IV medical devices who only sells either medical devices for which they hold a valid licence, or medical devices subject to Parts 2 and 3 of the Regulations, a manufacturer of a Class I medical device who imports or distributes solely through a licensed establishment, a person solely selling medical devices subject to Parts 2 and 3 of the Regulations, or a dispenser.
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