2018-2019 Report on Fees
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Table of Contents
- Minister's message
- About this report
- Remissions
- Overall totals, by fee type
- Totals for fees set by act, regulation or fees notice, by fee grouping
- Details on each fee set by act, regulation or fees notice
- Fees for Right to Sell Drugs
- Fees for Right to Sell a Licensed Class II, III or IV Medical Device
- Fees for Examination of a Submission — Drugs for Human Use
- Certificate of Supplemental 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
Minister's message
On behalf of Health Canada, I am pleased to present our report on fees for fiscal year 2018 to 2019, my organization's second annual report under the Service Fees Act.
The act provides a modern legislative framework that enables cost-effective delivery of services and, through better reporting to Parliament, improves transparency and oversight.
Last year, a detailed listing of individual fees under the department's authority, along with anticipated increases, was added to the reporting requirements.
This year's report provides more detail on each fee, such as the type and rate of adjustment, the service standard and the performance result. This information provides additional context on each fee, in the spirit of open and transparent fee management.
Additionally, this report includes the revision of the fees in respect of drugs and medical devices. In 2017, Health Canada began engaging with stakeholders to revise fees for regulatory activities related to human drugs, veterinary drugs, and medical devices and effective April 1, 2020, fees, where indicated, will be repealed from the Financial Administration Act and set under the authority of the Food and Drugs Act. In some instances, new fees are being introduced and some fees are being discontinued.
Cannabis fees were introduced on October 17, 2018 to support the legalization, strict regulation and restriction on access to cannabis under the Cannabis Act.
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 look forward to continuing 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 charge in the 2018 to 2019 fiscal year.
This report contains information about all fees that are under Health Canada's authority, even if some or all of the fees are collected by another department.
The information reported includes fees that:
- fall under the Service Fees Act
- are exempt from the Service Fees Act
The information covers fees set by:
- contract
- market-base, auction or both
- act, regulation or fees notice
For fees set by the following mechanisms, the report provides totals only:
- contract
- market-base, auction or both
For fees set by act, regulation or fees notice, the report provides totals for fee groupings, as well as detailed information for each individual fee.
Although the fees charged by Health Canada 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 fiscal year 2018 to 2019 can be found in our access to information report, which is posted on https://www.canada.ca/en/health-canada/corporate/about-health-canada/reports-publications.html.
Remissions
A remission is a partial or full return of a fee to a fee payer who paid for a service for which a department deemed that the service standard was not met.
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. This requirement does not take effect until April 1, 2020. This report therefore includes only those remissions issued under Health Canada's enabling legislation. It does not include remissions issued under the Service Fees Act.
Overall totals, by fee type
The following table presents the total revenue, cost and remissions for all fees that Health Canada had the authority to charge in fiscal year 2018 to 2019, by fee type.
| Fee type | Revenue ($) | Cost ($) | Remissions ($) |
|---|---|---|---|
| Fees set by contractTable 1 footnote * | 7,851,760 | 9,193,525 | Remissions do not apply to fees set by contract. |
| Fees set by market base, auction or both | 0 | 0 | Remissions do not apply to fees set by market base, auction or both. |
| Fees set by act, regulation or fees notice | 120,090,045 | 439,609,891 | 0 |
| Total | 127,941,805 | 448,803,416 | 0 |
Totals for fees set by act, regulation or fees notice, by fee grouping
The following tables present, for each fee grouping, the total revenue, cost and remissions for all fees that Health Canada had the authority to charge in fiscal year 2018 to 2019 that are set by any of the following:
- act
- regulation
- fees notice
A fee grouping is a grouping of all of the fees that a department has the authority to charge for activities relating to a single business line, directorate or program.
| Fee grouping | Fees for the Right to Sell Drugs | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 12,115,915 | 72,993,018 | 0 |
| Fee grouping | Fees for the Right to Sell Licensed Class II, III, or IV Medical Devices | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 8,607,115 | 23,128,668 | 0 |
| Fee grouping | Fees for Examination of a Submission — Drugs for Human Use | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 47,907,159 | 108,715,232 | 0 |
| Fee grouping | Certificate of Supplementary Protection Application Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 229,981 | 728,757 | 0 |
| Fee grouping | Fees for the Examination of Medical Device Licence Applications | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 6,132,439 | 22,607,534 | 0 |
| Fee grouping | Fees for Examination of a Submission — Drugs for Veterinary Use Only | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 582,022 | 6,139,407 | 0 |
| Fee grouping | Drug Establishment Licensing Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 16,798,078 | 32,885,388 | 0 |
| Fee grouping | Medical Devices Establishment Licensing Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 8,241,721 | 9,938,932 | 0 |
| Fee grouping | Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product: | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 5,397,880 | 36,746,746 | 0 |
| Fee grouping | Annual Charge (for a registered Pest Control Product) | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 9,342,992 | 30,211,129 | 0 |
| Fee grouping | Fees charged for filing a claim for exemption under the Hazardous Materials Information Review Act | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 458,994 | 3,246,547 | 0 |
| Fee grouping | Cannabis Fees | |
|---|---|---|
| Revenue ($) | Cost ($) | Remissions ($) |
| 4,185,748 | 92,268,533 | 0 |
Details on each fee set by act, regulation or fees notice
This section provides detailed information on each fee that Health Canada had the authority to charge in fiscal year 2018 to 2019, and that was set by any of the following:
- act
- regulation
- fees notice
In most cases, the Department does not currently report revenue collections at the individual fee level. Health Canada is working to implement financial system changes to enable lower-level fee reporting in the future.
Fees for Right to Sell Drugs
Health Canada monitors human and veterinary drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to maintain and sell human and veterinary drugs in Canada.
Fee: Human drugs
Fee-setting authority: 2018 to 2019
Fee-setting authority: 2019 and onwards
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards: fee discontinued April 1 2020
Year introduced: 1995
Last year fee-setting authority was amended: 2011
Fee type: Other Authorization
Fee amount ($): 1,176
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate (% or formula): Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard: 120 days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result: 100% completed on time
Fee: Human drugs - Disinfectant (item 1)
Fee-setting authority: 2018 to 2019: Not applicable, new fees as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not Applicable
Fee type: Other Authorization
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rat (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 1,285
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard: 20 days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result: Not applicable, new fee as of April 1 2020
Fee: Human drugs - Non-prescription (item 2)
Fee-setting authority: 2018 to 2019: Not applicable, new fees as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not Applicable
Fee type: Other Authorization
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 1,623
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard: 20 days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result: Not applicable, new fee as of April 1 2020
Fee: Human drugs - Prescription (drug other than one referred to in item 1 or 2)
Fee-setting authority: 2018 to 2019: Not applicable, new fees as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not Applicable
Fee type: Other Authorization
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 1,836
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard: 20 days to update the Drug Product Database following receipt of a complete Annual Notification Package
Performance result: Not applicable, new fee as of April 1 2020
Fee: Veterinary Drugs
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Other Authorization
Fee amount ($): 250
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula):Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 312
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
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
Fees for Right to Sell a Licensed Class II, III or IV Medical Device
Health Canada monitors medical devices on the Canadian market through post-market surveillance and compliance and enforcement activities. There is an annual fee for the right to sell a Class II, III, IV medical device.
Fee: Medical Device Right to Sell (if annual gross revenue medical device sales is less than $20,000)
Fee-setting authority: 2018 to 2019
Fee-setting authority: 2019 and onwards:
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards: fee discontinued April 1 2020
Year introduced: 1999
Last year fee-setting authority was amended: 2011
Fee type: Other Authorization
Fee amount ($): 63
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate (% or formula): Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard: 20 days from deadline for receipt of annual notification to update the Medical Devices License Listing (MDALL) database
Performance result: 99.94% completed on time
Fee: Medical Device Right to Sell
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1999
Last year fee-setting authority was amended: 2019
Fee type: Other Authorization
Fee amount ($): 383
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 381
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard: 20 days from deadline for receipt of annual notification to update the Medical Devices License Listing (MDALL) database
Performance result: 99.94% completed on time
Fees for Examination of a Submission — Drugs for Human Use
Before a drug is authorized for sale in Canada, Health Canada reviews it to assess its safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, biologics, disinfectants and sanitizers with disinfectant claims.
Fee: New active substance
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 348,606
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 400,288
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1): New drug submission (NDS) - 300 Days
Performance result (average): NDS - Pharmaceuticals (254 Days) Biologics (226 Days)
Fee: Clinical or non-clinical data and chemistry and manufacturing data
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 176,569
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 204,197
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1):
- New drug submission (NDS) - 300 Days
- Supplement to a new drug submission (SNDS) - 300 Days
- Drug identification number application (DIN A) - 210 Days
Performance result (average):
- NDS - Pharmaceuticals (278 Days) Biologics (275 Days)
- SNDS - Pharmaceuticals (270 Days) Biologics (300 Days)
- DIN A - Pharmaceuticals (206 Days)
Fee: Clinical or non-clinical data only
Fee-setting authority: 2018 to 2019
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 82,410
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 90,864
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1):
- Supplement to a new drug submission (SNDS) - 300 Days
- Drug identification number application (DIN A) - 210 Days
Performance result (average):
- SNDS - Pharmaceuticals (276 Days) Biologics (275 Days)
- DIN A - Pharmaceuticals (208 Days)
Fee: Comparative studies
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 49,811
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 53,836
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1):
- Abbreviated new drug submission (ANDS) - 180 Days
- New drug submission (NDS) - 180 Days
- Supplement to an abbreviated new drug submission (SANDS) - 180 Days
- Supplement to a new drug submission - 180 Days
- Drug identification number application (DIN A) - 210 Days
Performance result (average):
- ANDS- Pharmaceuticals (168 Days)
- NDS - Pharmaceuticals (178 Days)
- SANDS- Pharmaceuticals (148 Days)
- SNDS - Pharmaceuticals (173 Days) Biologics (179 Days)
- DIN A - Pharmaceuticals (202 Days)
Fee: Chemistry and manufacturing data only
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 23,551
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 27,587
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1)
- Abbreviated new drug submission (ANDS) - 180 Days
- New drug submission (NDS) - 180 Days
- Supplement to an abbreviated new drug submission (SANDS)- 180 Days
- Supplement to a new drug submission - 180 Days
- Drug identification number application (DIN A) - 210 Days
Performance result (average)
- ANDS - Pharmaceuticals (170 Days)
- NDS - Pharmaceuticals (178 Days)
- SANDS - Pharmaceuticals (155 Days)
- SNDS - Pharmaceuticals (162 Days) Biologics (143 Days)
- DIN A- Pharmaceuticals (194 Days) Biologics (207 Days)
Fee: Clinical or non-clinical data only, in support of safety upgrades to the labelling
Fee-setting authority: 2018 to 2019: Not applicable, new fees as of April 1 2020
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): Not applicable, new fees as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, new fees as of April 1 2020
2020 to 2021 fee amount ($): 19,442
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fees as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard (average time to complete Review 1): 120 Days
Performance result (average): Not applicable, new fees as of April 1 2020
Fee: Published data only
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards: fee discontinued April 1 2020
Year introduced: 1995
Last year fee-setting authority was amended: 2011
Fee type: Service
Fee amount ($): 19,530
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate: (% or formula) Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard (average time to complete Review 1):
- Supplement to a new drug submission (SNDS)- 300 Days
- Drug identification number application (DIN A) - 210 Days
Performance result (average):
- SNDS - Pharmaceuticals (271 Days) Biologics (273 Days)
- DIN A - Pharmaceuticals (189 Days)
Fee: Switch from prescription to non-prescription status
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards: fee discontinued April 1 2020
Year introduced: 1995
Last year fee-setting authority was amended: 2011
Fee type: Service
Fee amount ($): 47,421
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate: (% or formula) Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard (average time to complete Review 1): Supplement to a new drug submission (SNDS) - 180 Days
Performance result (average): Supplement to a new drug submission - 179 Days
Fee: Labelling only
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 3,174
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate: (% or formula) Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 3,816
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1):
- New drug submission (NDS) - 60 Days
- Supplement to a new drug submission (SNDS) - 60 Days
- Abbreviated new drug submission (ANDS) - 60 Days
- Supplement to an abbreviated new drug submission (SANDS)- 60 Days
- Drug identification number application (DIN A)- 180 Days
- * As of April 2020 will be 120 Days for all types
Performance result (average):
- NDS - Pharmaceuticals (50 Days) Biologics (59 Days)
- SNDS - Pharmaceuticals (52 Days) Biologics (58 Days)
- ANDS - Pharmaceuticals (40 Days)
- SANDS - Pharmaceuticals (37 Days)
- DIN A - Pharmaceuticals (159 Days) Biologics (105 Days)
Fee: Labelling only (generic drugs)
Fee-setting authority: 2018 to 2019: Not applicable, new fees as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate: (% or formula) Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 2,010
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard (average time to complete Review 1): 120 Days
Performance result (average): Not applicable, new fee as of April 1 2020
Fee: Administrative submission
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 331
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate: (% or formula) Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 432
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1):
- Abbreviated new drug submission (ANDS)- 45 Days
- New drug submission (NDS)- 45 Days
- Supplement to a new drug submission (SNDS) - 45 Days
- Supplement to an abbreviated new drug submission (SANDS)- 45 Days
- Drug identification number application (DIN A & B)- 45 Days
- Drug identification number application - Disinfectant (DIN D) - 45 Days
Performance result (average):
- ANDS - Pharmaceuticals (30 Days)
- NDS - Pharmaceuticals (28 Days)
- SNDS - Pharmaceuticals (24 Days)
- SANDS - Pharmaceuticals (26 Days)
- DIN A & B - Pharmaceuticals (25 Days) Biologics (40 Days)
- DIN D - Pharmaceuticals (34 Days)
Fee: Disinfectant - full review
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 4,392
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate: (% or formula) Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 5,712
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1):
- New drug submission (NDS) - 300 Days
- Drug identification number application (Disinfectant 210) (DIN D 210) - 210 Days
Performance result (average):
- NDS - Pharmaceuticals (294 Days)
- DIN D 210 - Pharmaceuticals (204 Days)
Fee: Labelling only (disinfectants)
Fee-setting authority: 2018 to 2019: Not applicable, new fee as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate: (% or formula) Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 2,507
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1): 120 Days
Performance result (average): Not applicable, new fee as of April 1 2020
Fee: Drug identification number application – labelling standards
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1995
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 1,761
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate: (% or formula) Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 1,616
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average time to complete Review 1):
- Drug identification number application (DIN A) - 45 Days
- Drug identification number application - Disinfectant (DIN D)- 45 Days
- Drug identification number application - Category IV (DIN F) - 45 Days
- * As of April 2020 it will be 60 Days for all types
Performance result (average):
- DIN A - Pharmaceuticals (41 Days)
- DIN D - Pharmaceuticals (40 Days)
- DIN F - Pharmaceuticals (41 Days)
Certificate of Supplemental Protection Application Fees
In agreeing to provisionally apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs.
Fee: Certificate of Supplemental Protection Application Fees
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2017
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): 9,192
Total fee revenue ($): 229,981
Adjustment type: Annual
Adjustment rate (% or formula): 2% rounded up to the nearest dollar
2020 to 2021 fee amount ($): 9,564
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1 2020
Fee-adjustment authority: Certificate of Supplementary Protection Regulations
Service standard (average): 60 Days for the first eligibility decision
Performance result (average): 40 Days
Fees for Examination of an Application for a Medical Device Licence
The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types of medical devices are exempt from medical device licensing and therefore no fees apply: Class I medical devices; custom-made medical devices; medical devices for special access; medical devices for investigational testing involving human subjects.
Fee: Applications for Class II licence
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1998
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 397
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 450
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 15 Days to complete Review 1
Performance result (average): 9 Days to complete Review 1
Fee: Applications for Class II licence amendment:
Fee-setting authority: 2018 to 2019: Not applicable, new fee as of April 1 2020
Fee-setting authority: 2019 and onwards: 2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 272
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard (average): 15 Days to complete Review 1
Performance result (average): Not applicable, new fee as of April 1 2020
Fee: Applications for Class III licence
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1998
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 5,691
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 7,477
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 60 Days to complete Review 1
Performance result (average): 49 Days to complete Review 1
Fee: Applications for Class III licence (near patient)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020
2020 and onwards:
Year introduced: 1998
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 9,687
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 12,851
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 60 Days to complete Review 1
Performance result (average): 49 Days to complete Review 1
Fee: Applications for Class III licence amendment - changes in manufacturing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1998
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 1,433
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 1,903
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 60 Days to complete Review 1
Performance result (average): 40 Days to complete Review 1
Fee: Applications for Class III licence amendment - significant changes not related to manufacturing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1998
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 5,330
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 6,608
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 60 Days to complete Review 1
Performance result (average): 48 Days to complete Review 1
Fee: Applications for Class IV licence
Fee-setting authority: 2018 to 2019: Not applicable, new fee as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 24,345
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 75 Days to complete Review 1
Performance result (average): Not applicable, new fee as of April 1 2020
Fee Applications for Class IV licence
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards: fee discontinued April 1 2020
Year introduced: 1998
Last year fee-setting authority was amended: 2011
Fee type: Service
Fee amount ($): 13,235
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate (% or formula): Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard (average): 75 Days to complete Review 1
Performance result (average): 58 Days to complete Review 1
Fee: Class IV - Licence Application (Devices that contain Human- Animal Tissue)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards: fee discontinued April 1 2020
Year introduced: 1998
Last year fee-setting authority was amended: 2011
Fee type: Service
Fee amount ($): 12,347
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate (% or formula): Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard (average): 75 Days to complete Review 1
Performance result (average): 54 Days to complete Review 1
Fee: Class IV - Licence Application (Near patient In Vitro Diagnostic Device)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards: fee discontinued April 1 2020
Year introduced1998
Last year fee-setting authority was amended: 2011
Fee type: Service
Fee amount ($): 22,560
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate (% or formula): Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee will be discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard (average): 75 Days to complete Review 1
Performance result (average): n/a no applications completed
Fee: Applications for Class IV licence amendment - changes in manufacturing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
- 2019 to 2020: same as 2018 to 2019
- 2020 and onwards:
Year introduced: 1998
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 1,433
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 1,903
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 75 Days to complete Review 1
Performance result (average): 49 Days to complete Review 1
Fee: Applications for Class IV licence amendment - significant changes not related to manufacturing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 1998
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 6,073
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 8,057
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment.
Service standard (average): 75 Days to complete Review 1
Performance result (average): 51 Days to complete Review 1
Fee: Applications for Class II, III or IV licence or licence amendment - private label medical device
Fee-setting authority: 2018 to 2019: Not applicable, new fee as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 147
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard (average): 15 Days to complete Review 1
Performance result (average): Not applicable, new fee as of April 1 2020
Fees for Examination of a Submission — Drugs for Veterinary Use Only
Before a veterinary drug is authorized for sale in Canada, Health Canada reviews it to assess it efficacy and safety in the intended species as well as human safety. Fees are calculated on a component basis.
Fee: Application for drug identification number
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- 720: 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
- 500: Published references or other data
- 250: 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
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($)
- 918: 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
- 638: Published references or other data
- 320: 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
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average): 120 Days to complete Review 1
Performance result (average): 93 Days to complete Review 1
Fee: Notification – veterinary health product
Fee-setting authority: 2018 to 2019: Not applicable, new fee as of April 1 2020
Fee-setting authority: 2019 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not applicable
Fee type: Service
Fee amount ($): Not applicable, new fee as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($):486: 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
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard (average): 30 Days to process notification
Performance result (average): Not applicable, new fee as of April 1 2020
Fee: New drug submission
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- 15,980: 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.)
- 9,680: 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
- 23,240: 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
- 31,470: Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species
- 2,900: Comparative (Pharmacodynamics, clinical or bioavailability) data to support an additional route of administration
- 480: Comparative (Pharmacodynamics, clinical or bioavailability) data to support each additional strength
- 21,790: 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
- 29,050: 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
- 2,900: For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration
- 14,520: 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
- 4,840: Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug
- 4,840: Chemistry and manufacturing data to support one strength of a single dosage form
- 2,420: Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as the above item
- 250: Documentation to support a change of manufacturer
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($):
- 20,375: 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.)
- 12,342: 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
- 29,631: 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
- 40,125: Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species
- 3,698: Comparative (Pharmacodynamics, clinical or bioavailability) data to support an additional route of administration
- 612: Comparative (Pharmacodynamics, clinical or bioavailability) data to support each additional strength
- 27,783: 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
- 37,040: 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
- 3,698: For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration
- 18,513: 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
- 6,171: Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug
- 6,171: Chemistry and manufacturing data to support one strength of a single dosage form
- 3,086: Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as the above item
- 320: Documentation to support a change of manufacturer
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average):
- 300 Days to complete Review 1 (other than Administrative NDS)
- 90 Days to complete review for Administrative NDS
Performance result (average):
- 262 Days to complete Review 1 (other than Administrative NDS)
- 19 Days to complete review for Administrative NDS
Fee: Supplement to a new drug submission
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- 12,590: Efficacy data to support an additional indication in one animal species
- 9,680: 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
- 15,980: Efficacy and safety data (in the intended species) to support an indication in another animal species
- 23,240: 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.
- 31,470: Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species
- 7,740: Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species
- 2,900: Comparative (Pharmacodynamics, clinical or bioavailability) data to support an additional route of administration
- 480: Comparative (Pharmacodynamics, clinical or bioavailability) data to support each additional strength
- 2,900: 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
- 14,520: 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
- 7,260: For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period
- 5,810: 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
- 4,840: Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process
- 2,420: Chemistry and manufacturing data to support a change in formulation or dosage form
- 1,930: Chemistry and manufacturing data to support a change in packaging or in the sterilization process
- 1,450: Chemistry and manufacturing data to support an extension of the expiry dating
- 1,450: Chemistry and manufacturing data to support the concurrent use of two drugs
- 480: Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms
- 250: Documentation to support a change to the name of a manufacturer or the brand name of a drug
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($):
- 16,053: Efficacy data to support an additional indication in one animal species
- 12,342: 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
- 20,375: Efficacy and safety data (in the intended species) to support an indication in another animal species
- 29,631: 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.
- 40,125: Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species
- 9,869: Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species
- 3,698: Comparative (Pharmacodynamics, clinical or bioavailability) data to support an additional route of administration
- 612: Comparative (Pharmacodynamics, clinical or bioavailability) data to support each additional strength
- 3,698: 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
- 18,513: 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
- 9,257: For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period
- 7,409: 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
- 6,171: Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process
- 3,086: Chemistry and manufacturing data to support a change in formulation or dosage form
- 2,462: Chemistry and manufacturing data to support a change in packaging or in the sterilization process
- 1,850: Chemistry and manufacturing data to support an extension of the expiry dating
- 1,850: Chemistry and manufacturing data to support the concurrent use of two drugs
- 612: Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms
- 320: Documentation to support a change to the name of a manufacturer or the brand name of a drug
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average): 240 Days to complete Review 1
Performance result (average): 186 Days to complete Review 1
Fee: Abbreviated new drug submission
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- Any applicable component listed under Supplement to a new drug submission
- 2,900: Comparative (Pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form
- 2,900: 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
- 4,840: Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug
- 4,840: Chemistry and manufacturing data to support a single dosage form
- 250: Documentation to support:
- a change of manufacturer, in the case of an abbreviated new drug submission; or
- 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
Total fee revenue ($): No data available at this time
Adjustment type : Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($):
- Any applicable component listed under Supplement to a new drug submission
- 3,698: Comparative (Pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form
- 3,698: 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
- 6,171: Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug
- 6,171: Chemistry and manufacturing data to support a single dosage form
- 320: Documentation to support:
- a change of manufacturer, in the case of an abbreviated new drug submission; or
- 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
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average): 300 Days to complete Review 1
Performance result (average): 269 Days to complete Review 1
Fee: Supplement to an abbreviated new drug submission
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- Any applicable component listed under Supplement to a new drug submission
- 2,900: Comparative (Pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form
- 2,900: 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
- 4,840: Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug
- 4,840: Chemistry and manufacturing data to support a single dosage form
- 250: Documentation to support:
- a change of manufacturer, in the case of an abbreviated new drug submission; or
- 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
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate: (% or formula) Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($):
- Any applicable component listed under Supplement to a new drug submission
- 3,698: Comparative (Pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form
- 3,698: 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
- 6,171: Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug
- 6,171: Chemistry and manufacturing data to support a single dosage form
- 320: Documentation to support:
- a change of manufacturer, in the case of an abbreviated new drug submission; or
- 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
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average): 240 Days to complete Review 1
Performance result (average): 117 Days to complete Review 1
Fee: Preclinical submission
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- 4,840: 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
- 3,870: 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
- 14,520: 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
- 21,790: 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
- 29,050: 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
- 7,260: 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
- 4,840: Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient
- 2,420: Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($):
- 6,171: 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
- 4,935: 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
- 18,513: 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
- 27,783: 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
- 37,040: 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
- 9,257: 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
- 6,171: Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient
- 3,086: Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average): 60 Days to review application
Performance result (average): n/a for 2018-19
Fee: Sale of new drug for emergency treatment
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- 50: Information to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal
- 100: Information to support the sale of a drug to be used in the emergency treatment of a food-producing animal
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($):
- 51: Information and material to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal
- 102: Information and material to support the sale of a drug to be used in the emergency treatment of a food-producing animal
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard (average): 2 business days to review application
Performance result (average): <2 business days to review application
Fee: Experimental studies certificate
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($):
- 960: Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal
- 480: 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
- 2,900: Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal
- 480: 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
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($):
- 980: Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal
- 490: 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
- 2,958: Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal
- 490: 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
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard (average): 60 Days to review application
Performance result (average): 42 Days to review application
Fee: Notifiable change
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 1,300: Information and material to support an application for Notifiable Change
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 1,658: Information and material to support an application for a notifiable change
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average): 90 Days to review application for Notifiable Changes
Performance result (average): 62 Days to review application for Notifiable Changes
Fee: Protocol
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards :
Year introduced: 1996
Last year fee-setting authority was amended: 2019
Fee type: Service
Fee amount ($): 1,300: 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
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, fee updated as of April 1 2020
2020 to 2021 fee amount ($): 1,658: 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
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee updated as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment.
Service standard (average): 60 Days to review package for Protocol
Performance result (average): 60 Days to review package for Protocol
Drug Establishment Licensing Fees
Any person in Canada must obtain a Drug Establishment Licence (DEL) if they are engaged in any of the six regulated activities (fabricate, import, distribute, wholesale, package/label, and test) with respect to human and/or veterinary drugs. A fee is charged for the examination of a DEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The DEL fee is calculated on a component basis; therefore, the fee amount varies by application. A DEL fee is charged for the application for a new DEL, an annual licence review of a DEL, certain amendments to a DEL, reinstatement of a suspended DEL, or re-activation of a cancelled or withdrawn DEL.
As of April 1, 2020, a more simplified DEL fee regime will be introduced, as indicated in the tables below.
Fee: Human Drug Establishment Licence Fee (component based)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards: fee discontinued April 1 2020
Year introduced: 1998
Last year fee-setting authority was amended: 2011
Fee type: Licence
Fee amount ($):
- 17,751: Fabrication - Basic Fee
- 4,449: Fabrication - Each Additional Category
- Dosage Form Classes:
- 8,883: Fabrication - Two classes
- 17,751: Fabrication - Three classes
- 22,198: Fabrication - Four classes
- 26,629: Fabrication - Five classes
- 31,064: Fabrication - Six classes
- 1,783: Fabrication - Each additional class
- 8,883: Fabrication - Sterile dosage forms
- 11,869: Packaging/labelling - Basic Fee
- 2,966: Packaging/labelling - Each Additional Category
- 5,920: Packaging/labelling - Two classes
- 8,883: Packaging/labelling - Three or more classes
- 7,402: Importation/Distribution - Basic Fee
- 1,853: Importation/Distribution - Each Additional Category
- 3,703: Importation/Distribution - Two classes
- 7,402: Importation/Distribution - Three or more classes
- 1,783: Importation/Distribution - Each fabricator
- 899: Importation/Distribution - Each additional dosage form class for each fabricator
- 4,449: Distribution and Wholesaling Fee
- 2,966: Testing - Testing Fee
- 29,582: Drug Analysis Component - Vaccines
- 11,836: Drug Analysis Component - Schedule D Drugs which are not vaccines or whole blood and its components
- 8,883: Drug Analysis Component - Drugs for human use that are prescription drugs, controlled drugs or narcotics
- 4,449: Drug Analysis Component - Drugs for human use, not included in any other item, for which a drug identification number has been assigned
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate (% or formula): Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard: 250 Calendar days to issue/ renew license
Performance result: Average number of days applicable to the DEL fee grouping (human and veterinary): 75 days
Fee: Human Drug Establishment Licence Fee (component based)
Fee-setting authority: 2018 to 2019: Not applicable, new fees as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not Applicable
Fee type: Licence
Fee amount ($): Not applicable, new fees as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, new fees as of April 1 2020
2020 to 2021 fee amount ($):
- 41,626: Fabrication - Sterile dosage form
- 27,359: Importation
- 27,000: Fabrication - non-sterile dosage form
- 12,560: Distribution
- 4,937: Wholesaling
- 6,061: Packaging/labelling
- 2,560: Testing
- 918: Building outside Canada (each)
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fees as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over four years as well as the annual CPI adjustment
Service standard: 250 Calendar days to issue/ renew license
Performance result: No performance result is available, since the new fee will be introduced on April 1 2020
Fee: Veterinary Drug Establishment Licence Fee (component based)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards: fee discontinued April 1 2020
Year introduced: 1998
Last year fee-setting authority was amended: Not Applicable
Fee type: Licence
Fee amount ($):
- 6,000: Fabrication - Basic Fee
- 1,500: Fabrication - Each Additional Category
- Dosage Form Classes:
- 3,000: Fabrication - Two classes
- 6,000: Fabrication - Three classes
- 7,500: Fabrication - Four classes
- 9,000: Fabrication - Five classes
- 10,500: Fabrication - Six classes
- 600: Fabrication - Each additional class
- 3,000: Fabrication - Sterile dosage forms
- 4,000: Packaging/Labelling - Basic Fee
- 1,000: Packaging/Labelling - Each Additional Category
- 2,000: Packaging/Labelling - Two classes
- 3,000: Packaging/Labelling - Three or more classes
- 2,500: Importation/Distribution - Basic Fee
- 625: Importation/Distribution - Each Additional Category
- 1,250: Importation/Distribution - Two classes
- 2,500: Importation/Distribution - Three or more classes
- 600: Importation/Distribution - Each fabricator
- 300: Importation/Distribution - Each additional dosage form class for each fabricator
- 1,500: Distribution and Wholesaling - Distribution and Wholesaling Fee
- 1,000: Testing - Testing Fee
- 250: Drug Analysis Component - Drug Identification Numbers for Veterinary Use
Total fee revenue ($): No data available at this time
Adjustment type: Not applicable, fee discontinued as of April 1 2020
Adjustment rate (% or formula): Not applicable, fee discontinued as of April 1 2020
2020 to 2021 fee amount ($): Not applicable, fee discontinued as of April 1 2020
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, fee discontinued as of April 1 2020
Fee-adjustment authority: Not applicable, fee discontinued as of April 1 2020
Service standard: 250 Calendar days to issue/ renew license
Performance result: Average number of days applicable to the DEL fee grouping (human and veterinary): 75 days
Fee: Veterinary Drug Establishment Licence Fee (component based)
Fee-setting authority: 2018 to 2019: Not applicable, new fees as of April 1 2020
Fee-setting authority: 2019 and onwards:
2020 and onwards:
Year introduced: 2019
Last year fee-setting authority was amended: Not Applicable
Fee type: Licence
Fee amount ($): Not applicable, new fees as of April 1 2020
Total fee revenue ($): No data available at this time
Adjustment type: Periodic
Adjustment rate (% or formula): Not applicable, new fees as of April 1 2020
2020 to 2021 fee amount ($):
- 40,198: Fabrication - Sterile dosage form
- 10,715: Importation
- 8,782: Fabrication - non-sterile dosage form
- 4,835: Distribution
- 1,933: Wholesaling
- 6,061: Packaging/labelling
- 1,315: Testing
- 765: Building outside Canada (each)
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fees as of April 1 2020
Fee-adjustment authority:
- Fees in Respect of Drugs and Medical Devices Order
- Fees phased in over seven years as well as the annual CPI adjustment
Service standard: 250 Calendar days to issue/ renew license
Performance result: No performance result is available, since the new fee will be introduced on April 1 2020
Drug Establishment Licensing Fees - Dealer's Licences
Fees for the examination of an application for a new dealer's licence or the renewal of a dealer's licence; issued under the Narcotic Control Regulations and Part G of the Food and Drug Regulations. There is no fee associated with the application for a new or renewal of a controlled substances licence issued under the Benzodiazepines and Other Targeted Substances Regulations and Part J of the Food and Drug Regulations.
Fee: Dealer's Licence Fees - Human Drugs
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as above
2020 and onwards:
- Financial Administration Act (FAA)
- Fees in Respect of a Dealer's Licences Regulations (SOR/2019-134)
Year introduced: 1998
Last year fee-setting authority was amended: 2011
Fee type: Licence
Fee amount ($): 5,184
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($): 5,394
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1 2020
Fee-adjustment authority: Fees in Respect of a Dealer's Licences Regulations (SOR/2019-134)
Service standard:
- 270 Calendar days to issue a decision on an application for a new dealer's licence for controlled substances, from the receipt of a complete application
- 90 Calendar days to issue a decision on an application to renew a dealer's licence for controlled substances, from the receipt of a complete application
Performance result:
- New: 56% of applications were processed within the service standard
- Renew: 100% of applications were processed within the service standard
Fee: Dealer's License Fees - Veterinary Drugs
Fee-setting authority: 2018 to 2019:
- Financial Administration Act (FAA)
- Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations
Fee-setting authority: 2019 and onwards:
- Financial Administration Act (FAA)
- Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations
Year introduced: 1998
Last year fee-setting authority was amended: Not Applicable
Fee type: Licence
Fee amount ($): 1,750
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2019 April All-items Consumer Price Index for Canada (2%) on current fees
2020 to 2021 fee amount ($): 1,824.27
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1 2020
Fee-adjustment authority: Section 17 of the Service Fees Act (Consumer Price Index)
Service standard:
- 270 Calendar days to issue a decision on an application for a new dealer's licence for controlled substances, from the receipt of a complete application
- 90 Calendar days to issue a decision on an application to renew a dealer's licence for controlled substances, from the receipt of a complete application
Performance result:
- New: 56% of applications were processed within the service standard
- Renew: 100% of applications were processed within the service standard
Medical Device Establishment Licensing Fees
A Medical Device Establishment Licence (MDEL) is required for the activities of importing or selling medical devices for human use in Canada with exceptionsFootnote 1. A fee is charged for the examination of an MDEL application, including all compliance and enforcement and supporting activities needed to ensure that the applicant/licence holder conforms to all regulatory requirements. The MDEL fee is a flat fee. The same fee is charged for an application for a new MDEL, an annual licence review of an MDEL, and the reinstatement of a suspended MDEL.
Fee: Application for new licence and annual review of licence
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
2019 to 2020: same as 2018 to 2019
2020 and onwards:
Year introduced: 2000
Last year fee-setting authority was amended: 2019
Fee type: Licence
Fee amount ($): 8,272
Total fee revenue ($): 8,241,721
Adjustment type: Annual
Adjustment rate (% or formula): Not applicable, new fee as of April 1 2020
2020 to 2021 fee amount ($): 4,590
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable, new fee as of April 1 2020
Fee-adjustment authority: Fees in Respect of Drugs and Medical Devices Order
Service standard: 120 Calendar days to issue/ renew licence
Performance result: Average number of days: 28 days
Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product
No person shall manufacture, possess, handle, store, transport, import, distribute or use a pest control product that is not registered under the Pest Control Products Act, except as otherwise authorized under the Act or unless specifically exempted by the Pest Control Products Regulations. Fees for applications to register or to amend the registration of a pest control product are payable by component submitted. The fee payable is the sum of the fees for the submitted components in addition to the basic processing fee.
Fee: Category A Component Based – 655 Days of Review (Conventional Chemicals and Import Maximum Residue Limits)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 77,324: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 17,848: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 5,874: 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
- 29,522: Metabolism data
- 16,155: Residue data
- 43,539: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,110: 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
- 38,023: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,164: 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
- 925: Value and effectiveness data for a pest control product
- 127,971: Specification of maximum residue limit for a previously unexamined pest control product
- 16,155: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 80,449: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,173: Toxicology data-acute toxicity studies
- 18,570: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 6,112: 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
- 30,716: Metabolism data
- 16,809: Residue data
- 45,299: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,085: 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
- 39,560: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,141: 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
- 963: Value and effectiveness data for a pest control product
- 133,142: Specification of maximum residue limit for a previously unexamined pest control product
- 16,809: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 655 Days of Review
Performance result: N/A (0 applications completed in 2018-19)
Fee: Category A Component Based – 555 Days (Reduced risk, other biopesticides, non-conventionals, non-straight-chain lepidopteran pheromone)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 77,324: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 17,848: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 5,874: 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
- 29,522: Metabolism data
- 16,155: Residue data
- 43,539: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,110: 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
- 38,023: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,164: 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
- 925: Value and effectiveness data for a pest control product
- 7,381: Registration of a new active ingredient – food use
- 4,428: Registration of a new active ingredient – non-food use
- 2,952: Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 80,449: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,173: Toxicology data-acute toxicity studies
- 18,570: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 6,112: 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
- 30,716: Metabolism data
- 16,809: Residue data
- 45,299: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,085: 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
- 39,560: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,141: 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
- 963: Value and effectiveness data for a pest control product
- 7,680: Registration of a new active ingredient – food use
- 4,608: Registration of a new active ingredient – non-food use
- 3,073: Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 555 Days of Review
Performance result: 100% (1/1 applications met the service standard)
Fee: Category A Component Based – 470 Days of Review (Microbials including User Requested Minor Use Registration (URMUR), and URMUR for conventional chemical, reduced risk, other biopesticides, non-conventionals, non-straight-chain lepidopteran pheromone)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 77,324: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 17,848: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 5,874: 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
- 29,522: Metabolism data
- 16,155: Residue data
- 43,539: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,110: 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
- 38,023: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,164: 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
- 925: Value and effectiveness data for a pest control product
- 7,381: Registration of a new active ingredient – food use
- 4,428: Registration of a new active ingredient – non-food use
- 2,952: Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 80,449: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,173: Toxicology data-acute toxicity studies
- 18,570: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 6,112: 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
- 30,716: Metabolism data
- 16,809: Residue data
- 45,299: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,085: 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
- 39,560: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,141: 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
- 963: Value and effectiveness data for a pest control product
- 7,680: Registration of a new active ingredient – food use
- 4,608: Registration of a new active ingredient – non-food use
- 3,073: Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 470 Days of Review
Performance result: N/A (0 applications completed in 2018-19)
Fee: Category A Component Based – 285 Days of Review (Non-straight-chain lepidopteran pheromones, including User Requested Minor Use Registration)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 285 Days of Review
Performance result: N/A (0 applications completed in 2018-19)
Fee: Category A Component Based – Submissions with atypical timelines and joint reviews
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 77,324: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 17,848: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 5,874: 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
- 29,522: Metabolism data
- 16,155: Residue data
- 43,539: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,110: 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
- 38,023: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 24,164: 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
- 925: Value and effectiveness data for a pest control product
- 7,381: Registration of a new active ingredient – food use
- 4,428: Registration of a new active ingredient – non-food use
- 2,952: Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data
- 591: Registration of new active ingredient
- 296: Amendment of registration
- 127,971: Specification of maximum residue limit for a previously unexamined pest control product
- 16,155: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 80,449: Toxicology data accompanying an application to register a pest control product that contains a new active ingredient
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,173: Toxicology data-acute toxicity studies
- 18,570: Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient
- 6,112: 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
- 30,716: Metabolism data
- 16,809: Residue data
- 45,299: Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,085: 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
- 39,560: Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient
- 25,141: 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
- 963: Value and effectiveness data for a pest control product
- 7,680: Registration of a new active ingredient – food use
- 4,608: Registration of a new active ingredient – non-food use
- 3,073: Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data
- 616: Registration of new active ingredient
- 309: Amendment of registration
- 133,142: Specification of maximum residue limit for a previously unexamined pest control product
- 16,809: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: Variable as per Management of Submission Policy Appendix I, Table 1
Performance result: 100% (1/1 applications met the service standard)
Fee: Category B Component Based – 425 Days of Review (Conventional Chemicals including emergency use and New Import Maximum Residue Limits for previously assessed active ingredient)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 5,319: Exposure data - other
- 29,522: Metabolism data
- 16,155: Residue data
- 11,777: Environmental fate data - other
- 2,515: Environmental toxicology data - other
- 925: Value and effectiveness data for a pest control product
- 16,155: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,137: Toxicology data-acute toxicity studies
- 5,535: Exposure data - other
- 30,716: Metabolism data
- 16,809: Residue data
- 12,254: Environmental fate data - other
- 2,618: Environmental toxicology data - other
- 963: Value and effectiveness data for a pest control product
- 16,809: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 425 Days of Review
Performance result: 87% (111/128 applications met the service standard)
Fee: Category B Component Based – 360 Days of Review (Reduced risk, other biopesticides, non-conventionals, non-straight chain lepidopteran pheromone including emergency use)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 5,319: Exposure data - other
- 29,522: Metabolism data
- 16,155: Residue data
- 11,777: Environmental fate data - other
- 2,515: Environmental toxicology data - other
- 925: Value and effectiveness data for a pest control product
- 1,476: Amendment of registration – data required, label changes
- 1,182: Amendment of registration – data required, other
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,137: Toxicology data-acute toxicity studies
- 5,535: Exposure data - other
- 30,716: Metabolism data
- 16,809: Residue data
- 12,254: Environmental fate data - other
- 2,618: Environmental toxicology data - other
- 963: Value and effectiveness data for a pest control product
- 1,537: Amendment of registration – data required, label changes
- 1,231: Amendment of registration – data required, other
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 360 Days of Review
Performance result: 83% (10/12 applications met the service standard)
Fee: Category B Component Based – 240 Days of Review (Microbials and straight chain lepidopteran pheromones including emergency use)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 1,476: Amendment of registration – data required, label changes
- 1,182: Amendment of registration – data required, other
- 296: Amendment of registration
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 1,537: Amendment of registration – data required, label changes
- 1,231: Amendment of registration – data required, other
- 309: Amendment of registration
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 240 Days of Review
Performance result: 100% (20/20 applications met the service standard)
Fee: Category B Component Based – 158 Days of Review (Streamlined; application rate changes, tank mixes, new pests or changes to level of control)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 925: Value and effectiveness data for a pest control product
- 1,476: Amendment of registration – data required, label changes
- 296: Amendment of registration – no data required, other
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 963: Value and effectiveness data for a pest control product
- 1,537: Amendment of registration – data required, label changes
- 309: Amendment of registration – no data required, other
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 158 Days of Review
Performance result: 96% (49/51 applications met the service standard)
Fee: Category B Component Based – Submissions with atypical timelines and joint reviews
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 5,319: Exposure data-other
- 29,522: Metabolism data
- 16,155: Residue data
- 11,777: Environmental fate data - other
- 2,515: Environmental toxicology data - other
- 925: Value and effectiveness data for a pest control product
- 1,476: Amendment of registration - data required, label changes
- 1,182: Amendment of registration - data required, other
- 296: Amendment of registration - no data required
- 296: Amendment of registration
- 16,155: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,137: Toxicology data-acute toxicity studies
- 5,535: Exposure data-other
- 30,716: Metabolism data
- 16,809: Residue data
- 12,254: Environmental fate data - other
- 2,618: Environmental toxicology data - other
- 963: Value and effectiveness data for a pest control product
- 1,537: Amendment of registration - data required, label changes
- 1,231: Amendment of registration - data required, other
- 309: Amendment of registration - no data required
- 309: Amendment of registration
- 16,809: Specification of maximum residue limit for an unregistered use of a previously examined pest control product
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: Variable as per Management of Submission Policy Appendix I, Table 2
Performance result: N/A (0 applications completed in 2018-19)
Fee: Category C Component Based – 240 Days of Review (New/Changes to Product Labels, Addition of Approved Minor Use, Similar Product)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 296: Amendment of registration – no data required
- 296: Amendment of registration
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 309: Amendment of registration – no data required
- 309: Amendment of registration
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 240 Days of Review
Performance result: 95% (570/599 applications met the service standard)
Fee: Category C Component Based – 180 Days of Review (New/Changes to TGAI, ISP, MA or EP Product Chemistry, Administrative Changes, Administrative Re-instatement)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 296: Amendment of registration – no data required
- 296: Amendment of registration
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 309: Amendment of registration – no data required
- 309: Amendment of registration
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 180 Days of Review
Performance result: 93% (120/129 applications met the service standard)
Fee: Category C Component Based – Submissions with atypical timelines and joint reviews
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 296: Amendment of registration – no data required
- 296: Amendment of registration
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 309: Amendment of registration – no data required
- 309: Amendment of registration
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: Variable as per Management of Submission Policy Appendix I, Table 2
Performance result: N/A (0 applications completed in 2018-19)
Fee: Category D Component Based – 246 Days of Review (Registration Renewal)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($): 82: Renewal
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($): 86: Renewal
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 246 Days of Review
Performance result: 100% (973/973 applications met the service standard)
Fee: Category D Component Based – 46 Days of Review (Registration/Amendment to Registration of active ingredient to be used in pest control product manufactured only for export)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 7,948: Registration of active ingredient to be used in pest control product manufactured only for export
- 1,156:Amendment to Registration of active ingredient to be used in pest control product manufactured only for export
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 8,307: Registration of active ingredient to be used in pest control product manufactured only for export
- 1,204: Amendment to Registration of active ingredient to be used in pest control product manufactured only for export
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 46 Days of Review
Performance result: 100% (2/2 applications met the service standard)
Fee: Category D Component Based – 42 Days of Review (Master Copies)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($): 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($): 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 42 Days of Review
Performance result: 91% (50/55 applications met the service standard)
Fee: Category D Component Based – 10 Days of Review (Private Labels)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($): 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($): 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 10 Days of Review
Performance result: 100% (2/2 applications met the service standard)
Fee: Category E Component Based – 159 Days of Review (Research Authorizations for New Technical Grade Active Ingredients)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 5,182: Research authorization – major crops, other than research authorizations set out in paragraphs (c) and (d)
- 5,182: Research authorization – minor use crops, other than research authorizations set out in paragraphs (c) and (d)
- 1,242: Research authorization – microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations
- 1,242: Research authorization – greenhouse crops and non-agricultural uses
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,392: Research authorization – major crops, other than research authorizations set out in paragraphs (c) and (d)
- 5,392: Research authorization – minor use crops, other than research authorizations set out in paragraphs (c) and (d)
- 1,293: Research authorization – microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations
- 1,293: Research authorization – greenhouse crops and non-agricultural uses
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 159 Days of Review
Performance result: 33% (12/36 applications met the service standard)
Fee: Category E Component Based – 69 Days of Review (Research Authorizations for New Uses of Registered Active Ingredients)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 5,182: Research authorization – major crops, other than research authorizations set out in paragraphs (c) and (d)
- 5,182: Research authorization – minor use crops, other than research authorizations set out in paragraphs (c) and (d)
- 1,242: Research authorization – microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations
- 1,242: Research authorization – greenhouse crops and non-agricultural uses
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,392: Research authorization – major crops, other than research authorizations set out in paragraphs (c) and (d)
- 5,392: Research authorization – minor use crops, other than research authorizations set out in paragraphs (c) and (d)
- 1,293: Research authorization – microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations
- 1,293: Research authorization – greenhouse crops and non-agricultural uses
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 69 Days of Review
Performance result: 13% (5/40 applications met the service standard)
Fee: Category E Component Based – 30 Days of Review (Research Notification for Research Carried out in Canada)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($): 252: Research notifications
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($): 264: Research notifications
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 30 Days of Review
Performance result: 50% (13/26 applications met the service standard)
Fee: Category F Component Based – 45 Days of Review (Registration and amendments to registered pest control products via notification)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($): 252: Applications not mentioned in schedules
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($): 264: Applications not mentioned in schedules
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 45 Days of Review
Performance result: 98% (822/842 applications met the service standard)
Fee: Category L Component Based – 425 Days of Review (Equivalency and data compensation assessment of end-use product and manufacturing concentrate with partial data package - conventional chemical)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 5,319: Exposure data - other
- 29,522: Metabolism data
- 16,155: Residue data
- 11,777: Environmental fate data - other
- 2,515: Environmental toxicology data – other
- 925: Value and effectiveness data for a pest control product
- 2,206: Identification of compensable data
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,137: Toxicology data-acute toxicity studies
- 5,535: Exposure data - other
- 30,716: Metabolism data
- 16,809: Residue data
- 12,254: Environmental fate data - other
- 2,618: Environmental toxicology data – other
- 963: Value and effectiveness data for a pest control product
- 2,297: Identification of compensable data
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 425 Days of Review
Performance result: 86% (18/21 applications met the service standard)
Fee: Category L Component Based – 365 Days of Review (Equivalency and data compensation assessment of active ingredient, end-use product and manufacturing concentrate with no data)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 2,206: Identification of compensable data
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 2,297: Identification of compensable data
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 365 Days of Review
Performance result: 97% (61/63 applications met the service standard)
Fee: Category L Component Based – 360 Days of Review (Equivalency and data compensation assessment of end-use product and manufacturing concentrate with partial data package - reduced risk, other biopesticides, non-conventionals, non-straight chain lepidopteran pheromone)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($)
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 5,319: Exposure data - other
- 29,522: Metabolism data
- 16,155: Residue data
- 11,777: Environmental fate data - other
- 2,515: Environmental toxicology data – other
- 925: Value and effectiveness data for a pest control product
- 2,206: Identification of compensable data
- 1,476: Amendment of registration – data required, label changes
- 1,182: Amendment of registration – data required, other
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type : Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,137: Toxicology data-acute toxicity studies
- 5,535: Exposure data - other
- 30,716: Metabolism data
- 16,809: Residue data
- 12,254: Environmental fate data - other
- 2,618: Environmental toxicology data – other
- 963: Value and effectiveness data for a pest control product
- 2,297: Identification of compensable data
- 1,537: Amendment of registration – data required, label changes
- 1,231: Amendment of registration – data required, other
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 360 Days of Review
Performance result: N/A (0 applications completed in 2018-19)
Fee: Category L Component Based 240 Days of Review (Equivalency and data compensation assessment of end-use product and manufacturing concentrate with partial data package - microbials and straight chain lepidopteran pheromone)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 2,206: Identification of compensable data
- 1,476: Amendment of registration – data required, label changes
- 1,182: Amendment of registration – data required, other
- 296: Amendment of registration
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 2,297: Identification of compensable data
- 1,537: Amendment of registration – data required, label changes
- 1,231: Amendment of registration – data required, other
- 309: Amendment of registration
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: 240 Days of Review
Performance result: N/A (0 applications completed in 2018-19)
Fee: Category L Component Based – Applications with atypical timelines (Tailgaters, renegotiated timelines, synchronized timelines, coordination with Re-Evaluation)
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Service
Fee amount ($):
- 4,971: Product Chemistry – active ingredient
- 2,768: Product Chemistry – end-use product or manufacturing concentrate
- 16,147: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,014: Toxicology data-acute toxicity studies
- 5,319: Exposure data - other
- 29,522: Metabolism data
- 16,155: Residue data
- 11,777: Environmental fate data - other
- 2,515: Environmental toxicology data – other
- 925: Value and effectiveness data for a pest control product
- 2,206: Identification of compensable data
- 1,476: Amendment of registration – data required, label changes
- 1,182: Amendment of registration – data required, other
- 296: Amendment of registration
- 1,156: Processing
Total fee revenue ($): No data available at this time
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded up to the nearest dollar)
2020 to 2021 fee amount ($):
- 5,173: Product Chemistry – active ingredient
- 2,881: Product Chemistry – end-use product or manufacturing concentrate
- 16,800: Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient
- 3,137: Toxicology data-acute toxicity studies
- 5,535: Exposure data - other
- 30,716: Metabolism data
- 16,809: Residue data
- 12,254: Environmental fate data - other
- 2,618: Environmental toxicology data – other
- 963: Value and effectiveness data for a pest control product
- 2,297: Identification of compensable data
- 1,231: Amendment of registration – data required, label changes
- 1,182: Amendment of registration – data required, other
- 309: Amendment of registration
- 1,204: Processing
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Pest Control Products Fees and Regulations
Service standard: Management of Submission Policy Appendix I, Table 7
Performance result: N/A (0 applications completed in 2018-19)
Annual Charge (for a registered Pest Control Product)
A registrant must pay each year, in respect of every pest control product that is registered in their name on April 1 of the year, an annual charge. All registered products including technical grade active ingredients (TGAI), import for manufacturing and export program (IMEPs), private label products and master copies must pay the annual charge.
Fee: Annual Charge:
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1997
Last year fee-setting authority was amended: 2017
Fee type: Other Authorization
Fee amount ($): The lesser of $3,600 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $100
Total fee revenue ($): $9,432,992
Adjustment type: Annual
Adjustment rate (% or formula): 2%
2020 to 2021 fee amount ($): The lesser of $3,752.78 and 4% of the actual gross revenue during the registrant's preceding fiscal year, but not less than $104.24.
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Section 17 of the Service Fees Act (Consumer Price Index)
Service standard: 100% of all invoices were issued by April 30th 2018
Performance result: 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
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1988
Last year fee-setting authority was amended: 2002
Fee type: Service
Fee amount ($):
- 1,800: Original Claim (up to 15)
- 400: Original Claim (between 16-25)
- 200: Original Claim (26+)
- A 50% reduction for a small business that meets certain criteria is available
Total fee revenue ($): 346,674
Adjustment type: Section 17 of the Service Fees Act (Consumer Price Index)
Adjustment rate (% or formula): 2%
2020 to 2021 fee amount ($):
- 1,876.39: Original Claim (up to 15)
- 416.98: Original Claim (between 16-25)
- 208.49: Original Claim (26+)
- A 50% reduction for a small business that meets certain criteria is available.
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Service Fees Act
Service standard: 7 calendar days from the date of the receipt of a complete application, for the issuance of a registry number
Performance result: 99% of claims (original and refiled) were completed within the service standard
Fee: Refiled Claims
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 1988
Last year fee-setting authority was amended: 2002
Fee type: Service
Fee amount ($):
- 1,440: Refiled Claims (up to 15)
- 320: Refiled Claims (between 16-25)
- 160: Refiled Claims (26+)
- A 50% reduction for a small business that meets certain criteria is available
Total fee revenue ($): 112,320
Adjustment type: Section 17 of the Service Fees Act (Consumer Price Index)
Adjustment rate (% or formula): 2%
2020 to 2021 fee amount ($):
- 1,501.11: Refiled Claims (up to 15)
- 333.58: Refiled Claims (between 16-25)
- 166.79: Refiled Claims (26+)
- A 50% reduction for a small business that meets certain criteria is available.
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Service Fees Act
Service standard: 7 calendar days from the date of the receipt of a complete application, for the issuance of a registry number
Performance result: 99% of claims (original and refiled) were completed within the service standard
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 Fee - Licence for micro-cultivation:
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 2
Fee amount ($): 1,638
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 1,709
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
Service standard: Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of licence applications from the date that payment is received for the application. The standard excludes time spent awaiting additional information from applicants.
Performance result: As the Cannabis Fees Order came into force on October 17, 2018, the full fiscal year of data is not available.
Fee: Licence Application Screening Fee - Licence for standard cultivation
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 2
Fee amount ($): 3,277
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 3,417
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
Service standard: Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of licence applications from the date that payment is received for the application. The standard excludes time spent awaiting additional information from applicants.
Performance result: As the Cannabis Fees Order came into force on October 17, 2018, the full fiscal year of data is not available.
Fee: Licence Application Screening Fee - Licence for a nursery
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 2
Fee amount ($): 1,638
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 1,709
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
Service standard: Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of licence applications from the date that payment is received for the application. The standard excludes time spent awaiting additional information from applicants.
Performance result: As the Cannabis Fees Order came into force on October 17, 2018, the full fiscal year of data is not available.
Fee: Licence Application Screening Fee - Licence for micro-processing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 2
Fee amount ($): 1,638
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 1,709
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
Service standard: Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of licence applications from the date that payment is received for the application. The standard excludes time spent awaiting additional information from applicants.
Performance result: As the Cannabis Fees Order came into force on October 17, 2018, the full fiscal year of data is not available.
Fee: Licence Application Screening Fee - Licence for standard processing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 2
Fee amount ($): 3,277
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 3,417
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
Service standard: Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of licence applications from the date that payment is received for the application. The standard excludes time spent awaiting additional information from applicants.
Performance result: As the Cannabis Fees Order came into force on October 17, 2018, the full fiscal year of data is not available.
Fee: Licence Application Screening Fee - Licence for sale for medical purposes
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 2
Fee amount ($): 3,277
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 3,417
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
Service standard: Health Canada is committed to a non-binding administrative service standard of 30 business days for the screening of licence applications from the date that payment is received for the application. The standard excludes time spent awaiting additional information from applicants.
Performance result: As the Cannabis Fees Order came into force on October 17, 2018, the full fiscal year of data is not available.
Fee: Application for a security clearance
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: Other Authorization
Fee amount ($): 1,654
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 1,725
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
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
Fee: Application for import or export permit
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: Permit
Fee amount ($): 610
Total fee revenue ($): Data not available
Adjustment type: Annual
Adjustment rate (% or formula): 2% (rounded to the next highest dollar)
2020 to 2021 fee amount ($): 637
Future fee-adjusted amount ($): Not applicable
Adjustment date: April 1, 2020
Fee-adjustment authority: Cannabis Fees Order (Consumer Price Index)
Service standard: Health Canada is committed to a non-binding administrative service standard of 30 business days from the date that payment is received for the application. The standard excludes time spent awaiting additional information from applicants.
Performance result: As the Cannabis Fees Order came into force on October 17, 2018, the full fiscal year of data is not available.
Fee: Annual fee - Licence for micro-cultivation
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 3
Fee amount ($):
- If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500; or
- if the cannabis revenue is greater than $1 million, the maximum amount determinable under (a) plus 2.3% of the amount by which the cannabis revenue exceeds $1 million
Total fee revenue ($): Data not available
Adjustment type: Exempt
Adjustment rate (% or formula): Not applicable as the fee is based on cannabis revenue
2020 to 2021 fee amount ($):
- If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500; or
- if the cannabis revenue is greater than $1 million, the maximum amount determinable under (a) plus 2.3% of the amount by which the cannabis revenue exceeds $1 million
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable as the fee is based on cannabis revenue
Fee-adjustment authority: Cannabis Fees Order
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
Fee: Annual fee - Licence for standard cultivation
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 3
Fee amount ($): The greater of 2.3% of the cannabis revenue and $23,000
Total fee revenue ($): Data not available
Adjustment type: Exempt
Adjustment rate (% or formula): Not applicable as the fee is based on cannabis revenue
2020 to 2021 fee amount ($): The greater of 2.3% of the cannabis revenue and $23,000
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable as the fee is based on cannabis revenue
Fee-adjustment authority: Cannabis Fees Order
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
Fee: Annual fee - Licence for a nursery
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 3
Fee amount ($):
- If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500; or
- if the cannabis revenue is greater than $1 million, the maximum amount determinable under (a) plus 2.3% of the amount by which the cannabis revenue exceeds $1 million
Total fee revenue ($): Data not available
Adjustment type: Exempt
Adjustment rate (% or formula): Not applicable as the fee is based on cannabis revenue
2020 to 2021 fee amount ($):
- If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500; or
- if the cannabis revenue is greater than $1 million, , the maximum amount determinable under (a) plus 2.3% of the amount by which the cannabis revenue exceeds $1 million
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable as the fee is based on cannabis revenue
Fee-adjustment authority: Cannabis Fees Order
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
Fee: Annual fee - Licence for micro-processing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 3
Fee amount ($):
- If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500; or
- if the cannabis revenue is greater than $1 million, the maximum amount determinable under (a) plus 2.3% of the amount by which the cannabis revenue exceeds $1 million
Total fee revenue ($): Data not available
Adjustment type: Exempt
Adjustment rate (% or formula): Not applicable as the fee is based on cannabis revenue
2020 to 2021 fee amount ($):
- If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500; or
- if the cannabis revenue is greater than $1 million, the maximum amount determinable under (a) plus 2.3% of the amount by which the cannabis revenue exceeds $1 million
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable as the fee is based on cannabis revenue
Fee-adjustment authority: Cannabis Fees Order
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
Fee: Annual fee - Licence for standard processing
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 3
Fee amount ($): The greater of 2.3% of the cannabis revenue and $23,000
Total fee revenue ($): Data not available
Adjustment type: Exempt
Adjustment rate (% or formula): Not applicable as the fee is based on cannabis revenue
2020 to 2021 fee amount ($): The greater of 2.3% of the cannabis revenue and $23,000
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable as the fee is based on cannabis revenue
Fee-adjustment authority: Cannabis Fees Order
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
Fee: Annual fee - Licence for medical purposes
Fee-setting authority: 2018 to 2019:
Fee-setting authority: 2019 and onwards:
Year introduced: 2018
Last year fee-setting authority was amended: Not applicable
Fee type: LicenceFootnote 3
Fee amount ($): The greater of 2.3% of the cannabis revenue and $23,000
Total fee revenue ($): Data not available
Adjustment type: Exempt
Adjustment rate (% or formula): Not applicable as the fee is based on cannabis revenue
2020 to 2021 fee amount ($): The greater of 2.3% of the cannabis revenue and $23,000
Future fee-adjusted amount ($): Not applicable
Adjustment date: Not applicable as the fee is based on cannabis revenue
Fee-adjustment authority: Cannabis Fees Order
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
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.
- Footnote 2
-
The application screening fee relates to the recovery of costs associated with the intake, screening, acceptance or rejection of new applications for certain licensed activities; the acceptance of the licence application indicates that the application will proceed to the next phase of licence review and does not mean that a new licence will be issued.
- Footnote 3
-
The annual regulatory fee recovers the aggregate costs of administering the cannabis regulatory program that are not covered under any of the other fees. The annual regulatory fee is payable annually by cultivation, processing and federal sales licence holders.
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