Supplementary Information Tables 2017-2018 : Health Canada

Fees

Fees for Right to Sell Drugs
Fees for the Examination of a Drug Submission (Pharmaceuticals and Biologic Products)
Fees for the Examination of Medical Device License Applications
Fee for Right to Sell a Licensed Class II, III or IV Medical Device
Veterinary Drug Evaluation Fee
Drug Master File Fees
Certificate of Supplementary Protection Application Fees
Drug Establishment Licensing Fees
Medical Device Establishment Licensing Fees
Certificate of Pharmaceutical Product Fees
Part 1 - 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.
National Dosimetry Services Products, Services and Fees Structure
Fees for processing requests filed under the Access to Information Act
Financial totals for all fee categories

Table A

General and financial information by fee category

General information - Fees for Right to Sell Drugs

Fee category

Fees for Right to Sell Drugs

Fee-setting authority

Financial Administration Act

Year introduced

1995

Year last amended

2011

Service standard

120 calendar days to update the Drug Product Database following notification

Performance results

100% within 120 calendar days

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
12,015,179	12,200,583	63,830,126	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Fees for the Examination of a Drug Submission (Pharmaceuticals and Biologic Products)

Fee category

Fees for the Examination of a Drug Submission (Pharmaceuticals and Biologic Products)

Fee-setting authority

Financial Administration Act

Year introduced

1995

Year last amended

2011

Service standard

Review 1 (average time in calendar days)

Pharmaceuticals

NAS: NDS = 300
CLIN C&M: NDS = 300
CLIN C&M: SNDS = 300
CLIN : NDS = 300
CLIN: SNDS = 300
CLIN: DIN A = 210
COMP C&M: ANDS = 180
COMP C&M: NDS = 180
COMP C&M: SANDS = 180
COMP C&M: SNDS = 180
COMP C&M: DIN A = 210
C&M: ANDS = 180
C&M: NDS = 180
C&M: SANDS = 180
C&M: SNDS = 180
C&M: DIN A = 210
PUBLISHED DATA: SNDS = 300
PUBLISHED DATA: SANDS = 300
PUBLISHED DATA: DIN A = 210
Rx to OTC Switch: NDS = 180
Rx to OTC Switch: SNDS = 180
DISINFECTANT: NDS-D = 300
DISINFECTANT: SNDS-D = 300
DISINFECTANT: DIN D 210 = 210
DISINFECTANT: DIN D 180 = 180
LABELLING ONLY: NDS = 60
LABELLING ONLY: SNDS = 60
LABELLING ONLY: ANDS = 60
LABELLING ONLY: SANDS = 60
LABELLING ONLY: DIN A = 180
LABEL STANDARD: DIN A = 45
LABEL STANDARD: DIN D = 45
LABEL STANDARD: DIN F = 45
ADMINISTRATIVE: ANDS = 45
ADMINISTRATIVE: NDS = 45
ADMINISTRATIVE: SNDS = 45
ADMINISTRATIVE: SANDS = 45
ADMINISTRATIVE: DIN A = 45
ADMINISTRATIVE: DIN D = 45
ADMINISTRATIVE: DIN F = 45

Biologics

NAS: NDS = 300
CLIN C&M: NDS = 300
CLIN C&M: SNDS = 300
CLIN C&M: DIN B = 210
CLIN: NDS = 300
CLIN: SNDS = 300
C&M: ANDS = 180
C&M: SANDS = 180
C&M: SNDS = 180
C&M: DIN B = 210
COMP C&M: ANDS = 180
COMP C&M: SNDS = 180
COMP C&M: DIN B = 210
LABELLING ONLY: NDS = 60
LABELLING ONLY: SNDS = 60
LABELLING ONLY: DIN B = 180
PUBLISHED DATA: SNDS = 300
ADMINISTRATIVE: NDS = 45
ADMINISTRATIVE: DINB = 45

Performance results

Review 1 (average time in calendar days)

Pharmaceuticals

NAS : NDS = 269
CLIN C&M: NDS = 300
CLIN C&M: SNDS = 270
CLIN: NDS = N/A
CLIN: SNDS = 269
CLIN: DIN A = 204
COMP C&M: ANDS = 164
COMP C&M: NDS = 180
COMP C&M: SANDS =171
COMP C&M: SNDS = 155
COMP C&M: DIN A = 200
C&M: ANDS = 167
C&M: NDS = N/A
C&M: SANDS = 149
C&M: SNDS = 167
C&M: DIN A = 191
PUBLISHED DATA: SNDS = 269
PUBLISHED DATA: SANDS = 276
PUBLISHED DATA: DIN A= 206
Rx to OTC Switch: NDS = N/A
Rx to OTC Switch: SNDS = N/A
DISINFECTANT: NDS-D = 299
DISINFECTANT: SNDS-D = N/A
DISINFECTANT: DIN D 210 = 208
DISINFECTANT: DIN D 180 = 171
LABELLING ONLY: NDS = 52
LABELLING ONLY: SNDS = 55
LABELLING ONLY: ANDS = 41
LABELLING ONLY: SANDS = 46
LABELLING ONLY: DIN A = 158
LABEL STANDARD: DIN A = 39
LABEL STANDARD: DIN D = 38
LABEL STANDARD: DIN F = 38
ADMINISTRATIVE: ANDS = 26
ADMINISTRATIVE: NDS = 33
ADMINISTRATIVE: SNDS = 27
ADMINISTRATIVE: SANDS = 31
ADMINISTRATIVE: DIN A = 29
ADMINISTRATIVE: DIN D = 38
ADMINISTRATIVE: DIN F = 34

Biologics

NAS: NDS = 260
CLIN C&M: NDS = 292
CLIN C&M: SNDS = 293
CLIN C&M: DIN B = N/A
CLIN: NDS = N/A
CLIN: SNDS = 277
C&M ANDS = 177
C&M: SANDS = N/A
C&M: SNDS = 136
C&M: DINB = 176
COMP C&M: ANDS = 177
COMP C&M: SNDS = 179
COMP C&M: DIN B = 177
LABELLING ONLY: NDS = 60
LABELLING ONLY: SNDS = 57
LABELLING ONLY: DIN B = 164
PUBLISHED DATA: SNDS = 270
ADMINISTRATIVE: NDS = 28
ADMINISTRATIVE: DIN B = 42

Other information

Review 1= Drug Submission Reviews

Acronyms

NDS: New Drug Submission
SNDS: Supplement to a New Drug Submission
ANDS: Abbreviated New Drug Submission
SANDS: Supplement to an Abbreviated New Drug Submission
DIN: drug identification number application
DIN A = drug identification number application for a pharmaceutical
DIN B = drug identification number application for a biologic
DIN D = drug identification number application for a disinfectant
DIN F = drug identification number application for a Category IV Monograph
NAS: New Active Substance
OTC: Over the Counter
Rx: Prescription
CLIN: Clinical
COMP: Comparative Bio, Clinical or Pharmacodynamics Studies
C&M: Chemistry and Manufacturing

N/A: At time of reporting either no submissions of that type were received or no reviews of that submission type were completed, therefore no performance information available.

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
43,609,604	47,998,937	102,956,423	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Fees for the Examination of Medical Device License Applications

Fee category

Fees for the Examination of Medical Device License Applications

Fee-setting authority

Financial Administration Act

Year introduced

1998

Year last amended

2011

Service standard

Review 1 (average time in calendar days)
Class II New = 15
Class III New = 60
Class III Near Patient =60
Class III Manufacturing Amendment = 60
Class III Significant Amendment = 60
Class IV New = 75
Class IV Human-Animal Tissue =75
Class IV Near Patient In Vitro Diagnostic Devices = 75
Class IV Manufacturing Amendment = 75
Class IV Significant Amendment = 75

Performance results

Review 1 (average time in calendar days)
Class II New = 12
Class III New = 52
Class III Near Patient = 56
Class III Manufacturing Amendment = 54
Class III Significant Amendment = 51
Class IV New = 68
Class IV Human-Animal Tissue= 64
Class IV Near Patient In Vitro Diagnostic Devices = NA
Class IV Manufacturing Amendment = 51
Class IV Significant Amendment = 59

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
6,261,776	6,116,671	20,979,592	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Fee for Right to Sell a Licensed Class II, III or IV Medical Device

Fee category

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

Fee-setting authority

Financial Administration Act

Year introduced

1999

Year last amended

2011

Service standard

20 calendar days from deadline for receipt of annual notification to update the Medical Devices License Listing (MDALL) database

Performance results

99.1% within 20 calendar days

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
8,412,791	8,955,877	15,713,214	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Veterinary Drug Evaluation Fee

Fee category

Veterinary Drug Evaluation Fee

Fee-setting authority

Financial Administration Act

Year introduced

1996

Year last amended

N/A

Service standard

Review 1 (average time in calendar days)
NDS = 300
ANDS = 300
SNDS = 240
SANDS = 240
ADMIN = 90
DIN (including changes to DINs) = 120
NC = 90
ESC = 60
Labels = 45 N/A (No longer reviewed)
Emergency Drug Release = 2
Performance results Review 1 (average time in calendar days)
NDS = 310
ANDS = 287
SNDS = 225
SANDS = 204
ADMIN = 11
DIN (including changes to DINs) = 110
NC = 71
ESC = 57
Labels = N/A
Emergency Drug Release = 2

Other information

Review 1= Drug Submission Reviews

Acronyms

NDS: New Drug Submission
ANDS: Abbreviated New Drug Submission
SNDS: Supplement to a New Drug Submission
SANDS: Supplement to an Abbreviated New Drug Submission
ADMIN: Administrative
DIN: Drug Identification Number
NC: Notifiable Change
ESC: Experimental Studies Certificate
N/A: No longer reviewed.

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
833,874	1,114,183	6,110,102	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Drug Master File Fees

Fee category

Drug Master File Fees

Fee-setting authority

Ministerial Authority to enter into Contract

Year introduced

1996

Year last amended

2017

Service standard

30 calendar days

Performance results

98%

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
773,663	993,181	1,469,899	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Certificate of Supplementary Protection Application Fees

Fee category

Certificate of Supplementary Protection Application Fees

Ministerial Authority to enter into Contract

Year introduced

2017

Year last amended

N/A

Service standard

60 calendar days

Performance results

43 days

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
N/A	117,143	155,181	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Drug Establishment Licensing Fees

Fee category

Drug Establishment Licensing Fees

Fee-setting authority

Financial Administration Act

Year introduced

1998

Year last amended

2011

Service standard

250 Calendar days to issue / renew license

Performance results

Average number of days: 122 days

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
16,766,144	16,593,274	22,472,562	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Medical Device Establishment Licensing Fees

Fee category

Medical Device Establishment Licensing Fees

Fee-setting authority

Financial Administration Act

Year introduced

2000

Year last amended

2011

Service standard

120 Calendar days to issue / renew license

Performance results

Average number of days: 22 days

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
10,655,054	10,134,538	9,336,613	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Certificate of Pharmaceutical Product Fees

Fee category

Certificate of Pharmaceutical Product Fees

Fee-setting authority

Ministerial Authority to enter into Contract

Year introduced

1996

Year last amended

N/A

Service standard

10 Calendar days to issue certificate

Performance results

Average number of days: eight days

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
274,449	258,731	287,637	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid Return to footnote b referrer

General information - Part 1 - Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product

Fee category

Part 1 - Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product

Fee-setting authority

Pest Control Products Act

Year introduced

1997

Year last amended

2017

Service standard

The performance standard is 90% of applications are to be processed within the applicable review timelines.
Category A: Review timelines range from 285 to 655 days.
Category B: Review timelines range from 158 to 470 days.
Category C: Review timelines range from 180 to 240 days.
Category D: Review timelines range from 10 to 244 days.
Category E: Review timelines range from 30 to 159 days.
Category F: Review timeline is 45 days.
Category L: Review timelines range from 45 to 425 days.

Performance results

Review performance:
Category A = 88%
Category B = 92%
Category C = 97%
Category D = 99%
Category E = 31%
Category F = 92%
Category L = 93%

Other information

Service standards are defined in Regulatory Directive DIR2017-01 Management of Submissions Policy (MOSP), March 8, 2017

Pre-Market Submission fees are identified in the Pest Control Products Fees and Charges Regulations ( PCPFCR – April 1, 2017), in Part 1 - Fees to be Paid for the Examination of an Application in Respect of a Pest Control Product

Under section 6 of the PCPFCR, fees under Part 1 include an annual escalator of 2%, rounded up to the nearest dollar.

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
2,590,800	5,218,518	33,159,373	N/A
Footnotes Footnote a Starting in 2017 the Pesticides Program revised the methodology to calculate costs for reporting. In previous years the Pesticides Program used direct expenditures, for 2017/18 the Pesticide Program has utilized the activity time tracking system with a full program costing methodology, consistent with other Programs in Health Canada. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid. Return to footnote b referrer

General information - Annual Charge (for a registered Pest Control Product)

Fee category

Annual Charge (for a registered Pest Control Product)

Fee-setting authority

Pest Control Products Act

Year introduced

1997

Year last amended

2017

Service standard

100% of all invoices were issued by April 30, 2018.

Performance results

100%

Other information

Annual Charge fees are identified in the Pest Control Products Fees and Charges Regulations (PCPFCR – April 1, 2017), in Part 2 –Annual Charge

Under the Service Fees Act, this fee is subject to Section 17(1) Annual Adjustment - Consumer Price Index, which will occur on April 1 of each year, commencing April 1, 2019.

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
5,304,800	8,174,445	24,084,509	N/A
Footnotes Footnote a Starting in 2017 the Pesticides Program revised the methodology to calculate costs for reporting. In previous years the Pesticides Program used direct expenditures, for 2017/18 the Pesticide Program has utilized the activity time tracking system with a full program costing methodology, consistent with other Programs in Health Canada. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid. Return to footnote b referrer

General information - Fees charged for filing a claim for exemption under the Hazardous Materials Information Review Act.

Fee category

Fees charged for filing a claim for exemption under the Hazardous Materials Information Review Act.

Fee-setting authority

Hazardous Materials Information Review Act, section 48 and
Hazardous Materials Information Review Regulations, sections 4, 5, and 7

Year introduced

1988

Year last amended

2002

Service standard

The Workplace Hazardous Materials Bureau commits to a service delivery standard of 7 calendar days from the date of the receipt of a complete application, for the issuance of a registry number on an application for a claim for exemption for Confidential Business Information (CBI).

Performance results

In 2017-2018, the Bureau processed 99% of claims for exemption applications within its service standard.

Annual service performance is measured over the course of the fiscal year (e.g., April 1 - March 31).

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
1,283,546	1,056,287	2,673,267	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid. Return to footnote b referrer

General information - National Dosimetry Services Products, Services and Fees Structure

Fee category

National Dosimetry Services Products, Services and Fees Structure

Fee-setting authority

Ministerial Authority to enter into Contract

Year introduced

2004

Year last amended

2017

Service standard

Provide timely, responsive and reliable dosimetry services:

Exposures reported within 45 calendar days of receipt – Canadian Nuclear Safety Commission (CNSC) regulatory standard;
Dosimeters shipped 10-13 working days prior to exchange date with clients;
Dose results for whole body and extremity services reported within internal service standards of 20-30 business days, depending on the dosimetry service;
Client account information updated within two business days;
Client voice mails responded to within one business day; and,
Client emails responded to within two business days.

Performance results

National Dosimetry Service (NDS) provided timely, accurate and reliable customer service to workers:

NDS processed and reported 611,042 dosimeter readings to client groups attaining 100% compliance with the 45 day regulatory (CNSC) standard;
NDS shipped out 88% of dosimeters 10-13 working days prior to exchange date;
NDS processed and reported 611,042 readings with 99% reported within the 20-30 business day internal standard, depending on the dosimetry service;
NDS processed 28,371 changes to client group requests (via Name Lists) with 94% completed within two business days;
NDS responded to 1,585 Client Services voice mail call backs with 91.1% being addressed within one business day; and,
NDS responded to 4,615 emails with 90.1% addressed within two business days.

Other information

N/A

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
5,810,715	6,163,812	6,140,049	N/A
Footnotes Footnote a The amount includes direct and indirect costs, where such costs are identifiable and material. Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid. Return to footnote b referrer

General information - Fees for processing requests filed under the Access to Information Act

Fee category

Fees for processing requests filed under the Access to Information Act

Fee-setting authority

Access to Information Act

Year introduced

1988

Year last amended

1992

Service standard

A response is provided within 30 days following receipt of a request; the response time may be extended under section 9 of the Access to Information Act.

Performance results

Health Canada achieved a compliance rate^{Footnote *} of 59.5% for fiscal 2017-18. Public Health Agency of Canada achieved a compliance rate of 77.2% for fiscal 2017-18.

Other information

The Act authorizes fees for certain aspects of processing formal requests and the fee structure is prescribed in the Access to Information (ATI) Regulations. However, Treasury Board Secretariat in May 2016 issued the Interim Directive on the Administration of the Access to Information Act which imposed a requirement to waive all fees chargeable other than the $5 application fee, regardless of the size and scope of the request or burden on the Department to process. Based on requests received in 2017-18, Health Canada collected $7,655 in application fees, and Public Health Agency of Canada collected $515 in application fees. Health Canada waived $2,788 in fees while Public Health Agency of Canada waived $313 in fees.

Financial information (dollars)
2016–17 Revenue	2017–18 Revenue	2017–18 Cost^{Footnote a}	2017–18 Remissions^{Footnote b}
6,928	8,170	10,960,057	N/A
Footnotes Footnote a The amount includes direct and indirect costs. Due to the Shared Services Partnership whereby Health Canada provides Access to Information (ATI) services on behalf of Public Health Agency of Canada, the Fiscal Year 2017-18 total costs detailed between the 2 departments are as follows: Health Canada Access to Information (ATI) - $10,304,134 Public Health Agency of Canada Access to Information ( ATI) - $655,923 Return to footnote a referrer Footnote b A remission is a partial or full return of a fee paid. Return to footnote b referrer

Footnotes

Footnote 14

Includes cases where a Notice of Extension is sent to the requester within 30 days of receipt of the request.

Return to footnote * referrer

Table 2B

Financial totals for all fee categories

Financial information (dollars)
2016–17 Total Revenue	2017–18 Total Revenue	2017–18 Total Cost	2017–18 Total Remissions
114,599,323	123,425,415	320,328,604	N/A

Note: the totals are the sums of the revenues, costs and remissions reported for all fee categories in the “Financial information” tables.

Table C

Fees under the department's authority

Fee amounts for 2017–18 and 2019–20 and for a future fiscal year, as applicable (dollars)
Name of fee	2017-18 Fee Amount	2019-20 Adjusted fee amount^{Footnote a}	Future fee amount and fiscal year^{Footnote b}
RIGHT TO SELL DRUGS FEE^{Footnote 1}
Human drugs	1,152	1,200	N/A
Vet Drugs	250	256	N/A
DRUG SUBMISSION EVALUATION FEES (PHARMACEUTICALS AND BIOLOGIC PRODUCTS)^{Footnote 1}
New active substance	341,770	355,579	N/A
Clinical or non-clinical data and chemistry and manufacturing data	173,106	180,101	N/A
Clinical or non-clinical data only	80,794	84,059	N/A
Comparative studies	48,834	50,808	N/A
Chemistry and manufacturing data only	23,089	24,023	N/A
Published data only	19,147	19,921	N/A
Switch from prescription to non-prescription status	46,491	48,370	N/A
Labelling only	3,111	3,238	N/A
Administrative Submission	324	338	N/A
Disinfectants	4,305	4,480	N/A
Drug identification number application – labelling standards	1,726	1,797	N/A
Remission Processing Fee	566	590	N/A
MEDICAL DEVICE LICENSE APPLICATION FEES^{Footnote 1}
Class II Medical Devices:^{Footnote 1}
Class II – Licence application	397	414	N/A
Class III Medical Devices			N/A
Licence application	5,691	5,922	N/A
Licence application for a near patient in vitro diagnostic devices	9,687	10,079	N/A
Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing	1,433	1,492	N/A
Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations	5,330	5,546	N/A
Class IV Medical Devices:
Licence application	13,235	13,770	N/A
Licence application for devices that contain human or animal tissue	12,347	12,846	N/A
Licence application for near patient in vitro diagnostic device	22,560	23,473	N/A
Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing	1,433	1,492	N/A
Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations	6,073	6,319	N/A
Remission Processing Fee	61	65	N/A
FEE FOR RIGHT TO SELL A LICENSED MEDICAL DEVICE^{Footnote 1}
Fee (if annual gross revenue medical device sales is less than $20,000)	61	65	N/A
Fee (in any other case)	375	391	N/A
VETERINARY DRUG EVALUATION FEES^{Footnote 1}
New Drug Submission:
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species. (In the case of an antiparasitic drug, several indications in one food animal species.)	15,980	16,332	N/A
Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species.	9,680	9,893	N/A
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration, dosage form and two indications in one animal species.	23,240	23,751	N/A
Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species.	31,470	32,162	N/A
Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration	2,900	2,964	N/A
Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength.	480	491	N/A
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.	21,790	22,269	N/A
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species.	29,050	29,689	N/A
For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration.	2,900	2,964	N/A
For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species.	14,520	14,839	N/A
Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug.	4,840	4,946	N/A
Chemistry and manufacturing data to support one strength of a single dosage form.	4,840	4,946	N/A
Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as the above item.	2,420	2,473	N/A
Documentation to support a change of manufacturer.	250	256	N/A
Supplement to a New Drug Submission:
Efficacy data to support an additional indication in one animal species.	12,590	12,867	N/A
Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species.	9,680	9,893	N/A
Efficacy and safety data (in the intended species) to support an indication in another animal species.	15,980	16,332	N/A
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species.	23,240	23,751	N/A
Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species.	31,470	32,162	N/A
Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species.	7,740	7,910	N/A
Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration.	2,900	2,964	N/A
Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength.	480	491	N/A
For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species.	2,900	2,964	N/A
For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species.	14,520	14,839	N/A
For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period.	7,260	7,420	N/A
For the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required.	5,810	5,938	N/A
Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process.	4,840	4,946	N/A
Chemistry and manufacturing data to support a change in formulation or dosage form.	2,420	2,473	N/A
Chemistry and manufacturing data to support a change in packaging or in the sterilization process.	1,930	1,972	N/A
Chemistry and manufacturing data to support an extension of the expiry dating.	1,450	1,482	N/A
Chemistry and manufacturing data to support the concurrent use of two drugs.	1,450	1,482	N/A
Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms.	480	491	N/A
Documentation to support a change to the name of a manufacturer or the brand name of a drug.	250	256	N/A
Abbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission:
Comparative (pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form.	2,900	2,964	N/A
For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product.	2,900	2,964	N/A
Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug.	4,840	4,946	N/A
Chemistry and manufacturing data to support a single dosage form.	4,840	4,946	N/A
Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission.	250	256	N/A
DIN Application:
Information, other than that referred to in item 2, to support an application for a DIN, including the submission of labelling material for a second review, if required.	720	736	N/A
Published references or other data.	500	511	N/A
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.	250	256	N/A
Preclinical New Drug Submission:
Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species.	4,840	4,946	N/A
Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated.	3,870	3,955	N/A
For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species.	14,520	14,839	N/A
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.	21,790	22,269	N/A
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species.	29,050	29,689	N/A
For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species.	7,260	7,420	N/A
Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient.	4,840	4,946	N/A
Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient.	2,420	2,473	N/A
Experimental Studies Certificate:
Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal.	960	981	N/A
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.	480	491	N/A
Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal.	2,900	2,964	N/A
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.	480	491	N/A
Emergency Drug Sale:
Information and material to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal.	50	51	N/A
Information and material to support the sale of a drug to be used in the emergency treatment of a food-producing animal.	100	102	N/A
MEDICAL DEVICE ESTABLISHMENT LICENCE FEE^{Footnote 1}
Medical Devices Establishment Licence	8,109	8,438	N/A
HUMAN DRUG ESTABLISHMENT LICENCE FEES^{Footnote 1}
Good Manufacturing Practices Component
A. Fabrication
Basic Fee	17,402	18,107	N/A
Each Additional Category	4,361	4,538	N/A
Dosage Form Classes
Two classes	8,708	9,061	N/A
Three classes	17,402	18,107	N/A
Four classes	21,762	22,642	N/A
Five classes	26,106	27,162	N/A
Six classes	30,454	31,686	N/A
Each additional class	1,748	1,819	N/A
Sterile dosage forms	8,708	9,061	N/A
B. Packaging/Labelling
Basic Fee	11,636	12,107	N/A
Each Additional Category	2,907	3,026	N/A
Dosage Form Classes
Two classes	5,803	6,039	N/A
Three or more classes	8,708	9,061	N/A
Importation/Distribution
Basic Fee	7,256	7,551	N/A
Each Additional Category	1,816	1,891	N/A
Dosage Form Classes
Two classes	3,630	3,778	N/A
Three or more classes	7,256	7,551	N/A
Each fabricator	1,748	1,819	N/A
Each additional dosage form class for each fabricator	881	917	N/A
Distribution and Wholesaling
Distribution and Wholesaling Fee	4,361	4,538	N/A
Testing
Testing Fee	2,907	3,026	N/A
Drug Analysis Component^{Footnote 2}
Vaccines	29,001	30,174	N/A
Schedule D Drugs which are not vaccines or whole blood and its components	11,603	12,073	N/A
Drugs for human use that are prescription drugs, controlled drugs or narcotics	8,708	9,061	N/A
Drugs for human use, not included in any other item, for which a drug identification number has been assigned	4,361	4,538	N/A
Dealer’s Licence^{Footnote 3}
Dealer’s Licence	5,082	5,288	N/A
VETERINARY DRUG ESTABLISHMENT LICENCE FEES^{Footnote 1}^{Footnote 2}^{Footnote 3}^{Footnote 4}
Good Manufacturing Practices Component
A. Fabrication
Basic Fee	6,000	6,132	N/A
Each Additional Category	1,500	1,533	N/A
Dosage Form Classes
2 classes	3,000	3,066	N/A
3 classes	6,000	6,132	N/A
4 classes	7,500	7,665	N/A
5 classes	9,000	9,198	N/A
6 classes	10,500	10,731	N/A
Each additional class	600	613	N/A
Sterile dosage forms	3,000	3,066	N/A
B. Packaging/Labelling
Basic Fee	4,000	4,088	N/A
Each Additional Category	1,000	1,022	N/A
Dosage Form Classes
2 classes	2,000	2,044	N/A
3 or more classes	3,000	3,066	N/A
C. Importation/Distribution
Basic Fee	2,500	2,555	N/A
Each Additional Category	625	639	N/A
Dosage Form Classes
2 classes	1,250	1,278	N/A
3 or more classes	2,500	2,555	N/A
Each fabricator	600	613	N/A
Each additional dosage form class for each fabricator	300	307	N/A
D. Distribution and Wholesaling
Distribution and Wholesaling Fee	1,500	1,533	N/A
E. Testing
Testing Fee	1,000	1,022	N/A
Drug Analysis Component
Drug Identification Numbers for Veterinary Use	250	256	N/A
Dealer’s Licence^{Footnote 3}
Dealer’s Licence	1,750	1,789	N/A
FEES SET BY MINISTERIAL AUTHORITY TO ENTER INTO CONTRACT
Certificate of Pharmaceutical Product Fee	86	90	N/A
Drug Master File Fees:
New Master Files (file registration)	1,200	1,248	N/A
Drug Master Files - letter of access	170	176	N/A
Drug Master Files - Update	520	541	N/A
Certificate of Supplementary Protection	9,011	9,375	N/A
Footnotes Footnote a The Adjusted Fee amounts reflect the predetermined 2% increase on current fees, or the 2018 April All-items Consumer Price Index (2.2%) on current fees as appropriate. Revised fees were consulted on in 2017 and 2018 and the Department is targeting implementation of new fees April 2019. These new fees will be published on the Health Canada website in advance of implementation. Return to footnote a referrer Footnote b The “Future fee amount and year” is the new amount of the fee, in a future fiscal year other than 2019–20, adjusted by a predetermined rate, in accordance with the authority in legislation or regulation. Return to footnote b referrer Footnote 1 Revised fees were consulted on in 2017 and 2018 and the Department is targeting implementation of new fees April 2019. These new fees will be published on the Health Canada website in advance of implementation. Return to footnote 1 referrer Footnote 2 Product laboratory analysis activities based on the risks associated with various broad product types. Return to footnote 2 referrer Footnote 3 Fees for the examination of dealer's licence application. Return to footnote 3 referrer Footnote 4 If an establishment has human and vet controlled substances and / or narcotics, then the human fee supersedes the veterinary fee. Return to footnote 4 referrer

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Name of fee	2017-18 Fee Amount	2019-20 Adjusted fee amount^{Footnote a}	Future fee amount and fiscal year^{Footnote b}
PEST CONTROL PRODUCTS FEES AND CHARGES
Schedule 1: Fees for application to register, or to amend the registration of, a Pest Control Product other than a semiochemical or Microbial Agent
1. Product Chemistry – active ingredient	4,873	5,071	N/A
2. Product Chemistry – end-use product or manufacturing concentrate	2,713	2,824	N/A
3.(a) Toxicology data accompanying an application to register a pest control product that contains a new active ingredient	75,807	78,871	N/A
3.(b) Toxicology data accompanying an application to register a pest control product –or to amend a pest control product –that contains an registered active ingredient	15,830	16,470	N/A
3.(c) Toxicology data-acute toxicity studies	2,954	3,075	N/A
4.(a) Exposure data accompanying an application to register a pest control that consists of or that contains a new active ingredient	17,498	18,205	N/A
4.(b) Exposure data accompanying an application to register a pest control product –or to amend the registration of a pest control product –that contains a registered active ingredient, when a new risk assessment is necessary	5,758	5,992	N/A
4. (c) Exposure data-other	5,214	5,426	N/A
5. Metabolism data	28,943	30,113	N/A
6. Residue data	15,838	16,479	N/A
7.(a) Environment fate data accompanying an application to register a pest control product that consists of or that contains a new active ingredient	42,685	44,410	N/A
7. (b) 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	23,637	24,593	N/A
7. (c) Environmental fate data-other	11,546	12.013	N/A
8. (a) Environment toxicology data accompanying an application to register a pest control product that consists of or that contains a new active ingredient	37,277	38,784	N/A
8. (b) Environmental toxicology data accompanying an application to register a pest control product ,or to amend the registration of a pest control product, that contains a registered active ingredient, when a new risk assessment is necessary	26,690	24,648	N/A
8. (c) Environmental toxicology data-other	2,465	2,566	N/A
9. Value and effectiveness data for a pest control product	906	944	N/A
10. Identification of compensable data	2,162	2,251	N/A
Schedule 2: Fees for application in respect of a Pest Control Product that is a semiochemical or Microbial Agent
1. Registration of a new active ingredient – food use	7,236	7,529	N/A
2. Registration of a new active ingredient – non-food use	4,341	4,517	N/A
3. Amendment of registration – new risk assessment necessary-environmental fate data, environmental toxicity data or exposure data	2,894	3,012	N/A
4. Amendment of registration – data required, label changes	1,447	1,506	N/A
5. Amendment of registration – data required, other	1,158	1,206	N/A
6. Amendment of registration – no data required	290	302	N/A
7. Registration of new active ingredient	579	603	N/A
8. Amendment of registration	290	302	N/A
Schedule 3: Fees for other applications in respect of a Pest Control Product
1.(a) Research authorization – major crops, other than research authorizations set out in paragraphs (c) and (d)	5,080	5,286	N/A
1.(b) Research authorization – minor use crops, other than research authorizations set out in paragraphs (c) and (d)	5,080	5,286	N/A
1. (c) Research authorization – microbial agents, semiochemicals and any substance listed in subparagraph 1(d) (ii) of these regulations.	1,217	1,267	N/A
1.(d) Research authorization – greenhouse crops and non-agricultural uses	1,217	1,267	N/A
2. Research notifications	247	258	N/A
3. (a) Registration of active ingredient to be used in pest control product manufactured only for export	7,827	8,144	N/A
3. (b) Amendment to Registration of active ingredient to be used in pest control product manufactured only for export	1,133	1,180	N/A
4. (a) Specification of maximum residue limit for a previously unexamined pest control product	125,461	130,531	N/A
4. (b) Specification of maximum residue limit for an unregistered use of a previously examined pest control product	15,838	16,479	N/A
Applications not mentioned in Schedules
Processing	1,133	1,180	N/A
Applications not mentioned in schedules	247	258	N/A
Renewal	80	84	N/A
Part II: Annual Charge
Annual Charge	3,600	3,679	N/A
Footnotes Footnote a The "Adjusted fee amount" is the new amount of the fee in 2019–20, adjusted either by the Consumer Price Index rate or by a predetermined rate, in accordance with the authority in legislation or regulation. Return to footnote a referrer Footnote b The "Future fee amount and year" is the new amount of the fee, in a future fiscal year other than 2019–20, adjusted by a predetermined rate, in accordance with the authority in legislation or regulation. Return to footnote b referrer

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Name of fee	2017-18 Fee Amount	2019-20 Adjusted fee amount^{Footnote a}	Future fee amount and fiscal year
FEES CHARGED FOR FILING A CLAIM FOR EXEMPTION UNDER THE HAZARDOUS MATERIALS INFORMATION REVIEW ACT
^{Footnote b} The following fees apply to each submission when up to 15 claims of that type are submitted at one time
Original Claim:
First 15 claims	1,800	1,840	N/A
Next ten claims	400	409	N/A
Over 25 claims	200	204	N/A
Refiled Claim:
First 15 claims	1,440	1,472	N/A
Next ten claims	320	327	N/A
Over 25 claims	160	164	N/A
Footnotes Footnote a The "Adjusted fee amount" is the new amount of the fee in 2019–20, adjusted either by the Consumer Price Index rate or by a predetermined rate, in accordance with the authority in legislation or regulation. Return to footnote a referrer Footnote b The "Future fee amount and year" is the new amount of the fee, in a future fiscal year other than 2019–20, adjusted by a predetermined rate, in accordance with the authority in legislation or regulation. Return to footnote b referrer

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Name of fee	2017-18 Fee Amount	2019-20 Adjusted fee amount	Future fee amount and fiscal year
FEES SET BY MINISTERIAL AUTHORITY TO ENTER INTO CONTRACT
National Dosimetry Products and Services Fees	All fees have been listed in this hyperlink	All fees have been listed in this hyperlink	N/A

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Date modified:: 2020-09-09