Supplementary Information Tables:  2016-17 Departmental Results Report

User Fees, Regulatory Charges and external fees

Reports on the User Fees Act

Table 2 A 2016-2017

Fee Right to Sell Drugs Fee

Fee name

Fee Right to Sell Drugs Fee

Fee type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

Year introduced

1995

Year last amended

2011

Performance standard

120 calendar days to update the Drug Product Database following notification

Performance results

100% within 120 calendar days

Other information

See Note 1

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
12,512,205 12,015,179 55,933,282
 
Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 12,525,575 61,809,399
2018-19 12,776,086 64,409,780
2019-20 13,031,608 68,379,579

Drug Establishment Licensing Fees

Fee name

Drug Establishment Licensing Fees

Fee type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

Year introduced

1998

Year last amended

2011

Performance standard

250 Calendar days to issue / renew license

Performance results

Average number of days: 108 days

Other information

See Note 1

Financial Information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
15,808,383 16,766,144 21,179,125
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 17,234,551 21,602,708
2018-19 17,579,242 22,034,762
2019-20 17,930,827 22,475,457

Drug Submission Evaluation Fees (Pharmaceuticals and Biologic Products)

Fee name

Drug Submission Evaluation Fees (Pharmaceuticals and Biologic Products)

Fee type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

Year introduced

1995

Year last amended

2011

Performance 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: 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: DINB = 210
COMP C&M: ANDS = 180
COMP C&M: SNDS = 180
COMP C&M: DINB = 210
LABELLING ONLY: NDS = 60
LABELLING ONLY: SNDS = 60
PUBLISHED DATA: SNDS = 300
ADMINISTRATIVE: NDS = 45
ADMINISTRATIVE: DINB = 45

Performance results

Review 1 (average time in calendar days)
Pharmaceuticals
NAS: NDS = 244
CLIN C&M: NDS = 285
CLIN C&M: SNDS = 282
CLIN : NDS = N/A
CLIN: SNDS = 272
CLIN: DIN A = N/A
COMP C&M: ANDS = 170
COMP C&M: NDS = 180
COMP C&M: SANDS =176
COMP C&M: SNDS = 179
COMP C&M: DIN A = 204
C&M: ANDS = 177
C&M: NDS = 179
C&M: SANDS = 146
C&M: SNDS = 158
C&M: DIN A = 203
PUBLISHED DATA: SNDS = 263
PUBLISHED DATA: DIN A= 196
Rx to OTC Switch: NDS = N/A
Rx to OTC Switch: SNDS = N/A
DISINFECTANT: NDS-D = N/A
DISINFECTANT: SNDS-D = N/A
DISINFECTANT: DIN D 210= 205
DISINFECTANT: DIN D 180 = N/A
LABELLING ONLY : NDS= 54
LABELLING ONLY : SNDS= 57
LABELLING ONLY : ANDS= 54
LABELLING ONLY : SANDS= 50
LABELLING ONLY : DIN A= 147
LABEL STANDARD: DIN A= 36
LABEL STANDARD: DIN D= 40
LABEL STANDARD: DIN F= 33
ADMINISTRATIVE: ANDS = 34
ADMINISTRATIVE: NDS = 37
ADMINISTRATIVE: SNDS = 33
ADMINISTRATIVE: SANDS = 36
ADMINISTRATIVE: DIN A = 31
ADMINISTRATIVE: DIN D = 39
ADMINISTRATIVE: DIN F = 27
Biologics
NAS: NDS = 259
CLIN C&M: NDS = 293
CLIN C&M: SNDS = 284
CLIN C&M: DIN B = N/A
CLIN: NDS = N/A
CLIN: SNDS = 264
C&M ANDS = 178
C&M: SANDS = N/A
C&M: SNDS = 141
C&M: DINB = 210
COMP C&M: ANDS = N/A
COMP C&M: SNDS = 171
COMP C&M: DIN B = 206
LABELLING ONLY: NDS = 57
LABELLING ONLY: SNDS = 56
PUBLISHED DATA: SNDS = 193
ADMINISTRATIVE: NDS = 26
ADMINISTRATIVE: DINB = N/A

Other information

Review 1= Drug Submission Reviews

  1. 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
    INDS: Investigation New Drug Submission
    ESC: Experimental Studies Certificate
    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 the time of reporting, either no submissions of that type were received or no reviews of that submission type were completed, therefore no performance information is available.

  1. Performance

    As per the User Fee Act (UFA), when, where a regulating authority's performance in a particular fiscal year in respect of a user fee does not meet the standards established by it for that fiscal year by a percentage greater than 10%, the UFA requires that the user fee be reduced by the percentage missed, up to a maximum of 50%. The reduced fees are in effect until the date of the next Departmental Results Report.

See Note 1

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
46,189,732 43,609,604 87,418,496

Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 44,902,344 87,415,128
2018-19 45,800,391 89,024,719
2019-20 46,716,399 90,538,542

Medical Device License Application Fees

Fee name

Medical Device License Application Fees

Fee type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

Year introduced

1998

Year last amended

2011

Performance 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 = 59
Class III Near Patient = 57
Class III Manufacturing Amendment = 58
Class III Significant Amendment = 61
Class IV New = 74
Class IV Human-Animal Tissue= 76
Class IV Near Patient IVD = NA
Class IV Manufacturing Amendment = 46
Class IV Significant Amendment= 74

Other information

Performance
As per the User Fee Act (UFA), when, where a regulating authority's performance in a particular fiscal year in respect of a user fee does not meet the standards established by it for that fiscal year by a percentage greater than 10%, the UFA requires that the user fee be reduced by the percentage missed, up to a maximum of 50%. The reduced fees are in effect until the date of the next Departmental Performance Report.

Two Medical Device License Application fees lines did not meet the performance standard, but did not exceed the target by more than 10%, therefore there are no penalties incurred. They are:

  1. Class III Significant Amendment, with a target of 60 days, and a performance of 61 days.
  2. Class IV Human-Animal Tissue with a target of 75 days, and a performance of 76 days.

See Note 1

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
5,615,432 6,261,776 20,112,968
Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 6,473,580 16,295,244
2018-19 6,603,052 16,595,441
2019-20 6,735,113 16,877,929

Fee for Right to Sell a Licensed Medical Device

Fee name

Fee for Right to Sell a Licensed Medical Device

Fee type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

Year introduced

1999

Year last amended

2011

Performance 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
See Note 1

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
8,336,607 8,412,791 14,091,638
Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 8,614,413 17,691,362
2018-19 8,786,701 18,010,286
2019-20 8,962,435 18,303,763

Medical Device Establishment Licensing Fees

Fee name

Medical Device Establishment Licensing Fees

Fee type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

Year introduced

2000

Year last amended

2011

Performance standard

120 Calendar days to issue / renew license

Performance results

Average number of days: 20 days.

Other information

See Note 1

Financial Information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
9,625,198 10,655,054 9,339,534
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 10,117,702 9,526,324
2018-19 10,320,056 9,716,851
2019-20 10,526,457 9,911,188

Veterinary Drug Evaluation Fees

Fee name

Veterinary Drug Evaluation Fees

Fee type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

Year introduced

1996

Year last amended

N/A

Performance standard

Review 1 (average time in calendar days)
NDS (including Priority Review) = 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 (including Priority Review) = 307
ANDS = 339
SNDS = 222
SANDS = 221
Admin = 41
DIN (including changes to DINs) = 102
NC = 80
ESC = 83
Labels = N/A
Emergency Drug Release = < 2

Other information

i. 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
ESC: Experimental Studies Certificate
NC: Notifiable Change
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.
ii. Performance
Three Veterinary Drug Evaluation Fee fees lines did not meet the performance standard, but are not subject to the User Fees Act, therefore there are no penalties incurred. They are:

  1. New Drug Submission (including Priority Review) with a target of 300 days, and a performance of 307 days.
  2. Abbreviated New Drug Submission, with a target of 300 days and a performance of 339 days.
  3. Experimental Studies Certificate with a target of 60 days and a performance of 83 days.

See Note 1

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
914,000 833,874 5,673,729
Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 914,000 5,766,989
2018-19 914,000 5,873,282
2019-20 914,000 5,973,355

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

Fee name

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

Fee type

Regulatory (R)

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

Performance standard

95% of claims registered within 7 days of receipt of the complete application package.

Performance results

98% of claims were registered within 7 days of receipt of the complete application package.

Other information

Fees not subject to the User Fees Act (UFA) as fees have not been updated since the UFA came into force.

Financial Information, 2016-17 (dollars)

Forecast revenue Actual revenue Full cost
700,000 1,283,545.60 2,699,758.10
Financial Information, 2017-18, 2018-19, and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 570,000 2,700,000
2018-19 570,000 2,700,000
2019-20 570,000 2,700,000

Pest Control Product Application Examination Service

Fee name

Pest Control Product Application Examination Service

Fee type

Regulatory (R)

Fee-setting authority

Pest Control Products Act (PCPA)

Year introduced

1997

Year last amended

N/A

Performance 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 timeline is 240 days.
Category D: Review timelines range from 10 to 247 days.
Category E: Review timelines range from 30 to 159 days.

Performance results

Category A = 84%
Category B = 90%
Category C = 99%
Category D = 95%
Category E = 55%

Other information

Fees not subject to User Fees Act as at March 31, 2017 (2016-17) but have since been updated effective April 1, 2017 (2017-18) and will therefore be subject to the Service Fees Act (SFA).

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
3,490,000 2,590,800 20,079,000
Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 3,648,000 22,665,000
2018-19 3,732,000 22,957,000
2019-20 3,843,000 23,332,000

Right or Privilege to manufacture or sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in relation to a Pest Control Product

Fee name

Right or Privilege to manufacture or sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in relation to a Pest Control Product

Fee type

Regulatory (R)

Fee-setting authority

Financial Administration Act (FAA)

Year introduced

1997

Year last amended

N/A

Performance standard

100% of all fees for the right or privilege to manufacture or sell a pest control product in Canada are invoiced by April 30th of each fiscal year.

Performance results

100% of all invoices were issued by April 30, 2016.*

Other information

Fees not subject to User Fees Act as at March 31, 2017 (2016-17) but have since been updated effective April 1, 2017 (2017-18) and will therefore be subject to the Service Fees Act (SFA).

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

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
4,500,000 5,304,300 41,110,000
Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 7,149,000 44,410,000
2018-19 7,312,000 44,984,000
2019-20 7,530,000 45,717,000

Fees for processing requests filed under the Access to Information Act

Fee name

Fees for processing requests filed under the Access to Information Act

Fee type

Other products and services

Fee-setting authority

Access to Information Act

Year introduced

1988

Year last amended

1992

Performance 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* of 58.7% for fiscal 2016-17. Public Health Agency of Canada achieved a compliance rate of 88.5% for fiscal 2016-17.

Other information

The Act authorizes fees for certain aspects of processing formal requests and the fee structure is prescribed in the ATI Regulations. However, TBS 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 2016-2017, HC collected $5,720 in application fees and $728 in search fees for a total of $6,448, and PHAC collected $480 in application fees. HC waived $3,787 in fees and PHAC waived $380 in fees. These search fees were collected before the May 2016 TBS Interim Directive.

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

Financial information, 2016-17 (dollars)
Forecast revenue Actual revenue Full cost
8,000 6,928* 9,175,000
Financial information, 2017-18, 2018-19 and 2019-20 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 8,500* 12,150,000
2018-19 8,500* 12,150,000
2019-20 8,500* 12,150,000

Note 1 - The forecasted revenues and estimated full costs are point estimates based on available data at the time of the preparation of these figures. Further, user fees related to drugs and medical devices are currently undergoing fee renewal review. As such, the actual revenues and full costs in the future may vary from these forecasts and estimates.

Table 2 B: Health Canada's Summary of Financial Information for All User Fees and Regulatory Charges 2016-2017 (dollars)
  Forecast revenue Actual revenue Full cost
Regulatory subtotal 107,691,557 107,733,067 277,637,530
Other products and services subtotal 8,000 6,928 9,175,000
Total, all fee types 107,699,557 107,739,995 286,812,530
Health Canada Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2017-18 112,157,665 302,032,154
2018-19 114,402,037 308,456,121
2019-20 116,768,339 315,308,813
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