Page 8: Health Canada – 2015-2016 – Supplementary Information Tables – Departmental Performance Report – User Fees, Regulatory Charges and External Fees

User Fees, Regulatory Charges and External Fees

Reporting on User Fees Act

Fee Rights to Sell Drugs Fee

Fee type

Regulatory (R)

Fee-setting authority

Financial Administration 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

N/A

Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
11,769,634 12,227,398 61,203,734
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 12,512,205 60,669,474
2017-18 12,762,449 60,234,256
2018-19 13,017,698 61,446,235
 

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: 73 days

Other information

N/A

Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
13,817,312 15,393,771 22,077,735
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 15,808,383 23,029,202
2017-18 16,124,550 23,738,596
2018-19 16,447,041 24,250,323
 

Drug Submission Evaluation Fees (Pharmaceuticals and Biologic Products)

Fee type

Regulatory (R)

Fee-setting authority

Financial Administration 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
  • DISINFECTANT: DIN D = 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
  • 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 = 281
  • CLIN C&M: NDS = 285
  • CLIN C&M: SNDS = 218
  • CLIN: NDS = N/A
  • CLIN: SNDS = 277
  • CLIN: DIN A = 115
  • COMP C&M: ANDS = 167
  • COMP C&M: NDS = 184
  • COMP C&M: SANDS =163
  • COMP C&M: SNDS = 177
  • COMP C&M: DIN A = 144
  • C&M: ANDS = 178
  • C&M: NDS = 175
  • C&M: SANDS = 160
  • C&M: SNDS = 164
  • C&M: DIN A = 206
  • PUBLISHED DATA: SNDS = 274
  • PUBLISHED DATA: DIN A= 193
  • Rx to OTC Switch: NDS = 180
  • Rx to OTC Switch: SNDS = N/A
  • DISINFECTANT: NDS-D = 292
  • DISINFECTANT: SNDS-D = N/A
  • DISINFECTANT: DIN D = 195
  • DISINFECTANT: DIN D = 164
  • LABELLING ONLY: NDS= 57
  • LABELLING ONLY: SNDS= 53
  • LABELLING ONLY: ANDS= 35
  • LABELLING ONLY: SANDS= 35
  • LABELLING ONLY: DIN A= 149
  • LABEL STANDARD: DIN A= 30
  • LABEL STANDARD: DIN D= 33
  • LABEL STANDARD: DIN F= 7
  • ADMINISTRATIVE: ANDS = 33
  • ADMINISTRATIVE: NDS = 35
  • ADMINISTRATIVE: SNDS = 36
  • ADMINISTRATIVE: SANDS = 36
  • ADMINISTRATIVE: DIN A = 17
  • ADMINISTRATIVE: DIN D = 28
  • ADMINISTRATIVE: DIN F = 10

Biologics

  • NAS: NDS = 230
  • CLIN C&M: NDS = 271
  • CLIN C&M: SNDS = 286
  • CLIN C&M: DIN B = N/A
  • CLIN: NDS = N/A
  • CLIN: SNDS = 283
  • C&M ANDS = N/A
  • C&M: SANDS = N/A
  • C&M: SNDS = 153
  • C&M: DINB = 204
  • COMP C&M: ANDS = N/A
  • COMP C&M: SNDS = 178
  • LABELLING ONLY: SNDS = 45
  • PUBLISHED DATA: SNDS = 284
  • ADMINISTRATIVE: NDS = 37
  • 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
    • DIN A = drug identification number application for a pharmaceutical
    • DIN B = drug identification number application for a biological
    • DIN D = drug identification number application for a disinfectant
    • DIN F = drug identification number application for a Category IV Monograph
    INDS
    Investigational 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 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
  2. 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 ten per cent, 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.

    One Pharmaceuticals Drug Evaluation fee line did not meet the performance standard, but did not exceed the target by more than 10%, so there are no penalties incurred. They are:

    1. COMPARATIVE STUDIES C&M / NDS, with a target of 180 days, and a performance of 184 days.
Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
42,853,497 43,081,247 80,817,471
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast  revenue Estimated full cost
2016-17 46,189,732 84,880,915
2017-18 47,113,527 87,305,916
2018-19 48,055,798 88,991,960
 

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 = 15
  • Class III New = 60
  • Class III Near Patient = 54
  • Class III Manufacturing Amendment = 61
  • Class III Significant Amendment = 64
  • Class IV New = 76
  • Class IV Human-Animal Tissue = 70
  • Class IV Near Patient In Vitro Diagnostic Devices = 48
  • Class IV Manufacturing Amendment = 67
  • Class IV Significant Amendment = 69
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 ten per cent, 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.

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

  1. Class III Manufacturing Amendment, with a target of 60 days, and a performance of 61 days.
  2. Class III Significant Amendment, with a target of 60 days, and a performance of 64 days.
  3. Class IV New, with a target of 75 days, and a performance of 76 days.
Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
6,303,279 5,184,702 19,668,614
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 5,615,432 18,400,043
2017-18 5,727,741 16,851,187
2018-19 5,842,296 17,190,222
 

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

99.9% within 20 calendar days

Other information

N/A

Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
8,076,010 8,350,294 14,969,666
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 8,336,607 15,252,706
2017-18 8,503,339 15,599,129
2018-19 8,673,406 15,912,990
 

Medical Device Establishment Licensing Fees

Fee type

Regulatory (R)

Fee-setting authority

Financial Administration Act

Year introduced

2000

Year last amended

2011

Performance standard

120 Calendar days to issue / renew license

Performance results

Average number of days: 31 days.

Other information

N/A

Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
9,052,447 8,811,064 8,067,410
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 9,625,198 8,754,254
2017-18 9,817,702 9,198,729
2018-19 10,014,057 9,356,670
 

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 = N/A
  • Emergency Drug Release = 2
Performance results

Review 1 (average time in calendar days)

  • NDS (including Priority Review) = 352
  • ANDS = 364
  • SNDS = 238
  • SANDS = 187
  • Admin = 19
  • DIN (including changes to DINs) = 125
  • NC = 88
  • ESC = 55
  • Labels = N/A
  • Emergency Drug Release = 2 days
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
    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
  2. Performance

    Three Veterinary Drug Evaluation Fee fees lines did not meet the performance standard, but are not subject to the User Fees Act, so there are no penalties incurred. They are:

    1. New Drug Submission (including Priority Review) with a target of 300 days, and a performance of 352 days.
    2. Abbreviated New Drug Submission, with a target of 300 and a performance of 364 days.
    3. Drug Identification Number (including changes to DINs) with a target of 120 and a performance of 125 days.
Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
853,401 1,064,378 8,648,587
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 914,000 8,812,187
2017-18 932,280 9,012,138
2018-19 950,926 9,193,457
 

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

All claims registered within seven days of receipt of the complete application package.

Performance results

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

Other information

Issues specifically related to program transition and the development of new Confidential Business Information (CBI) processes reduced the ability of Workplace Hazardous Material Directorate (WHMD) to maintain its seven-day service standard over the 2015-16 fiscal year.

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

Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
570,000 603,650 2,417,807
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 700,000 2,500,000
2017-18 570,000 2,500,000
2018-19 570,000 2,500,000
 

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 = 87%
  • Category B = 88%
  • Category C = 95%
  • Category D = 92%
  • Category E = 60%
Other Information

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

Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
3,490,000 2,675,000 20,679,566
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast  revenue Estimated full cost
2016-17 2,717,000 21,014,000
2017-18 2,717,000 20,957,000
2018-19 2,717,000 19,678,000
 

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 type

Regulatory (R)

Fee-setting authority

Financial Administrative Act

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, 2015

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, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
4,500,000 5,193,000 40,142,000
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast  revenue Estimated full cost
2016-17 5,273,000 40,791,000
2017-18 5,273,000 40,685,000
2018-19 5,273,000 38,199,000
 

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 55.6% for fiscal 2015-16. Public Health Agency of Canada achieved a compliance rate of 92.0% for fiscal 2015-16.

Other information

Under the Access to Information Act, fees under $25 may be waived when deemed to be in the public interest. Fees waived during 2015-16 for Health Canada was $3,262. Fees waived during 2015-16 for Public Health Agency of Canada was $182.

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

Financial Information, 2015-16 (dollars)
Forecast revenue Actual revenue Full cost
9,000 5,293 8,200,000
Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)
Planning year Forecast revenue Estimated full cost
2016-17 8,000 10,350,000
2017-18 8,000 12,150,000
2018-19 8,000 12,150,000
 

Summary of Financial Information for All User Fees and Regulatory Charges

Summary of Financial Information for All User Fees and Regulatory Charges, 2015-16 (dollars)
  Forecast revenue Actual revenue Full cost
Regulatory subtotal 101,285,580 102,584,504 278,692,590
Other products and services subtotal 9,000 5,293 8,200,000
Total all fee types 101,294,580 102,589,797 286,892,590
Health Canada Financial Information, 2016-17, 2017-18 and 2018-19 (dollars)Table note *
Planning year Forecast revenue Estimated full cost

Table notes

Table note *

The forecasted revenues and estimated full costs are point estimates based on available data at the time of the preparation of these figures. The actual revenues and full costs in the future may vary from these forecasts and estimates.

Return to table note * referrer

2016-17 107,699,577 294,453,781
2017-18 109,549,588 298,231,951
2018-19 111,569,222 298,868,857
 

Reporting on the Policy on Service Standards for External Fees

General Information by Fee
A. External Fee Service standard Performance Result Stakeholder Consultation

Table footnotes

Footnote *

Denotes Fees Set by Contract (not subject to User Fees Act).

Return to footnote * referrer

Right to Sell Drugs Fees 120 calendar days to update the Drug Product Database following notification 100% within 120 calendar days. In April 2010, Health Canada's Proposal to update current user fees for regulatory activities related to human drugs and medical devices was tabled in Parliament, as required by the User Fees Act (UFA). The Senate Standing Committee on Social Affairs, Science and Technology undertook the review of the proposal, and recommended to the Senate that the proposal be approved with no changes. On May 26, 2010, the Senate adopted the report of its Committee, thereby concluding the Parliamentary review of Health Canada's Proposal.

As user fees are set in regulations, any changes to update them are required to go through the Canada Gazette process. The regulatory proposal was published in the Canada Gazette, Part I on November 13, 2010 for a 75-day consultation period. A summary of stakeholders' comments and Health Canada's responses was published in Canada Gazette, Part II, as part of the Regulatory Impact Analysis Statement that accompanied the regulations. The regulations containing updated user fees came into force on April 1, 2011.

There is an annual 2% increase in regulatory fees along with the updated non-regulatory fees (Drug Master Files (DMF) and Certificate of Pharmaceutical Products (CPP)). These increases come into effect April 1st of every year. Notice of the updates is posted in the Canada Gazette annually as per the requirements for updating the fees.

In addition, the Health Canada user fee website was updated to provide notice of the fee updates along with links to the Canada Gazette notice, and a communiqué message was sent to notify industry stakeholders of the updated non-regulatory fees.

In October 2014, Health Canada published the 2014 Review of the Fees in Respect of Drugs and Medical Devices Regulations. This document fulfils Health Canada’s commitment to review its fees, costs and operational performance for services every three years and highlights the successes and challenges Health Canada has experienced during the implementation of the user fee regulations.
Footnote * Certificates of Pharmaceutical Product (Drug Export) Fees 10 working days to issue certificate Average number of days: 9 Days.
Drug Establishment Licensing Fees 250 calendar days to issue / renew licence Average number of days: 73 Days.
Footnote * Drug Master File Fees 30 calendar days

Within 30 calendar days upon receipt of a complete package for:

  • Drug Master File: 98.3%
  • Letter of Access: 99.1%
  • Biannual Update: 99.8%
Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products) 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
  • DISINFECTANT: DIN D = 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
  • LABELLING ONLY: SNDS = 60
  • PUBLISHED DATA: SNDS = 300
  • ADMINISTRATIVE: NDS = 45
  • ADMINISTRATIVE: DIN B = 45
Review 1 (average time in calendar days)

Pharmaceuticals

  • NAS: NDS = 281
  • CLIN C&M: NDS = 285
  • CLIN C&M: SNDS = 218
  • CLIN: NDS = N/A
  • CLIN: SNDS = 277
  • CLIN: DIN A = 115
  • COMP C&M: ANDS = 167
  • COMP C&M: NDS = 184 
  • COMP C&M: SANDS =163
  • COMP C&M: SNDS = 177
  • COMP C&M: DIN A = 144
  • C&M: ANDS = 178
  • C&M: NDS = 175
  • C&M: SANDS = 160
  • C&M: SNDS = 164
  • C&M: DIN A = 206
  • PUBLISHED DATA: SNDS = 274
  • PUBLISHED DATA: DIN A= 193
  • Rx to OTC Switch: NDS = 180
  • Rx to OTC Switch: SNDS = N/A
  • DISINFECTANT: NDS-D = 292
  • DISINFECTANT: SNDS-D = N/A
  • DISINFECTANT: DIN D = 195
  • DISINFECTANT: DIN D = 164
  • LABELLING ONLY: NDS= 57
  • LABELLING ONLY: SNDS= 53
  • LABELLING ONLY: ANDS=  35
  • LABELLING ONLY: SANDS= 35
  • LABELLING ONLY: DIN A= 149
  • LABEL STANDARD: DIN A= 30
  • LABEL STANDARD: DIN D= 33
  • LABEL STANDARD: DIN F= 7
  • ADMINISTRATIVE: ANDS =  33
  • ADMINISTRATIVE: NDS = 35
  • ADMINISTRATIVE: SNDS =  36
  • ADMINISTRATIVE: SANDS = 36
  • ADMINISTRATIVE: DIN A = 17
  • ADMINISTRATIVE: DIN D = 28
  • ADMINISTRATIVE: DIN F = 10

Biologics

  • NAS: NDS = 230
  • CLIN C&M: NDS = 271
  • CLIN C&M: SNDS = 286
  • CLIN C&M: DIN B = N/A
  • CLIN: NDS = N/A
  • CLIN: SNDS = 283
  • C&M ANDS = N/A
  • C&M: SANDS = N/A
  • C&M: SNDS = 153
  • C&M: DINB = 204
  • COMP C&M: ANDS = N/A
  • COMP C&M: SNDS = 178
  • LABELLING ONLY: SNDS = 45
  • PUBLISHED DATA: SNDS = 284
  • ADMINISTRATIVE: NDS = 37
  • ADMINISTRATIVE: DIN B = N/A
Medical Device Licence Application Fees 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 IVD = 75
  • Class IV Manufacturing Amendment = 75
  • Class IV Significant Amendment = 75
Review 1 (average time in calendar days)
  • Class II New = 15
  • Class III New = 60
  • Class III Near Patient = 54
  • Class III Manufacturing Amendment = 61
  • Class III Significant Amendment = 64
  • Class IV New = 76
  • Class IV Human-Animal Tissue = 70
  • Class IV Near Patient IVD = 48
  • Class IV Manufacturing Amendment = 67
  • Class IV Significant Amendment = 69
Fees for Right to Sell a Licensed Medical Device 20 calendar days from deadline for receipt of annual notification to update the Medical Devices Active License Listing (MDALL) database 99.9% within 20 calendar days
Medical Device Establishment Licensing Fees 120 calendar days to issue / renew licence Average number of days: 31 Days.
Veterinary Drug Evaluation Fees 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 = N/A
  • Emergency Drug Release = 2
Review 1 (average time in calendar days)
  • NDS (including Priority Review) = 352
  • ANDS = 364
  • SNDS = 238
  • SANDS = 187
  • Admin = 19
  • DIN (including changes to DINs) = 125
  • NC = 88
  • ESC = 55
  • Labels = N/A
  • Emergency Drug Release = 2 Days
Vet Drugs fees have not been updated since 1995. As such, they are not subject to the User Fees Act. During the 2015-16 year, there were no consultations on the fees related to Veterinary Drugs. However, should there be any changes proposed, stakeholders will be consulted.

Service standards have been in place for Veterinary Drugs Directorate activities since 2007 and have been published on the departmental web site as part of the Guidance to industry for the Management of Regulatory submissions.
Fees Charged for filing a claim under the Hazardous Material Information Reviews Act All claims registered within seven days of receipt of the completed application package 95% of claims were registered within Seven days of receipt of the complete application package

(The 95% is not subject to the User Fees Act (UFA) and penalties since the fees have not been updated since the UFA came into force).
No consultation took place in 2015-16.

The next consultation on service standards will be held in 2016-17.
Footnote * National Dosimetry Services Product (NDSP), Service and Fee Structure (S&F) Provided timely, responsive and reliable dosimetry services to over 100,000 workers in 12500 client groups (Customers):
  1. Exposure Reported within 45 calendar days of receipt
  2. Dosimeters shipped 10-13 working days prior to exchange date with clients
  3. Dose results for whole body and extremity services reported within internal service standards
  4. Updated account information within two business days
  5. Message call backs ( phone, e-mails) within two business days
Provided timely, accurate and reliable costumer service to 108,623 workers in 13,110 client groups (Customers):
  1. National Dosimetry Services (NDS) processed and reported 546,748 dosimeter readings to client groups with 100% compliance to the 45 days reporting regulatory (CNSC) standard.
  2. NDS shipped out 98% of dosimeters 10-13 working days prior to exchange date.
  3. NDS processed and reported over 546,748 readings with 93% reported within 20-30 business days, depending on the dosimetry service.
  4. NDS processed 27, 497 changes to client group requests ( via Name Lists) with 95.5% completed within 2 business days.
  5. NDS responded to 1807 Client Services voice mail call backs with 92% being addressed within 1 business day.
  6. NDS responded to 2816 emails with 91.4% addressed within 2 business days.
  • NDS negotiates contracts that state service standards as described in section 5.3 of TBS Policy on Service Standards for External Fees.
  • Improvements expected in 2016-2017
  • Remaining manual TLD clients are expected to be transitioned onto the new InLight Nova automated dosimetry service by the end of FY (March 31, 2017).NDS maintained regular contact with Clients through its Call Centre. As well, selected clients were contacted to participate in satisfaction questionnaires or in exit questionnaires when they departed.
  • NDS maintained regular contact with clients through its Call Centre. As well, selected clients were contacted to participate in satisfaction questionnaires or in exit questionnaires when they departed.
  • Improvements implemented in 2015-16:
    • NDS launched the new InLight Nova automated dosimetry service and successfully transitioned about 50% of the manual Thermoluminescent Dosimeter (TLD) clients onto the new dosimetry service
  • Improvement expected in 2016-2017
    • Remaining manual TLD clients are expected to be transitioned onto the new InLight Nova automated dosimetry service by the end of FY (March 31, 2017).
Fees to be paid for Pest Control Product Application Examination Service The performance Standard is 90% of submissions to be processed within the applicable review timelines

PMRA Service Standards:

  • Category A: Review timelines range from 285 to 655 days.
  • Category B: Review timelines range from 158 to 470 days.
  • Category C: Review timelines is 240 days.
  • Category D: Review timelines range from 10 to 247 days
  • Category E: Review timelines range from 30 to 159 days
  • Category A = 87%
  • Category B = 88%
  • Category C = 95%
  • Category D = 92%
  • Category E = 60%

(This is not currently subject to the User Fee Act).

Following consultations in 2014 on changes to proposed fees, and the subsequent Pre-Proposal Notice consultation period, which closed in January 2015, both Houses of Parliament approved the revised user fee proposal tabled by the Minister in the spring of 2015. Publication in the Canada Gazette Part I on the proposed Pest Control Product Fees Regulations is planned to occur in Q1 of fiscal year 2016-17.

(These revised Fees will be subject to the User Fee Act).

Fees to be paid for the 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. Target is for 100% of all fees to manufacture or sell a pest control product in Canada are invoiced by April 30th of each fiscal year.

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

(This is not currently subject to the User Fee Act).

Following consultations in 2014 on changes to proposed fees, and the subsequent Pre-Proposal Notice consultation period, which closed in January 2015, both Houses of Parliament approved the revised user fee proposal tabled by the Minister in the spring of 2015. Publication in the Canada Gazette Part I on the proposed Pest Control Product Fees Regulations is planned to occur in Q1 of fiscal year 2016-17.

(These revised Fees will be subject to the User Fee Act).

Footnote * Employee Assistance Services (EAS)

(Fees are charged through contractual or formally-based agreements between HC and other departments, agencies and federally-regulated organizations.)

Customers are billed by means of IS transactions, JV; invoice and cheques, etc.

Services provided for fees includes:
  • Employee Assistance Programs (EAP)
  • Specialized Organizational Services (SOS)
N.B. The fees are not external but internal to federal government departments and agencies who transfer funds to HC in exchange for the services listed above. The fees are aligned with the overall costs of delivering the services including oversight, quality management, outsourcing, invoicing processing, financial and business processes, auditing of files, training of staff, in accordance to accreditation standards, and departmental support as well as accommodation costs. EAS aims at being 100% cost recovery. No individual client or Canadian is being charged for these services. (1)
As per formal agreement, varies depending on customer organization’s requirements, needs and EAS capacity to meet service levels.

Service Standards include:

  • Less than 5% of incoming to the Crisis and Referral Centre calls go to voicemail.
  • First contact between mental health professional and client is 48 hours.
  • First appointment within three to five business days.
  • Client receives follow-up from counsellor two to three weeks after the last session.
  • Helping 90% of clients achieve problem resolution within EAS short term counselling model.
As per results from customer surveys, client satisfaction surveys, Bell telephone reports, and data collected from affiliate mental health professionals, EAS is meeting all of the service standards outlined in the contractual agreements.
  • Current call volume that are directed to voicemail or choosing the option to hold the line to maintain call priority is less than 5%. Actual rate for 2015-16 indicates that clients were greeted by a live voice is over 95% of calls.
  • First contact between client and councillor within 48 hours of original call is occurring over 95% of cases. Actual rate for 2015-16 was 99.6%.
  • The Quality Assurance periodic check indicates that 90.2% of the counsellors are in compliance with our requirements. Letters are sent to non-compliers and they are re-assessed in the next fiscal period.
  • First appointment within 5 business days is offered in over 97% of cases.
  • The number of clients who received their follow-up from their counsellor in 2015-2016 was 32.9%. This statistic is somewhat skewed as there are cases when clients request that the counsellor not follow-up with them, some clients may not have completed their counselling sessions when the survey was conducted.
  • EAS is helping clients achieve problem resolution without outside referral in 90% of cases.
i) Customers:
  • Federal departments and agencies comprise the majority of EAS’ customer base, and they are consulted on a regular basis. Utilization data is provided bi-annually and annually to each customer organization. Formal agreements to renew contractual or Interdepartmental Letter of Agreement/Memorandum Of Understanding-type agreements are completed every one, two, or three years. Customers are formally surveyed every two years, but contacts are communicated with regularly to ensure satisfaction and build customer relations.
ii) Clients:
  • EAS is the largest provider of EAP to the public sector. EAS handled more than 22,060 cases last fiscal cycle, and provided over 88,000 hours of counselling sessions.
  • Client satisfaction is one of the most key indicators of service quality. For each service delivered, clients are informed that their feedback regarding service quality is valuable and appreciated.
iii) Affiliates:
  • EAS’s network of more than 856 affiliates ensures that EAS has the capacity to offer services across Canada within industry-standard timeframes. This network covers Canada from coast to coast; it forms an invaluable source of feedback regarding service provision with respect to the client base at large.
iv) Legislating/Regulating Bodies:
  • As a government entity, many of EAS practices and procedures regarding finance, human resources and operational management are prescribed by specific policies, regulations and/or laws. As such, EAS is accountable to these rules and must, at regular intervals, report on: the usage of funds; adherence to key legislation, such as Official Languages, Financial Administration Act, and Privacy Act.
v) Staff:
  • Retention of knowledgeable and experienced staff has become a recognized problem in much of the federal public service. EAS, however, has consistently demonstrated a significantly higher level of staff retention when compared with the department as a whole.

Notes:

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
    • DIN A   drug identification number application for a pharmaceutical
    • DIN B   drug identification number application for a biological
    • DIN D   drug identification number application for a disinfectant
    • DIN F   drug identification number application for a Category IV Monograph
    INDS
    Investigational New Drug Submission
    ESC
    Experimental Studies Certificate
    NC
    Notifiable Change
    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

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 ten per cent, 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.

One Pharmaceuticals Drug Evaluation fee line did not meet the performance standard, but did not exceed the target by more than 10%, so there are no penalties incurred. It is:

  1. COMPARATIVE STUDIES C&M / NDS, with a target of 180 days, and a performance of 184 days.

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

  1. Class III Manufacturing Amendment, with a target of 60 days, and a performance of 61 days.
  2. Class III Significant Amendment, with a target of 60 days, and a performance of 64 days.
  3. Class IV New, with a target of 75 days, and a performance of 76 days.

Three Veterinary Drug Evaluation Fee fees lines did not meet the performance standard, but are not subject to the User Fees Act, so there are no penalties incurred. They are:

  1. New Drug Submission (including Priority Review) with a target of 300 days, and a performance of 352 days.
  2. Abbreviated New Drug Submission, with a target of 300 and a performance of 364 days.
  3. Drug Identification Number (including changes to DINs) with a target of 120 and a performance of 125 days.
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