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
Summary of Financial Information for All User Fees and Regulatory Charges
Reporting on the Policy on Service Standards for 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

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
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:

Class III Manufacturing Amendment, with a target of 60 days, and a performance of 61 days.
Class III Significant Amendment, with a target of 60 days, and a performance of 64 days.
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

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

Reporting on the Policy on Service Standards for External Fees

General Information by Fee
A. External Fee	Service standard	Performance Result	Stakeholder Consultation
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): Exposure Reported within 45 calendar days of receipt 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 Updated account information within two business days 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): 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. NDS shipped out 98% of dosimeters 10-13 working days prior to exchange date. NDS processed and reported over 546,748 readings with 93% reported within 20-30 business days, depending on the dosimetry service. NDS processed 27, 497 changes to client group requests ( via Name Lists) with 95.5% completed within 2 business days. NDS responded to 1807 Client Services voice mail call backs with 92% being addressed within 1 business day. 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.
Table footnotes Footnote * Denotes Fees Set by Contract (not subject to User Fees Act). Return to footnote * referrer

Notes:

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
- 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

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:

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:

Class III Manufacturing Amendment, with a target of 60 days, and a performance of 61 days.
Class III Significant Amendment, with a target of 60 days, and a performance of 64 days.
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:

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

Page details

Date modified:: 2016-11-21