Table 4a: User Fees Act


1 - Health Products and Foods Branch
  2007 - 2008 Planning Years
A. User Fees Fee Type Fee-setting authority Date Last Modified Forecast Revenue ($000) Actual Revenue ($000) Full Cost ($000) Performance Standard Performance Results Fiscal Year Forecast Revenue ($000) Estimated Full Cost ($000)
Authority to Sell Drugs Fees Regulatory  (R) Financial Administration Act (FAA) Dec.1994 8,000 8,185 35,147 120 calendar days to update the Drug Product Database following notification 100% within 120 calendar days 2008-09
2009-10
2010-11
8,035
18.500
18,988
36,075
37,027
38,005
Certificates of Pharmaceutical Product (Drug Export) Fees Other (O) Ministerial authority to enter into contract May 2000 110 100 397 5 working days to issue certificate 95% certificates issued within 5 working days 2008-09 2009-10 2010-11 105
157
161
408
418
429
Drug Establishment Licensing Fees R FAA Dec. 1997 5,200 5,490 9,403 250 calendar days to issue / renew licence 90% licenses issued/renewed within 250 calendar days 2008-09
2009-10
2010-11
6,014
13,900
14,267
9,651  
9,906
10,168
Drug Master File Fees O Ministerial authority to enter into contract Jan. 1996 130 178 415 30 calendar days 100% within 30 calendar days 2008-09
2009-10
2010-11
150
378
388
425
437
448
Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products) R FAA Aug. 1995 21,000 20,598 70,144 Review time to first decision (calendar days) Average review time to first decision (calendar days) 2008-09
2009-10
2010-11
21,275
49,600
50,909
75,083
77,065
79,099
              NDS: Priority NAS = 180
NDS: NOC-C NAS = 200
NDS: NAS = 300
NDS: Clin/C&M=300
NDS: Comp / C&M = 180
NDS: Labelling only = 60
ANDS: C&M/Labelling = 180
ANDS: Comp/C&M = 180
SNDS: Priority Clin Only = 180
SNDS: NOC-c Clin/ C&M = 300
SNDS: NOC-c Clin Only = 200
SNDS: Clin/C&M = 300
SNDS: Clin only = 300
SNDS: Comp/C&M = 180
SNDS: C&M/ Labelling = 180
SNDS: Rx to OTC New INDIC = 300
SNDS: Labelling only = 60
SNDS-C: Clin only =300
SANDS: Comp / C&M = 180
SANDS: C&M / Labelling = 180
SANDS: Labelling only = 60
DINA with data = 210
DINA form only = 180
DIND with data = 210
DIND form only = 180


NDS: Priority NAS = 180
NDS: Priority Clin/C&M = 180
NDS: NOC-C NAS = 200
NDS: NAS = 300
NDS: Clin/C&M=300
SNDS: Clin/C&M = 300
SNDS: Clin only = 300
SNDS: C&M/ Labelling = 180
DINB with data = 210
DINB form only = 180
Pharmaceutical Products
NDS: Priority NAS = 178
NDS: NOC-C NAS = 199
NDS: NAS = 279
NDS: Clin/C&M = 259
NDS: Comp / C&M = 180
NDS: Labelling only = 34
ANDS: C&M/Labelling = 170
ANDS: Comp/C&M = 174
SNDS: Priority Clin Only = 180
SNDS: NOC-c Clin/ C&M = 295
SNDS: NOC-c Clin Only = 197
SNDS: Clin/C&M = 281
SNDS: Clin only = 257
SNDS: Comp/C&M = 169
SNDS: C&M/ Labelling = 151
SNDS: Rx to OTC New INDIC = 299
SNDS: Labelling only = 54
SNDS-C: Clin only = 268
SANDS: Comp / C&M = 176
SANDS: C&M / Labelling = 176
SANDS: Labelling only = 84
DINA with data = 356
DINA form only = 197
DIND with data = 204
DIND form only = 153

Biologic Products
NDS: Priority NAS = 180
NDS: Priority Clin/C&M = 180
NDS: NOC-C NAS = 200
NDS: NAS = 292
NDS: Clin/C&M = 275
SNDS: Clin/C&M = 265
SNDS: Clin only = 263
SNDS: C&M/ Labelling = 157
DINB with data = 87
DINB form only = 185
     
Medical Device Licence Application Fees R FAA Aug.1998 3,400 3,635 21,351 Time to first decision (calendar days) Time to first decision (calendar days) 2008-09
2009-10
2010-11
3,500
7,200
7,390
21,914
22,493
23,087
Class II = 15
Class II amendment = 15
Class II Private Label = 15
Class II Private Label amendment = 15
Class III = 60
Class III amendment = 60
Class IV = 75
Class IV amendment = 75
Class II = 11
Class II amendment = 9
Class II Private Label = 12
Class II Private Label amendment = 8
Class III = 49
Class III amendment = 48
Class IV = 74
Class IV amendment = 66
Fees for Right to Sell a Licensed Medical Device R FAA Aug. 1998 1,750 1,824 10,519 20 calendar days from deadline for receipt of annual notification to update the Medical Devices Active License Listing (MDALL) database 100% within 20 calendar days 2008-09
2009-10
2010-11
1,800
6,300
6,466
10,796
11,081
11,374
Medical Device Establishment Licensing Fees R FAA Jan 2000 2,163 3,179 5,415 120 calendar days to issue / renew licence 98% licences issued/renewed  within 120 calendar days 2008-09
2009-10
2010-11
2,700
13,900
14,267
5,558  
5,704  
5,855
Veterinary Drug Evaluation Fees R FAA Mar. 1996 600 467 8,152 Review time to first decision (calendar days) Average review time to first decision (calendar days) 2008-09
2009-10
2010-11
600
600
616
8,367
8,588
8,815
NDS 300 ABNDS = 300
SNDS = 240
SABNDS = 240
Admin = 90
DIN = 120
NC = 90
IND/ESC = 60
Labels = 45
Emergency Drug Release = 2
NDS = 562
ABNDS = 474
SNDS = 334
SABNDS = 439
Admin = 43
DIN = 132
NC = 140
IND/ESC = 48
Labels = 47
100+% within 2 days
Subtotal (R)       42,113 43,378 160,131     2008-09 2009-10 2010-11 43,924
110,000
112,904
167,444
171,865
176,402
Subtotal (O) 240 278 812 2008-09
2009-10
2010-11
255
535
549
833
855
878
Total 42,353 43,656 160,943 2008-09
2009-10
2010-11
44,179
110,535
113,452
168,277
172,719
177,280
B. Date Last Modified:
C. Other Information: Acronyms
NDS: New Drug Submission
SNDS: Supplemental New Drug Submission
ANDS/ABNDS: Abbreviated New Drug Submission
SANDS/SABNDS: Supplemental Abbreviated New Drug Submission
DIN: Drug Identification Number Application
INDS: Investigational New Drug Submission
ESC: Experimental Studies Certificate
NC: Notifiable Change
NAS: New Active Substance
OTC: Over the Counter
Rx: Prescription
Clin: Clinuical
Comp: Comparative Bio, Clinical or Pharmacodynamic
C&M: Chemistry and Manufacturing
NOC-C: Notice of Compliance with Conditions
Detailed performance targets Human drugs
Medical Devices
Veterinary drugs

Detailed performance information

Forecast and actual revenue are reported on a modified cash accounting basis. Costing information was developed using the Program Activity Architecture coding structure as directed through Treasury Board.

The Health Products and Foods Branch (HPFB) is actively engaging stakeholders in the development of a cost recovery framework, including relevant service standards. An initial framework of cost recovery fees and service standards was developed in 2006-2007 and presented for consultation in April 2007. Consultations continued in 2007-2008 including the Cost Recovery Framework: Official Notice of Fee Proposal for Human Drugs and Medical Devices followed by a complaints process and the establishment of two Independent Advisory Panels. The proposed fees and service standards are targeted to be tabled in Parliament in the fall of 2008 with implementation in the 2009-2010 fiscal year.

Revised fees and service standards related to veterinary drug product activities are under development, but no specific proposals have been presented to stakeholders.



2 - Pest Management Regulatory Agency (PMRA)
  2007-08 Planning Years
A. User Fee Fee Type Fee-setting Authority Date Last Modified Forecast Revenue ($000) Actual Revenue ($000) Full Cost ($000) Performance Standard Performance Results Fiscal Year Forecast Revenue ($000) Estimated Full Cost ($000)
Fees to be paid for Pest Control Product Application Examination Service Regulatory (R) Pest Control Products Act (PCPA) April 1997 3,490. 4,471. 40,501 (includes Health Canada Internal Services allocation) Target is 90% of submissions in all categories to be processed within time shown.

Category A
Standard - 550 days User Request Minor Use Registration (URMUR) - 365 days

Category B
Standard/priority - 365 days

Category C
Standard - 180 or 225 days

Category D
IMEP - 32 days OUI - 56 days URMULE - 60 days and Master Copy - 21 days

Category E
New Active - Food - 365 days New Active - Non-food - 165 days

Category A = 48%
Category B = 72%
Category C = 88%
Category D = 93%
Category E = 43%

In the first half 2007-08, PMRA registered more new active ingredients (Category A) than in all of 2006-07.
There was also a 40% increase in the number of Category A submissions received and the size and complexity of submissions have increased due to the number of minor uses added to a new active ingredient, as well as the evolving science.

08-09 09-10 10-11 7,990
7,990
7,990
67,461.
69,622
71,683.
  (based on vote net authority) (includes Health Canada Internal Services allocation @ 15,000 each year)
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. R Financial Adminis- tration Act (FAA) April 1997 4,500. 4,641. 26,598. 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. 100% of all invoices issued by April 30th, 2007      
Total       7,990 9,112 67,099     08-09
09-10
10-11
TOTAL
7,990
7,990
7,990
23,970
7,461.
9,622.
1,683.
208,766.
B. Date Last Modified
C. Other Information


3 - Corporate Services Branch
  2007-08 Planning Years
User Fee Fee Type Fee Setting Authority Date Last Modified Forecast Revenue ($000) Actual Revenue ($000) Full Cost ($000) Performance Standard Performance Results1 Fiscal Year Forecast Revenue ($000) Estimated Full Cost ($000)
Fees charged for the processing of access requests filed under the Access to Information Act (ATIA) Other products and service (O) Access to Information Act 1992 $20.93 $12.0 $1,740 Response provided within 30 days following receipt of request; the response time may be extended pursuant to section 9 of the ATIA. Notice of extension to be sent within 30 days after receipt of request. The Access to Information Act provides fuller details. Of the 1,520 requests, 1,164 (76.6%) requests were completed during the 2007-2008 reporting period. The Department was able to respond within 30 days or less in 444 (38.1%) of completed cases. Response times for the remaining cases were 163 (14.0%) within 31 days to 60 days, 260 (22.3%) within 61 to 120 days, and 297 (25.5%) in 121 or more days. 2007-08 $13.00 $1,400
2008-09 $13.00 $1,400
2009-10 $13.00 $1,400
  See note 2 under Section C - Other Information Section Note3 under Section C - Other Information
 
Sub-Total (R)         $0 $0     Sub-total 2007-08 $13.00 $1,400
Sub-Total (O) $12.0 $1,740 Sub-total 2008-09 $13.00 $1,400
Total $12.0 $1,740 Sub-total 2009-10 $13.00 $1,400
      Total $39.00 $4,200
B. Date Last Modified: N/A
C. Other Information:
  1. 1.Projection based on actual revenue received during FY 2006-07.Due to the nature and varying complexity of ATI requests, it is unknown what fees may be applicable until a request is processed. Under certain circumstances, fees may be waived.
  2. 2.Estimated direct cost associated with ATI requests.

Table 4b: Policy on Service Standards for External Fees


1 - Healthy Environments and Consumer Safety Branch (HECS)
External Fee Service Standard Performance Result Stakeholder Consultation
National Dosimetry Services Product, Services and Fee Structure (NDS P, S&F) Provide timely, responsive and reliable customer services to 95,000 workers in 12,700 groups:

i) Registration and inspections of incoming dosimeters within 48 hours

ii) Exposures over regulatory limits reported within 24 hours

iii) Dosimeters leave NDS premises 10-13 working days prior to exchange date

iv) Message call backs (phone, e-mail) within 24 hours

v) Updated account information within 48 hours

vi) Additional request dosimeters shipped within 24 hours

vii) Exposure Reports for regular service sent out within 10 days of dosimeter receipt

Provided timely, responsive and reliable customer services to 95,000 workers in 12,700 groups.  The standards were met as follows:

i) > 99% Registration & inspection of incoming dosimeters within 48 hours

ii) 100%Exposures over regulatory limits reported within 24 hours

iii)   >  99% Dosimeters leave NDS premises 10-13 working days prior to exchange date

iv) >  99% Message call backs done within 24 hours

v)   > 99% Account information updated within 48 hours

vi) >  99% Additional request dosimeters shipped within 24 hours

vii) 65% Exposure Reports sent out within 10 days of dosimeter receipt

NDS staff engage clients on a daily basis through the Call Centre system using phone, e-mail and other communication tools. Nearly 51,000 interactions were completed for purposes of updating client requirements. These interactions allowed NDS to measure levels of service satisfaction as well as gain insight into new requirements for products and services. NDS staff document and assess customer feedback (compliments and criticism) using a centralized electronic database that is accessible by Customer Service staff. Additional information on service is obtained during regular contact sessions with the client and, as required, through exit questionnaires. This year, NDS will be engaging selected clients in a service specific questionnaire. On a basis of over 510,000 dosimeter readings annually, NDS satisfaction rate is more than 99.9%.
Ship Sanitation Certificate Services
(Formerly known as Deratting Services)
Health Canada provides 7-day service in designated ports and all requests are responded to within 48 hours.
See Note 1 below.
100% of requests received were responded to within 48 hours or less. There were no changes to service standards.
Health Canada has implemented a more comprehensive inspection service to comply with the revised International Health Regulations.
The costing analysis was completed.
Cruise Ship Inspection Program Periodic inspections done a minimum of once a sailing season on ships in Canadian waters.
Final reports submitted within 10 working days.
Re-inspection done on any ships with scores of less than 85%.
See Notes 2 and 3 below.
100%
There were no changes to service standards. Health Canada meets with stakeholders on an annual basis to review and discuss any proposed changes to service standards. The standards are consistent with the CDC/VSP (Vessel Sanitation Program) administrative guideline and criteria for inspections, and any changes would be synchronized to harmonize the process with the U.S.
Common Carrier Inspection (e.g. trains, ferries, airports/airlines, seaports) See Note 3 below. See Note 4 below. Service standards are negotiated and included in MOUs/contracts; service standards/MOUs remained unchanged. Stakeholders were consulted at the annual HC-industry meeting.
Employee Assistance Services (EAS)
(Fees are charged through contractual or formally-based agreements between HC and other departments, agencies and federally-regulated organizations.)
Services provided for fees include:
  • Employee Assistance Programs (EAP)
  • Specialized Organizational Services (SOS)
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 calls to the Crisis and Referral Centre go to voicemail;
  • First contact between mental health professional and client is within 48 hours;
  • First appointment is within 3 to 5 business days;
  • Client receives follow-up from counsellor 2 to 3 weeks after the last session.
EAS is an accredited service (EASNA).
Voluntary satisfaction surveys, customer surveys, telephone surveys and follow-ups with clients and customers are done on a regular basis.
Results are shared at year-end with each customer (Annual Review and Program Plan), as per formal agreement.
Other performance assessments are completed regularly (audits, capacity assessments, strategic review, etc.)
Customer survey and meeting with customer are conducted at least once a year. Formal agreement to renew contract (MOU, ILA, Service Agreement), is done annually (or every two to three years) for EAP and individually for SOS.
Utilization data is provided every six months (minimum) to each customer.
Medical Marihuana
Dried marihuana
($5.00 / gram)
Cannabis seeds
($20.00 / packet of 30 seeds)
Dried marihuana
Health Canada provides tested dried marihuana lots prior to distribution to authorized persons.
Cannabis seeds
Health Canada provides tested marihuana seed lots prior to distribution to authorized persons.
Processing time
Health Canada's processing time for orders is 14 working days (from the time the order is received to the delivery of the shipment to the recipient).
Dried marihuana
Test result requirements were met for all 14 lots distributed. Quality control test results are posted on the Health Canada website.
The number of pouches distributed is 8,672.
The number of returned pouches is 263.
Return rate due to product non-satisfaction is 0.78%.
Cannabis seeds
Test result requirements were met for the two lots distributed.
The number of seed packets distributed is 400.
The number of returned seed packets is 19.
Return rate is 4.75%. (Note that the return rate for seeds may not necessarily be due to non-satisfaction.)
Processing time
Processing time was below the service standard of 14 working days for all shipment orders of dried marihuana (2,948 shipment orders) and Cannabis seeds (208 shipment orders).
1MMAD staff engage clients on a daily basis through the Call Centre system using phone, e-mail and other communication tools. Nearly 21,000 interactions were completed for purposes of responding to client requirements. These interactions allowed MMAD to assess the level of service and product satisfaction and gain insight into requests for new and/or different products. MMAD staff document and assess customer feedback (compliments and criticism) using a centralized electronic database.
There were no changes to service standards.
The Medical Marihuana Access Program surveyed qualitatively physicians supporting an application to access marihuana for medical purposes.
The results of the survey indicate that participating physicians support the use of marihuana as a compassionate use medication. Many physicians mentioned that they lack knowledge about marihuana. In 2008-2009, Health Canada will consult physicians on the findings of this report and other aspects of the program.

Note 1: Derat certificates were replaced by Ship Sanitation Certificates in June 2007. Total: 136 Derat certificates and 556 Ship Sanitation Certificates.

See table below for details on service standards.


Service standards
Day of the Week Prior Notification Required
Weekday Service - Designated Ports 24 hours
Weekend Service - Designated Ports 48 hours
Regular Weekend Service - Designated Ports For service on Saturday, notice must be received Thursday by 1300 hours local time.
For service on Sunday, notice must be received Friday by 1300 hours local time.
Holiday Weekend Service - Designated Ports When Friday is the statutory holiday
  • for service on Friday, notice must be received Wednesday by 1300 hours local time;
  • for service on Saturday or Sunday, notice must be received Thursday by 1300 hours local time.
When Monday is the statutory holiday
  • for service on Saturday, notice must be received Thursday by 1300 hours local time;
  • for service on Sunday or Monday, notice must be received Friday by 1300 hours local time.
Prior Notice for Service - Non-designated Ports 72 hours prior notice is requested for service at non-designated ports.

NOTE: The fee for short notice service i.e. less than 24 hours for weekdays, less than 48 hours for weekends, at both designated and non-designated ports, will be the normal fee plus a 25% surcharge.

Note 2: Health Canada publishes scores obtained from the Cruise Ship Inspection Program

Note 3: In regards to service standards, Cruise Ship and Common Carrier Inspections are performed following procedures and protocols that have been published and distributed to clients. Health Canada's protocols are consistent with programs in other countries. Copies of the inspection protocols for these programs may be requested by e-mail from: phb_bsp@hc-sc.gc.ca.

Note 4: Service Standards for Conveyance Inspection Program


Service Standards for Conveyance Inspection Program
Conveyance Inspection Program Service Standard Performance Result
Passenger Train - On Board Periodic inspection is done on each passenger train line as determined by MOU between Health Canada and passenger train industry.
Final inspection report is provided to industry within 10 working days.
100% of reports are provided within 10 working days.
Passenger Train - Off Board Sanitation inspection is done twice a year.
Final report is provided to industry within 10 working days
100% of reports are provided within 10 working days.
Flight Kitchen Scheduled number of announced audits per year is based on the number of meals prepared by the kitchen.
Final audit inspection report is provided within 10 working days of inspection.
100% of reports are provided within 10 working days.
Ferry - On Board Food Unannounced inspections are made as per predetermined contractual obligations.
Final inspection report is provided within 10 working days of inspection.
100% of reports are provided within 10 working days.
Ferry - Potable Water Unannounced inspections are made as per predetermined contractual obligations.
100% of reports are provided within 10 working days.
100% of reports are provided within 10 working days.

B. Other Information

National Dosimetry Services (NDS)
NDS plans to update their products, services and fee schedule in 2008-2009 to address introduction of new dosimeter products, as well as impacts from financial performance (i.e. cost of living), business capacity (i.e. competition), and client demands/expectations for enhanced levels of other products and services.
Medical Marihuana Program

The Medical Marihuana Program was included in the Auditor General of Canada's audit in 2007-2008 for the Management of Fees in Selected Departments and Agencies. In response to the audit findings, Health Canada has committed to:

  • Apply the Corporate Cost Allocation Model to determine the full cost of the Medical Marihuana Program and to establish a schedule on which the full cost of the program will be recalculated; 
  • Review the medical marihuana fee including consideration of changing program costs and the portion of the fee that should accrue to fee payers and taxpayers respectively; and 
  • Consider developing a longer term approach to the fee structure; review the performance information available for the Medical Marihuana Program - what is relevant and how it should be reported. 

As established pursuant to the Policy on Service Standards for External Fees:

  • Service standards may not have received Parliamentary review; and 
  • Service standards may not respect all performance standard establishment requirements under the User Fees Act  (UFA) (e.g. international comparison; independent complaint address) 
  • Performance results are not legally bound to section 5.1 of the UFA regarding fee reductions for underachieved performance. 

2 - Health Products and Food Branch
A. External Fee Service Standard Performance Result Stakeholder Consultation
Authority to Sell Drugs Fees 120 calendar days to update the Drug Product Database following notification 100% within 120 calendar days The Health Products and Foods Branch (HPFB) is actively engaging stakeholders in the development of a cost recovery framework, including relevant service standards. An initial framework of cost recovery fees and service standards was developed in 2006-2007 and presented for consultation in April 2007. Consultations continued in 2007-2008 including the Cost Recovery Framework: Official Notice of Fee Proposal for Human Drugs and Medical Devices followed by a complaints process and the establishment of two Independent Advisory Panels. The proposed fees and service standards are targeted to be tabled in Parliament in the fall of 2008 with implementation in the 2009-2010 fiscal year.
Certificates of Pharmaceutical Product (Drug Export) Fees 5 working days to issue certificate 95% certificates issued within 5 working days
Drug Establishment Licensing Fees 250 calendar days to issue / renew licence 90% licenses issued/renewed within 250 calendar days
Drug Master File Fees 30 calendar days 100% within 30 calendar days
Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products) Review 1 (average time in calendar days)
NDS: Priority NAS = 180
NDS: NOC-C NAS = 200
NDS: NAS = 300
NDS: Clin/C&M=300
NDS: Comp / C&M = 180
NDS: Labelling only = 60
ANDS: C&M/Labelling = 180
ANDS: Comp/C&M = 180
SNDS: Priority Clin Only = 180
SNDS: NOC-c Clin/ C&M = 300
SNDS: NOC-c Clin Only = 200
SNDS: Clin/C&M = 300
SNDS: Clin only = 300
SNDS: Comp/C&M = 180
SNDS: C&M/ Labelling = 180
SNDS: Rx to OTC New INDIC = 300
SNDS: Labelling only = 60
SNDS-C: Clin only =300
SANDS: Comp / C&M = 180
SANDS: C&M / Labelling = 180
SANDS: Labelling only = 60
DINA with data = 210
DINA form only = 180
DIND with data = 210
DIND form only = 180
NDS: Priority NAS = 180
NDS: Priority Clin/C&M = 180
NDS: NOC-C NAS = 200
NDS: NAS = 300
NDS: Clin/C&M=300
SNDS: Clin/C&M = 300
SNDS: Clin only = 300
SNDS: C&M/ Labelling = 180
DINB with data = 210
DINB form only = 180
Review 1 (average time in calendar days)
Pharmaceutical Products
NDS: Priority NAS = 178
NDS: NOC-C NAS = 199
NDS: NAS = 279
NDS: Clin/C&M = 259
NDS: Comp / C&M = 180
NDS: Labelling only = 34
ANDS: C&M/Labelling = 170
ANDS: Comp/C&M = 174
SNDS: Priority Clin Only = 180
SNDS: NOC-c Clin/ C&M = 295
SNDS: NOC-c Clin Only = 197
SNDS: Clin/C&M = 281
SNDS: Clin only = 257
SNDS: Comp/C&M = 169
SNDS: C&M/ Labelling = 151
SNDS: Rx to OTC New INDIC = 299
SNDS: Labelling only = 54
SNDS-C: Clin only = 268
SANDS: Comp / C&M = 176
SANDS: C&M / Labelling = 176
SANDS: Labelling only = 84
DINA with data = 356
DINA form only = 197
DIND with data = 204
DIND form only = 153
Biologic Products
NDS: Priority NAS = 180
NDS: Priority Clin/C&M = 180
NDS: NOC-C NAS = 200
NDS: NAS = 292
NDS: Clin/C&M = 275
SNDS: Clin/C&M = 265
SNDS: Clin only = 263
SNDS: C&M/ Labelling = 157
DINB with data = 87
DINB form only = 185
Medical Device Licence Application Fees Review 1 (average time in calendar days)
Class II = 15
Class II amendment = 15
Class II Private Label = 15
Class II Private Label amendment = 15
Class III = 60
Class III amendment = 60
Class IV = 75
Class IV amendment = 75
Review 1 (average time in calendar days)
Class II = 11
Class II amendment = 9
Class II Private Label = 12
Class II Private Label amendment = 8
Class III = 49
Class III amendment = 48
Class IV = 74
Class IV amendment = 66
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 100% within 20 calendar days
Medical Device Establishment Licensing Fees 120 calendar days to issue / renew licence 98% licenses issued/renewed within 120 calendar days
Veterinary Drug Evaluation Fees Review time to first decision (calendar days)
NDS 300
ABNDS = 300
SNDS = 240
SABNDS = 240
Admin = 90
DIN = 120
NC = 90
IND/ESC = 60
Labels = 45
Emergency Drug Release = 2
Average review time to first decision (calendar days) NDS = 562
ABNDS = 474
SNDS = 334
SABNDS = 439
Admin = 43
DIN = 132
NC = 140
IND/ESC = 48
Labels = 47
100+% within 2 days
Revised fees and service standards related to veterinary drug product activities are under development, but no specific proposals have been presented to stakeholders.
B. Other Information:


3 - Pest Management Regulatory Agency (PMRA)
A. External Fee Service Standard Performance Result Stakeholder Consultation
Fees to be paid for Pest Control Product Application Examination Service Target is 90% of submissions in all categories to be processed within time shown.

Category A
Standard - 550 days User Request Minor Use Registration (URMUR) - 365 days

Category B
Standard/priority - 365 days

Category C
Standard - 180 or 225 days

Category D
IMEP - 32 days
OUI - 56 days
URMULE - 60 days
Master Copy -; 21 days

Category E
New Active - Food - 365 days
New Active - Non-food - 165 days

Category A = 48%
Category B = 72%
Category C = 88%
Category D (Minor Use only) = 93%
Category E = 43%
In the first half of 2007-2008, PMRA registered more new active ingredients (Category A) than in all of 2006-2007. There was also a 40% increase in the number of Category A submissions received. The size and complexity of submissions have increased due to the number of minor uses added to a new active ingredient, as well as the evolving science.
Stakeholder consultation conducted annually when required.
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 (MRL) in relation to a pest control product. Target is 100% of fees for the right or privilege to manufacture or sell a pest control product in Canada to be invoiced by April 30 of each fiscal year. 100% of fees were invoiced by April 30. All stakeholders have been consulted on the proposed service standard for invoicing clients.
B. Other Information: N/A


4- Corporate Services Branch (CSB)
A. External Fee Service Standard Performance Result Stakeholder Consultation
Fees charged for the processing of access requests filed under the Access to Information Act (ATIA) Response provided within 30 days following receipt of request; response time may be extended pursuant to section 9 of the ATIA. Notice of extension to be sent within 30 days of receipt of request.
ATIA
The Department responded within 30 days or less in 626 (38.1%) of completed cases. Response times for the remaining cases were 280 (17.0%) within 31 to 60 days, 400 (24.3%) within 61 to 120 days, and 337 (20.5%) in 121 or more days. Service standards are prescribed by law in the Access to Information Act and the Privacy Act, compliance with which is overseen by the Office of the Information Commissioner. The Treasury Board is also a stakeholder as it is the guardian of the policy and directives around Access to Information and Privacy. The legislation requires the Department to report to Parliament annually.
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