This page has been archived.
Information identified as archived on the Web is for reference, research or recordkeeping purposes. It has not been altered or updated after the date of archiving. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats on the "Contact Us" page.
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. |
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 Category B Category C Category D Category E |
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. |
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 |
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:
|
Table 4b: Policy on Service Standards for External Fees
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:
|
As per formal agreement, varies depending on customer organization's requirements, needs and EAS capacity to meet service levels. Service Standards include:
|
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.
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
|
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
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:
As established pursuant to the Policy on Service Standards for External Fees:
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: |
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 Category B Category C Category D Category E |
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 |
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. |