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User Fees Act 2008-09

**1- Health Products and Foods Branch**
					2008 - 2009					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	8,035	8,162	44,702	120 calendar days to update the Drug Product Database following notification	100% within 120 calendar days	2009-10 2010-11 2011-12	8,035 7,400 12,000	45,989 47,314 48,676
Certificates of Pharmaceutical Product (Drug Export) Fees	Other (O)	Ministerial authority to enter into contract	May 2000	105	110	1,558	5 working days to issue certificate	90% within 5 working days	2009-10 2010-11 2011-12	105 110 200	1,603 1,649 1,696
Drug Establishment Licensing Fees	R	FAA	Dec. 1997	6,014	6,797	15,054	250 calendar days to issue / renew licence	84% licenses issued/renewed within 250 calendar days	2009-10 2010-11 2011-12	6,014 5,500 11,800	15,487 15,933 16,392
Drug Master File Fees	O	Ministerial authority to enter into contract	Jan. 1996	150	170	315	30 calendar days	100% within 30 calendar days	2009-10 2010-11 2011-12	130 100 300	324 334 343
Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products)	R	FAA	Aug. 1995	21,275	22,163	97,942	Review time to first decision (calendar days)	Average review time to first decision (calendar days)	2009-10 2010-11 2011-12	21,000 30,300 41,100	100,762 103,664 106,650
							NDS: Priority NAS = 180 NDS: NOC-C NAS = 200 NDS: NAS = 300 NDS: Clin/C&M=300 NDS: C&M/Labelling = 300 ANDS: C&M/Labelling = 180 ANDS: Comp/C&M = 180 ANDS: Labelling only = 50 SNDS: Priority Clin Only = 180 SNDS: Priority Clin/C&M= 180 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: NAS = 300 NDS: Clin/C&M=300 SNDS: C&M/ Labelling = 180 ANDS: C&M/Labelling = 180 SNDS: Priority Clin/C&M= 180 SNDS: Clin/C&M = 300 SNDS: Clin only = 300 SNDS: Comp/C&M = 180 SNDS: C&M/ Labelling = 180 SNDS: Labelling only = 60 DINB with data = 210 DINB form only = 180	Pharmaceuticals Products NDS: Priority NAS = 179 NDS: NOC-C NAS = 200 NDS: NAS = 283 NDS: Clin/C&M = 283 NDS: C&M/Labelling = 300 ANDS: C&M/Labelling = 167 ANDS: Comp/C&M = 182 ANDS: Labelling only = 49 SNDS: Priority Clin Only = 180 SNDS: Priority Clin/C&M = 79 SNDS: Clin/C&M = 287 SNDS: Clin only = 243 SNDS: Comp/C&M = 194 SNDS: C&M/Labelling = 169 SNDS: Rx to OTC New INDIC = 300 SNDS: Labelling only = 55 SNDS-C: Clin only =309 SANDS: Comp/C&M = 141 SANDS: C&M/Labelling = 160 SANDS: Labelling only = 53 DIN A with data = 423 DIN A form only = 173 DIN D with data = 232 DIN D form only = 223 Biologic Products NDS: Priority NAS = 171 NDS: NAS = 245 NDS: Clin/C&M = 336 NDS: C&M/Labelling = 220 ANDS: C&M/Labelling = 180 SNDS: Priority Clin only = 179 SNDS: Clin/C&M = 287 SNDS: Clin only = 281 SNDS: Comp/C&M = 180 SNDS: C&M/Labelling = 156 SNDS: Labelling only = 57 DIN B with data = 77 DIN B form only = 116
Medical Device Licence Application Fees	R	FAA	Aug.1998	3,500	4,169	16,382	Review time to first decision (calendar days)	Average review time to first decision (calendar days)	2009-10 2010-11 2011-12	3,500 4,900 6,600	16,854 17,339 17,838
Medical Device Licence Application Fees	R	FAA	Aug.1998	3,500	4,169	16,382	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 = 9 Class II amendment = 10 Class II Private Label = 10 Class II Private Label amendment = 12 Class III = 73 Class III amendment = 70 Class IV = 112 Class IV amendment = 103	2009-10 2010-11 2011-12	3,500 4,900 6,600	16,854 17,339 17,838
Fees for Right to Sell a Licensed Medical Device	R	FAA	Aug. 1998	1,800	1,969	4,470	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	2009-10 2010-11 2011-12	1,800 1,700 5,600	4,599 4,731 4,868
Medical Device Establishment Licensing Fees	R	FAA	Jan 2000	2,700	3,627	5,813	120 calendar days to issue / renew licence	95% within 120 calendar days	2009-10 2010-11 2011-12	2,700 2,130 7,900	5,980 6,153 6,330
Veterinary Drug Evaluation Fees	R	FAA	Mar. 1996	600	901	7,798	Review time to first decision (calendar days)	Average review time to first decision (calendar days)	2009-10 2010-11 2011-12	900 910 920	8,023 8,254 8,492
Veterinary Drug Evaluation Fees	R	FAA	Mar. 1996	600	901	7,798	NDS = 300 ABNDS = 300 SNDS = 240 SABNDS = 240 Admin = 90 DIN = 120 NC = 90 IND/ESC = 60 Labels = 45 Emergency Drug Release = 2	NDS = 564 ABNDS = 604 SNDS = 311 SABNDS = 439 Admin = 56 DIN = 125 NC = 114 IND/ESC = 46 Labels = 51 Emergency Drug Release = 100% within 2 days	2009-10 2010-11 2011-12	900 910 920	8,023 8,254 8,492
Subtotal (R)				43,924	47,788	192,161			2009-10 2010-11 2011-12	43,949 51,930 85,920	197,695 203,389 209,246
Subtotal (O)				255	281	1,873			2009-10 2010-11 2011-12	235 210 500	1,927 1,983 2,040
Total				44,179	48,069	194,034			2009-10 2010-11 2011-12	44,184 52,140 86,420	199,622 205,371 211,286

B. Date Last Modified: N/A

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: http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd_e.html
Medical Devices: http://hc-sc.gc.ca/dhp-mps/md-im/applic-demande/pol/mdlapp_demhim_pol_e.html
Veterinary drugs: http://hc-sc.gc.ca/dhp-mps/vet/applic-demande/guide-ld/mors-gspr_pol_e.html

Detailed performance information: http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/perform-rendement/index_e.html

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 Food Branch continues to progress in the development of an updated cost recovery framework and in doing so has taken into consideration comments received in response to the publication of the Official Notice of Fee Proposal for Human Drugs and Medical Devices (July 2007) and the subsequent recommendations of the two Independent Advisory Panels. It is anticipated that the User Fees Proposal (including fees and service standards) will be tabled in Parliament in the fall of 2009 with implementation in the 2010/2011 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)**
				2008 - 2009					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)
Fees to be paid for Pest Control Product Application Examination Service	Regulatory (R)	Pest Control Products Act (PCPA)	April 1997	3,490	4,808	36,572 (includes Health Canada Internal Services allocation)	Target is 90% of submissions in all categories to be processed within time shown. www.pmra-arla.gc.ca/ english/ pdf/pro/ pro9601-e.pdf 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 = 55% Category B = 56% Category C = 88% Category D = 91% Category E = 18% Category A and B submission workload continues to rise. While performance for regulatory actions addressed within services standards have a broad range among all categories, performance for priority submissions targeted to meeting Canadian grower needs as a result of consultations, was 97%	2009-10 2010-11 2011-12	3,490 3,490 3,490	30,430 30,990 31,300 (includes Health Canada Internal Services allocation)
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	3,682	27,928 (includes Health Canada Internal Services allocation)	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 were issued by April 30, 2008 for the 2008-2009 fiscal year.	2009-10 2010-11 2011-12	4,500 4,500 4,500	39,200 40,590 40,320 (includes Health Canada Internal Services allocation)
Total				7,990	8,490	64,500			2009-10 2010-11 2011-12 TOTAL	7,990 7,990 7,990	69,630 71,580 71,620

B. Date Last Modified: N/A

C. Other Information

**3- Corporate Services Branch**
				2008 - 2009					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)
Fees charged for the processing of access requests filed under the Access to Information Act (ATIA)	Other products and services (O)	Access to Information Act	1992	$13K	$7K	$1.6M	Response provided within 30 days following receipt of request; the response time may be extended pursuant to section 9 of the ATIA. The Access to Information Act provides fuller details: http://laws. justice. gc.ca/ en/A-1/ 218072.html.	During fiscal year 2008-2009, Health Canada completed processing 950 (62.6%) of 1517 active requests. Health Canada was able to respond within 30 days or less in 214 (23 percent) of completed cases. The remaining requests were completed within 31 to 60 days in 146 (15 percent) cases, 61 to 120 days in 230 (24 percent) cases and 121 or more days in 360 (38 percent) cases.	2009-10 2010-11 2011-12	10K 10K 10K	$1.4M $1.4M $1.4M
Sub-Total (R) Sub-Total (O) Total					$7K	$1.6M			Sub-total 2009-10 Sub-total 2010-11 Sub-total 2011-12 Total	10K 10K 10K 30K	$1.4M $4.2 M

B. Date Last Modified: N/A

C. Other Information:

Projection based on actual revenue received during FY .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.

Estimated direct cost associated with ATI requests.

Policy on Service Standards for External Fees 2008-2009

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 over 12,700 groups: Registration and inspections of incoming dosimeters within 48 hours Exposures over regulatory limits reported within 24 hours Dosimeters leave NDS premises 10-13 working days prior to exchange date Message call backs (phone, e-mail) within 24 hours Updated account information within 48 hours Additional request dosimeters shipped within 24 hours Exposure Reports for regular service sent out within 10 days of dosimeter receipt	Provided timely, responsive and reliable customer services to over 95,000 workers in 12,500 groups. The standards were met as follows: > 99% Registration & inspection of incoming dosimeters within 48 hours 100% Exposures over regulatory limits reported within 24 hours > 99% Dosimeters leave NDS premises 10-13 working days prior to exchange date > 95% Message call backs done within 24 hours. 83% of incoming calls answered immediately. > 90% Account information updated within 48 hours > 99% Additional request dosimeters shipped within 24 hours 90% Exposure Reports sent out within 10 days of dosimeter receipt	NDS staff were in daily contact with clients via phone, fax and e-mail. More than 35,000 requests were handled related to the client's product and service requirements. These interactions allowed NDS to measure level of service satisfaction as well as insight into new requirements for products and services. NDS expects to implement new products and services April 2010. Client feedback (both complimentary and critical) was addressed as required. Additional information on service was obtained during regular contact sessions with the client and, as required, through exit questionnaires. The total numbers of complaints were reduced to 105, a reduction of 30% since last year. NDS also administered a satisfaction questionnaire to 99 client groups. Based on feedback, about 80% of clients very satisfied with timeliness of service delivery of dosimeters and exposure reports, provision of clear and understandable documents, courteous and polite interactions with the Client Service Representative (CSR) and addressing the client's request to their satisfaction. Areas for improvement focussed on the phone messaging system and delays in reaching a CSR. On a basis of over 500,000 dosimeter readings in 2008-2009, NDS= satisfaction rate is more than 99.5%.
Ship Sanitation Certificate Services (Formerly known as Deratting Services)	Health Canada provides 7-day service in Standard Rate (Designated) Ports and all requests are responded to within 48 hours. See Note 1 below.	732 Ship Sanitation Certificate Inspections were conducted in 2008-2009, out of which 524 were conducted at Standard Rate Ports. All requests were responded to within 48 hours.	Communicated the new fee schedule, and provided information on the IHR 2005, and what is involved with issuing Ship Sanitation Certificates to the Canadian Shipping Federation and the Chamber of Shipping of British Columbia. New fee structure was posted in the Canada Gazette.
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 on any ships with scores of less than 85%. See Note 2	74 Cruise Ship Inspections were conducted in 2008-2009. All final reports were submitted within 10 working days. 1 Cruise Ship did not achieve the 85% score, however it was re-inspected.	Minor changes were made to the Cruise Ship Administrative Guide, and communicated with the Cruise Ship Industry. Annual industry meeting was held in February 2008, which served as a forum to go over the year's inspection results, and to provide feedback on policies and guidelines.
Common Carrier Inspection (e.g. trains, ferries, airports/airlines, seaports)	See Note 3 below.	See Note 4 for reporting of Services Standards for Conveyance Inspection Programs.	Conducted a review exercise of existing policy and guideline documents for Flight Kitchens, On Board and Off Board Passenger Train, Passenger Ferry Food and Sanitation Inspections and Potable Water Inspections, as well as the Cruise Ship Administrative Guide. Draft documents were shared with the industry stakeholders, and meetings were held with individual operators to discuss changes. Annual industry meeting was held in February 2008, which served as a forum to go over the year's inspection results, and to provide feedback on policies and guidelines.
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 includes: 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 to the Crisis and Referral Centre calls go to voicemail. First contact between mental health professional and client is 48 hours. First appointment 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 to each customer (Annual Review and Program Plan), as per formal agreement. Other performance assessments completed regularly (audits, capacity assessments, strategic review, etc.)	Customer survey and meeting with customer at least once a year. Formal agreement to renew contractual (MOU, ILA, Service Agreement, - type agreement) done annually (or every two to three years) for EAP and individually for Organizational Services. Utilization data is provided every six months (minimum) to each customer
NOTE: EAS is now the responsibility of RAPB
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 processing time for orders is 14 working days (from the time the order is received to the delivery of shipment to the recipient).	Dried marihuana Test result requirements were met for all 12 lots distributed. Quality control test results are posted on Health Canada website. The number of pouches distributed was 12,180. The number of returned pouches was 226. Return rate due to product non-satisfaction was 0.8% Cannabis seeds Test result requirements were met for the two (2) lots distributed. The number of seed packets distributed was 550.The number of returned seed packets was 23. Return rate was 4.2% (note that the return rate for seeds may not necessarily be due to non-satisfaction). Processing time was below service standard of 14 working days for all shipment orders of dried marihuana (total 4,234 shipment orders) and Cannabis seeds (total 331 shipment orders)	MMAD staff engages 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 provide 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 the service standards in 2008-2009.

**Note 1:** Service Standards for Ship Sanitation Certificate Services
Day of the Week	Prior Notification Required
Weekday Service	24 hours
Weekend Service	48 hours
Regular Weekend Service	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	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.

Note: The fee for short notice service i.e. less than 24 hours for week days, less than 48 hours for weekends, at both Standard Rate and Non-Standard Rate ports, will be the normal fee plus a 25% surcharge (ie. $937.50).

Note 2: Health Canada publishes scores obtained from the Cruise Ship Inspection Program at: http://www.hc-sc.gc.ca/hl-vs/travel-voyage/general/ship-navire-eng.php

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 at: 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	eriodic inspection done on each passenger train line as determined by MOU between Health Canada and passenger train industry. Final inspection report provided to industry within 10 working days.	31 On-Board Passenger Train inspections were conducted in 2008-2009. 19 were announced inspections, 12 were unannounced. 28 out of 31 (90%) of final inspections reports were submitted within 10 working days of the inspection.
Passenger Train - Off Board	Sanitation inspection done twice a year. Final report provided to industry within 10 working days	10 Off-Board Passenger Train inspections were conducted in 2008-2009. 1 announced and 1 unannounced inspection was conducted at each Employee Service Centre (ESC). All final reports (100%) were submitted within 10 working days of the inspection.
Flight Kitchen	Scheduled number of announced audits per year is based on the number of meals prepared by the kitchen. Final audit inspection report provided within 10 working days of inspection.	18 Flight Kitchen audits were conducted in 2008-2009. 16 out of 18 (89%) final audit/inspection reports were submitted within 10 working days of the inspection.
Ferry B On Board Food	Unannounced inspections as per predetermined contractual obligations. Final inspection report provided within 10 working days of inspection.	83 Food and Sanitation inspections were conducted on passenger ferries in 2008-2009. 77 out of 83 (93%) of final inspection reports were submitted within 10 working days of the inspection.
Ferry B Potable Water	Unannounced inspections as per predetermined contractual obligations. 100% of reports provided within 10 working days.	56 Potable Water inspections were conducted on passenger ferries in 2008-2009. 48 of 56 (86%) of final inspection reports were submitted within 10 working days of the inspection.

B. Other Information

National Dosimetry Services
NDS will be increasing its pricing in 2009-2010 marginally (about 4%) to address cost of living expenses.
In April 2010, NDS is expected to update their products, services and fee schedule to address introduction of new dosimeter products, as well as impacts from financial performance ( ie, cost of living), business capacity ( ie, competition), and client demands and expectations for enhanced levels of other products and services.

2- Regions and Programs Branch (RAPB)

External Fees	Service Standards	Performance Results	Stakeholder Consultations
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 includes: 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: Helping 70% of clients achieve problem resolution within EAS short term counselling model.	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 to each customer (Annual Review and Program Plan), as per formal agreement. Service Standard results: Clients are currently achieving problem resolution in 90% of cases.	Customer survey and meeting with customer at least once a year. Formal agreement to renew contractual (MOU, ILA, Service Agreement, - type agreement) done annually (or every two to three years) for EAP and individually for Organizational Services. Utilization data is provided every six months (minimum) to each customer

3- Health Products and Foods Branch (HPFB)

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 Food Branch continues to progress in the development of an updated cost recovery framework and in doing so has taken into consideration comments received in response to the publication of the Official Notice of Fee Proposal for Human Drugs and Medical Devices (July 2007) and the subsequent recommendations of the two Independent Advisory Panels. It is anticipated that the User Fees Proposal (including fees and service standards) will be tabled in Parliament in the fall of 2009 with implementation in the 2010/2011 fiscal year.
Certificates of Pharmaceutical Product (Drug Export) Fees	5 working days to issue certificate	90% within 5 working days
Drug Establishment Licensing Fees	250 calendar days to issue / renew licence	84% 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) Pharmaceuticals NDS: Priority NAS = 180 NDS: NOC-C NAS = 200 NDS: NAS = 300 NDS: Clin/C&M = 300 NDS: C&M/Labelling = 180 ANDS: C&M/Labelling = 180 ANDS: Comp/C&M = 180 ANDS: Labelling only = 60 SNDS: Priority Clin Only = 180 SNDS: Priority Clin/C&M = 180 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 DIN A with data = 210 DIN A form only = 180 DIN D with data = 210 DIN D form only = 180 Biologics NDS: Priority NAS = 180 NDS: NAS = 300 NDS: Clin/C&M = 300 NDS: C&M/Labelling = 180 ANDS: C&M/Labelling = 180 SNDS: Priority Clin only = 180 SNDS: Clin/C&M = 300 SNDS: Clin only = 300 SNDS: Comp/C&M = 180 SNDS: C&M/Labelling = 180 SNDS: Labelling only = 60 DIN B with data = 210 DIN B form only = 180	NDS: Priority NAS = 179 NDS: NOC-C NAS = 200 NDS: NAS = 283 NDS: Clin/C&M = 283 NDS: C&M/Labelling = 300 ANDS: C&M/Labelling = 167 ANDS: Comp/C&M = 182 ANDS: Labelling only = 49 SNDS: Priority Clin Only = 180 SNDS: Priority Clin/C&M = 79 SNDS: Clin/C&M = 287 SNDS: Clin only = 243 SNDS: Comp/C&M = 194 SNDS: C&M/Labelling = 169 SNDS: Rx to OTC New INDIC = 300 SNDS: Labelling only = 55 SNDS-C: Clin only =309 SANDS: Comp/C&M = 141 SANDS: C&M/Labelling = 16 SANDS: Labelling only = 53 DIN A with data = 423 DIN A form only = 173 DIN D with data = 232 DIN D form only = 223 NDS: Priority NAS = 171 NDS: NAS = 245 NDS: Clin/C&M = 336 NDS: C&M/Labelling = 220 ANDS: C&M/Labelling = 180 SNDS: Priority Clin only = 179 SNDS: Clin/C&M = 287 SNDS: Clin only = 281 SNDS: Comp/C&M = 180 SNDS: C&M/Labelling = 156 SNDS: Labelling only = 57 DIN B with data = 77 DIN B form only = 116
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	Class II = 9 Class II amendment = 10 Class II Private Label = 10 Class II Private Label amendment = 12 Class III = 73 Class III amendment = 70 Class IV = 112 Class IV amendment = 103
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	95% 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	NDS = 564 ABNDS = 604 SNDS = 311 SABNDS = 439 Admin = 56 DIN = 125 NC = 114 IND/ESC = 46 Labels = 51 Emergency Drug Release = 100% within 2 days

B. Other Information: N/A

4- 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. www.pmra-arla.gc.ca/english/pdf/pro/pro9601-e.pdf 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 = 55% Category B = 56% Category C = 88% Category D = 91% Category E = 18% Category A and B submission workload continues to rise. While performance for regulatory actions addressed within services standards have a broad range among all categories, performance for priority submissions targeted to meeting Canadian grower needs as a result of consultations, was 97%	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 in relation to a pest control product.	Target is 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 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.	All stakeholders have been consulted on the service standard for invoicing clients

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. www.pmra-arla.gc.ca/english/pdf/pro/pro9601-e.pdf

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 = 55%

Category B = 56%

Category C = 88%

Category D = 91%

Category E = 18%

Category A and B submission workload continues to rise. While performance for regulatory actions addressed within services standards have a broad range among all categories, performance for priority submissions targeted to meeting Canadian grower needs as a result of consultations, was 97%

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 in relation to a pest control product.

Target is 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 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.

All stakeholders have been consulted on the service standard for invoicing clients