Health Canada
www.hc-sc.gc.ca
Common menu bar links
Cost Recovery Framework: Consultation
Annexe 1
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 155 K)HPFB Fees and Service Standards (2007-08)
Table 1: Submission and Application Evaluation Fees
Table 2: Establishment Licensing Fees
Table 3: Master Files/Certifications
Table 4: Authority to Sell Fees
HPFB service standard: the associated target time(s) for each respective fee category will be met within 10%.
Target Time is the time expected for completion of the target activity described, expressed in calendar days.
Target time shown may be representative of additional target times defined for specific applications related to that fee element e.g. drug submissions for unmet medical needs have shorter time targets than the identified category time target of 300 days - i.e., priority=180 days & NOC/c submissions=200 days as time targets.
More detailed description of specific fee elements, service standard target times and processes can be found in existing product group guidance documents.
Haut de la page| Fee Category | Fee Description | Current Fee | Full Unit Cost | Proposed Fee | Target Time Description | Target Time | ||
|---|---|---|---|---|---|---|---|---|
| Drug Establishment Licensing Fees | ||||||||
| NOTE: The Target Time to issue a licence is 250 for any combination of the activities below. | days to issue a licence | 250 | ||||||
| Good Manufacturing Practices Component | ||||||||
| A. Fabrication Fees | ||||||||
| Basic Fee | $6,000 | $15,450 | $15,450 | |||||
| Each Additional Category | $1,500 | $3,862 | $3,870 | |||||
| Dosage from Classes | ||||||||
| 2 classes | $3,000 | $7,725 | $7,730 | |||||
| 3 classes | $6,000 | $15,450 | $15,450 | |||||
| 4 classes | $7,500 | $19,312 | $19,320 | |||||
| 5 classes | $9,000 | $23,175 | $23,180 | |||||
| 6 classes | $10,500 | $27,037 | $27,040 | |||||
| each additional class | $600 | $1,545 | $1,550 | |||||
| Sterile dosage forms | $3,000 | $7,725 | $7,730 | |||||
| B. Packaging/Labelling Fees | ||||||||
| Basic Fee | $4,000 | $10,300 | $10,300 | |||||
| Each Additional Category | $1,000 | $2,575 | $2,580 | |||||
| Dosage from Classes | ||||||||
| 2 classes | $2,000 | $5,150 | $5,150 | |||||
| 3 or more classes | $3,000 | $7,725 | $7,730 | |||||
| C. Importation/Distribution Fees | ||||||||
| Basic Fee | $2,500 | $6,437 | $6,440 | |||||
| Each Additional Category | $625 | $1,609 | $1,610 | |||||
| Dosage from Classes | ||||||||
| 2 classes | $1,250 | $3,219 | $3,220 | |||||
| 3 classes | $2,500 | $6,437 | $6,440 | |||||
| Each fabricator | $600 | $1,545 | $1,550 | |||||
| Each additional dosage from class for each fabricator | $300 | $772 | $780 | |||||
| D. Distribution and Wholesaling | ||||||||
| Distribution and Wholesaling Fee | $1,500 | $3,862 | $3,870 | |||||
| E. Testing | ||||||||
| Testing Fee | $1,000 | $2,575 | $2,580 | |||||
| F. Good Clinical Practice | ||||||||
| GCP Fee | N/A | $650 | $650 | |||||
| Drug Analysis Component | ||||||||
| Product laboratory analysis activities based on the risks associated with various broad products types. |
||||||||
| Vaccines | $10,000 | $25,750 | $25,750 | |||||
| Schedule D Drugs which are not vaccines or whole blood and its components | $4,000 | $10,300 | $10,300 | |||||
| Drugs for Human Use listed in Schedule F to the Food and Drug Regulations or controlled drugs or narcotics | $3,000 | $7,725 | $7,730 | |||||
| Drugs with DINs or GPS (not included in any other item) | $1,500 | $3,862 | $3,870 | |||||
| Controlled Substances Component | ||||||||
| Controlled Substance Inspection | The Controlled Substances component applies to inspection of security and record keeping of firms Licensed to handle controlled drugs or narcotics. | $1,750 | $4,507 | $4,510 | ||||
| Medical Device Establishment Licensing Fees | ||||||||
| Medical Devices Establishment Licence | $2,120 | $8,467 | $8,470 | days to issue a licence | 120 | |||
| Natural Health Product Site Licence Fees* | ||||||||
| Site Licence Application | An application for a Site Licence, under Section 27 of the NHP Regulations, for the authorization to manufacture, package, label and/or import a NHP. An application may contain multiple sites/addresses to be authorized. Fee is per site/address to be licenced | N/A | $2,103 | $2,110 | days to review an application | 60 | ||
| Site Licence Amendment | An application for amendment to the Site Licence, defined under Section 32 of the NHP Regulations, describing changes to the authorized sites/addresses listed on the Site Licence. Fee is per site/address to be licenced | N/A | $2,009 | $2,010 | days to review an amendment | 60 | ||
| NHP Site Licence Renewal Fee | Renewal of a licence becomes effective on the day after the anniversary of the day on which the Site Licence was issued, according to the renewal schedule under Section 36 of the NHP Regulations. Fee is per site/address to be licenced | N/A | $1,668 | $1,670 | days to review an application | 60 | ||
* With respect to NHP site licences, an address is the physical site at which the activities (manufacturing, packaging, labelling and/or importing) occur. The address relates to the address(es) listed in Part 3 (Canadian Site Information) and Part 4 (Foreign Site Information) of the Site Licence Application Form at which the activities take place.
