Health Canada
Symbol of the Government of Canada
Skip to content | Skip to institutional links

Common menu bar links

Home > Drugs & Health Products > Funding & Fees > Fees in Respect of Human Drugs and Medical Devices

Institutional links

Drugs and Health Products

Drug Establishment Licence

Drug Establishment Licensing Fees as of April 1, 2013
Fee Category Description Veterinary Drug FeeTable 1 footnote * Human Drug as of April 1, 2012 Human Drug as of April 1, 2013Table 1 footnote *

Table 1 footnotes

Table 1 footnote 1

If an establishment has human and vet controlled substances and / or narcotics, then the human fee supersedes the veterinary fee.

Return to table 1 footnote * referrer
Good Manufacturing Practices Component
A. Fabrication
Basic Fee   $6,000 $15,759 $16,075
Each Additional Category   $1,500 $3,948 $4,027
Dosage form Classes        
2 classes   $3,000 $7,885 $8,043
3 classes   $6,000 $15,759 $16,075
4 classes   $7,500 $19,707 $20,102
5 classes   $9,000 $23,644 $24,117
6 classes   $10,500 $27,581 $28,133
Each additional class   $600 $1,581 $1,613
Sterile dosage forms   $3,000 $7,885 $8,043
B. Packaging/Labelling
Basic Fee   $4,000 $10,537 $10,748
Each Additional Category   $1,000 $2,632 $2,685
Dosage form Classes        
2 classes   $2,000 $5,253 $5,359
3 or more classes   $3,000 $7,885 $8,043
C. Importation/Distribution
Basic Fee   $2,500 $6,569 $6,701
Each Additional Category   $625 $1,643 $1,676
Dosage form Classes        
2 classes   $1,250 $3,285 $3,351
3 or more classes   $2,500 $6,569 $6,701
Each fabricator   $600 $1,581 $1,613
Each additional dosage form class for each fabricator   $300 $796 $812
D. Distribution and Wholesaling
Distribution and Wholesaling Fee   $1,500 $3,948 $4,027
E. Testing
Testing Fee   $1,000 $2,632 $2,685
Drug Analysis Component
Vaccines Product laboratory analysis activities based on the risks Associated with various broad product types N/A $26,265 $26,791
Schedule D Drugs which are not vaccines or whole blood and its components N/A $10,506 $10,717
Drugs for Human Use that are listed in Schedule F to the Food and Drug Regulations or that are controlled drugs or narcotics N/A $7,885 $8,043
Drugs for human use, not included in any other item, for which a drug identification number has been assigned N/A $3,948 $4,027
Drug Identification Numbers for Veterinary Use   $250 N/A N/A
Dealer's License
Dealer's Licence Fees for the examination of dealer's licence application $1,750 $4,601 $4,694
Date Modified: 2013-03-18

Top of Page
Important Notices