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Drugs and Health Products

Drug Establishment Licence

Drug Establishment Licensing Fees as of April 1, 2017
Fee Category Description Veterinary Drug FeeTable 1 footnote 1 Human Drug Fee as of April 1, 2016 Fee as of April 1, 2017

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 1 referrer

Good Manufacturing Practices Component
A. Fabrication
Basic Fee   $6,000 $17,060 $17,402
Each Additional Category   $1,500 $4,275 $4,361
Dosage form Classes
2 classes   $3,000 $8,537 $8,708
3 classes   $6,000 $17,060 $17,402
4 classes   $7,500 $21,335 $21,762
5 classes   $9,000 $25,594 $26,106
6 classes   $10,500 $29,856 $30,454
Each additional class   $600 $1,713 $1,748
Sterile dosage forms   $3,000 $8,537 $8,708
B. Packaging/Labelling
Basic Fee   $4,000 $11,407 $11,636
Each Additional Category   $1,000 $2,850 $2,907
Dosage form Classes
2 classes   $2,000 $5,689 $5,803
3 or more classes   $3,000 $8,537 $8,708
C. Importation/Distribution
Basic Fee   $2,500 $7,113 $7,256
Each Additional Category   $625 $1,780 $1,816
Dosage form Classes
2 classes   $1,250 $3,558 $3,630
3 or more classes   $2,500 $7,113 $7,256
Each fabricator   $600 $1,713 $1,748
Each additional dosage form class for each fabricator   $300 $863 $881
D. Distribution and Wholesaling
Distribution and Wholesaling Fee   $1,500 $4,275 $4,361
E. Testing
Testing Fee   $1,000 $2,850 $2,907
Drug Analysis Component
Vaccines Product laboratory analysis activities based on the risks Associated with various broad product types N/A $28,432 $29,001
Schedule D Drugs which are not vaccines or whole blood and its components N/A $11,375 $11,603
Drugs for human use that are prescription drugs, controlled drugs or narcotics. N/A $8,537 $8,708
Drugs for human use, not included in any other item, for which a drug identification number has been assigned N/A $4,275 $4,361
Drug Identification Numbers for Veterinary Use   $250    
Dealer's License
Dealer's Licence Fees for the examination of dealer's licence application $1,750 $4,982 $5,082