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Drugs and Health Products

Drug Establishment Licence

Drug Establishment Licensing Fees as of April 1, 2016
Fee Category Description Veterinary Drug FeeFootnote 1 Human Drug Fee as of April 1, 2015 Fee as of April 1, 2016

Footnotes

Footnote 1

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

Return to footnote 1 referrer

Good Manufacturing Practices Component
A. Fabrication
Basic Fee   $6,000 $16,725 $17,060
Each Additional Category   $1,500 $4,191 $4,275
Dosage form Classes
2 classes   $3,000 $8,369 $8,537
3 classes   $6,000 $16,725 $17,060
4 classes   $7,500 $20,916 $21,335
5 classes   $9,000 $25,092 $25,594
6 classes   $10,500 $29,270 $29,856
Each additional class   $600 $1,679 $1,713
Sterile dosage forms   $3,000 $8,369 $8,537
B. Packaging/Labelling
Basic Fee   $4,000 $11,183 $11,407
Each Additional Category   $1,000 $2,794 $2,850
Dosage form Classes
2 classes   $2,000 $5,577 $5,689
3 or more classes   $3,000 $8,369 $8,537
C. Importation/Distribution
Basic Fee   $2,500 $6,973 $7,113
Each Additional Category   $625 $1,745 $1,780
Dosage form Classes
2 classes   $1,250 $3,488 $3,558
3 or more classes   $2,500 $6,973 $7,113
Each fabricator   $600 $1,679 $1,713
Each additional dosage form class for each fabricator   $300 $846 $863
D. Distribution and Wholesaling
Distribution and Wholesaling Fee   $1,500 $4,191 $4,275
E. Testing
Testing Fee   $1,000 $2,794 $2,850
Drug Analysis Component
Vaccines Product laboratory analysis activities based on the risks Associated with various broad product types N/A $27,874 $28,432
Schedule D Drugs which are not vaccines or whole blood and its components N/A $11,151 $11,375
Drugs for human use that are prescription drugs, controlled drugs or narcotics. N/A $8,369 $8,537
Drugs for human use, not included in any other item, for which a drug identification number has been assigned N/A $4,191 $4,275
Drug Identification Numbers for Veterinary Use   $250    
Dealer's License
Dealer's Licence Fees for the examination of dealer's licence application $1,750 $4,884 $4,982