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Drugs and Health Products

Drug Establishment Licence

Drug Establishment Licensing Fees as of April 1, 2015
Fee Category Description Veterinary Drug FeeFootnote 1 Human Drug as of April 1, 2014 Fee as of April 1, 2015

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 $16,397 $16,725
Each Additional Category   $1,500 $4,108 $4,191
Dosage form Classes
2 classes   $3,000 $8,204 $8,369
3 classes   $6,000 $16,397 $16,725
4 classes   $7,500 $20,505 $20,916
5 classes   $9,000 $24,600 $25,092
6 classes   $10,500 $28,696 $29,270
Each additional class   $600 $1,646 $1,679
Sterile dosage forms   $3,000 $8,204 $8,369
B. Packaging/Labelling
Basic Fee   $4,000 $10,963 $11,183
Each Additional Category   $1,000 $2,739 $2,794
Dosage form Classes
2 classes   $2,000 $5,467 $5,577
3 or more classes   $3,000 $8,204 $8,369
C. Importation/Distribution
Basic Fee   $2,500 $6,836 $6,973
Each Additional Category   $625 $1,710 $1,745
Dosage form Classes
2 classes   $1,250 $3,419 $3,488
3 or more classes   $2,500 $6,836 $6,973
Each fabricator   $600 $1,646 $1,679
Each additional dosage form class for each fabricator   $300 $829 $846
D. Distribution and Wholesaling
Distribution and Wholesaling Fee   $1,500 $4,108 $4,191
E. Testing
Testing Fee   $1,000 $2,739 $2,794
Drug Analysis Component
Vaccines Product laboratory analysis activities based on the risks Associated with various broad product types N/A $27,327 $27,874
Schedule D Drugs which are not vaccines or whole blood and its components N/A $10,932 $11,151
Drugs for human use that are prescription drugs, controlled drugs or narcotics. N/A $8,204 $8,369
Drugs for human use, not included in any other item, for which a drug identification number has been assigned N/A $4,108 $4,191
Drug Identification Numbers for Veterinary Use   $250 N/A  
Dealer's License
Dealer's Licence Fees for the examination of dealer's licence application $1,750 $4,788 $4,884