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Drugs and Health Products

Drug Establishment Licence

Drug Establishment Licensing Fees as of April 1, 2014
Fee Category Description Veterinary Drug FeeTable 1 footnote * Human Drug as of April 1, 2013Table 1 footnote * Human Drug as of April 1, 2014Table 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 $16,075 $16,397
Each Additional Category   $1,500 $4,027 $4,108
Dosage form Classes        
2 classes   $3,000 $8,043 $8,204
3 classes   $6,000 $16,075 $16,397
4 classes   $7,500 $20,102 $20,505
5 classes   $9,000 $24,117 $24,600
6 classes   $10,500 $28,133 $28,696
Each additional class   $600 $1,613 $1,646
Sterile dosage forms   $3,000 $8,043 $8,204
B. Packaging/Labelling
Basic Fee   $4,000 $10,748 $10,963
Each Additional Category   $1,000 $2,685 $2,739
Dosage form Classes        
2 classes   $2,000 $5,359 $5,467
3 or more classes   $3,000 $8,043 $8,204
C. Importation/Distribution
Basic Fee   $2,500 $6,701 $6,836
Each Additional Category   $625 $1,676 $1,710
Dosage form Classes        
2 classes   $1,250 $3,351 $3,419
3 or more classes   $2,500 $6,701 $6,836
Each fabricator   $600 $1,613 $1,646
Each additional dosage form class for each fabricator   $300 $812 $829
D. Distribution and Wholesaling
Distribution and Wholesaling Fee   $1,500 $4,027 $4,108
E. Testing
Testing Fee   $1,000 $2,685 $2,739
Drug Analysis Component
Vaccines Product laboratory analysis activities based on the risks Associated with various broad product types N/A $26,791 $27,327
Schedule D Drugs which are not vaccines or whole blood and its components N/A $10,717 $10,932
Drugs for human use that are prescription drugs, controlled drugs or narcotics N/A $8,043 $8,204
Drugs for human use, not included in any other item, for which a drug identification number has been assigned N/A $4,027 $4,108
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 $4,694 $4,788