Human Drug Establishment Licence

Human Drug Establishment Licensing Fees as of April 1, 2019
Fee Category Description Fee as of
Apri 1, 2018
Fee as of
April 1, 2019
Good Manufacturing Practices Component
A. Fabrication
Basic Fee - $17,751 $18,107
Each Additional Category - $4,449 $4,538
Dosage form Classes
2 classes - $8,883 $9,061
3 classes - $17,751 $18,107
4 classes - $22,198 $22,642
5 classes - $26,629 $27,162
6 classes - $31,064 $31,686
Each additional class - $1,783 $1,819
Sterile dosage forms - $8,883 $9,061
B. Packaging/Labelling
Basic Fee - $11,869 $12,107
Each Additional Category - $2,966 $3,026
Dosage form Classes
2 classes - $5,920 $6,039
3 or more classes - $8,883 $9,061
C. Importation/Distribution
Basic Fee - $7,402 $7,551
Each Additional Category - $1,853 $1,891
Dosage form Classes
2 classes - $3,703 $3,778
3 or more classes - $7,402 $7,551
Each fabricator - $1,783 $1,819
Each additional dosage form class for each fabricator - $899 $917
D. Distribution and Wholesaling
Distribution or Wholesaling Fee - $4,449 $4,538
E. Testing
Testing Fee - $2,966 $3,026
Drug Analysis Component
Vaccines Product laboratory analysis activities based on the risks Associated with various broad product types $29,582 $30,174
Schedule D Drugs which are not vaccines or whole blood and its components $11,836 $12,073
Drugs for human use that are prescription drugs, controlled drugs or narcotics. $8,883 $9,061
Drugs for human use, not included in any other item, for which a drug identification number has been assigned $4,449 $4,538
Drug Identification Numbers for Veterinary Use - - -
Dealer's License
Dealer's Licence Fees for the examination of dealer's licence application $5,184 $5,288
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