Fees for Examination of an Application for an Establishment Licence: Drugs for Human Use

Fees for Examination of an Application for an Establishment Llicence: Drugs for human use as of April 1, 2020
Item Name of fee Fee as of April 1, 2020
Activity
1 Fabrication – sterile dosage form $41,626
2 Importation $27,359
3 Fabrication – nonsterile dosage form $27,000
4 Distribution $12,560
5 Wholesaling $4,937
6 Packaging/labelling $6,061
7 Testing $2,560
8 Foreign building (Each) $918
Fees for Examination of an Application for an Establishment Licence: Drugs for human use as of April 1, 2019
Fee category Description Fee as of
April 1, 2019
Good Manufacturing Practices Component
A. Fabrication
Basic Fee - $18,107
Each Additional Category - $4,538
Dosage form Classes
2 classes - $9,061
3 classes - $18,107
4 classes - $22,642
5 classes - $27,162
6 classes - $31,686
Each additional class - $1,819
Sterile dosage forms - $9,061
B. Packaging/Labelling
Basic Fee - $12,107
Each Additional Category - $3,026
Dosage form Classes
2 classes - $6,039
3 or more classes - $9,061
C. Importation/Distribution
Basic Fee - $7,551
Each Additional Category - $1,891
Dosage form Classes
2 classes - $3,778
3 or more classes - $7,551
Each fabricator - $1,819
Each additional dosage form class for each fabricator - $917
D. Distribution and Wholesaling
Distribution or Wholesaling Fee - $4,538
E. Testing
Testing Fee - $3,026
Drug Analysis Component
Vaccines Product laboratory analysis activities based on the risks Associated with various broad product types $30,174
Schedule D Drugs which are not vaccines or whole blood and its components $12,073
Drugs for human use that are prescription drugs, controlled drugs or narcotics. $9,061
Drugs for human use, not included in any other item, for which a drug identification number has been assigned $4,538
Drug Identification Numbers for Veterinary Use - -
Dealer's License
Dealer's Licence Fees for the examination of dealer's licence application $5,288
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