Drug Establishment Licence (for Human Use) and Associated Fees

Fees for Examination of an Application for an Establishment Licence: 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 – non-sterile dosage form $27,000
4 Distribution $12,560
5 Wholesaling $4,937
6 Packaging/labelling $6,061
7 Testing $2,560
8 Building Outside Canada (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 - -

The following are fees associated with drug establishment licences but were not part of the recently revised fees under the Cost Recovery Renewal Initiative. The updated fee amounts shown below reflect the annual fee adjustment required by the fee-setting authority governing each fee line.

Fee for Examination of an Application for a Dealer's Licence as of April 1, 2020
Fee category Description Fee as of
April 1, 2019
Fee as of
April 1, 2020
Dealer's Licence Fees for the examination of dealer's licence application $5,288 $5,394

Certificate of a Pharmaceutical Product Fee as of April 1, 2020

The fee for each certificate of a pharmaceutical product (CPP) is $92.00 plus applicable taxes in force (PST & HST) based on the applicant's current address (province).

For information on how to pay the CPP fee, please refer to section 4.3 of the Guidance document on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024).

Relevant guidance documents and forms:

For Drug Establishment Licences

For Dealer's Licences

For Certificates of a Pharmaceutical Product

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