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, 2022
Item Name of fee Fee as of
April 1, 2021
Fee as of
April 1, 2022
1 Fabrication - sterile dosage form $41,647 $43,171
2 Importation $28,975 $31,688
3 Fabrication - non-sterile dosage form $28,308 $30,677
4 Distribution $13,855 $15,691
5 Wholesaling $6,159 $7,962
6 Packaging/labelling $6,049 $6,255
7 Testing $3,194 $4,129
8 Building outside Canada (each) $917 $949

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, 2022
Fee category Description Fee as of
April 1, 2021
Fee as of
April 1, 2022
Dealer's Licence Fees for the examination of dealer's licence application $5,502 $5,613
Certificate of a Pharmaceutical Product Fee as of April 1, 2022
Fee category Description Fee as of
April 1, 2021
Fee as of
April 1, 2022
Certificate of a pharmaceutical product (CPP)

Fee for each certificate of a pharmaceutical product

Note: There are also applicable taxes in force (PST & HST) based on the applicant's current address (province).
$94 $96

For more information and on how to pay the CPP fee, please consult: 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

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