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, 2021
Item Name of fee Fee as of
April 1, 2020
Fee as of
April 1, 2021
Activity
1 Fabrication - sterile dosage form $41,626 $41,647
2 Importation $27,359 $28,975
3 Fabrication - non-sterile dosage form $27,000 $28,308
4 Distribution $12,560 $13,855
5 Wholesaling $4,937 $6,159
6 Packaging/labelling $6,061 $6,049
7 Testing $2,560 $3,194
8 Building Outside Canada (each) $918 $917

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, 2021
Fee category Description Fee as of
April 1, 2020
Fee as of
April 1, 2021
Dealer's Licence Fees for the examination of dealer's licence application $5,394 $5,502

Certificate of a Pharmaceutical Product Fee as of April 1, 2021

The fee for each certificate of a pharmaceutical product (CPP) is $94.00 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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