Drug Establishment Licence Calculator

From Health Canada

Welcome to Health Canada's Drug Establishment Licensing (DEL) Fee Calculator. This calculator is a guide and provides estimates on current DEL fees.

If the estimated fee total generated by the DEL Fee Calculator for an application differs from actual DEL fees payable as calculated by Health Canada, the latter calculation will apply.

For information on the fees please consult the Fees for the Review of Human and Veterinary Drug Establishment Licence Applications guidance document.

Valid for fiscal year 2024-2025 (April 1, 2024 to March 31, 2025)

Domestic building(s) New domestic building(s)

Ensure to select the most upstream activity for each domestic building. Each building must only be listed once. Ensure to select the most upstream activity for each new domestic building. Each new building must only be listed once.

Estimated fees for domestic building(s): Estimated fees for domestic building(s):
Unique foreign building

For amendment applications, should there be new foreign building(s) associated with the new domestic building to be added to the licence, these foreign building(s) will be charged as part of the Annual Licence Review process.

Unique foreign building - buildings which do not share the same address

If two foreign buildings are located at the same address, the foreign building fee will be payable once only.

For New Applications or Reinstatements, in order to identify the total unique number of foreign buildings, only count a foreign building once even if the foreign buildings conducts activities with both Finished Dosage Forms (FDF) and Active Pharmaceutical Ingredients (API). This will ensure that the fees are not duplicated for the same foreign building.

Unique foreign building - buildings which do not share the same address

If two foreign buildings are located at the same address, the foreign building fee will be payable once only.

For Annual License Review (ALR), in order to identify the total unique number of foreign buildings, only count a foreign building once even if the foreign buildings conducts activities with both Finished Dosage Forms (FDF) and Active Pharmaceutical Ingredients (API). This will ensure that the fees are not duplicated for the same foreign building.

Other information

Small business

Companies must register as a small business before submitting their application. If already registered, ensure the status has not expired prior to submitting. For information on who may qualify and how to register, visit the Small business mitigation for drugs and medical devices: Small business fee reduction measures[https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/small-business-mitigation.html] webpage.

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