Fees for human drugs

Information for the pharmaceutical industry about fees related to human drugs, with links to supporting guidance and forms.

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Fee to evaluate human drug submissions

Before a drug is authorized for sale in Canada, Health Canada assesses its safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, biologics, disinfectants and sanitizers with disinfectant claims.

Master file fees

A master file is a reference that contains information about specific processes or components used in the manufacturing, processing or packaging of a drug. It's a useful way to provide confidential business information to Health Canada when the information isn't available to:

  • the manufacturer of the dosage form, or
  • the sponsors of a:
    • drug submission
    • drug identification number (DIN) application or
    • clinical trial application (CTA)

Health Canada must protect confidential business information in accordance with the Access to Information Act and the Food and Drugs Act.

Fee to examine an application for an establishment licence

Health Canada has facility inspection programs to evaluate whether establishments are complying with regulatory requirements. This evaluation includes the production, importation, testing and distribution of drugs.

Fee for the right to sell drugs

Health Canada monitors human drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to sell human drugs and to maintain those drugs on the Canadian market.

How fees are set and how to pay them

Fees for regulatory activities related to human drugs (pharmaceutical and biological) are charged based on:

For all other human drug guidance documents and forms for submissions and applications, please visit:

Please visit Certificates of supplementary protection (CSP) and applications for information regarding the CSP fee.

For information about paying invoices, refer to How to pay fees.

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