Fees for veterinary drugs

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

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Fees to evaluate a veterinary drug submission

Before a veterinary drug is authorized for sale in Canada, Health Canada assesses its efficacy and safety in the intended species as well as human safety.

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

For all other veterinary drug guidance documents and forms for submissions and applications, please consult:

Fee for dealer's licence for controlled drugs and narcotics

A dealer's licence is required for each physical location where activities are conducted with controlled substances. Health Canada has compliance and enforcement programs to ensure that holders or applicants of a dealer's licence comply with all regulatory requirements related to the use of the facility.

How fees are set and how to pay them

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

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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