Fees for veterinary drugs

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

On this page

• Fees to evaluate a veterinary drug submission
• Master fee files
• Fee to examine an application for an establishment licence
• Fee for the right to sell drugs
• Fee for dealer's licence for controlled drugs and narcotics
• How fees are set and how to pay them

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.

• Veterinary drug submission evaluation fees
• Guidance document: Fees for the review of veterinary drug submissions and applications
• Veterinary drugs: Management of regulatory submissions guidance
• Veterinary drugs submissions applications and fee form [in effect as of April 1, 2024]
  • Veterinary drugs submissions applications and fee form  [in effect until March 31, 2024]

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.

• Guidance on procedures and administrative requirements for master files
• Master file application form
  • Download stylesheet ZIP file
• Fees for drug master files

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.

• Veterinary drug establishment licence fees
• Guidance document: Fees for the review of human and veterinary drug establishment licence applications
• Guidance on drug establishment licences (GUI-0002)
• Drug establishment licence application: Forms and instructions (FRM-0033)
• Management of applications and performance for drug establishment licences (GUI-0127)

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.

• Fees for the right to sell veterinary drugs
• Guidance document: Fees for the right to sell drugs

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

• Guidance documents: Legislation and guidelines for veterinary drugs
• Forms: Applications and submissions for veterinary drug products
• Establishment licences

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.

• Fees for the examination of application for a dealer's licence
• Guidance document: Fees for reviewing applications for dealers' licenses for controlled drugs and substances (veterinary use only)

How fees are set and how to pay them

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

• Fees in Respect of Drugs and Medical Devices Order
• Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations

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.