Fees for human drugs

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

On this page

• Fee to evaluate human drug submissions
• Master file fees
• Fee to examine an application for an establishment licence
• Fee for the right to sell drugs
• How fees are set and how to pay them

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.

• Guidance on evaluation fees for human drugs and disinfectants
• Human drug (pharmaceutical and biological) submission and application review fees
• Guidance document: Management of drug submissions and applications
• Guidance document: Management of disinfectant drugs applications

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 master files for human drugs

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.

• Drug establishment licensing 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 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.

• Fees for the right to sell drugs for humans
• Guidance document: Fees for the right to sell drugs
• Information sheet: Management of drug company contact and financial account information

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

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

• Guidance documents: Applications and submissions for drug products
• Forms: Applications and submissions for drug products
• Establishment licences

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.