Existing Fee Regulations, Guidance Documents

Health Canada is responsible for developing regulations and contracts, within federal legislation and policy, that define the parameters for setting user fees, along with creating supporting policy and guidance documents.

Since 1995, the Health Products and Food Branch has developed regulations to support charging for certain programs and services. Please note that the regulations and other documents listed here may be affected by the final outcomes of the current review being undertaken through the HPFB Cost Recovery Initiative.

Fees and Guidance Documents

• Authority to Sell Drugs Fees Regulations & Guidance Document
• Drug Evaluation Fees Regulations & Guidance Document
• Establishment Licencing Fees Regulations & Guidance Document
• Fees in Respect of Medical Devices Regulations & Guidance Document
• Veterinary Drugs Evaluation Fees Regulations & Guidance Document
• Certificates of Pharmaceutical Product (previously Export Certificate Fees; not in regulation)
• Drug Master File

Other Related Guidance Documents

• How to Pay Fees (HPFB)