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User Fees


Name of User Fee Fee Type Fee-setting Authority Reason for Planned Introduction of or Amendment to Fee Effective Date of Planned Change Consultation and Review Process Planned
Authority to Sell Drugs Fees - Amended Regulatory Service (R) Financial Administration Act (FAA) Fees are being amended because:
  • fees have not been revised since originally implemented in 1995-98, while there have been significant cost increases and organizational restructuring
  • Auditor General recommended (2004, 2006) costing and funding be revised
  • the Branch needs to establish a sustainable funding platform, addressing funding shortfalls
2008-09 Building on consultations, the Independent Advisory Panels and the Parliamentary Review of the Fee Proposals conducted in 2007-08, publication of proposed fees is planned in Canada Gazette in 2008-09.
Certificates of Pharmaceutical Product (Drug Export) Fees - Amended Other Goods and Services (O) Ministerial authority to enter into contract
Drug Establishment Licensing Fees - Amended R FAA
Drug Master File Fees - Amended O Ministerial authority to enter into contract
Drug Submission Evaluation Fees - Amended R FAA
Medical Device Licence Application Fees - Amended R FAA
Fees for Right to Sell a Licensed Medical Device - Amended R FAA
Medical Device Establishment Licensing Fees - Amended R FAA
Veterinary Drug Evaluation Fees - Amended R FAA Fees are being reviewed because:
  • they have not been revised since originally implemented in 1996, while there have been significant cost increases and organizational restructuring
  • the Branch needs to establish a sustainable funding platform, addressing funding shortfalls
2010 Fees related to veterinary drug product activities will be undergoing revision, and existing service standards may also be revisited, but no specific proposals or time lines are yet targeted for stakeholders. Consultations with stakeholders will take place prior to implementation.
Natural Health Product Site Licensing Fee - New R FAA Currently charging fees for similar activities for other product lines; will support program delivery; provides direct benefit to licence holder. 2008-09 Building on consultations conducted in late 2007-08, an official fee proposal will be published in early 2008-09, and Independent Advisory Panels will be arranged as required before presenting the proposal to Parliament.
Active Pharmaceutical Ingredient Establishment Licensing Fees - New R FAA
Good Clinical Practice Clinical Trial Site Registration Fee - New R FAA

Additional information is available on the Health Products and Food Branch Cost Recovery Initiative website (http://www.hc-sc.gc.ca/dhp-mps/finance/costs-couts/index_e.html)