Cost recovery is a federal government policy intended to promote more business-like and equitable management of government programs. The policy stipulates that specific individuals or firms, who benefit directly from or cause government activity should bear some or all of the cost of those activities.
Many of Health Canada's regulatory activities represent a direct benefit to or are triggered by companies selling therapeutic products on the Canadian market; therefore, these activities are considered appropriate for cost recovery.
Fees for the Right to Sell Drugs
Master File Fees
- Updated Drug Master File Applications Form [2012-03-13]
- Master File (MF) Application Fee Form for Human Drugs (PDF fillable/saveable - 870 KB) [2017-05-01]
(DOC Version - 67 KB)
Establishment Licence Fees
Submission Evaluation Fees
- Guidance Document - Fees for the Review of Drug Submissions and Applications [2015-12-10]
- Drug Submission - Application Fee Form for Human and Disinfectant Drugs (PDF fillable/saveable - 500 KB) [2017-03-03]
(DOC Version - 113 KB)
Cost Recovery Initiative
In April 2011, the Health Products and Food Branch (HPFB) updated user fees for the human drugs and medical devices regulatory programs, as part of its Cost Recovery Initiative.
Building on and consistent with Health Canada policies and direction, the Cost Recovery Initiative's goal is to develop and implement a cost recovery framework to provide a long-term stable funding source for HPFB's regulatory activities.
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