Health Canada: Fee Increase Proposal

 In news, Regulatory Affairs

Fee Proposal for Drugs and Medical Devices Published for Consultation

By: Teri Dickinson Jenner, Manager, Regulatory Affairs Group, email

Budget 2017 signaled the Government of Canada’s commitment to modernize business fees, stating that “businesses should pay their fair share for the services the Government provides”. Reflecting this commitment, the 2017 Budget Implementation Act replaced the User Fees Act with the Service Fees Act.

This has lead to Health Canada proposing new fees which would apply to regulatory activities related to human drugs, disinfectants, veterinary drugs, and medical devices.

In addition to significant increases to the existing fee structure for Product applications, there are also amendments and right to sell fees. Major changes affecting Disinfectant registrants are:

SubmissionOld FeeNew Fee
Administrative Submission$324$1401
Category IV Monograph/Labelling Standard$1726$1901
Full review of new Disinfectant with efficacy submission$4305$16,214
Drug Right to Sell annual fee$1152$4587

Fees related to food and human natural health products are not part of this proposal. Health Canada will review fees for products that will be part of the Self‐Care Framework, including human natural health products and over‐the‐counter (OTC) products.

Stakeholders are invited to provide feedback on the Fee Proposal For Drugs and Medical Devices by January 4, 2018.

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