Fee Proposal for Drugs and Medical Devices

 In news, Regulatory Affairs

Fee Proposal for Drugs and Medical Devices Published for Consultation

By: Teri Dickinson, Manager Regulatory Affairs Group, email

On May 24th, 2018 published the revised proposal for Drugs and Medical Devices based on comments received.  There were a few significant changes in cost structures which will now be phased in over 4 years and a bit of relief for disinfectants.

Current Fee
Formerly Proposed Fee
2019/20 Proposed Fee
2020/21  Proposed Fee
2021/22 Proposed Fee
2022/23 Proposed Fee
Administrative Submission$324$1401$423$529$662$828
Category IV Monograph/Labelling Standard$1726$1901$1584$1584$1584$1584
Full review new Disinfectant with efficacy submission$4305$16,214$5600$7000$8750$10938
Drug Right to Sell annual fee (Disinfectant)$1152$4587$1259$1317$1375$1433

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.

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