On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices in the Canada Gazette, Part I.
Each year Health Canada’s fees for drugs and medical devices are subject to an annual fee adjustment. The fee adjustment is a cost-recovery practice by the federal government. Cost recovery as defined by Health Canada is “fees charged to recoup a portion, or the entirety, of costs incurred to deliver regulatory programs and ensure businesses pay their fair share.”
The annual fee adjustment is viewed as a common practice amongst international regulators of health products and Health Canada aims to provide license holders with sufficient notice, to allow companies to plan accordingly.
Starting April 1, 2022, Health Canada will be adjusting its human and veterinary drugs and medical devices fees for the fiscal year of 2022–2023 by the Consumer Price Index (CPI), 3.4%. Most of the CPI-adjusted fees are currently being phased in over 4 to 7 years and will therefore be different than those stipulated in the fees order.
Veterinary Drug Dealer’s Licence fees will also be adjusted by the Consumer Price Index. Fees for other regulatory and non-regulatory activities and services, including but not limited to Human Drug Dealer’s Licences, Certificate of Supplementary Protection and Drug Master File, will be subject to the established annual fee for drugs and medical devices increase of 2%.
The associated fee web pages and application forms will be updated to reflect the adjusted fees on the Health Canada website by April 1, 2022.
Furthermore, Health Canada made a prior commitment to engage with stakeholders annually to discuss key elements of cost recovery including performance, costs and program efficiencies. Originally, the Annual Cost Recovery Stakeholder meeting was scheduled to take place in spring 2020.
However, due to the COVID-19 pandemic, the meeting was postponed. The meeting will now take place in February and will consist of four virtual sessions, articulated around specific health products and services. The sessions will take place over Zoom with simultaneous translations available.
How Quality Smart Solutions can help
Our team at Quality Smart Solutions will be attending all the virtual sessions to keep updated with the changing regulations and attend on behalf of our clients, to be able to provide guidance and feedback regarding the adjusted fees for drugs and Medical Devices.
Please reach out to our team if you have any questions about the annual fee adjustment. Please Contact us today or call us at 1-800-396-5144. We look forward to serving you!
Government of Canada, P. W. and G. S. C. (2021, December 10). Government of Canada. Canada Gazette, Part 1, Volume 155, Number 50: Index. Retrieved February 11, 2022, from https://canadagazette.gc.ca/rp-pr/p1/2021/2021-12-11/html/index-eng.html