Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd.
After two years of extensive engagement, new fees and policies will come into force April 1, 2020 as per the Fee Ministerial Order published May 8, 2019.
Health Canada has been implementing a “Process Improvement Plan” over the last 2 years for its pharmaceutical review program. Health Canada is prepared to deliver on-time performance for all application types by April 2020.
Starting April 1, 2020 new fees will be phased in over the next 4 years for human drugs and 7 years for veterinary drugs. Beginning April 1, 2021 fees will also increase by an amount equivalent to the Consumer Price Index from the previous year. Adjusted fees will be published each year in Canada Gazette and a revised Fee Form will be posted online in March.
Not only are the fees changing but the time at which you pay is also changing. Once your submission has been accepted into first review an invoice will be generated and payment is required within 30 days of receipt of invoice. Interest will be begin to accumulate after 30 days. Right to sell invoices will remain to be issued by October 1.
There will be fee mitigation measures put in place for small businesses which requires registration with Health Canada to be eligible. Details on the registration process for small businesses will be provided during a training session being offered by Health Canada in March 2020.
Other modifications will come into force including product application and establishment licensing processes, these include:
- Updated Application forms
- New Pause the Clock policy - review clock can pause during the review period for cost-recovered submissions/applications
- New performance standards
- Fees credited back for missed performance targets
References:
- Fees in Respect of Drugs and Medical Devices Order: https://laws-lois.justice.gc.ca/eng/regulations/SOR-2019-124/FullText.html