Fees for Human, Disinfectant, and Over-the-Counter Drugs

 In Regulatory Affairs, Uncategorized

By: Teri Dickinson, Regulatory Affairs Group Manager, email

Are you ready for Cost Recovery implementation coming into force on April 1, 2020?  You may want to get your submissions in now.

After two years of extensive engagement, new fees and policies will come into force April 2020 as per the Fee Ministerial Order published this past May.

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.

What fees can I expect to pay?

Disinfectant SubmissionDisinfectant Right to Sell Annual Fees

Not only are the fees changing but the time at which you pay is also changing.  Once your submission has been accepted into the first review an invoice will be generated and payment is required within 30 days.

There will be fee mitigation measures put in place for small businesses, but you must register with Health Canada to become eligible.

What else will change?

  • New fee lines:
    • Clinical or non-clinical data only, in support of safety updates to the labeling
    • Labeling only (generic drugs)
    • Labeling only (Disinfectants)
  • Updated definition of administrative submissions
  • Changes to Clarification Request (Clarifax) timelines
  • Pause the Clock policy

Need help understanding the changes?

Dell Tech Laboratories

Dell Tech has provided professional, confidential consulting services to the chemical specialty

industry in Canada, the USA, Europe, and Asia for the last 40 years.

Contact us today for more information.




Recommended Posts

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.

en_CAEnglish (Canada)
Medical Care Tools Isolated On WhiteMedical Bottles And Pills