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
Currently$4,480.00$1,200.00
2020$5,712.00$1,285.00
2023$11,157.00$1,462.00

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?

Contact:
Dell Tech Laboratories
Teri Dickinson
Manager, Regulatory Affairs
519-858-5068
tdickinson@delltech.com


Dell Tech has provided professional, confidential consulting services to the chemical specialty industry in Canada, the USA, Europe and, Asia for the last 39 years. Contact us today for more information.

www.delltech.com

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