DIN Fee Increase Effective April 1st, 2019

 In news

By: Sarah Calder, Regulatory Affairs Specialist, email

Notice: Fees associated with drug submission applications for Human and Disinfectant Drugs increase April 1st, 2019.

Fees have been updated and forms are available online.

The following submission types and associated fees are in effect April 1st:

Disinfectant Drug$4,480.00
Administrative DIN $338.00
Category IV Monograph/Labeling Standard$1,797.00
Labeling Only$3,238.00

Also coming into effect on this date is the requirement for disinfectant drug submissions under the Administrative DIN pathway to be simply copy products.  Master copies based on the large master product labels will now be submitted under the Labeling Only pathway.

If you have any questions regarding these changes, contact Dell Tech today.

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.




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