By: Sarah Calder, Regulatory Affairs Specialist, email
The challenge with hard surface disinfectant registration in Canada is determining the differences in regulations compared with countries like the United States who regulate these products as antimicrobial pesticides with the EPA.
In Canada, hard surface disinfectants are considered drugs and regulated under the Food and Drug Act and Regulations. Specifically, they fall under the Natural and Non-Prescription Health Products Directorate (NNHPD).
Although they are considered drugs under the regulations, hard surface disinfectants have unique exemptions compared to other drugs in Canada. Hard surface disinfectants are exempt from certain requirements such as the Drug Facts Table and Drug Establishment Licensing.
The submission requirements for a disinfectant product are determined by the types of claims specified on the product label and their intended uses and are not required to use a registered source of the active ingredient. Submissions can also be reviewed in a variety of classes, some with reduced timelines (ie. monograph, labeling standard, or Administrative submissions).
If you need support navigating the registration pathway for your disinfectant, contact us today.
Contact:
Dell Tech Laboratories
info@delltech.com
519-858-5021
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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