By: Sarah Calder, Regulatory Affairs Specialist, email
Does a hand sanitizer require pre-approval in Canada before going to market?
Hand sanitizers, hand sanitizing wipes, and antibacterial hand washes are regulated as over-the-counter drugs or natural health products, dependent on their active ingredient(s). An application for a Drug Identification Number (DIN) or Natural Product Number (NPN) is required to obtain approval before the sale and importation of these types of products in Canada. Efficacy of the products’ antimicrobial action must be verified, although there are options for streamlined applications where only the specific product formulation and label will require government approval before sale in Canada.
As part of the regulation of drugs and natural health products in Canada, the establishments that manufacture, package, label, and import these products require licensing. The standards for good manufacturing practices will require government review and acceptance for Canadian facilities as well as foreign sites.
Are you confused about whether your antimicrobial hand product is a drug or natural health product, or what type of license is required?
Dell Tech has been working in the consulting industry for 40 years providing professional, confidential consulting services to the chemical specialty industry in Canada, the US, Europe, and Asia. Let us assist you through the often-complex regulatory processes in Canada.
Please let us know how we can support your business.
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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.
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