Registering a Hand Sanitizer in Canada

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 In Disinfectants & Sanitizers, Hand Sanitizers

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.

Dell Tech Laboratories
Toll-Free: 1.844.858.5021
Office: 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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Showing 6 comments
  • Roland

    We want to import a good quantity of hand sanitizers to Canada, and we have seen the product sold in Canada before? Does that mean that it already has a license to be imported into Canada, or do we also require to license it first?

    • Dell Tech

      Thank you for your comment. All hand sanitizers in Canada must be registered products. We will reach out to you to see how we can be of assistance.

  • Javad darzi ramandi

    Hello. I order sanitizer from China and don’t know I need Canadian certificate and health license. Now my order here and they need certificate. My sanitizer have FDA certificate. Please help me for release this order . Thanks

  • Paramjit Singh

    I am interested in starting a manufacture and supply of sanitizer in Canada. How can i proceed in this matter, can you guide and help me

  • Javad darzi ramandi

    Hello. How can register sanitizer in Canada. I order sanitizer with NDC number. This is have FDA certificate but I don’t know we need certificate of Canada.
    Please let me know how I can apply for this
    My order Already in Toronto Monday .

  • Dishant, Anuj

    WE want to import hand sanitizer to Canada. We need to know the documentation and certification in order to import.

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