TAGS: Toiletries
Health Canada has simplified and expedited licensing approach for the production and distribution of alcohol-based hand sanitizers. It is to support companies that intend to use their facilities to manufacture, package, label or import alcohol-based hand sanitizers in response to the COVID-19 pandemic.
Sanitizers Must Meet NHPR Requirements
Alcohol-based hand sanitizers containing the following medicinal ingredients are natural health products (NHPs) in Canada and are regulated under the Natural Health Products Regulations (NHPR):
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Ethanol also known as “anhydrous alcohol”, “ethyl alcohol”, or “grain alcohol”
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Isopropanol also known as “isopropyl alcohol” or “2-propanol”
All approved alcohol-based hand sanitizers must meet the necessary requirements under the NHPR. A site license is required to manufacture, package, label and/or import an NHP hand sanitizer in Canada. A product license is required to legally distribute or donate the products.
Simplified Application Process for Licenses
To facilitate the safe and efficient production of NHP hand sanitizers, the organization has simplified and expedited the application and review processes for both site and product licenses.
This interim approach applies to products that strictly comply with Health Canada’s Antiseptic Skin Cleansers (Personal Domestic Use) monograph. A monograph sets out pre-cleared information about an ingredient or product. The monograph can be used to support the safety and efficacy of alcohol-based hand sanitizers with a final concentration of 60-80% ethanol or 60-75% isopropanol.
Products licensed through a monograph are generally for personal use only. Given the COVID-19 pandemic, and as part of this interim measure, alcohol-based hand sanitizers can be distributed for use in hospitals, clinics, commercial settings, and other acceptable facilities.
The interim approach is also available to the companies currently holding valid site and/or product licenses that want to contribute to the public health response to the COVID-19 pandemic.
Source: Health Canada