Product Licences & Site Licences – Hand Sanitizers

The Natural and Non-prescription Health Products Directorate of Health Canada has adopted an interim licensing approach to support companies that intend to use their facilities to manufacture, package, or label alcohol-based hand sanitizers in response to the COVID-19 pandemic.

Alcohol-based hand sanitizers containing ethanol and isopropanol are classified as natural health products (NHPs) in Canada. All NHPs sold to Canadians must meet the necessary requirements under the Natural Health Product Regulations. To facilitate the safe and efficient production of NHP hand-sanitizers during the COVID-10 pandemic Health Canada is simplifying the application and review process for both site licenses and product licenses; which are the two licenses that need to be in place before sale of NHPs in Canada.

This temporary approval process applies to products that strictly comply with Health Canada’s Antiseptic Skin Cleanser monograph. The dedicated 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. However given the COVID-19 pandemic alcohol-based hand sanitizers can be distributed for use in hospitals, clinic and commercial settings as long as certain conditions are met.

In order to remove any confusion over the different types of licenses, Health Canada is reminding industry of the following different requirements depending on business plans for NHPs. For those who do not currently manufacture, package and/or label alcohol-based hand sanitizers but intend to manufacture and distribute them an application must be submitted for both a site license and a product license. Groups that wish only to manufacture, package and/or label alcohol-based hand sanitizers on behalf of another company are required to apply for a site license only. And those groups who wish to distribute alcohol -based hand sanitizers made by another company are required to apply for a product licence only.

Note there are several facilities in Canada that have already received their site license for manufacture and import of other natural health products. These site license holders may add an alcohol-based hand sanitizer to their product line-up once they have received the necessary product license.

For all applications, an accurate cover letter will help Health Canada expedite the processing of applications. This interim approach is in effect immediately and will be in effect until March 31, 2021 or until a notice is issued by Health Canada to licence holders (whichever is earliest).