In response to the COVID-19 pandemic, Health Canada implemented in March and April 2020 interim measures aimed to facilitate the importation of products that can help to limit the spread of COVID-19 such as alcohol-based hand sanitizers. For companies that desire to support the unprecedented demand of these products, the interim measures enable access to the Canadian market place at different levels – including retail level as well as health care, commercial and industrial settings.
Alcohol-based hand sanitizers containing the following medicinal ingredients are classified as Natural Health Products (NHPs) in Canada and pursuant to the Natural Health Products Regulations (NHPR):
- Ethanol, also known as “anhydrous alcohol”, “ethyl alcohol”, or “grain alcohol”.
- Isopropanol, also known as “isopropyl alcohol” or “2-propanol”.
Under the standard Health Canada approval process, all approved alcohol-based hand sanitizers must meet the various requirements under the NHPR. A Site License (SL) is required to manufacture, package, label and/or import the product along with other regulatory compliance requirements. A Product License (PL), represented by a Natural Product Number (NPN) is required to legally sell, distribute and event to donate the product.
With the interim expedited licensing process, Health Canada is simplifying the application and review process for both site licenses and product licenses. This allow certain products to be sold in Canada, including:
- Products that are authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g. English-only label, different packaging form what was authorized).
- Products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances
Importers of products that fall under the above categories are required to file a notification with Health Canada and submit the product and shipment information prior to importation.
As of May 2020, Health Canada issued an amendment to the interim measures requiring domestic manufacturers and importers of alcohol-based hand sanitizers to comply with the following labeling requirements:
- If the packaging of the imported product is in French-only or English-only, or English or French and another language; importers are required to post the bilingual label text on their website and the website should not contain any additional advertising or claims that are not authorized by Health Canada for these products.
- Importers must provide sellers with a means to inform consumers, at the time of sale, where they can access bilingual information on the product.
- Importers of hand sanitizers approved with unilingual labelling prior to May 2020 must meet the above requirements by June 8, 2020.
- Domestic manufacturers of hand sanitizers must apply the bilingual labelling on the product
The product notification must be approved by Health Canada before the products can be imported. Once approved, the product will be added to the online list of notified products that are permitted to be sold in Canada under interim policies, the complete list is available here.
As added measures, Health Canada is also expediting the review of applications for Site Licenses to manufacture, package, label and/or import and for market authorizations related to hand sanitizers. The four expedited approval channels implemented under the interim expedited process are:
- Companies that do not manufacture, package, label and/or import alcohol-based hand sanitizers and intend to manufacture and distribute these products need to apply for both a Site License and a Product License.
- Companies that intend only to manufacture, package, label and/or import alcohol-based hand sanitizers on behalf of another company need to apply for a Site License only.
- Companies that intend only to distribute alcohol-based hand sanitizers made by another company need to apply for a Product License only.
- If a manufacturer already holds a Site License to manufacture, package, label and/or import a Natural Health Products and intend to add an alcohol-based hand sanitizer to its product line with the intention of distributing the product, the manufacture needs to apply for a Product License only.
If your company is seeking to bring its alcohol-based hand sanitizers into Canada and benefit from the interim measures or obtain both a product and a site license, we are here to help! Contact dicentra for assistance with your products to ensure they meet the requirements and avoid issues with the approval and importation process or, click here to request a quote.
dicentra is a contract research organization and professional consulting firm that specializes in addressing all matters related to safety, quality, and compliance for all product categories in the life sciences and food industries.