Hand Sanitizers & COVID-19 – Canada

In light of the unprecedented demand and urgent need for disinfectants and hand sanitizers during the COVID-19 pandemic, Health Canada is temporarily permitting the importation of some supplies that may not fully meet Canadian regulatory requirements under the Food and Drugs Act and its Regulations.

In Canada, disinfectant products are classified as non-prescription drugs and hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients. NHPs and non-prescription drugs typically require authorization from Health Canada before they are sold in Canada and importers require a Drug Establishment Licence for drugs or a Site Licence for NHPs. To help manage the spread of COVID-19, Health Canada will facilitate the importation of 1) products that are already authorized for sale in Canada but are not fully compliant with Health Canada, and 2) products that are not authorized for sale in Canada but are authorized or registered in the United States or an MRA country.

Importers of products that fall under these categories may submit information on the products to allow for immediate import. Interested parties should use the Health Canada Application and Notification Form for Exceptional Release of Disinfectant and Sanitizing Products form to capture the product and shipment details for all NHPs and drug products. Health Canada will work together with the Canada Border Services Agency to facilitate importation. It should be noted that companies are required to maintain records to assist with product recalls if needed. Accepted products will be added to a public communication posted on the Health Canada website. As an added measure, Health Canada is also expediting the review of applications for market authorization related to disinfectants or hand sanitizers. Any COVID-19 related product licence applications will be reviewed using adjusted service standards which will be confirmed in future announcements.