This interim approach takes into account the current policies and best practices of foreign regulatory partners as well as recommendations of the World Health Organization (WHO).
The quality of IPA used in manufacturing hand sanitizers must be fit for purpose and meet safety, efficacy and quality requirements in the Natural Health Products Regulations (NHPR). To protect the health and safety of Canadians, we remain committed to our mandate while balancing the need for exceptional measures during the COVID-19 pandemic. It also highlights acceptable formulations and considerations for parties interested in manufacturing IPA-based hand sanitizers during this emergency situation. This document provides further guidance on the quality requirements for IPA used in the production of hand sanitizers. The Guide has useful information on the authorizations required to manufacture, package, label and/or distribute alcohol-based hand sanitizers, including information on the simplified and expedited pathway to obtaining the required authorizations (a product licence and/or a site licence) in the context of the COVID-19 response. Please also refer to the Guide on the licensing approach for the production and distribution of alcohol-based hand sanitizers, which we launched on March 27, 2020. Numerous entities and industries that are not currently regulated by Health Canada have expressed interest in providing additional and/or alternate sources of alcohol for use in the production of hand sanitizers to support the national response to the supply shortage during the COVID-19 pandemic. This document provides information on the use of isopropyl alcohol (IPA) as the medicinal ingredient in alcohol-based hand sanitizers sold in Canada.
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