Health Canada is currently accepting applications for expedited reviews to obtain a Drug Establishment Licence (DEL) or Site Licence (SL) to conduct activities related to hand sanitizers and disinfectants. Notification is still required to sell these products in Canada and authorization will be granted upon fulfillment of the requirements.
Health Canada recently released a “Guide on Health Canada’s interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers” which is intended to provided information about the interim expedited licensing approach implemented by Health Canada to support companies that intend to use their facilities to manufacture, package, label and/or import alcohol-based hand sanitizers.
Alcohol-based hand sanitizers containing ethanol or isopropanol are natural health products (NHPs) in Canada and are regulated under the Natural Health Products Regulations (NHPR). A Natural Product Number (NPN) must be obtained to legally distribute NHPs. Additionally, an SL is required to manufacture, package, label and/or import an NHP hand sanitizer in Canada.
Health Canada is temporarily authorizing the use of technical-grade ethanol in hand sanitizer products.
High demand for hand sanitizer has led to a shortage of raw materials such as ethanol. Normally, hand sanitizers are made with United States Pharmacopeia (USP) or food-grade ethanol. Health Canada has temporarily modified its rules to allow manufacturers to use other types of ethanol in hand sanitizer products without compromising safety, efficacy, and quality. Technical-grade ethanol may now be used on a short-term case-by-case basis, under specific conditions.
There are some additional labeling requirements for manufacturers taking advantage of this legislative change:
- Clearly indicate that technical-grade ethanol is included as an ingredient;
- Provide specific directions for use and warnings that these products are intended for adult use only, that they should not be used on broken or damaged skin, that they should not be used by women who are pregnant or breastfeeding, and that they should not be inhaled;
- Provide information on how to report adverse reactions to Health Canada.
Health Canada is advising Canadians to always follow the label directions when using alcohol-based hand sanitizers.