{"id":635532,"date":"2020-04-13T08:14:38","date_gmt":"2020-04-13T12:14:38","guid":{"rendered":"https:\/\/www.thecompliancecenter.com\/ca\/?p=635532"},"modified":"2025-01-01T07:00:48","modified_gmt":"2025-01-01T12:00:48","slug":"health-canadas-new-rules-make-things-easier-for-hand-sanitizer-providers","status":"publish","type":"post","link":"https:\/\/www.thecompliancecenter.com\/ca\/help-center\/articles\/health-canadas-new-rules-make-things-easier-for-hand-sanitizer-providers\/","title":{"rendered":"Health Canada\u2019s New Rules Make Things Easier for Hand Sanitizer Providers"},"content":{"rendered":"

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With the onslaught of COVID-19, a warrior has come to the forefront in public health protection \u2013 the humble hand sanitizer. Companies, from <\/span>huge distilleries<\/span><\/a> to small health and beauty firms, want to sell sanitizers to a public eager to be armed with the best protection possible. But this common product, which in pre-virus days was treated as an afterthought, is actually a regulated \u201cdrug\u201d according to both Health Canada and the US Food and Drug Administration. Creating a hand sanitizer is more complicated than dishing up a mix of alcohol and gelling agents. Fortunately, Health Canada is assisting suppliers to do it the right way with a <\/span>new interim measure to expedite access to disinfectants and hand sanitizers<\/span><\/a>.<\/span><\/p>\n

Alcohol-based sanitizers (the typical type of hand sanitizer) are regulated by Health Canada under the \u201c<\/span>Natural Health Products Regulations<\/span><\/a>\u201d (NHPR). These sanitizers contain either ethanol (found in beverage alcohol, which is why distilleries and breweries are capable of making it) or isopropanol (found in rubbing alcohol). The NHPR has strict requirements for quality control and proof of effectiveness \u2013 we don\u2019t want hand sanitizer coming on the market that doesn\u2019t actually protect people. This will, in normal times, require that the manufacturer obtain a Site License and a Product License before selling the sanitizer.\u00a0<\/span><\/p>\n

However, we\u2019re not in normal times, and Health Canada has relaxed the rules in order to increase the supply of sanitizers for the personal use of the public. (Note this doesn\u2019t apply to products specifically for use in medical facilities.) These new rules apply to products that meet Health Canada\u2019s <\/span>Antiseptic Skin Cleaners (Personal Domestic Use)<\/span><\/a> monograph, which lays out known safety and effectiveness data for standard concentrations of ethanol and isopropanol cleaners, so suppliers don\u2019t have to provide data on products already well-known to be safe.<\/span><\/p>\n

Health Canada\u2019s goals are, as they explain:<\/span><\/p>\n

\u201cWhile these products are typically subject to regulatory requirements, such as licensing and bilingual labelling, Health Canada will allow certain products to be sold in Canada under this interim measure, including:<\/span><\/p>\n