Health Canada has released a guide document pertaining to the temporary expedited process for the production and distribution of hand sanitizers in Canada. The document highlights acceptable quality grades and medicinal ingredient concentrations, formulation recommendations, details on applications, and also includes contact information for questions on this matter.
Health Canada has provided interim expedited licensing to support facilities to manufacture, package, and label alcohol-based hand sanitizers during this desperate time of need for these products. It should be noted that hand sanitizers containing ethanol labeled as ‘anhydrous alcohol’, ‘ethyl alcohol’, or ‘grain alcohol’ are considered Natural Health Products (NHPs). Hand sanitizers containing isopropanol labeled as ‘isopropyl alcohol’ or ‘2-propanol’ are considered NHPs as well. A Site Licence (SL) is required to import, manufacture, package, or label hand sanitizers in Canada while a Product Licence is required to distribute and sell hand sanitizers. The final hand-sanitizer product should be 60-80% ethanol or 60-75% isopropanol, as per the Antiseptic Skin Cleansers (Personal Domestic Use) Monograph. The hand-sanitizer must also fully comply with the monograph in order to qualify for the expedited process onto the Canadian market. It should be noted that Health Canada still requires the reporting of adverse reactions to products, if any develop. These temporary regulations will be in place until March 31, 2021 or until a statement is made from Health Canada to licence holders regarding timelines and next steps for this interim process.
For Site Licences, companies must state which Good Manufacturing Practices (GMPs) they are attesting to when completing the application. This may be part three of the NHPR, Division 2 of Food and Drug Regulations, Guide to Food Safety, or Good manufacturing Practices for Cosmetic Products. Certain GMPs, such as stability testing and providing GMP evidence such as Quality Assurance Reports (QARs), are temporarily waved. With that being said, facilities should ensure that the appropriate controls are in place to avoid product contamination. The Health Canada guidance document also includes details about Product Licence Applications (PLAs) and instructs to include that the application type is ‘Compendial’ and is a ‘Antiseptic Hand Cleanser’. The primary brand name should indicate generic descriptor of the product as well as alcohol content and should not have any reference to the coronavirus or any specific virus directly. The medicinal ingredients should only include ‘ethanol’, ‘ethyl alcohol’, ‘isopropanol’, or ‘isopropyl alcohol’ within the quality per dosage unit, as indicated above. If these measures and details are properly followed, the Product Licence for the hand sanitizer product should be made available quickly.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.