Health Canada’s Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers

Author:  Joe McCarthy, Dell Tech Laboratories Ltd.

To facilitate the safe and efficient production of Natural Health Product (NHP) hand sanitizers during the COVID-19 pandemic, Health Canada has simplified and expedited the application and review processes for both Site Licences and Product Licences.

 TWO LICENCES ARE REQUIRED FOR ALCOHOL-BASED HAND SANITIZERS

 A Product Licence. This is the licence to sell, offer to sell, or even donate or give away the product. Hand sanitizers based on alcohol or isopropyl alcohol are registered as Natural Health Products and will be assigned a Natural Product Number (NPN).

A Site Licence. This is the licence that is required to manufacture, package, label, or import, the hand sanitizer. It is for the actual physical location of the site where the hand sanitizer is manufactured or first received when imported into Canada.

The guidance issued on March 27^th, 2020, advises that applications for alcohol-based hand sanitizers that meet the Antiseptic Skin Cleanser Monograph, the Site Licence, and Product Licence, will be issued within 24 hours.

 The guidance also details that:

• A Site Licence issued will remain valid only while the interim approach is in effect. Following this period, if you wish to maintain a valid Site Licence to produce NHPs, the supporting evidence mentioned above (i.e. Quality Assurance Report, stability testing, finished product testing) will be required as per the Natural Health Product Regulations (NHPR), and the site will be required to meet the Good Manufacturing Practice (GMP) standards outlined in Part 3 of the NHPR.
• This interim approach is in effect immediately, and will be in effect until March 31, 2021 or until a notice is issued by Health Canada to licence holders (whichever is earliest). When the approach expires, production must cease, although existing product stock can be exhausted.

Reference:

Guide on Health Canada’s interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/covid-19-expediated-licensing-alcohol-hand-sanitizer.html