Health Canada’s Interim Expedited Licencing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers Suspended
By: Joe McCarthy, Lab Service Manager/Senior Regulatory Affairs Specialist, email
Effective immediately Health Canada has suspended the interim measures introduced in March 2020 to enable expedited product and site licencing for alcohol-based hand sanitizers to address the shortage of these products during the coronavirus pandemic.
What does this mean for Site Licences?
No new temporary COVID-19 Site Licence will be issued for the Manufacture, Package, Label, or Import of alcohol-based hand sanitizers.
New Site Licence Applications will require a complete Site Licence application as per Section 28 of the Natural Health Products Regulations including evidence demonstrating compliance with NHP Good Manufacturing Practices (GMP), a stability testing program, and a performance target to issue Site Licences of 35-65 days depending on the type of GMP evidence provided.
Existing temporary COVID-19 Site Licences remain valid until March 31, 2021, or until 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. Health Canada will provide advanced notice to companies that received temporary COVID-19 Site Licences outlining the process to follow should they convert to a permanent Site Licence. As such, no action is required at this time from holders of temporary COVID-19 Site Licences.
What does this mean for Product Licences?
Existing Product Licences authorized under the interim approach are not temporary or interim in nature, as applications were assessed against the requirements of the Antiseptic Skin Cleansers (Personal Domestic Use) monograph. As such, no action is required at this time from Product Licence holders. However, to continue to sell a product after the pandemic, as outlined above, a valid Site Licence will be required for the manufacture, package, label, and/or import.
For New Product Licences, Health Canada will process the applications under the regular service standard for compendial applications (i.e. applications submitted according to a monograph), which is 60 calendar days.
Two Licences are required for Alcohol-based Hand Sanitizers
1. 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 an NPN number.
2. 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.
Contact us for help to get your Hand Sanitizer Product and Site Licence application in today.
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