Which measures were implemented in Canada to facilitate the commercialisation of hand sanitizers?
Canada, like France and other countries, chose to implement an interim expedited licensing approach for the production and commercialisation of hand sanitizers. This derogation will be in place until 31st March 2021 unless otherwise indicated by Health Canada.
When the approach expires, production must cease, but existing product stock can be exhausted. The specificities are as follows:
Product Specifications
The interim guidance applies to products that strictly comply with the Health Canada monograph. Specifically, Alcohol-based hand sanitizers containing the following ingredients:
- Ethanol (60-80%)
- Isopropanol (60-75%)
The use of denaturants is recommended, but is not required under this interim approach. However, once this interim approach ceases to be in effect, Health Canada may request confirmation that denaturants will be used in the manufacture of all hand sanitizer products from that point on.
Usually, monograph products are for personal use only. However, given the COVID-19 pandemic, alcohol-based hand sanitizers can be distributed for use in hospitals, clinics, commercial settings and other acceptable facilities. Health Canada must be notified of this intent by email, prior to distribution.
Submission Requirements
These hand sanitizer products continue to require:
- A Site Licence for the Canadian importer or manufacturer
- A Product Licence for each product
- Labelling requirements
The Site and Product Applications require:
- Company Code request
- Cover Letter
- Confirmation of good manufacturing practices
- According to Natural Health Product Regulation, Food and Drug Regulations, or Cosmetic ISO 22716
- Outside of this pandemic situation ISO 22716 would not be accepted
- Site/Product Licence Application Form
Good Manufacturing Practices (GMP)
For this interim approach, certain GMP requirements are waived during this period, specifically:
- Stability testing
- A Quality Assurance Report
- Finished product testing for microbiological contaminants
Regardless of the GMP standard selected, appropriate controls must be in place in order to avoid contamination throughout the entire manufacturing and packaging process.
Adverse Reaction Reporting
Product Licence holders are required to report serious adverse reactions that occur in Canada and internationally. You must report any adverse reactions to Health Canada within 15 days of receiving the information.
Hand sanitizers: essential goods amidst a global pandemic
For several months now, the Covid-19 pandemic has been striking the world. Several countries are subject to shortages of disinfectant, masks and other necessary products in the fight against the virus’s propagation. Health Canada, to ensure the availability of hand sanitizers, chose to facilitate access to products that may not fully meet current regulatory requirements and to expedite approvals of products and site licences.
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