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Clarifications and requirements regarding the interim measure for Hard Surface Disinfectants and Hand Sanitizers

Clarifications and requirements regarding the interim measure for Hard Surface Disinfectants and Hand Sanitizers

In light of the current COVID-19 pandemic, Health Canada is taking action to increase supplies of disinfectants and hand sanitizers. Regarding the interim measure currently in place for hard surface disinfectants and hand sanitizers, Health Canada has recently provided the following clarifications and additional requirements. 

Labeling requirements

  • Packaging of imported product may be in
    • French-only or,
    • English-only or,
    • English or French and another language
  • Importers are required to post the bilingual label text (English and French) on their website. This website should not contain any additional advertising or claims outside what is authorized for these products.
  • Importers must provide sellers with a means to inform consumers, at time of sale, of where they can access bilingual information on the product. For example, a sticker applied directly to the products, posters, or signage with take-away pamphlets at the point of sale.
  • Domestic manufacturers of these products must use bilingual labelling on the product.
  • Products previously accepted with unilingual labelling under the interim measure will be required to move to bilingual labelling by June 8, 2020.
  • These requirements apply to both DIN or NHP products

Expiry of interim measure

  • Health Canada is monitoring supplies of these products to ensure that Canadians have access to products that limit the spread of COVID-19. Health Canada will lift this interim measure when the regular supply stabilizes.

Relaxed requirements

  • A Drug Establishment Licence (DEL) is not required to import or sell:
    • DIN hand sanitizers
    • DIN hard surface disinfectants considered antimicrobial agents.
  • Health Canada can authorize:
    • use of technical grade ethanol in the manufacture of hand sanitizers
    • the distribution of hands sanitizers containing technical grade ethanol provided that the supplier of the technical grade ethanol is on an approved list.

Health Canada is facilitating the importation of the following disinfectant and sanitizer products: 

  • Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements.
  • Products that are not authorized for sale in Canada but are authorized or registered in the United States, or an MRA country, or a PIC/s country.
  • Importers of these products are required to notify and submit information to Health Canada prior to importation
  • For alcohol-based hand sanitizers, the grade of alcohol used
  • the official language on the product label (French or English or Both)
  • if applicable, the website where the bilingual product label can be found, and the method to be used to inform the consumer at point of sale of the website
  • a copy of the product label that will be distributed in Canada
  • Valid DEL or SL number, if available
  • Name of the logistics company to be used

If you or your company is looking to market your COVID-19-related disinfectants and hand sanitizers in Canada, now is the time act. Quality Smart Solutions has a team of experts who can provide product licensing, label compliance, and import solutions for you. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting over 500 clients worlwide for 14 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada, United States and Mexico. Ask us for details or visit our website at www.qualitysmartsolutions.com.