Health Canada’s COVID-19 Interim Guidance on Hand Sanitizers

by | Aug 19, 2020 | Coronavirus, COVID-19, FDA, Medical Devices, Quality, Regulatory

Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at its peak, NNHPD released an interim guidance for expedited approval of hand sanitizers to help mitigate supply shortages. The expedited process allowed for manufacturers to obtain a site license and a product license by implementing any of the following GMPs:1

  • Part 3 of the NHPR
  • Division 2 of the Food and Drug Regulations
  • Guide to Food Safety, or
  • Good Manufacturing Practices for Cosmetic Products

 

Companies obtaining a site license were also exempted from providing a Quality assurance report or evidence of GMP implementation.

On July 13, 2020, Health Canada rescinded its interim guidance for expedited approval of hand sanitizers and is now processing site license and product license application as per its regular service standards. This means that hand sanitizers must be manufactured, distributed, imported, labeled, and packaged in accordance with Part 3 of the Natural Health Products Regulations (SOR/2003-196).2

Companies obtaining site licenses will have to provide evidence of GMP compliance by either submitting a product report or by submitting certificates of compliance to the other internationally recognized standards. According to Health Canada, product licenses issued under the previous expedited licensing approach were not temporary and remain valid. However, manufacturers, packagers, labelers, and importers will require a valid site license once the regular supply of hand sanitizers stabilizes.2

Companies that received an interim site license under the previous expedited attestation process will be notified when the interim period ends (when the demand for alcohol-based hand sanitizers stabilizes). When notified, companies will have 60 days to stop manufacturing, importing, packaging, labeling or distributing alcohol-based hand sanitizers and apply for a valid site license to continue producing hand sanitizers until they receive a decision on their application.2

Are you planning to sell your hand sanitizer in Canada? Call us today at 248-987-4497 or email us at info@emmainternational.com for more information.


1Health Canada- ARCHIVED: Guide on Health Canada’s interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers retrieved on 08/12/2020 from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/covid-19-expediated-licensing-alcohol-hand-sanitizer/archive-01.html

2Health Canada (July 2020) Licensing approach to produce and distribute alcohol-based hand sanitizers: guidance document retrieved on 08/12/2020 from 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

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This