With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help prevent and reduce the spread of the coronavirus Health Canada is taking action with interim measures to increase the supply of these products. This post is to help answer questions related to these actions and help you make an informed decision as it relates to licensing and marketing your hand sanitizer.

1. What action is Health Canada taking to increase the supply of disinfectants and hand sanitizers?

On March 17, 2020 Health Canada announced actions they take as an interim measure to increase the supply of hand sanitizers and disinfectants.  A summary of these actions can be found here:

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php

On February 16, 2023 Health Canada announced the interim measure for hand sanitizers has expired.

2. I am a distiller of alcoholic beverages in Canada. Do I need any special license to make hand sanitizers?

There are 3 requirements to manufacture and sell hand sanitizers. You must obtain a Natural Product NPN license (if the hand sanitizer is ethanol or isopropyl alcohol based).  Licensing timelines can take 60 to 90 days for this class of natural health products.  Second, you will require a site license to manufacture, package and/or label hand sanitizers.  Third, you will need to obtain a Specially Denatured Alcohol (SDA) registration. This is issued by the Canada Customs and Revenue Agency (CCRA).  Quality Smart Solutions can help you with all 3 of these requirements.

3. Which countries does Health Canada recognize as being licensed and approved hand sanitizers?

As of February 216, 2023 the interim program has expired. As such, Health Canada will not accept authorization in other PIC/S countries as equivalent to sell hand sanitizers in Canada.  Hand sanitizers from those countries must obtain a NPN license.  However, GMP from manufacturers of those countries may help in equivalency to Canada’s GMP requirements.  Countries that are part of the PIC/S scheme are as follows:

These countries are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

4. If I have a hand sanitizer license and/or authorization from one of these countries does this mean I can sell hand sanitizers in Canada?

No, as of February 16, 2023.   A Natural Health Product Number (NPN) or Drug Identification Number (DIN) is required.   You will also need to partner with a Health Canada licensed importer.  Quality Smart Solutions can file your NPN or DIN application.  

5. My hand sanitizer is registered in the United States but my label is based on  FDA regulations. Can I sell this in Canada?

You must obtain a NPN or DIN to sell your hand sanitizer in Canada. We can register your hand sanitizer whether it requires a NPN or DIN.   If your hand sanitizer is a NHP that requires a NPN we can act as your Health Canada importer through our sister company, Quality IMPORT Solutions. 

6. How can Quality Smart Solutions help me?

We can assist you with licensing your hand sanitizer. We have extensive experience having registered over 8000 Natural Health Products successfully obtaining Natural Product Number (NPN) licenses for hundreds of companies worldwide including many hand sanitizer companies.  Our sister company, Quality IMPORT Solutions, is a Health Canada licensed importer of Natural Health Products.  We currently import several hand sanitizer brands.  If you are planning to manufacture your hand sanitizer in Canada we will complete your SDA registration of your facility with CCRA.

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.