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, 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:
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). Health Canada will expedite the licensing of these products. Second, you will require a site license to manufacture, package and/or label hand sanitizers. Health Canada will expedite this licensing. 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?
The countries where authorization was obtained that Health Canada will accept as equivalent to Canadian regulations, in the interim, include the following:
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?
Yes. A Natural Health Product Number (NPN) or Drug Identification Number (DIN) isn’t required, in the interim, if the hand sanitizer is authorized in one of these countries. You will also need to partner with a Health Canada licensed importer. Quality Smart Solutions can complete a HC Disinfectant Sanitizing Form on your behalf prior to your shipment to Canada.
5. My hand sanitizer is registered in the United States but my label is based on FDA regulations. Can I sell this in Canada?
As an interim measure, if you are registered with the FDA your USA, English only label will be acceptable in Canada. We can complete the HC Disinfecting Santizing Form on your behalf detailing the US registration and the Health Canada importer you would be using.
6. How can Quality Smart Solutions help me?
We can assist you with licensing your hand sanitizer. We have extensive experience having registered over 5000 Natural Health Products successfully obtaining Natural Product Number (NPN) licences 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, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.
How We Can Help
Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.
Contact us today to learn more about how we can support your compliance needs during and after licensing!