Hand Sanitizer Regulations
Regulation - First Step is to get the product notification complete. The following is from the Health Canada Program
Note that in order to be eligible for a Notification process, the product itself needs to be registered in a PIC/S or MRA country (e.g. FDA registration number for the product_NDC). In addition, the medicinal ingredients should be captured by the HC’ monograph for antiseptics.
Also note that the foreign label should be used for product imported under the Notification stream and that the only adjustments allowed are:
The summary of the process below:
If you import a hand sanitizer containing ethanol or isopropanol (Natural Health Product), proceed as follows:
In addition, please confirm on the Notification form that the grade of alcohol used in the product is pharmacopoeial or food grade. Consult the attached document "Interim guide on the production of ethanol for use in alcohol based hand sanitizers".
If the product is not imported but manufactured in Canada, a Site Licence and a Product Licence (NPN) are required.
Once You have Completed These Forms
Email to This Address:
Canadian Cosmetic Cluster Team
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