Drug Establishment Licenses

LicenseSince 1997, every manufacturer, packager, labeller, tester, and importer in Canada is required to apply for and maintain a Canadian Drug Establishment Licence in order to carry out activities in Canada. The Canadian Establishment Licensing requirements also apply to some distributors and wholesalers. DSA Consultants can help you determine if licensing requirements apply to you.

It is important to note that foreign companies who want to sell their drug products in Canada, must ship their products directly to the designated Canadian importer who is licensed by Health Canada. It is a violation of the Canadian Food and Drugs Act (FDA) for foreign companies to ship products directly to Canadian retailers.

If you don’t have a Canadian Importer, DSA Consultants can provide insight and guidance on your options with respect to drug establishment licensing.


Contact us to find out more about our regulatory consulting services or download a free copy of our DSA Whitepaper on marketing a health care product in Canada.

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