Drug Establishment Licenses

Since 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 licensable 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, with few exceptions, foreign companies who want to sell their drug products in Canada, must ship their products directly to the designated Canadian Iimporter who is licensed by Health Canada. DSA can help determine if your firm requires a drug establishment license or if you need to ship to a licensed Canadian Importer.

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