Are you an Importer? Do you need a Site license?

Are you an Importer? Do you need a Site license?

Did you know that 71% of Canadians have used natural health products like vitamins and minerals, herbal products, and homeopathic medicines? Canada also classifies many everyday consumer products like antiperspirants, shampoos, facial treatment products and even sunscreens as natural health products. 

Companies must hold a site in order to be allowed to import natural health products (NHPs) in Canada. Health Canada grants site licences to companies based on the review of the documents in their applications and random site inspections. Not only the importer but also the manufacturer, packager and labeler (fabricator) of the NHPs in Canada and outside must follow the good manufacturing practices (GMP) requirements in the Canadian Natural Health Product Regulations (the Regulations) when carrying out their activities.

These requirements are specific for NHPs (“NHP GMPs”). Importers need to prove that the foreign companies that manufacture, package and label the products they import from follow Canadian NHP GMPs. This can be done by Health Canada adding foreign sites to the importer’s site licence once appropriate supporting evidence is submitted to the Directorate for review and approval.

Quality assurance is the area concerned with all aspects of site licence maintenance, and finished product specifications, sampling, testing, including documentation and ultimate release procedures.

Importers need to make sure the products they import have been fabricated under proper conditions and were tested for safety and quality. Importers also need a process in place for product accountability and recalls. The importer’s quality assurance person must ensure that each product is suitable for sale. This regulation ensures that the necessary and relevant tests for finished product and stability testing are carried out and no products are released for sale until their quality has been determined to be adequate by confirming that product specifications are met and the product meets its proposed shelf life.

Unsure if your product needs to be addressed? Don’t worry: our team at Source is here for all your Site licensing, finished product testing and stability testing needs and questions.

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