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A Site licence is required for manufacturing, packaging, labeling and importing facilities in Canada.
If manufactured, packaged, and labeled at foreign sites, it is the requirement of the importer to obtain a site licence, and provide evidence that products coming from foreign sites are GMP compliant to Canadian standards or equivalent standards.
• Site Licence renewal required every year if licensee has held the licence for less than 3 years.
• Site Licence renewal required every 2 years if licensee has held the licence for more than 3 years but less than 9 years.
• Site Licence renewal required every three years if licensee has held the licence for more than 9 years.
Site Licences FAQ
A Site Licence is a 6-digit number that is given by Health Canada to a facility that demonstrates Good Manufacturing Practices according to the fabrication, packaging, labelling or importing of Natural Health products. A Site Licensed facility must uphold quality operations via the evaluation of its Places, People, Products and Processes.
Facilities that fabricate, package, label, or import a natural health product in Canada requires a Site Licence. To legally sell a Natural Health product in Canada, a Site Licenced facility must be associated with the product.
Health Canada’s performance standards depends on the type of GMP evidence provided and the number of sites. With precleared evidence the review is estimated 35 business days, while using other GMP evidence increases the time to 65 business days for up to 9 sites, and with greater than 9 sites would take 90 business days.
There is no Health Canada fee associated with a Site Licence application.
Yes, a site licence renewal is required. Once every year for years 1-3. Once every two years for years 4-8. Once every 3 years for 9 years+.