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NATURAL HEALTH PRODUCTS
NATURAL HEALTH PRODUCTS SITE LICENCE
All companies in Canada who want to manufacture, package, label or import a natural health product for sale must have a Site Licence (SL) that has been issued by Health Canada.
Foreign sites performing these activities must be listed as approved foreign sites on a Canadian Company's SL. It is a violation of the Canadian Food and Drugs Act (FDA) for foreign companies to ship products directly to retailers in Canada. A firm in Canada must be licensed as the designated importer and this Canadian firm is responsible for ensuring compliance with the NHP Regulations for Site Licensing and GMPs.
In order to apply for a SL, you must provide detailed information to the Natural Health Products Directorate (NHPD) which shows that both the domestic Canadian site and any foreign sites are compliant with NHP GMPs.
There are many options for establishing evidence of GMP compliance, including but not limited to the Quality Assurance Report (QAR). MEDERA can either prepare your QAR, or review and update a QAR that has been prepared by your staff.
NHPD reviews your QAR or other evidence of GMP compliance, and if acceptable, will use this as the basis for issuing your Site Licence.
For natural health products, the following activities are subject to NHP site licensing: