Foreign Site Reference Numbers

Health Canada’s Natural Health Product Regulations require natural health products (NHPs) sold in Canada to be manufactured and packaged by a facility in possession of a site license. When NHPs are imported into Canada, the Canadian facility into which products are imported must hold an importer site license. In situations of importing, non-Canadian facilities manufacturing NHPs destined for Canada are not eligible to apply themselves for a site license, however they must be recognized by Health Canada as compliant with Good Manufacturing Practices. These facilities, often referred to as foreign (non-Canadian) facilities are not entitled to apply for a site license themselves because site licensed facilities may only be located in Canada. However Health Canada has created a separate application stream for foreign facilities who wish to independently apply to Health Canada for a foreign site reference number (FSRN) which confirms their site’s compliance with Part 3, Good Manufacturing Practices (GMP) of the Natural Health Product Regulations.

The FSRN application process benefits foreign sites by allowing them to communicate directly to Health Canada, maintaining confidentiality of all provided documentation. The FSRN process can save time for those importers wishing to receive products from an approved FSRN holder. An FSRN is considered pre-cleared evidence when the FSRN is included in an importer’s site licence application and when in place can significantly reduce the review period of site license applications.

FSRN applications must be accompanied by acceptable evidence of GMP compliance to adequately demonstrate the foreign site’s ability to manufacture, package and/or label NHPs in accordance with the requirements outlined in Health Canada’s Natural Health Product Regulations. To maintain the status of the FSRN, FSRN holders must renew and amend their foreign site information, as well as renew their FSRN before the FSRN expiry date.

Any groups intending to apply for an FSRN should pay special attention to Regulations 44 and 52 which cover finished product testing and stability, two key regulations that may not be covered and therefore considered in regions outside of Canada. When the Natural and Non-prescription Health Product Directorate reviews FSRN applications deficient in these sections, an FSRN may still be awarded. However the FSRN will only be a partially compliant one, and these two sections will require attention and completion by the Canadian importer.

Once the foreign site has been issued a reference number, the number can be used immediately to support an importer’s site licence application. All foreign sites to that export NHPs to a particular facility must be listed on that facility’s site licence. Or said another way, the FSRN is not an authorization for direct export of NHPs into Canada. The FSRN holder will engage in a partnership with a licensed Canadian importer in order to export NHPs into Canada.

FSRN holders can provide their number to an unlimited number of Canadian importers as long as the reference number remains valid. FSRN holders will no doubt offer a competitive advantage to potential import partners based on the fact that import facilities need only list the FSRN of suppliers on site license applications, which require less time for review by Health Canada.

Site license holder information is posted publicly on the Health Canada website at https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/site-licensing/list-site-licence-holders/foreign-site.html