Foreign Site Reference Numbers

Foreign manufacturers planning to export natural health products to Canada face a challenging and somewhat complex procedure based on the requirements of the Natural Health Product Regulations. Foreign sites must be deemed compliant with Health Canada’s Good Manufacturing Practices (GMP) in addition to being listed on an importers site license, all before selling products to Canadians.

Previously,  Health Canada had allowed foreign sites to directly apply to Health Canada for a Foreign Site Reference Number (FSRN). This process involved submitting information on the foreign site’s operations and ability to comply with Canadian GMP. After review of a foreign site’s submission, Health Canada issues an FSRN to foreign sites, which the foreign site can then provide to an importer for use in the importer site license application.

 A foreign site in possession of an FSRN designation could be viewed as more desirable to an importer based on the fact that the foreign site had undergone a partial assessment by Health Canada. Importers may be more likely to form a partnership with foreign sites that have an FSRN in place, as this designation can reduce the document requirements and timelines when awaiting an importer site license approval.

As of February 16, 2026 Health Canada has ended the FSRN process and will no longer accept FSRN applications from foreign sites. Moving forward, the information that would normally support an FSRN must instead be submitted by the importer through the usual site licensing pathway. This effectively removes the option for foreign sites to work directly with Health Canada on their GMP certification.  As per Health Canada’s announcement this move will result in a streamlined approval process with reduced regulatory burden. Health Canada will be better positioned to focus efforts on site license submissions only rather than reviewing both FSRN and site license applications.

The consequence of removing the FSRN option is not necessarily more work. Instead relationships between foreign sites and importers will now require consideration and documentation as early as possible, in order to reduce delays in applying for, and receiving a site license from Health Canada.