On February 16, 2026, the Health Product Compliance Directorate released Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10, confirming the end of the Foreign Site Reference Number (FSRN) process and clarifying the regulatory treatment of foreign warehouses. This update marks a significant shift in how Good Manufacturing Practices (GMP) evidence for foreign facilities is assessed within Canada’s Natural Health Product (NHP) framework. The decision to end FSRNs aims to simplify administrative steps, reduce duplicative submissions, and align evidence review directly with the existing site licensing pathway.
This article provides an overview of why the change occurred and what NHP companies should anticipate moving forward.
The Role of FSRN in Site Licensing
An FSRN was a unique reference number issued by Health Canada for sites located outside of Canada that manufactured, packaged, or labelled NHPs for the Canadian market. It indicated that the foreign site had undergone a partial assessment and was found compliant with select requirements under Part 3 GMP in the Natural Health Products Regulations.
It is important to note that an FSRN was never required under the Natural Health Products Regulations. It was not equivalent to a site licence for a foreign site and it did not authorize a foreign facility to export NHPs directly into Canada without a licensed Canadian importer. Rather, it functioned as an administrative reference tied to a limited GMP assessment and did not represent the same scope of review applicable to Canadian-based sites.
Why Health Canada Ended the FSRN Process
The February 2026 bulletin explains that the FSRN process no longer supported Health Canada’s objectives of efficiency, clarity, and regulatory consistency. A departmental review concluded that the process was redundant, particularly because GMP evidence from foreign sites is already assessed under the established site licensing program for Canadian-based sites.
By integrating all foreign site GMP submissions into a single pathway, Health Canada aims to eliminate confusion, reduce duplicative administrative steps, and improve predictability for applicants. This consolidation allows regulatory staff to focus on core components of the site licence framework and supports a more transparent and streamlined assessment model. The Department also noted that direct communication with foreign facilities will remain available, when required, to protect confidential information.
What This Change Means for Natural Health Product Companies
Foreign sites that previously relied on the FSRN process to support their addition to a Canadian importer’s site licence will now need to submit the same GMP evidence through the site licensing pathway used by the Canadian partners. As such, the responsibility shifts to ensuring that foreign site GMP evidence is included in the importer’s site licence submission and meets the regulatory requirements and expectations. Applicants should refer to the Site Licensing Guidance Document for the acceptable options for demonstrating foreign site GMP compliance.
Foreign Site GMP Evidence
Foreign sites must now be supported through the importer’s standard site licence submission, using acceptable GMP evidence that aligns with the Natural Health Products Regulations. This approach replaces the former reliance on an FSRN as an administrative reference when listing foreign sites.
Updates to Forms and Guidance
Health Canada has acknowledged that certain materials still cite FSRN authorization as acceptable GMP evidence, including the Harmonized Site Licence and Foreign Site Reference Number Application Form and portions of the Site Licensing Guidance Document. These references are now outdated, and Health Canada has indicated they will be removed from its website as updates are implemented.
Status of Existing FSRNs
For companies that already hold an FSRN, Health Canada will list these numbers as “discontinued” in the Site Licence and Foreign Site Reference Number Holders List. Any new request for an FSRN will be rejected.
Direct Communication With Health Canada
Foreign sites may continue to communicate directly with Health Canada, as needed, using the site licensing email address to support confidentiality of information during review.
Foreign Warehouses Are No Longer Listed on Site Licences
The bulletin also clarifies a long-standing point of confusion for many licence holders: warehouses located outside of Canada do not need to be captured on a Canadian site licence for products to be imported and distributed in compliance with the framework. Going forward, Health Canada will no longer list foreign warehouses on site licences, and any foreign warehouse locations that were previously added will be removed when the licence is next updated, such as during an amendment or renewal.
It is important to interpret this as an administrative change, not a relaxation of the GMP expectations. Foreign warehouses remain part of the regulated supply chain supporting Canadian licence holders, and they must still operate in a manner that meets the applicable requirements.
For warehouses, this means that storage conditions, material segregation and protection measures, pest control, sanitation, distribution records, and other handling controls must continue to meet applicable GMP requirements to maintain product quality and to prevent mix-ups, contamination, or deterioration, notwithstanding that the warehouse address will no longer be listed on the Canadian site licence.
Timeline for Implementation
All changes took effect on February 16, 2026. As of this date, Health Canada no longer accepts FSRN applications or requests to add warehouses located outside of Canada to a site licence. Foreign facilities supporting a Canadian importer must now be supported through the site licensing program using acceptable GMP evidence aligned with NHP regulations.
Alignment With Recent GMP (GUI-0158) Updates
This bulletin aligns closely with Health Canada’s broader objectives outlined in the updated Good Manufacturing Practices Guide for Natural Health Products (GUI-0158), which comes into force on March 4, 2026. Taken together, the message is consistent: GMP oversight for NHPs is to be anchored more firmly within the site licensing program, with clearer expectations that licence holders maintain appropriate, current evidence for the foreign sites and supply chain activities that support their Canadian operations.
By ending the FSRN process and discontinuing the administrative practice of listing foreign warehouses on site licences, Health Canada is consolidating assessment and compliance accountability into one regulated pathway, while reinforcing that GMP obligations remain fully applicable across storage, handling, and quality system controls.
Final Remarks
The end of the FSRN process represents a modernization of Canada’s NHP oversight structure. By removing a duplicative mechanism and consolidating foreign GMP evidence assessment under the existing site licensing framework, Health Canada is promoting clarity and strengthening regulatory consistency. Companies with foreign manufacturing partners should review their GMP evidence packages to ensure alignment with these updated expectations.
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