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On February 16, 2026, Health Canada announced the immediate elimination of the Foreign Site Reference Number (FSRN) process and the requirement to list foreign warehouses on site licences.
These changes are intended to streamline processes, improve efficiency, and reduce administrative burden, and was communicated through the Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin and was implemented without prior notice to industry.
What has changed?
Effective immediately:
- Foreign sites can no longer submit an FSRN authorization form in support of Good Manufacturing Practices (GMP) evidence.
- Foreign warehouses will no longer appear on site licences.
- New FSRN applications will be refused.
- Existing FSRN holders will be listed as "discontinued" on Health Canada's published list.
Despite the immediate effect of this policy change, Health Canada has not yet updated the site licence application forms or associated guidance documents. These materials are now considered outdated and will be removed from the website "in the near future."
GMP evidence requirements for all foreign sites
It is important to note that GMP evidence has always been required for each foreign site referenced on a site licence under the Natural Health Products Regulations (NHPR). The elimination of the FSRN process does not introduce a new GMP requirement. Rather, it removes the administrative mechanism that allowed foreign sites to submit an FSRN Authorization Form to facilitate the use of pre-cleared evidence across multiple importers.
Under the revised policy, foreign sites must now provide GMP evidence as part of each importer's site licence application.
GMP evidence includes:
- Pre-cleared GMP evidence:
- GMP certificate from a qualified authority or a Quality Assurance Report (QAR), or
- Certain third-party certifications (e.g., NSF International Standard 173, Section 8 or UL Dietary Supplement GMP Certificate) may partially meet pre-cleared evidence requirements when supported by the required documents.
Where pre-cleared evidence is not available, a Quality Assurance Report (QAR) may be submitted. Noting that Health Canada expects the QAR to include:
- Relevant standard operating procedures (e.g., product release, recalls, testing, stability).
- Records supporting finished product release.
- Testing documentation (e.g., certificates of analysis).
- Stability data and related records.
Implications of eliminating the FSRN process
While FSRNs were not required under the NHPR and did not serve as site licences for foreign sites, they provided practical efficiencies for industry. In particular, FSRNs:
- Allowed direct communication with Health Canada.
- Reduced administrative burden for foreign sites working with multiple importers.
- Enabled the ability to use an approved FSRN as pre-cleared evidence for shorter service standards.
However, Health Canada has stated that discontinuing the FSRN process will better align GMP evidence review with the site licensing process, reduce confusion, and help prevent delays. In practical terms, importers that previously relied on FSRNs should plan for increased coordination with foreign manufacturers and packagers to obtain full GMP evidence packages for each site licence application or amendment. In cases where multiple importers rely on the same foreign site, they may experience an increased administrative burden due to repeated evidence submissions.
It also remains unclear how confidential communications with foreign sites will be managed going forward. While Health Canada stated its intention to maintain confidentiality with foreign sites, updated guidance on this process has not yet been published.
Removal of foreign warehouses from site licences
Health Canada has also removed the requirement to list foreign warehouses on site licences.
Previously approved listings will be removed during future site licence amendments or renewals. Importantly, this administrative change does not alter the requirement that all foreign warehouses comply with Part 3 – Good Manufacturing Practice of the NHPR.
Importers remain responsible for ensuring that all foreign storage facilities handling NHPs meet applicable GMP requirements.
Companies with existing FSRNs or supply chain structures that rely on the FSRN process should review their current site licence strategies and GMP documentation processes to ensure continued compliance.
If you would like assistance assessing the impact of these changes on your site licence or import activities, our Life Sciences, Food and Beverage, or Advertising and Product Regulatory
Read the original article on GowlingWLG.com
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