If you manage regulatory submissions for natural health products, you likely already know that Health Canada ends FSRN acceptance as of February 16, 2026. Health Canada announced this change through Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10.
The change affects how foreign manufacturing sites demonstrate GMP compliance when supporting a Canadian importer’s site licence application. For regulatory teams managing active licences or preparing new submissions, the window to adapt is already open.
This is not just an administrative update. Ending the Foreign Site Reference Number program reshapes how GMP evidence from foreign sites enters the site licensing pathway. It also removes a tool that many importers have relied on to support their submissions. Understanding what changed, what Health Canada no longer accepts, and what you need to do now will help you avoid delays, rejections, or compliance gaps that can stall a product launch.
What the Foreign Site Reference Number Was
Health Canada issued a Foreign Site Reference Number as a unique identifier for manufacturing, packaging, or labelling sites located outside of Canada. Receiving an FSRN meant a foreign site had completed a partial GMP assessment and met certain requirements under Part 3 of the Natural Health Products Regulations. For Canadian importers, a foreign supplier holding a valid FSRN simplified the site licence application by providing a recognized shorthand for that site’s compliance status.
That said, the FSRN was never a full site licence equivalent. It did not authorize a foreign site to export NHPs directly into Canada, and the regulations never required it. Over time, the process created confusion and added administrative burden without meaningfully improving GMP oversight.
Health Canada concluded that folding foreign site GMP evidence directly into the site licensing process would produce better results with less duplication.
What Changes on February 16, 2026
The bulletin is direct. After February 16, 2026, Health Canada will no longer accept new FSRN applications. Any application submitted after this date will face outright rejection. Health Canada will also mark existing FSRN holders as “discontinued” in the Site Licence and Foreign Site Reference Number Holders List.
The FSRN authorization will eventually be removed from the Harmonized Site Licence and FSRN Application Form and the Site Licensing Guidance Document, though Health Canada has noted that housekeeping update is still in progress.
Foreign warehouses follow a parallel change on the same date. Site licence holders no longer need to list warehouses outside of Canada on their site licence. Health Canada will remove previously approved foreign warehouses from site licences when those licences go through an amendment or renewal. Removing a warehouse from the licence does not eliminate GMP obligations.
Foreign warehouses must still meet all applicable requirements under the Natural Health Products Regulations, regardless of whether they appear on a site licence.
How Foreign Sites Must Now Submit GMP Evidence
Foreign sites that previously relied on an FSRN to support an importer’s site licence application must now submit GMP evidence through the standard site licensing pathway. This means the evidence is submitted as part of the importer’s site licence application, and the same standards for acceptable documentation apply.
Health Canada’s Site Licensing Guidance Document outlines the acceptable forms of GMP evidence, which may include inspection reports, certificates of compliance, or other recognized documentation.
Direct communication between Health Canada and foreign sites can still occur through the site licence generic email address, which allows for confidential exchange of information where needed. This channel remains available to support the transition and ongoing compliance discussions.
If your current site licence lists foreign suppliers who held FSRNs, or if you are planning a new submission that would have previously included an FSRN, you will need to reassess your documentation strategy.
Quality Smart Solutions’ NHP regulatory consultants can help you identify compliant GMP evidence alternatives and prepare submissions that meet Health Canada’s current expectations.
What You Should Review Right Now
Given that these changes are already in effect, focus your attention on the following areas:
- Review any active site licence applications or pending amendments that reference an FSRN as GMP evidence. That reference is now outdated and may trigger a rejection.
- Confirm with your foreign manufacturing partners that they hold current GMP documentation suitable for submission through the site licensing pathway.
- Check whether your site licence lists any foreign warehouses. Those will be removed during your next renewal or amendment cycle. Confirm that those warehouses still meet GMP requirements even without appearing on the licence.
If you manage multiple product lines across several foreign sites, the administrative workload can escalate quickly. Acting early costs far less than responding to a site licence delay mid-launch.
FAQs
Does our foreign supplier need to start from scratch now that the FSRN is gone?
Not necessarily, though the transition does require action. Many foreign sites already hold GMP documentation in formats that Health Canada accepts through the site licensing pathway. The shift is not about re-qualifying your supplier but about how and where that evidence is submitted. Reviewing your supplier’s existing compliance documentation against the acceptable evidence options in Health Canada’s Site Licensing Guidance Document is the practical starting point.
Will existing FSRNs still be recognized while our licence is under review?
This is a common concern, and the answer requires careful attention. As of February 16, 2026, existing FSRNs are marked as discontinued and the FSRN authorization is considered outdated. Submitting a licence application that relies on a discontinued FSRN as its primary GMP evidence introduces real risk of rejection or a request for additional information. The safest path is to replace the FSRN reference with current, acceptable GMP documentation before or alongside your next submission.
Do foreign warehouse changes affect our current licence immediately?
Not immediately in most cases. Previously approved foreign warehouses will remain on site licences until the licence is next updated through an amendment or renewal. However, once that update occurs, the warehouse will be removed. Businesses should use this transition window to confirm that all foreign warehouses continue to meet GMP requirements under the Natural Health Products Regulations, since the compliance obligation does not disappear when the listing does.
Key Takeaways
- Health Canada ends FSRN acceptance effective February 16, 2026, and will reject any new FSRN applications submitted after that date.
- Health Canada now classifies existing Foreign Site Reference Numbers as discontinued, making them unacceptable as GMP evidence in site licence submissions.
- Foreign sites must now submit GMP evidence directly through the site licensing pathway using documentation that meets the standards in the Site Licensing Guidance Document.
- Foreign warehouses no longer require listing on site licences, but they remain subject to all applicable GMP requirements.
- Any active applications or upcoming renewals that reference an FSRN need immediate review to avoid delays or rejections.
Stay Ahead of Compliance Changes Before They Affect Your Timeline
Regulatory changes rarely arrive with generous lead time, and their effects on product launches or licence renewals can be significant. The path forward here is clear. Foreign sites need compliant GMP documentation submitted through the right channel, and Health Canada has well-established standards for what qualifies.
If you need support reviewing your current site licence, updating your GMP evidence package, or preparing a new submission under the revised process, contact our regulatory experts at Quality Smart Solutions. Our NHP site licensing services are designed to help businesses move through Health Canada’s requirements accurately and efficiently, without the costly back-and-forth that comes from submissions that miss the mark.
