If your business imports Natural Health Products (NHPs) into Canada, February 16, 2026 marked a regulatory shift you can’t afford to miss. Health Canada has officially discontinued the Foreign Site Reference Number (FSRN) process and removed the requirement to list foreign warehouses on site licences. These changes will affect how you prove GMP compliance for foreign manufacturers in your supply chain.
What was an FSRN and why did it exist?
The FSRN was a reference number Health Canada issued to manufacturers, packagers, or labelers of NHPs located outside Canada, as a way of identifying that the site had completed a partial Good Manufacturing Practices (GMP) assessment. Canadian importers could then reference that number when applying for their own site licence.
It wasn’t a site licence itself, and it wasn’t required under the Natural Health Products Regulations, but in practice, many importers leaned on it as a streamlined pathway to demonstrate GMP compliance of their foreign sites.
What Health Canada changed, and why
Health Canada determined that the FSRN process had become redundant. Rather than running a parallel assessment stream for foreign sites, the agency wants all GMP evidence consolidated under the main site licensing pathway, the same process already used for all Canadian sites.
The practical result of Bulletin No. 10, effective February 16, 2026:
- New FSRN applications will no longer be accepted and will be rejected outright.
- Existing FSRNs are now marked “discontinued” in Health Canada’s public Site Licence and FSRN Holders List. They remain visible for reference but carry no weight as standalone compliance evidence going forward.
- GMP documentation for foreign sites must now be submitted as part of the importer’s site licence application/renewal application, following the options outlined in the Site Licensing Guidance Document.
One important note: Health Canada confirmed that direct communication between the agency and foreign sites will still be available when needed to protect the confidentiality of the foreign site’s information.
Foreign warehouses are no longer listed on site licences
Alongside the FSRN change, Health Canada has also dropped the requirement to list foreign warehouses on site licences. Previously approved foreign warehouses will be removed the next time the Site Licence is amended or renewed.
This doesn’t mean those facilities are off the hook however, they are still required to meet all applicable GMP requirements under the regulations. So while the listing requirement is gone; the compliance obligation is not.
What This Means for Your NHP Site Licensing Strategy
The most immediate impact falls on importers who relied on a foreign site’s FSRN to carry part of the compliance burden. That shortcut no longer exists.
Going forward, you’ll need to work more closely with those foreign manufacturers, packagers, and labelers to gather GMP documentation that meets Health Canada’s site licensing standards before you submit. Waiting until the application is in progress to chase down evidence from overseas partners is a recipe for disaster.
For businesses approaching an amendment or renewal, now is a good time to audit what foreign sites are currently listed on your licence, confirm they have current, acceptable GMP documentation on hand, and understand how what specific GMP evidence will now need to be included in the submission.
How Dell Tech Can Help
At Dell Tech, we work directly with NHP importers and their international partners to navigate these NNHPD GMP requirements. Whether you’re preparing a new site licence application, managing a renewal, or trying to understand how your existing foreign site relationships need to change, we can help you build a submission that holds up.
Contact our regulatory team to talk through your situation and make sure your licensing pathway stays on track.
