Health Canada is abolishing Foreign Site Reference Numbers (FSRNs).

The details are outlined below, but the key takeaway is this: FSRNs are no longer available or accepted, and foreign site GMP evidence must now be handled entirely through the site licensing process. If you are uncertain how this change affects your site licence, foreign manufacturers, or upcoming submissions, dicentra is here to help.

On February 16, 2026, Health Canada, through the Health Product Compliance Directorate (HPCD), published Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10. The bulletin confirms the end of the FSRN process and removes the requirement to list foreign warehouses on Canadian site licences, effective immediately.

Scope & Purpose

The objectives of Health Canada’s bulletin are to:

• Formally end the Foreign Site Reference Number (FSRN) process
• Integrate foreign site GMP review into the standard site licensing pathway
• Eliminate the requirement to list foreign warehouses on site licences

These changes are part of Health Canada’s broader effort to streamline oversight while maintaining GMP compliance under the Natural Health Products Regulations.

What Has Changed?

1. The FSRN Process Has Ended

An FSRN was a reference number issued to foreign sites that manufacture, package, or label Natural Health Products. It indicated partial GMP compliance but was never a regulatory requirement, nor did it authorize export into Canada.

Effective February 16, 2026:

• Health Canada will no longer accept FSRN applications
• Any new FSRN submissions will be rejected
• Existing FSRNs are now considered discontinued
• Foreign site GMP evidence must be submitted directly through the site licence application, amendment, or renewal process

Although some Health Canada forms and guidance documents still reference FSRNs as acceptable GMP evidence, this information is outdated and will be removed.

Foreign sites may continue to communicate directly with Health Canada, as needed, to support confidentiality during GMP assessments.

2. Foreign Warehouses No Longer Appear on Site Licences

Health Canada has also eliminated the requirement to list warehouses located outside of Canada on a site licence.

As a result:

• Site licence holders no longer need to apply to add foreign warehouses
• Health Canada will stop listing foreign warehouses on licences
• Previously listed foreign warehouses will be removed during amendments or renewals

This is an administrative change only. Foreign warehouses must still comply with all applicable GMP requirements.

What This Means for Industry

For most companies, this change does not create new compliance obligations, but it does change how foreign site compliance is demonstrated.

If you previously relied on an FSRN to support a foreign manufacturer or packager, that pathway is now closed. All foreign site GMP evidence must be reviewed as part of the Canadian site licence assessment.

In practice, this means fewer parallel processes, but greater emphasis on having complete, acceptable GMP documentation ready at the site licensing stage.

How to Be Prepared

If you’re wondering, “Do I need to do anything right now?”, the answer depends on your setup.

If you are not currently amending or renewing a site licence, there may be nothing immediate to file. However, you should be aware of the change and prepared for how it will affect your next submission.

In practical terms, companies should:

• Understand whether any foreign partners previously relied on FSRNs and ensure GMP evidence is available for site licence review instead
• Expect foreign warehouses to disappear from licences at renewal or amendment—this is normal and not a deficiency
• Ensure foreign manufacturers, packagers, and labellers can provide acceptable GMP evidence under current site licensing guidance
• Remove references to FSRNs from internal procedures and regulatory templates to avoid confusion

If any of this is unclear, that’s not unusual, many companies used FSRNs informally without realizing how limited their regulatory role actually was.

Get Expert Advice

Health Canada’s decision to end the FSRN process simplifies site licensing, but it also shifts responsibility squarely onto the quality of foreign GMP evidence submitted with a site licence.

dicentra has supported more than 24,000 regulatory and quality projects, including NHP site licences, foreign GMP evidence reviews, importer compliance strategies, and licence renewals. We regularly help clients interpret changes like this in practical terms, what matters, what doesn’t, and what (if anything) needs to be done.

If you’ve read the headline and thought, “What does this actually mean for us?”, don’t hesitate to contact us, we’re happy to walk you through it.