Health Canada has announced that as of February 16, 2026, it is ending the Foreign Site Reference Number (FSRN) process and changing how foreign warehouses are managed under the NHP Regulations.
Key Changes:
- Ending the FSRN Process: Health Canada will no longer issue new FSRNs. This process—previously used to pre-assess foreign sites—is being discontinued to streamline licensing.
- New Pathway for Foreign Sites: Foreign manufacturers, packagers, and labelers must now submit their Good Manufacturing Practices (GMP) evidence directly through the standard site licensing pathway rather than using a separate FSRN application.
- Foreign Warehouses: Site licence holders are no longer required to list warehouses located outside of Canada on their licences. Existing foreign warehouses will be removed from licences during future updates (amendments or renewals).
- Compliance Still Required: Even though they no longer need to be listed on a licence, foreign warehouses must still meet all applicable GMP requirements.
Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10
