Foreign Site Reference Number

26 Feb 2026

Health Canada Ends the NHP FSRN Process in Canada

Site LicensingForeign Site Reference Number, FSRN, FSRN application process, health canada, NHP Site Licensing

On February 16, 2026, the Health Product Compliance Directorate released Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10, confirming the end of the Foreign Site Reference Number (FSRN) process and clarifying the regulatory treatment of foreign warehouses. This update marks a significant shift in how Good…

07 Oct 2025

Foreign Site Reference Number (FSRN) for Canada: A Complete Guide

Site LicensingCanadian site licence, foreign site GMP evidence, Foreign Site Reference Number, FSRN application process, FSRN Canada, FSRN renewal, GMP compliance Canada, Health Canada FSRN, Health Canada site licensing, natural health product regulations, NHP import Canada

Please note that Health Canada officially ended the Foreign Site Reference Number (FSRN) process on February 16, 2026. The Department determined that the mechanism was no longer necessary and has consolidated the review of foreign site Good Manufacturing Practices (GMP) evidence within the existing site licensing pathway. Any new FSRN…

23 Sep 2025

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

NHPsBatch Records, canadian regulations, CAPA, consulting experts, Data Integrity, Foreign Site Reference Number, FSRN, GMP, GUI-0158, health canada, Health Canada inspections, master production documents, natural health products, NHP, NHP importing, NHP manufacturing, QAP responsibilities, QMS, quality management system, quality risk management, quality systems, Regulatory Compliance, site licensing, stability programs, supplier qualification

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The…

14 Aug 2025

NHP Site Licensing Made Simple for Canadian Market

Site LicensingForeign Site Reference Number, GMP compliance, Health Canada Regulations, natural health products, NHP importing, NHP manufacturing, NHP packaging, NHP site licence application, regulatory compliance Canada, site licence Canada

In Canada, any business that manufactures, packages, labels, or imports natural health products (NHPs) must hold a valid site licence obtained from Health Canada. This licence confirms that the company complies with the requirements set out in the Natural Health Products Regulations and Site Licensing Guidance Document, including adherence to…