Site Licensing - SNI Inc.

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…

17 Feb 2026

Health Canada NHP Site Licence Renewal Process and Requirements

Site Licensingforeign site GMP evidence, GMP requirements, Health Canada compliance, Natural Health Products regulations, NHP site licence renewal, NNHPD guidance, QAP responsibilities, regulatory affairs Canada, renewal timelines, site licence amendment

All Natural Health Product (NHP) site licence holders in Canada must renew their licence in accordance with the Natural Health Products Regulations. Although the renewal term varies by licence and is assigned directly by Health Canada, the obligation remains consistent across all sites: confirm continued compliance with Part 3 Good Manufacturing Practices (GMP) and keep Health…

18 Nov 2025

2025 GMP Overhaul for Natural Health Products (NHPs): What It Means for Canadian Importers and Site Licence Holders

Site LicensingCAPA, GMP compliance, GUI-0158, health canada, Importer Requirements, natural health products, quality management system, Site Licence, Validation and Stability Testing

When Health Canada released Version 4.0 of the Good manufacturing practices guide for natural health products (GUI-0158) on September 4, 2025, it marked the first major revision of good manufacturing practices (GMP) expectations in a decade. The new guide, which will become enforceable on March 4, 2026, following a six-month…

11 Nov 2025

How to Obtain a Foreign Site Reference Number (FSRN) – A Brief Executive Overview

Site LicensingForeign Site Reference Number Canada, FSRN Health Canada, FSRN Natural Health Products, GMP compliance Canada NHPs, Health Canada site licence support

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…

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…

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…