09 Jun 2026
How to Prepare for a Health Canada NHP Site Licence Inspection 

How to Prepare for a Health Canada NHP Site Licence Inspection 

Site Licensing
To sell a natural health product (NHP) in Canada, companies must consider both product licensing and site licensing requirements. A product licence authorizes the sale of a specific NHP, while a site licence is required for the Canadian physical site where NHPs are manufactured, packaged, labelled, or imported for sale.  Obtaining these licences requires…
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26 Feb 2026
Health Canada Ends the NHP FSRN Process in Canada 

Health Canada Ends the NHP FSRN Process in Canada 

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…
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17 Feb 2026
Health Canada NHP Site Licence Renewal Process and Requirements 

Health Canada NHP Site Licence Renewal Process and Requirements 

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

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

Site Licensing, , , , , , , ,
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…
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11 Nov 2025
How to Obtain a Foreign Site Reference Number (FSRN) – A Brief Executive Overview

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

Site Licensing, , , ,
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…
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07 Oct 2025
Foreign Site Reference Number (FSRN) for Canada: A Complete Guide

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

Site Licensing, , , , , , , , , ,
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…
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14 Aug 2025
NHP Site Licensing Made Simple for Canadian Market

NHP Site Licensing Made Simple for Canadian Market

Site Licensing, , , , , , , , ,
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…
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