NHP Site Licensing

09 Jun 2026

How to Prepare for a Health Canada NHP Site Licence Inspection

NHP 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…

26 Feb 2026

Health Canada Ends the NHP FSRN Process in Canada

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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

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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

NHP 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

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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

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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

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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…

01 Apr 2024

UPDATE: Natural Health Products in Canada

Natural Health Products (NHPs), NHP Quality Assurance, NHP Regulations, NHP Site LicensingCost recovery, health canada, Licensed NHPs, Natural Health Product, NHP, NHP Product License, NNHPD, update

On March 27, SNI attended an invited session on NNHPD’s Updated Proposal for NHP Cost Recovery We want to share some updates regarding the ongoing cost recovery initiative that has been imposed on the NHP sector. Last year, Health Canada proposed a new fee structure for Natural Health Products (NHPs)…

08 Dec 2023

The Changing Landscape of NHPs

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Keeping up with constantly changing regulations is a challenge for any company selling natural health products (NHPs) in Canada. Notably, recent changes to NHP labelling standards and the introduction of potential cost recovery measures have raised numerous questions and concerns within the industry. Regarding labelling requirements, Health Canada released an…

12 Jun 2023

The FTC Puts 670 Brands on Notice for Unsupported Product Claims

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The Federal Trade Commission in the U.S. recently caught the attention of nearly 700 companies after sending them warning letters (known as penalty offenses) due to unsubstantiated product claims. MOST OF THE COMPANIES ARE: Dietary Supplements, Homeopathic Products, Functional Foods, as well as some Pharmaceuticals What Happens When a Brand…