Health Canada Ends the NHP FSRN Process in Canada 

Health Canada Ends the NHP FSRN Process in Canada 

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…
Read More
Health Canada NHP Site Licence Renewal Process and Requirements 

Health Canada NHP Site Licence Renewal Process and Requirements 

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…
Read More
Food or Natural Health Product (NHP)? A Practical Guide to Classification and Compliance  

Food or Natural Health Product (NHP)? A Practical Guide to Classification and Compliance  

If you manufacture or import functional foods, fortified beverages, gummies, probiotics, botanicals, powders, or “wellness” products, you have likely run into the Canadian classification question: is this a food or a natural health product (NHP)?  In Canada, that decision is not exclusively linked to marketing preference. It is a regulatory classification that drives your allowed claims, label…
Read More
Health Canada Publishes 19 Updated NHP Monographs

Health Canada Publishes 19 Updated NHP Monographs

Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has officially published 19 updated Natural Health Product (NHP) monographs as part of the January 30, 2026 load. These updates affect a wide range of botanical ingredients, amino acids, and commonly used actives across the Canadian NHP market. For regulatory teams,…
Read More
Foundations of OOS Investigations for Natural Health Products (NHPs) in Canada 

Foundations of OOS Investigations for Natural Health Products (NHPs) in Canada 

Unexpected laboratory results are an unavoidable reality in natural health products (NHPs) manufacturing. A potency value that does not match historical performance, a microbial result that sits uncomfortably close to its limit, or a chromatographic profile that looks unfamiliar can all signal that something requires closer attention. These results do not automatically…
Read More
Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status

Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status

Health Canada has officially updated the Prescription Drug List to clarify the non prescription status of nicotine buccal pouches containing 4 milligrams of nicotine or less per dosage unit. This change provides long awaited clarity for manufacturers, importers, and retailers entering the rapidly growing nicotine pouch category. The amendment, effective…
Read More
Selling Vitamins in Canada: In-Depth Review of Regulations and Licensing Considerations

Selling Vitamins in Canada: In-Depth Review of Regulations and Licensing Considerations

Vitamins are among the most widely used consumer health products in Canada, yet their regulatory oversight is frequently underestimated. While often perceived as low-risk supplements, vitamins sold for health purposes are regulated as Natural Health Products (NHPs) and are subject to a comprehensive oversight framework administered by Health Canada. This framework governs every stage…
Read More
CAPA for Natural Health Products (NHPs) in Canada: A Complete Technical Guide for GMP Compliance

CAPA for Natural Health Products (NHPs) in Canada: A Complete Technical Guide for GMP Compliance

Corrective and Preventive Actions (CAPA) sit at the centre of every strong and dependable quality system in the natural health product (NHP) space. Whether you manufacture, package, label, import, or distribute NHPs, in Canada or internationally, CAPA demonstrates that you can recognize issues early, correct them effectively, and establish controls that prevent them from recurring…
Read More
NHP Cost Recovery Paused: What NHP Companies Should Know

NHP Cost Recovery Paused: What NHP Companies Should Know

The natural health products (NHP) sector in Canada continues to evolve as Health Canada progresses toward a modernized, risk-based regulatory framework. Many industry stakeholders have been monitoring the proposed cost recovery initiative with a tentative target implementation date of December 1, 2025. Health Canada has confirmed that this implementation date…
Read More
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

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…
Read More