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

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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Unlock the Secrets: Health Canada’s NHP Labelling Flexibilities for 2028

Unlock the Secrets: Health Canada’s NHP Labelling Flexibilities for 2028

As part of the upcoming Plain Language Labelling (PLL) requirements for Natural Health Products (NHPs) sold in Canada, Health Canada has introduced several flexibilities to help manufacturers address the challenges of fitting standardized Product Facts Table (PFT) content on small or uniquely shaped packaging. These flexibilities provide alternative approaches for…
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Foreign Site Reference Number (FSRN) for Canada: A Complete Guide

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

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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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

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

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…
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Health Canada’s 2025 Red Tape Reduction Plan: What You Need to Know

Health Canada’s 2025 Red Tape Reduction Plan: What You Need to Know

Cutting red tape is at the heart of Health Canada and the Public Health Agency of Canada’s new regulatory modernization plan. In July 2025, the Government of Canada launched a federal Red Tape Review to address growing concerns that outdated, duplicative, and overly complex rules are slowing market access, discouraging…
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What are the new NHP Monograph Updates? July 25, 2025 Revisions

What are the new NHP Monograph Updates? July 25, 2025 Revisions

On July 25, 2025, Health Canada published six new Natural Health Product (NHP) monographs, along with minor revisions to five existing monographs. These updates form part of Health Canada’s ongoing effort to align the Natural Health Products Ingredients Database (NHPID) and related monographs with the latest scientific evidence, safety considerations,…
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NHP Site Licensing Made Simple for Canadian Market

NHP Site Licensing Made Simple for Canadian Market

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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Canada’s New Natural Health Product Labelling Rules: A High-level Overview

Canada’s New Natural Health Product Labelling Rules: A High-level Overview

The Canadian Natural Health Product (NHP) industry is preparing for one of its most significant regulatory shifts in nearly two decades. With the introduction of Health Canada’s new Plain Language Labelling (PLL) Regulations (Labelling for Natural Health Products), businesses that manufacture, distribute, or sell NHPs must rethink how their product…
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Nicotine Tablets Now Non-Prescription in Canada: Health Canada Updates the Prescription Drug List 

Nicotine Tablets Now Non-Prescription in Canada: Health Canada Updates the Prescription Drug List 

Overview of the Prescription Drug List Change  On July 21, 2025, Health Canada implemented a regulatory amendment that exempts certain nicotine tablets from the human-use section of the Prescription Drug List (PDL). This change applies specifically to orally disintegrating and sublingual nicotine tablets that contain no more than 4 milligrams…
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Natural Health Product (NHP) Regulations in Canada: A High-Level Overview for Businesses

Natural Health Product (NHP) Regulations in Canada: A High-Level Overview for Businesses

Canada’s growing wellness market presents a strong opportunity for companies looking to expand their product offerings, especially in the natural health space. But before launching any Natural Health Product (NHP), businesses must navigate Canada’s robust regulatory framework. Understanding the basics of NHP compliance is key to accessing the Canadian market,…
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