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
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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,…
Read More
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…
Read More