canadian regulations

25 Mar 2026

Webinar Recap: Health Canada GMP (GUI-0158 v4.0) Update for NHPs

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In our recent webinar, our team provided a detailed overview of Health Canada’s updated Good Manufacturing Practices (GMP) Guide for Natural Health Products (GUI-0158 v4.0) and the practical implications for companies operating in the Canadian market. The session focused on how the revised guidance reshapes expectations for quality systems, importer accountability, and end-to-end supply chain…

05 Feb 2026

Health Canada Publishes 19 Updated NHP Monographs

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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,…

27 Jan 2026

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

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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…

23 Sep 2025

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

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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…

18 Sep 2025

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

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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 In July 2025, the Government of Canada launched a federal Red Tape Review to address growing concerns that outdated, duplicative, and overly complex rules are slowing market access, discouraging…

16 Sep 2025

New and Upcoming FDA Changes in 2025: GRAS Rules, FOP Labelling, and Supplement Ingredients – What You Need to Know

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On September 4, 2025, the U.S. Food and Drug Administration (FDA) published its Unified Regulatory Agenda, a key planning document that outlines the Agency’s top priorities over the coming year. Among the many proposed and final rules, three initiatives stand out for their potential to significantly impact food and dietary…

09 Sep 2025

Chewing Gum Exemption for “Free of Sugars” Claim Reinstated

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On September 2, 2025, Health Canada updated the Table of Permitted Nutrient Content Statements and Claims, modifying the table to once again exempt chewing gum from the energy conditions set out under the “free of sugars” claim. Learn more about this regulatory change and what it means for manufacturers and…

04 Sep 2025

Health Canada Adds New Ingredients to the Prescription Drug List

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Health Canada has announced updates to the Prescription Drug List (PDL) that affect both human and veterinary drugs. This amendment introduces four new medicinal ingredients that now require a prescription and revises the conditions under which benzoyl peroxide is considered prescription-only for human use. These changes are effective immediately as…

10 Jun 2025

A Cost-Effective Compliance Strategy: Over-labelling for Packaging in the Canadian Market

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Expanding into the Canadian food and natural health product market presents a unique set of regulatory challenges. From bilingual packaging requirements to specific nutrition facts and allergen declarations, manufacturers often face barriers that can delay product launches and increase operational costs. One practical and cost-effective solution to this issue is…

23 Apr 2025

NHP Sampling Regulations for Tradeshows in Canada

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Distributing Natural Health Product (NHP) samples at tradeshows in Canada is subject to clear regulatory requirements designed to protect consumer safety, ensure accurate labelling, and uphold Health Canada’s standards. From proper packaging and compliant promotional claims to valid licensing and record-keeping obligations, all participants are responsible for operating in accordance…