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How to Notify a Veterinary Health Product (VHP) in Canada: Avoiding Delays, Rejections, and Costly Mistakes
VHPs

How to Notify a Veterinary Health Product (VHP) in Canada: Avoiding Delays, Rejections, and Costly Mistakes

Veterinary Health Products, commonly referred to as VHPs, are regulated in Canada as low-risk drugs under the Food and Drugs Act and the Food and Drug Regulations. Within this framework, VHPs are finished, ready to use products sold in a "dose” format, such as tablets, capsules, liquids, powders, pastes, chews,...
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Health Canada’s 2026 Proposed Updates to the Cosmetic Ingredient Hotlist: What Cosmetic Brands Need to Know 
Cosmetics

Health Canada’s 2026 Proposed Updates to the Cosmetic Ingredient Hotlist: What Cosmetic Brands Need to Know 

Health Canada has begun a new consultation on proposed revisions to the Cosmetic Ingredient Hotlist, opening the door to significant changes in how cosmetic ingredients are reviewed, classified, and permitted for use in Canada. The consultation period runs from November 19th, 2025, to February 17th, 2026, marking a critical window for industry to...
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Health Canada Proposes New Food Enzyme Authorization: Exo-inulinase 
Food

Health Canada Proposes New Food Enzyme Authorization: Exo-inulinase 

On November 20th, 2025, Health Canada released a new proposal signalling its intention to authorize exo-inulinase from Trichoderma reesei strain AR 577 as a permitted food enzyme in Canada. If the proposal moves forward, the change would be implemented through an update to the List of Permitted Food Enzymes following a public consultation period that closes on February 3rd, 2026.  The List of...
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CAPA for Natural Health Products (NHPs) in Canada: A Complete Technical Guide for GMP Compliance
NHPs

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...
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Nutrition Facts Table Regulations in Canada: How to Meet the Requirements 
Food

Nutrition Facts Table Regulations in Canada: How to Meet the Requirements 

General Overview of Nutrition Facts Table RegulationsMandatory Nutrients Declared in Nutrition Facts Tables (NFts)Rounding Rules for Nutrition Values in the Nutrition Facts TableReview of Key Nutrition Facts Table (NFt) ElementsThe Serving Size RequirementsServing Size for Single-Serving and Multi-Serving FoodsThe Role of Reference Amounts (RAs)Daily Value (DV) and Percent Daily Value...
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NHP Cost Recovery Paused: What NHP Companies Should Know
NHPs

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...
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2025 GMP Overhaul for Natural Health Products (NHPs): What It Means for Canadian Importers and Site Licence Holders
Site Licensing

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...
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Hierarchy in Label Design: Elements, Levels, and Best Practices (2025) 
Creative Services

Hierarchy in Label Design: Elements, Levels, and Best Practices (2025) 

A product label is often the first interaction a consumer has with a brand. It captures attention, communicates purpose, and conveys trust within seconds. However, a label’s success depends on more than just good design; it must also comply with strict regulatory standards. In Canada, where bilingual labelling, standardized Nutrition...
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How to Obtain a Foreign Site Reference Number (FSRN) – A Brief Executive Overview
Site Licensing

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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Canadian Pet Food Import Regulations Guide
Pet Products

Canadian Pet Food Import Regulations Guide

Importing pet food into Canada demands rigorous oversight, meticulous documentation, and consistent traceability. Under the jurisdiction of the Canadian Food Inspection Agency (CFIA), finished pet food, treats, and chews destined for the Canadian market must satisfy admissibility criteria based on species, ingredient origin, processing standards, and disease-control safeguards.  These rules reflect Canada’s...
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Unlock the Secrets: Health Canada’s NHP Labelling Flexibilities for 2028
Uncategorized

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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Understanding MDSAP and Its Role in Canadian Market Access
Medical Devices

Understanding MDSAP and Its Role in Canadian Market Access

The Medical Device Single Audit Program (MDSAP), developed by the International Medical Device Regulators Forum (IMDRF), is a harmonized audit framework that allows a single ISO 13485:2016 audit, conducted by an approved Auditing Organization (AO), to meet the quality management system (QMS) requirements of multiple regulatory authorities simultaneously.  In Canada, MDSAP serves as the recognized mechanism...
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Health Canada to Implement ICH E6(R3): What It Means and How to Prepare 
Clinical Trials

Health Canada to Implement ICH E6(R3): What It Means and How to Prepare 

On October 17th, Health Canada has confirmed it will implement the ICH E6(R3) Good Clinical Practice (GCP) guideline, a major international update to the way clinical trials are designed, managed, and documented. The goal is to strengthen participant safety, improve data quality, and modernize how clinical research is conducted in Canada. ...
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Cosmetic Labelling in Canada: What You Need to Know 
Cosmetics

Cosmetic Labelling in Canada: What You Need to Know 

When introducing a new cosmetic product to the Canadian market, manufacturers and importers must meet several key regulatory obligations. Products must contain only safe ingredients that are permitted for cosmetic use, be properly notified to Health Canada through a Cosmetic Notification Form (CNF), and display labels that fully comply with...
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Veterinary Health Product (VHP) Labelling Requirements in Canada: What You Need to Know
VHPs

Veterinary Health Product (VHP) Labelling Requirements in Canada: What You Need to Know

An essential element of regulatory compliance for Veterinary Health Products (VHPs) is ensuring that labels meet Canadian requirements and clearly communicate safe and proper use. Labels are more than a design feature; they are a primary tool to support product identification, responsible administration, and consumer confidence. In Canada, VHPs are...
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Pet Food vs. Livestock Feed in Canada: What You Need to Know
Pet Products

Pet Food vs. Livestock Feed in Canada: What You Need to Know

For manufacturers and brand owners preparing to enter the Canadian market, one of the most critical early steps is determining whether a product will be classified as pet food or as livestock feed. This classification is not simply a formality. It defines which regulations apply, which authorities are responsible, and...
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Canadian Bilingual Food Labelling Requirements: What You Need to Know
Food

Canadian Bilingual Food Labelling Requirements: What You Need to Know

In Canada, bilingual food labelling is a core requirement that ensures consumer transparency, accessibility, and trust. Both English and French must appear on most consumer prepackaged foods sold at retail.  These requirements are enforced under the Food and Drug Regulations (FDR) and the Safe Food for Canadians Regulations (SFCR), with...
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Foreign Site Reference Number (FSRN) for Canada: A Complete Guide
Site Licensing

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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Pet Food Labelling in Canada: What You Need to Know
Pet Products

Pet Food Labelling in Canada: What You Need to Know

An essential element of regulatory compliance in any product sector is ensuring that product labels meet the specific requirements of the country where the products are sold and that they clearly communicate the product’s intended use. This requirement is no different for pet food products, which are also subject to...
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NHP Clinical Trials – Feasibility and Portfolio Assessment
Clinical Trials

NHP Clinical Trials – Feasibility and Portfolio Assessment

Clinical trials for natural health products (NHPs) such as vitamins, herbal remedies, and probiotics bring scientific rigour to traditional health claims. In Canada, where consumer protection and evidence-based regulation are priorities, sponsors are beginning to shift away from running isolated trials toward building comprehensive clinical research strategies. This shift reflects...
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