Health Canada

Understand a Regulatory Model That’s Very Different from the U.S.

Companies accustomed to the U.S. dietary supplement framework can encounter a very different regulatory model when entering the Canadian market.

In Canada, Natural Health Products (NHPs) are regulated as a subset of drugs rather than foods, and products require licensing before they can be sold.

In this fast-paced, practical session, EAS Consulting Group Senior Consultant Paula Brock, Ph.D., MCSI will demystify Health Canada’s Natural Health Product framework and explain what companies need to understand when evaluating products for the Canadian market.

You’ll explore how NHPs are defined and classified, how Health Canada monographs are used, what evidence is needed to support claims, how the Natural Product Number (NPN) licensing process works, and important labeling considerations.

What You’ll Learn

Health Canada’s NHP Regulatory Framework
Understand the role of the Natural and Non-prescription Health Products Directorate (NNHPD) and how Canada’s approach to NHPs differs from the U.S. dietary supplement model.

NHP Scope and Classification
Learn which types of ingredients and products can fall within the NHP framework and important exclusions.

Using Health Canada Monographs
Understand single-ingredient and product monographs and how conformity with established monographs can affect product licensing and evidence requirements.

Product Licensing and Natural Product Numbers (NPNs)
Explore the different licensing pathways and how product formulation, claims and deviations from established monographs can affect the level of Health Canada review.

Claims and Supporting Evidence
Learn how Health Canada takes a risk-based approach to NHP claims and how the strength of evidence should correspond to the type and risk level of the claim.

Clinical Trials
Understand when existing monographs and evidence may not be sufficient and when a Health Canada-authorized clinical trial may be necessary.

Labeling Requirements
Review key considerations for compliant NHP labeling, including required product information and other Canadian labeling requirements.

Who Should Attend

This short course is designed for:

• Regulatory affairs professionals
• Quality and compliance teams
• R&D and formulation professionals
• Marketing and labeling teams
• Companies currently marketing Natural Health Products in Canada
• U.S. dietary supplement companies evaluating expansion into the Canadian market

What You’ll Take Away

After this course, you’ll have a clearer understanding of:

• How to determine where a product fits within Canada’s NHP regulatory framework
• How monographs can affect product formulation, claims and licensing
• How the Class I–III product licensing pathways differ
• What evidence may be necessary to substantiate different types of claims
• How the NPN process fits into Canadian market entry
• Key labeling considerations when preparing an NHP for the Canadian market