In this workshop, attendees will learn how Natural Health Products (NHPs) are regulated in Canada under the Food and Drugs Act and the Natural Health Products Regulations, including the roles of Health Canada, the NNHPD, and enforcement bodies. The workshop also explains what qualifies as an NHP, how NHPs differ from drugs and supplemented foods, and why correct product classification is critical for compliance. Attendees will gain an understanding of key regulatory concepts such as product licensing, application classes, monographs, claims and evidence requirements, traditional and homeopathic products, and the tools used to submit and manage applications. Additional information covered includes post-licensing obligations, such as labeling, adverse reaction reporting, recalls, and ongoing compliance responsibilities, providing a practical overview of the full regulatory lifecycle of an NHP.
This workshop is intended for students and professionals who work with, or plan to work with, Natural Health Products in Canada and need a clear understanding of regulatory requirements across the product lifecycle. It is particularly valuable for individuals in regulatory affairs, quality assurance, product development, manufacturing, labeling, compliance, and market authorization roles, as well as importers, distributors, consultants, and entrepreneurs involved in bringing NHPs to market. The workshop is also appropriate for students in life sciences, nutrition, health sciences, pharmaceutical sciences, or regulatory affairs programs who require foundational knowledge of NHP classification, licensing, claims, and post-market obligations. Professionals responsible for claims development, label review, or post-market compliance will benefit from the practical, compliance-focused perspective covered.
By the end of this workshop, participants will be able to:
Explain the Canadian regulatory framework for Natural Health Products
including the roles of Health Canada, the NNHPD, and enforcement bodies under the Food and Drugs Act and the Natural Health Products Regulations.
Correctly classify health products
by distinguishing between NHPs, drugs, supplemented foods, traditional medicines, and homeopathic products, and identify the compliance risks associated with misclassification.
Describe and apply product licensing pathways
including application classes, monographs, claims and evidence requirements, master files, and the use of regulatory tools such as ePLA, NHPID, and LNHPD.
Interpret operational compliance requirements
including site licensing, foreign site references, Good Manufacturing Practices (GMPs), inspections, record-keeping, stability testing, adverse reaction reporting, and recall obligations.
Compare Canadian NHP regulation with international frameworks
including U.S. dietary supplement regulation under DSHEA and European Union requirements for food supplements and herbal medicinal products, to assess global compliance and market access considerations.
All participants will receive a certificate of attendance upon completion of the workshop.
885 Sheppard Avenue West
Toronto, Ontario
M3H 2T4, Canada
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