Before a product hits the Canadian market, companies must determine how it will be classified by Health Canada. Is it a cosmetic, a natural health product (NHP), or a drug? The answer shapes everything — from the approval process and ingredient restrictions to labeling and claims.
Our product classification assessment helps you make that decision accurately and strategically.
We analyze your product’s composition, claims, and intended use to guide you toward the correct regulatory path — ensuring full compliance from the start and avoiding costly misclassification.
Understanding how Health Canada defines and distinguishes product categories isn’t always straightforward. Our classification service includes:
Regulatory interpretation: We review Health Canada’s classification guidelines and apply them to your specific product profile;
Claim and format analysis: Product claims, form, and route of administration are assessed to identify whether it fits as a cosmetic, NHP, or drug;
Cross-category review: When your product has overlapping features, we help determine the dominant category and required licensing path;
Supporting documentation guidance: Get clarity on what documents and evidence may be needed depending on classification;
Strategic advice: We offer recommendations on how to adjust claims or formulation to align with your target classification, if needed.
This process helps confirm that your product is correctly classified and positioned for Health Canada approval.
Canadian regulations are ingredient-specific. Even a single prohibited substance can block market access.
Health Canada enforces strict compliance. Submitting a non-compliant formula could lead to rejection or enforcement actions.
Expert review avoids delays and reformulations. Catching issues early saves time, money, and protects your brand reputation.
Choosing the wrong classification can delay approval, trigger audits, or force costly reformulations and relabeling. That’s why a precise assessment is essential.
With Sobel’s expert assessment, navigating Health Canada’s product categories becomes a clear, informed process, setting your launch up for success in the regulatory journey.
Not sure if your product is a cosmetic, a drug, or a natural health product? We’ll help you assess the right category and ensure full alignment with Health Canada’s expectations.
Send a message and trust Sobel to guide your classification process — so you can focus on bringing your product to market with confidence.
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