Dell Tech prepares and submits Natural Health Product (NHP) applications to Health Canada. Our team supports product classification, formula and label review, safety and efficacy documentation, and NPN submissions to help ensure timely approval and compliance with the Natural Health Products Regulations.
We examine your product’s ingredients and dosage to determine if the formulation meets Canadian regulatory requirements. Our team identifies any compliance concerns and flags substances that may require additional justification or are not permitted.
Dell Tech determines whether your product qualifies as an NHP or should be submitted under a different regulatory stream. We outline the most efficient pathway and prepare the application package accordingly.
We assist in assembling the required evidence to support your product’s safety and efficacy. This may include clinical studies, monograph references, or traditional use evidence.
Our consultants compile the full application, including product specifications, label text, and scientific references. We submit the application through Health Canada’s ePost Connect system and communicate with regulators on your behalf throughout the review process.
Dell Tech ensures your product label aligns with the approved license, including required disclosures and formatting. We verify that claims and content comply with NHP labeling standards.
Health Canada reviews Natural Health Product applications in the order they are received. Processing times vary depending on the complexity of your formula and the strength of your supporting documentation. Products that closely match approved NHP monographs often move more quickly through the system.
If deficiencies are found, the regulator may issue an Information Request Notice (IRN), which must be answered within a limited timeframe. Dell Tech manages all correspondence and ensures you meet deadlines and resolve outstanding issues efficiently.
You must file an NHP application if your product falls under the definition of a Natural Health Product, which includes:
If your product is sold for therapeutic use, includes medicinal ingredients listed in Health Canada’s NHP monograph database, or makes health claims, it likely requires a product license before entering the Canadian market.
Submitting an NHP application involves much more than completing a form. Errors in formulation, insufficient evidence, or noncompliant claims can lead to costly delays or rejection.
Dell Tech provides full-service support to ensure your product meets Canadian regulatory expectations before launch. We reduce your internal workload, improve review times, and help you avoid enforcement actions after your product reaches store shelves.
Additional Services for NHP Clients:
If you are preparing a Natural Health Product Application or are unsure whether your product qualifies as an NHP, contact Dell Tech for a consultation. Our experts will review your documentation and provide a clear, actionable plan for approval.
