What is a Natural Health Product?
In Canada, Natural Health Products (NHPs) are a distinct regulatory category that includes vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, and certain sports nutrition and personal care products used for health maintenance.
NHPs are regulated under the Natural Health Products Regulations (NHPR), administered by Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD).
You cannot legally sell an NHP in Canada without a product licence. Each licensed product receives a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the label.
Step 1: Determine if Your Product is an NHP
Before applying, confirm your product falls under the NHP definition. The product must:
- Be used to maintain or restore health
- Contain a medicinal ingredient from the NHP ingredient database
- Not be classified as a prescription drug or conventional food
Some products may be classified differently — for example, meal replacements and certain probiotics may be regulated as foods rather than NHPs.
Step 2: Obtain an NHP Site Licence
Before applying for a product licence, the facility manufacturing, packaging, labeling, or importing the NHP must hold a Site Licence from Health Canada.
Site licence applications require evidence of Good Manufacturing Practices (GMP) compliance, including:
- Facility description and activities
- Evidence of GMP standards (ISO 22716, NSF/ANSI 455-2, or equivalent)
- Quality management documentation
Site licences must be renewed annually.
Step 3: Prepare the Product Licence Application
Product licence applications are submitted to Health Canada through the Natural Health Products Online System (NHPOLS). The application must include:
Evidence of Safety and Efficacy
Health Canada requires evidence that your product is safe and effective for its intended use. The level of evidence required depends on the product class:
- Class I (lowest risk): Relies on traditional use evidence — typically 50+ years of use in a recognized reference
- Class II: Requires published literature or non-pivotal clinical trials
- Class III (highest risk): Requires pivotal clinical trial data
Traditional use references accepted by Health Canada include the General References Table (e.g., Commission E monographs, ESCOP, WHO monographs, Herbal Medicines by Blumenthal).
Recommended Conditions of Use
You must specify:
- Recommended dose and duration of use
- Recommended route of administration
- Target population (adults, children, pregnant women, etc.)
- Risk information (cautions, warnings, contraindications, known adverse reactions)
Medicinal and Non-Medicinal Ingredients
List all medicinal ingredients with their quantities and the non-medicinal ingredients (fillers, coatings, preservatives) and their purposes.
Step 4: Labeling Requirements
NHP labels must include:
- Product name
- NPN or DIN-HM (once approved)
- Medicinal ingredients with quantities per dosage unit
- Non-medicinal ingredients
- Recommended use and conditions of use
- Cautions and warnings
- Name and address of the licence holder
- Lot number and expiry date
- Bilingual labeling in English and French
How Long Does Approval Take?
Health Canada's review timelines vary by product class:
- Class I: Approximately 60 days
- Class II: Approximately 120 days
- Class III: Approximately 300 days
Incomplete applications or requests for additional information can significantly extend these timelines. Working with an experienced regulatory consultant can minimize back-and-forth with Health Canada.
Common Reasons for Application Refusal
- Insufficient evidence of safety and efficacy
- Use of medicinal ingredients not found in Health Canada's reference databases
- Labeling claims that exceed the evidence provided
- Incomplete or inconsistent application data
- Missing site licence for the manufacturer or importer
Dual-Market Strategy: FDA + Health Canada
If you plan to sell in both the U.S. and Canada, a coordinated strategy is essential. A product marketed as a dietary supplement under FDA/DSHEA in the U.S. will typically need an NHP product licence for Canada. The documentation requirements differ significantly, and claims that are acceptable in the U.S. may not be approved by Health Canada.
How United Regulatory Can Help
Our team has extensive experience preparing Health Canada NHP product licence applications across all three evidence classes, supporting site licence applications, and developing dual-market FDA/Health Canada strategies for supplement and natural health product companies. Contact us for a free consultation.