Natural Health Products (NHP)/Supplements
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Natural Health Products (NHP)/Supplements
In Canada, any natural health product (NHP) โ including supplements, herbal remedies, vitamins, probiotics, and traditional medicines โ must receive a valid Natural Product Number (NPN) from Health Canadaโs Natural and Non-prescription Health Products Directorate (NNHPD) before it can be legally sold or marketed. Regulatory compliance also includes finished product specifications, formulation assessment, lab testing coordination, and GMP site licensing to support safe and compliant manufacturing and distribution.
GNHP Consulting provides end-to-end regulatory consulting for NHP and supplement companies, from developmental strategy to regulatory submission and post-licensing support โ helping you navigate the Natural Health Products Regulations (NHPR) with clarity, precision, and confidence.
Natural Health Products in Canada include:
- Vitamins, minerals, enzymes, probiotics
- Herbal and botanical remedies
- Traditional medicines
- Homeopathic medicines
- Functional nutritional supplements
Before any product can be sold in Canada, it must have a valid NPN on the label, demonstrating that the product has been reviewed and authorized by Health Canada.
Canadian Regulatory Requirements for NHPs
A product licence โ evidenced by an eight-digit NPN โ must be obtained prior to marketing. Health Canada reviews submissions for safety, potency, and efficacy based on evidence such as ingredient monographs, clinical data, traditional use sources, and scientific literature.
Before preparing an application, it is essential to confirm that your product meets the NHPR definition of an NHP. This includes evaluating:
- Medicinal and non-medicinal ingredient lists
- Intended use and health claims
- Dosage form and route of administration
Incorrect classification is a major reason for submission delays or refusals.
Health Canada may request Finished Product Specifications as part of the submission or upon inquiry. These include documented tests and standards for purity, composition, stability, and identity that demonstrate that your product meets defined quality parameters.
Labels must comply with regulations, including:
- NPN display
- Ingredient and dosage statements
- Recommended use and caution statements
- Bilingual (English/French) formatting
Non-compliant labeling is a top cause of regulatory refusals.
If your product is manufactured, packaged, labelled, or imported into Canada, the associated site(s) must be licensed and compliant with Good Manufacturing Practices (GMP). Compliance demonstrates consistent product quality, good documentation practices, and a robust quality management system.
We offer a complete regulatory compliance package tailored to NHPs/supplements โ from concept to regulatory readiness and beyond.
Product Development & Formulation Review
- Product concept assessment
- Formulation optimization with regulatory alignment
- Ingredient compliance checks against NHP standards
- Evidence strategy for intended use and claims
This ensures your product stands the best chance of a positive regulatory outcome.
- Preparation of finished product specification documentation
- Coordination with analytical laboratories for required tests
- Quality-focused evaluation of test results and regulatory readiness
We help you streamline quality, compliance, and documentation โ essential for NPN success.
- Complete NPN submission dossier preparation
- Attestation drafting and evidence compilation
- Submission via Health Canadaโs NHP Online System
- Management of correspondence and Information Requests (IRNs)
We prepare submissions that meet regulatory expectations and reduce deficiency risk.
- Bilingual label review
- Claim support documentation
- Risk statement verification
- Pre-submission label compliance check
Proper labeling dramatically improves the likelihood of approval and marketplace acceptance.
- Site licence application preparation
- Guidance on GMP documentation and quality systems
- Support for inspections and compliance verification
We help you achieve site readiness for manufacturing, packaging, labelling, and importing activities.
Common Reasons NPN Applications Are Delayed
- Improper product classification
- Unsupported claims
- Ingredient compliance issues
- Incomplete specifications
- Non-compliant labeling
- Missing testing documentation
We help identify these risks before submission.
We work with:
- US, International brands entering the Canadian market
- Canadian Startups launching new Natural health products/supplements
- Amazon and e-commerce sellers whose products require regulatory alignment
- Manufacturers, packagers, and importers requiring site licensing
- Companies addressing application refusals or deficiency notices
If youโre unsure whether your product requires licensing or how to proceed, we can begin with a regulatory classification review.
Why Companies Choose GNHP Consulting
GNHP Consulting combines regulatory expertise with practical execution and industry insight:
- Deep understanding of Health Canadaโs NHP regulatory framework
- End-to-end support from formulation to market entry
- Structured submission strategies and evidence planning
- Responsive coordination with NNHPD processes
- Minimization of delays and common submission pitfalls
We help you move forward with compliance confidence and operational clarity.
Selling supplements and NHPs in Canada without the appropriate NPN and compliance framework can lead to refusals, delays, or marketplace restrictions. Our team can help you secure regulatory approval and launch your products successfully.
Begin Your Compliance Journey With Us Today
Frequently Asked Questions
About Natural Health Product (NHP)/Supplements Licensing in Canada
To legally sell a Natural Health Product (NHP) in Canada, you must first obtain a product licence from Health Canada. This involves submitting a Product Licence Application (PLA) to the Natural and Non-prescription Health Products Directorate (NNHPD).
Health Canada will review your product's ingredients, dosage form, recommended use, safety, efficacy, and quality information. Once approved, your product will receive a Natural Product Number (NPN) or a DIN-HM for homeopathic medicines.
Without an NPN or DIN-HM, your product cannot be legally marketed, advertised, imported, or sold in Canada.
GNHP Consulting can guide you through the entire NPN licensing process, from formulation review to final approval.
Importing an NHP into Canada requires more than simply shipping products across the border. Importers must ensure that:
- The product has a valid NPN or DIN-HM.
- Manufacturing facilities comply with Good Manufacturing Practices (GMPs).
- Canadian labelling requirements are met.
- Appropriate quality assurance procedures are in place.
- The importer complies with applicable Health Canada requirements.
Many imported products require regulatory assessment before entering the Canadian market.
GNHP Consulting helps international manufacturers and Canadian importers navigate Health Canada requirements and market entry strategies.
No.
Under the Natural Health Products Regulations, all Natural Health Products sold in Canada must have a valid Natural Product Number (NPN) or DIN-HM issued by Health Canada.
Selling or advertising an unlicensed NHP may result in enforcement actions, product seizures, stop-sale orders, or other compliance measures.
Before launching your product, it is essential to confirm that all licensing requirements have been met.
Need help determining whether your product requires an NPN? Contact GNHP Consulting for a regulatory assessment.
Yes.
Health Canada requires NHPs to meet established quality standards. Depending on the product and ingredients involved, quality requirements may include:
- Identity testing
- Potency testing
- Microbial testing
- Heavy metals analysis
- Stability studies
- Product specifications
Manufacturers and importers must maintain evidence demonstrating that products consistently meet quality requirements.
GNHP Consulting can help determine the testing requirements appropriate for your product category and regulatory pathway.
Approval timelines depend on the complexity of the application.
Typical NNHPD service standards include:
- Class I applications: Approximately 60 days
- Class II applications: Approximately 90 days
- Class III applications: Approximately 180 days or longer
Applications that contain deficiencies, unsupported claims, or ingredient issues may require additional review time.
Working with experienced regulatory professionals can help minimize delays and improve the likelihood of a successful first submission.
Not always.
Product classification in Canada depends on:
- Product ingredients
- Intended use
- Claims made on labels and marketing materials
- Route of administration
A cream, toothpaste, or shampoo may be classified as:
- A cosmetic
- A Natural Health Product
- A non-prescription drug
- A medical device
Determining the correct classification is often one of the most important regulatory decisions for a company.
GNHP Consulting specializes in Health Canada product classification assessments to help businesses choose the correct regulatory pathway.
Currently, Health Canada does not charge government review fees for Product Licence Applications (PLAs) or Site Licence Applications (SLAs) for Natural Health Products.
However, businesses should budget for:
- Regulatory consulting services
- Quality and laboratory testing
- Label reviews
- Scientific evidence preparation
- GMP compliance activities
- Translation and packaging updates
The total cost of bringing a product to market depends on product complexity and regulatory requirements.
A Quality Assurance Person (QAP) is responsible for ensuring that Natural Health Products are manufactured, packaged, labelled, imported, stored, and distributed in compliance with Good Manufacturing Practices (GMPs).
The QAP oversees quality systems and verifies that products meet established specifications before release for sale.
For many companies, having access to qualified quality assurance support is a critical component of regulatory compliance.
GNHP Consulting provides Quality Assurance and GMP support services to Natural Health Product companies across Canada.
Manufacturers, packagers, labellers, and importers involved in the production of Natural Health Products must comply with Canadian GMP requirements.
If your products are manufactured outside Canada, Health Canada expects importers to verify that foreign facilities meet Canadian GMP standards or equivalent requirements.
Failure to maintain adequate supplier qualification and GMP documentation can delay product licensing and market access.
GNHP Consulting assists companies with supplier qualification, GMP assessments, and regulatory compliance strategies.
Health Canada maintains the Natural Health Products Ingredients Database (NHPID), which contains information on medicinal and non-medicinal ingredients commonly used in NHPs.
However, determining ingredient acceptability often involves more than simply checking the database. Factors such as dosage, route of administration, ingredient source, intended use, and supporting evidence can affect whether an ingredient will be accepted.
GNHP Consulting can conduct ingredient assessments and identify potential regulatory concerns before submission.
Consumers, retailers, and distributors can search Health Canada's Licensed Natural Health Products Database (LNHPD) to verify whether a product has been authorized for sale.
The database allows searches by:
- Product name
- NPN or DIN-HM
- Company name
- Medicinal ingredient
- Intended use
Checking the LNHPD is the fastest way to confirm whether a product is currently licensed in Canada.
Whether you're launching a new Natural Health Product, importing products into Canada, evaluating ingredients, obtaining an NPN, or addressing compliance challenges, GNHP Consulting provides expert regulatory support tailored to your business.
Contact GNHP Consulting today to discuss your project and accelerate your path to market.
