Expert NHP Licensing, Formulation & Compliance Support for the Canadian Market
In Canada, any natural health product (NHP) — including supplements, herbal remedies, vitamins, probiotics, and traditional medicines — must receive a valid Natural Product Number (NPN) from Health Canada’s 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 — helping you navigate the Natural Health Products Regulations (NHPR) with clarity, precision, and confidence.
What Are Natural Health Products (NHPs)?
Natural Health Products in Canada include:
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
Product Licensing (NPN)
A product licence — evidenced by an eight-digit NPN — 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.
Eligibility & Classification
Before preparing an application, it is essential to confirm that your product meets the NHPR definition of an NHP. This includes evaluating:
Incorrect classification is a major reason for submission delays or refusals.
Finished Product Specifications
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.
Labeling & Claims Compliance
Labels must comply with regulations, including:
Non-compliant labeling is a top cause of regulatory refusals.
Site Licensing & GMP
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.
How GNHP Consulting Supports Your NHP Project
We offer a complete regulatory compliance package tailored to NHPs/supplements — from concept to regulatory readiness and beyond.
Product Development & Formulation Review
This ensures your product stands the best chance of a positive regulatory outcome.
Finished Product Specifications & Lab Testing Coordination
We help you streamline quality, compliance, and documentation — essential for NPN success.
Regulatory Submission Preparation & NPN Application
We prepare submissions that meet regulatory expectations and reduce deficiency risk.
Label & Claims Compliance Review
Proper labeling dramatically improves the likelihood of approval and marketplace acceptance.
Site Licensing & GMP Support
We help you achieve site readiness for manufacturing, packaging, labelling, and importing activities.
We help identify these risks before submission.
Who We Support
We work with:
If you’re unsure whether your product requires licensing or how to proceed, we can begin with a regulatory classification review.
Book Your Regulatory Strategy Consultation
Why Companies Choose GNHP Consulting
GNHP Consulting combines regulatory expertise with practical execution and industry insight:
We help you move forward with compliance confidence and operational clarity.
Start Your NHP Regulatory Pathway with Confidence
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.
Book an NHP Regulatory Consultation
+1-604-379-1230
info@gnhpconsulting.com
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:
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:
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:
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:
A cream, toothpaste, or shampoo may be classified as:
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:
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:
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.
