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.
