Health Canada

Natural Health Products (NHPs) are health products containing naturally occurring substances derived from plants, animals, microorganisms, and marine sources that are used to restore or maintain good health.

NHPs are available in tablets, capsules, tinctures, solutions, creams, ointments, and drops. Toothpaste, antiperspirants, shampoos, facial products, and mouthwashes also fall under the NHP classification when the medicinal ingredient(s) come from a natural source.

All NHPs sold in Canada are subject to the Natural Health Products Regulations. The Regulations apply to the sale of NHPs, the manufacture, packaging, labelling, and importation for the sale of natural health products, the distribution of natural health products, and the storage of natural health products to meet quality requirements.

The licencing requirements of the Natural Health Products Regulations apply to any person or company that manufactures, packages, labels, or imports NHPs for commercial sale in Canada.

Manufacturers and suppliers of Natural Health Products (NHP) can only have their products sold in Canada if Health Canada issues a product license. To apply for a license, applicants must give detailed information about the product to Health Canada. The report will include medical ingredients, the source of the medical ingredients, the potency, non-medical ingredients, and the suggested use(s). 

Evaluation of the safety and usefulness of the NHP has to be backed by evidence collected through clinical trials or references to published studies, journals, pharmacopeias, and traditional sources. The kind and quantity of supporting evidence required are contingent on the proposed health claim of the product and the overall risks it could pose.

Health Canada will assess the product for safety, effectiveness, and quality. When the product is approved, Health Canada will issue an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the product label. The number lets the consumer know that Health Canada has approved the product.

The label on the NHP product will have the following information:

• product name
• product license number
• quantity of product in the bottle
• complete list of medicinal and non-medicinal ingredients
• recommended use
• any cautionary statements, warnings, contra-indications, and possible adverse reactions associated with the product
• any special storage conditions

The label's design helps consumers make safe and informed choices and identify that the product has been certified through Health Canada.

All NHPs must have a product license to be legally sold in Canada. In addition, the Canadian sites that manufacture, package, label, and import these products must also have site licences.

The importer of the NHP must obtain a site licence.

All Canadian manufacturers, packagers, labelers, and importers of NHPs must obtain a site licence. To receive a site licence, proper distribution records, and procedures for product recall, handling, storage, and delivery, must prove that they meet Good Manufacturing Practice (GMP) requirements.

Good Manufacturing Practices ensure that the proper standards and practices for the testing, manufacturing, storage, handling and distribution of NHPs are met. These practices are in place to certify that the product is safe and effective and meets quality requirements.

An applicant must submit an application for a site licence to the Minister of Health that includes but is not limited to the following:

• A breakdown of who you are.
• Specify if the site will manufacture, package, label, or import the NHP
• The physical address of each building the importer intends to manufacture, import, package, or label an NHP.
• The physical address of each building that will be storing the NHP.
• Evidence of GMP compliance for each site

At CCLS, we offer in-house regulatory consultants that can help companies apply for NHP product and site licenses with Health Canada. We provide this expertise for our customers to help guide them on getting licensed to distribute in Canada.

CCLS is a license holder for Natural Health Products importation and labelling. We hold a Drug Establishment license for secondary packaging and labelling of over-the-counter Drug (DIN) products.

CCLS also follows Good Manufacturing Practices (GMPs) for the testing, manufacturing, storing, and distributing natural health products on behalf of our clients. CCLS offers GMP-compliant warehousing facilities with programs that include temperature and humidity monitoring, staff training, pest control, and sanitation. Our validated Warehouse Management System provides our customers with complete inventory control and lot traceability, expiry date compliance, and recall support. Our SOPs ensure all imported natural health products are assessed for compliance before release for sale in Canada.