• Assistance in licencing and importation of
    natural health products
    Assistance in licencing and importation of natural health products
Home-Services - Natural Health Products

Natural Health Products

Since year 2004 in Canada, Natural Health Products must comply with standards similar to those for drugs products.

Site Licence

For activities of manufacturing, packaging, labelling and even importation of Natural Health Products, a Site Licence must be obtained.  Health Canada will issue a Site Licence once a person or a company has clearly demonstrated that its operations are in compliance with the standards especially created for the Natural Health Products.  These standards are called the “Good Manufacturing Practices” (GMP).  GMPs establish standards for the premises, equipment, personnel, quality assurance department, hygiene, operations, specifications, finished product stability, samples, records and product recall.

Product Licence (NPN : Natural Product Number)

The Natural Health Product Regulation requires that each Natural Health Product be granted of a Product Licence identified with a Natural Product Number or NPN before it is offered for sale. In order to get an NPN, the sponsor must submit to Health Canada the list of natural active ingredients in his product, their source, their quantity and their therapeutic role.  He must also support the efficacy and safety of his product by supplying pertinent evidence.  The acceptable evidences for efficacy may vary from serious references from literature to clinical trials depending on the type of natural health product.  The efficacy of Traditional Natural Health Products may be supported with traditional references while evidences of efficacy for Non Traditional Natural Health Products will be supported with scientific data such as meta-analysis, clinical trials, etc.

Find out more about our consulting services NPN

Contact an expert of natural health product standards

Contacter SPHARMA

Téléphone: (438) 830-8242