NHP License Experts (a division of Quality Smart Solutions) has successfully registered over 5000 Natural Health Products (NHPs) since 2007 serving over 500 clients globally. We offer a complete solution so you can legally sell your NHP in Canada. This includes licensing your health product, ensuring your label meets language (English and French) and label regulations. Lastly, if your product is manufactured outside of Canada, we can act as your importer of record through our sister company, Quality IMPORT Solutions.
The category of NHPs includes vitamins, minerals, herbal products, homeopathic medicines (designated with a HM-DIN), traditional medicines such as ayurvedic and traditional Chinese medicines, probiotics and other products like amino acids and essential fatty acids. There are three different classes of Natural Health Products. Class 1 are those NHPs that follow one monograph and are licensed in approximately 60 days. Class 2 are NHPs that reference 2 or more NHP Monographs with licensing timelines being approximately 90 days and Class 3 are those NHPs whose ingredients either are not monographed or fall outside the scope of one or more NHP monographs (eg. dosage, claims, plant part or source material). Class 3 NHPs are licensed in 210 days or less after submission acknowledgement letter is received.
In Canada there are several distinct differences in the regulations and categorization of dietary supplements. First, dietary supplements (often called food supplements in other countries such as in Europe) are called Natural Health Products and require a Natural Product Number (NPN) license to legally sell and market in Canada. Licenses are issued by the Non-Prescription and Natural Health Products Directorate (NNHPD) which is a department within in Health Canada. Licensing is based on at least one health claim to support at least one of the medicinal ingredients in the product. This health claim can be structure-function, therapeutic or preventative in nature. For example, a claim of reducing pain related to osteoarthritis would be allowed if evidence is presented to support such a claim. The route of administration for Natural Health Products is broader than in other countries. It includes topical products. Some sunscreens, eczema creams, acne products are classified as NHPs. Licensing can vary from as fast as 60 days to as long as 7 months depending on various factors and level of evidence that must be provided.
A Natural Product Number (NPN) must be obtained. Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product license along with an eight-digit NPN or Homeopathic Medicine Number (DIN-HM). This number lets you know that the product has been reviewed and approved by Health Canada. License issuance timeline varies between 60 days to 7 months depending on the class of application. The NPN or DIN-HM must appear on the principal display panel of the NHP.
All Natural Health Products (NHPs) are required to be bilingual (English & French) and labelled/packaged according to the Natural Health Products Regulations before sale in Canada. This includes the NPN on the principal display panel, a medicinal ingredient listing (in either tabular or linear format), directions for use, recommended use or purpose, cautions and warnings and other details. Bilingual labelling should be considered early in the label and package development process to accurately determine the amount of label space needed to accommodate required product information.
NHPs manufactured outside of Canada require an importer of record who holds a valid site license from Health Canada. The NHP being imported must land into a warehouse/storage facility that is annexed to the importer’s site license. The foreign manufacturing site must also be annexed to the importer’s site license, and attest to following Good Manufacturing Practices (GMP). NHPs manufactured in Canada do not require an importer, however, the NHP must be manufactured, packaged and labelled at a facility that holds a valid site license for the applicable activities.
There is presently no charge by Health Canada for submitting NPNs.
Bars, beverages, gums and other food format products fall outside the scope of Natural Health Products. These are under the jurisdiction of the Food directorate and the Canadian Food Inspection Agency. Fortified foods may qualify for a Temporary Market Authorization License (TMAL). Ask us for details.
Our fees start from $795 and are based on number of ingredients and the classification of the NHP.
Both official languages, English and French, are required on labels. This can be enforced starting at the border through to the various jurisdictions with the most stringent and impactful enforcement being in Quebec, a predominantly French speaking province, where stop sale, recall and even fines can result. There are also specific NHP labelling requirements that differ from other countries so it’s advised that label be completely compliant both in language and NHP regulations.
Our first phase in licensing your product is to conduct a feasibility evaluation to determine if your product would qualify for NPN. There are some ingredients that are considered scheduled drugs in Canada and would have to be removed from the formula before it can proceed to be licensed as a Natural Health Product. Only after the NPN is issued can the Natural Health Product be legally allowed to be sold at any retail outline (stores or online).