The Western world is hungry for health products, and industry is meeting that demand with increased product innovation and global expansion like never before. In Canada, consumer health products are categorized as foods, drugs, cosmetics, and natural health products (NHPs). NHPs (referred to as dietary supplements in the U.S.) are health products sold in traditional medicinal formats. Vitamins and minerals, protein powders, herbal medicines, probiotics, and many others, are all examples of products that are sold as NHPs. A 2010 survey showed that 73% of Canadians consume NHPs regularly, proving Canadian consumers are more interested in alternative health products than ever before.
Canada is an increasingly attractive market for global health product companies. If you are interested in expanding your market share into The Great North, read on for the three requirements to successfully launch your NHP in Canada.
Obtain an NPN License
An NPN, or Natural Product Number, is an 8-digit number found on the principal display panel of all NHP's in Canada. The primary difference between NHPs and dietary supplements in the U.S. is the pre-market approval required to gain Canadian market access. Licensing your product with an NPN is done through Health Canada and can take anywhere from 60 to 210 days depending on the license class (I, II, or III).
License class differentiation depends on whether the evidence presented is pre-cleared by Health Canada. Pre-cleared information exists on documents called Monographs, which are publicly available on Health Canada's website. Monographs outline the dosing and indications that are pre-cleared on an individual ingredient basis.
- Class I licenses reference one Monograph and take up to 60 days for processing
- Class II includes more than one Monograph but follows the guidelines presented, taking up to 90 days for processing
- Class III licenses fall outside the parameters of a Monograph (e.g., dosages higher than Monograph guidance) OR at least one of the medicinal ingredients do not have a Monograph. These applications can take up to 210 days to review and process
An NHP Compliant Label
The Canadian NHP labelling requirements are nuanced and complex. There are many requirements to satisfy beyond product size, name, and best before date. Here is a list of just some of the additional labelling requirements for NHPs in Canada:
- NPN visible on the principal display panel
- Caution and risk statements on the back panel
- Direction and duration of use
- List of medicinal ingredients per dosage units
- Importer of record (if manufactured outside of Canada)
- License holder
- Bilingual (English and French) label, on both inner and outer packaging
Importer of record
For companies manufacturing outside of Canada, who are exporting a finished product into Canada for sale, an Importer of Record is required. They are licensed by Health Canada for import activity and is a necessary step to ensure successful market access. The Importer will then have specific requirements to achieve the desired outcome.
SGS Nutrasource is a global contract research organization (CRO) that helps companies gain market access with strong science and regulatory confidence. If you are interested in launching a health product in Canada or anywhere across the globe, contact us today.