Natural Product Number (NPN) License Registration

Registered over 6,000 NPNs! Expertise in preparing all Classes of Natural Health Product License Applications in a cost-effective and efficient manner!

Natural Product Number (NPN)

After Health Canada assesses your product and decides it is safe, effective and of great quality, it issues a product license along with a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). This 8-digit identifier number must appear on the principal display panel of the NHP label. The natural product number on the label indicates that Health Canada has reviewed and approved the health product. Acquiring an NPN is mandatory to enter the Canadian market.

Classes of Natural Health Product License Applications

The Natural Health Products Directorate (NHPD) now the Natural and Non-prescription Health Products Directorate (NNHPD) has introduced a system to review Natural Health Product (NHP) applications. The submission of the application is categorized into one of three-class systems (Classes I, II and III). The class categorizes NHPs based on their ingredients level certainty. Each class comes with different review times and different levels of pre-market review.

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Class I

Class I is based on a single NHP Monograph. It has the highest level of ingredients certainty with an established efficacy and safety profile for the remedial ingredient. NNHPD performance target is approximately 60 days for an NPN.

Class II

NHPs in this class are based on 2 or more NHPD Monographs. This class possesses a safety and efficacy profile of medium certainty. NNHPD performance target is approximately 90 days for an NPN.

Class III

At least 1 ingredient in the formula is either not monographed or outside the scope of an NHP Monograph (eg. dosage level, ingredient source or plant part, claims). NNHPD performance target is 210 days for an NPN after an acknowledgement letter is received.

How Quality Smart Solutions can help you obtain a NPN licence

Applications are one of our core competencies. We assist you in acquiring an NPN license, meeting compliant bilingual label requirements. In case the NHP is manufactured, packaged and labelled outside Canada, we can serve as your Importer of Record through our sister company, Quality IMPORT Solutions.  Here’s how our time tested proven process works:

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