Health Canada NHP applications are one of our core competencies.  The following steps are represented by our time-tested proven process to acquire your NPN and ensure that bilingual label requirements are met.

• Conduct a formula feasibility review of your NHP ingredients to ensure they meet safety and efficacy requirements
• Complete a web-based natural health product licence application (web PLA) form for a class I, II, or III NHP
• Prepare an evidence summary report (it includes information for safety and efficacy support) for a class III NHP
• Prepare a finished product specification form
• Answer all information request notice (IRN) questions from Health Canada until an NPN is successfully issued.
• Assist with bringing your NHP label into compliance by preparing French translations and reviewing against the NHP regulations.

A Health Canada NPN is assigned after Health Canada finishes assessing your product to ensure safety, efficacy, and quality.  This 8-digit identifier number must appear on the principal panel of the NHP label.  It indicates that Health Canada has reviewed and approved the health product for sale in the Canadian market.

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. The NNHPD performance target is approximately 60 days for NPN issuance.

Class II

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

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). The NNHPD performance target is 210 days for NPN issuance after an acknowledgment letter is received.

Once the NNHPD has decided that your product is effective, safe, and of high quality, you’ll receive an NPN or DIN-HM (Homeopathic Medicine Number).  There are no government fees associated with receiving this number and they do not expire.

To acquire an NPN in Canada you’ll need to complete a Product License Application form and submit supporting safety, efficacy, label text, and quality information when applying for a Natural Product Number.  Contact us at info@qualitysmartsolutions.com if you require assistance in this process.

No, all natural health products must have an NPN or DIN-HM before they can be sold in Canada.

A Drug Identification Number (DIN) number is assigned by Health Canada to a drug product prior to being available for sale in Canada and is a type of product license. This is similar to  the NPN which is issued to natural health products.