Natural Product Number | NPN Number License Registration

We’ve obtained over 6,000 NPN Numbers from Health Canada! We have expertise in preparing all classes of NPN Number & NHP license applications in a cost-effective and efficient manner!

Natural Product Number (NPN Number) Canada

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 (NPN) Number or Homeopathic Medicine Number (DIN-HM). This 8-digit identifier NPN number must appear on the principal display panel of the NHP label. The Health Canada NPN number on the label indicates that Health Canada has reviewed and approved the health product. Acquiring an NPN number is mandatory to enter the Canadian market.

Classes of Natural Health Product (NHP) 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.

npn canada
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 number.

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. NNHPD performance target is approximately 90 days for an NPN number.

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 number after an acknowledgement letter is received.

How Quality Smart Solutions can help you obtain a NPN Number license

Health Canada NHP applications are one of our core competencies. We can assist you in acquiring your NPN number and meeting compliant bilingual label requirements. If your NHP is manufactured, packaged and labeled outside of 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

npn number Canada

Distinctions between NHP's and Drugs & how to pass quality tests:

NHPs may be regulated by the FDA or other governmental agencies depending on the intended use. For example, some foods and dietary supplements are regulated by the FDA while others are not. NHPD regulates products containing NHP ingredients under its Natural Health Products Regulations (NHPR). This allows companies to sell certain NHPs without going through extensive clinical trials or approval processes.

If you want to make sure your product passes quality tests and has a nice label, this is what you should do:

  • Make sure your product passes quality tests.
  • Make sure your product has a nice label.
  • Follow the regulations so that you can sell it in Canada or the United States. You can find out what they are by reading the regulations or by asking someone who knows about them if they are confusing or hard to understand. If they don’t make sense, ask someone else! You can always ask more than one person until someone explains things very clearly to you!
  • Have a good business plan before starting on any kind of project like this one because it will help lower risks later on down the line if anything goes wrong during development stages which means less money lost overall for everyone involved including yourself so just remember that when deciding whether or not something makes sense financially speaking (or whatever other factors are important). Also remember never forget how important it is too always keep track of revenue generated from each sale made using these types

NHP Claims Requirements (Health Claims Labelling Requirements)

The labelling requirements for natural health products are different from those for conventional drugs. These differences are outlined in the Natural Health Products Regulations. For example, a label on a conventional drug must include:

Frequently Asked Questions - NPN Number Canada Registration

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.

Need help securing a Natural Product Number (NPN)?

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