Top 5 Tips to Successfully Secure an NPN Number
In order to sell a Natural Health Product (NHP) in Canada you’ll require an NPN. NPN stands for Natural Product Number, which is a product license that is issued by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada. The NNHPD oversees all NHP applications submitted in accordance with the Natural Health Products Regulation (NHPR). Here are our top 5 tips to successfully secure an NPN number:
- Determine the Correct NPN Classification
For starters, obtaining an NPN can take anywhere between 60 days to 210 days depending on the class of the application. There are 3 different classes of an NPN applications, Class I, II or III. Determining the correct class of NPN application is extremely important, if the class is not identified correctly the application may be refused. Learn more about the different NHP application classes here: The Difference between a Class I, II and III NHP Application
- Knowing the Risk of each NPN
The NNHPD has developed what is known as a Compendium of Monographs. These monographs are used to support NPN applications and can speed up the evaluation of safety and efficacy for certain medicinal ingredients. Class I and II NPN applications are supported entirely with NNHPD monographs, which makes them very low risk when complying strictly to these monographs. Class III NPN applications often have the most risk. This is because these NPN’s usually fall outside of these monographs and therefore require additional safety and efficacy studies.
- Having Enough NPN Evidence – Class III Only
For Class III applications additional safety and efficacy studies are required for any new novel ingredients or claims. Class III NPN’s also includes partially referencing monograph information but they go beyond the parameters established in the monographs. This ensures that there is enough high-quality evidence to really assist Health Canada in evaluating and approving the NPN.
- Prompt Responses to Information Request Notices (IRNs) – Class II and III
For Class II and III NPN applications Health Canada will sometimes require additional information during their review. These requests are called IRNs which are time sensitive and comes with a specific deadline, if the information is not provided to Health Canada by the specific deadline the NPN application will be refused. Ensuring all necessary information is provided to Health Canada in a timely manner will prevent avoidable refusals.
- Proper NPN Administrative Documents
Finally, making sure to have all the proper administrative documents prior to submitting an NPN application. This is immensely important as having insufficient documents can lead to an NPN administrative refusal. This will require you to re-submit an entirely new NPN application which can cause further delays in getting an NPN insurance.
How Quality Smart Solutions can help
Our Experts at Quality Smart Solutions are here to help and offer any NHP-related regulatory advice and support on successfully securing your NPN. We provide help by responding to potential IRNs, keeping your product license updated, and reviewing your NHP labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: https://qualitysmartsolutions.com/contact/