Natural Health Product Licensing (NHP-PLA-NPN)
The Natural Health Product Licensing Process (NHP-PLA-NPN)
Here is a brief summary on Natural Product Numbers (NPN's), which are issued by Health
Canada, and are required on all Natural Health Products prior to being sold in Canada.
● In order to apply for Natural Health Product Licensing through the NNHPD Application Stream, you are required to complete a Trading Partner Agreement Package with Health Canada.
○ This package must be physically printed, signed and sent via courier or regular mail to Health Canada in order to begin your licensing relationship with them.
○ Additionally you will be required to set up an ePost Connect account with Canada Post. This is the platform that Health Canada will use to securely communicate with you regarding your licensing applications and any further requirements they may have.
○ Through ePost Connect, Health Canada will provide you with the necessary Company Code required to complete applications.
● Natural Health Products are required to be produced in a GMP Certified Manufacturing Facility.
○ This involves applying for a Site License. To receive a site license, the following is required. These are all services that HgH can provide if you should so require.
■ Completed Site License Application Form
■ Designated Party Authorization (if applicable)
■ GMP Qualification including Standard Operating Procedures for your company
● Products being imported from outside Canada also require an importer of record and there are also site license requirements. If you require these services, we can refer you to a strategic partner that can facilitate this process for you.
● The process to receive an NPN is called a Product Licence Application (PLA).
○ PLA's are submitted as either Class 1, Class 2, or Class 3.
○ Classification is based on number of ingredients, desired claims, as well as status of ingredient on pre-established monographs.
○ A monograph means that an ingredient or product class (i.e. fish oils, probiotics) is pre-approved within certain limits and already has a pre-defined list of claims that can be made when including this ingredient.
■ A Class 1 submission typically takes 60 days to be processed by Health Canada.
■ A Class 2 submission typically takes 90 days to be processed by Health
■ A Class 3 submission typically takes 210 days to be processed by Health Canada.
● The length of time to prepare an NNHPD application by NatHealth depends on the availability of all required information within the application. If all information is available, it can be completed in 1-3 weeks depending on availability of our regulatory consultant.