NPN Number – Natural Health Products Licensing
An NPN number (Natural Product Number) is the eight-digit number that appears on the label of Canadian Natural Health Products. An NPN Number is assigned to all licensed Natural Health Products. An NPN license is granted to applicants only after their product has passed an assessment by Health Canada (sometimes referred to as the Canadian FDA). All Canadian Health Products are regulated by the Natural Health Products Directorate and are not permitted to be sold until receiving a Health Canada NPN.
Before receiving an NPN, the applicant must provide extensive information to Health Canada including proof of the Natural Health Product’s safety, efficacy, and quality. Applying for an NPN can be a very complex and daunting process. If all the required information is not included in the application package, it may be rejected and the applicant will need to resubmit the entire application, which can take anywhere from 10-180 days to be assessed.
Once a product has been issued a license, it will appear in an online Health Canada NPN database called the Licensed Natural Health Products Database, along with thousands of other products currently on the market. This Natural Products Database also includes an NPN number search feature, to navigate through the thousands of publicly available licenses.
Natural Health Products
What are Natural Health Products?
Natural Health Products (NHPs) are made from naturally occurring substances, that are marketed to prevent undesirable conditions, reduce health risks, or to maintain good health. These natural supplements are often produced from botanicals, microorganisms, animals, and marine sources. NHPs in the Natural Product Database include: natural or organic vitamins and mineral supplements, natural herbal supplements, workout supplements, and everyday consumer products like certain toothpastes and shampoos.
Selling Natural Products
Natural Health Supplements sold in Canada are required to abide by the Natural Health Product Regulations. There are numerous steps that need to be taken before Canadian Natural Health Products are approved for sale and can be sold legally in the Canadian market.
Applying for an NPN doesn’t have to be difficult if you work with a professional NPN consultant. Learn More.
Natural Health Products Ingredients
- Ensure all medicinal ingredients in the health product are NHP ingredients (and in accordance with schedules 1 and 2 of the Natural Health Product Regulations.) The product license application (PLA) cannot be filed unless all the medicinal ingredients are included in the Natural Health Products Ingredient Database (NHPID).
- Ensure that the dosage form, route of administration and non-medicinal ingredient purposes are all deemed acceptable by the Natural and Non-Prescription Health Products Directorate (NNHPD).
Trading Partner Agreement
- The NNHPD highly recommends filing PLAs online. This benefits applicants by reducing courier costs, allowing for timely processing, and ultimately getting products to market faster.
- To file a PLA online, the applicant must be enrolled as a Trading Partner. To enroll as a Trading Partner applicants are required to:
- Sign up for an epost Connect Account (to correspond with the NNHPD) and download the required forms.
- Prepare and submit an enrollment application. The application gets screened and a notification is provided if clarification/modification is required.
- Attend an interview with the NNHPD.
- Receive Trading Partner confirmation.
Avoid the lengthy process of applying to be a Trade Partner. With an up to date Trading Partner status, Supplement Analyst can apply for licensing on your behalf. Learn More.
- To successfully receive an NPN, applications must complete the License Application, which includes:
Applicant and Contact Information
A) Applicant/Licensee information (name and location)
B) Senior Official (name, location contact information)
C) Specific Application Contact (name, title, company, location, contact information)
D) Representative in Canada (name, title, company, location, contact information)
E) Contact to whom the product license is to be sent
A) Product License Application (type of application, hypothetical formulation)
B) Submission Content (Designated Party Authorization, Label Text, Evidence Summary Report, References, Safety Summary Report, Quality Summary Report, Other Claim Evidence)
C) Reference Submissions
D) NHPD Master File Reference
A) Company name and location
A) Primary brand name, other brand names, dosage form, and route of administration
B) Medicinal Ingredient(s) (standard, quantity, unit, ingredient names, proper name, common name, source, source material, synthetic/animal tissue)
C) Non-Medicinal Ingredient(s) (standard/grade, common name, purpose, quantity, unit, source, animal tissue)
D) Ingredient(s) used in processing
E) Recommended conditions of use (dose, duration, risk information)
- Applications take 10 – 180 days to be assessed.
- If an application is approved, the license is added to the Health Canada database and the applicant may begin selling the Natural Health Product right away.
- Rejected applicants must submit an entirely new application in order for their health product to be considered for licensing.
Last updated: October 4 2016
Scientific Research Referenced in this Article
- Canadian Food Inspection Agency. Foods or Natural Health Products (NHP). – View reference 15 07 2016.
- Health Canada. About Natural Health Product Regulation in Canada. – View reference 11 8 2016.
- Health Canada. About Natural Health Products. – View reference 14 3 2016. 28 9 2016.
- Health Canada. Compendium of Monographs. – View reference 12 3 2009.
- Health Canada. Electronic Product Licence Application form. – View reference 15 5 2014. 28 09 2016.
- Health Canada. Licensed Natural Health Products Database. – View reference 04 05 2015.
- Health Canada. Management of product licence applications for natural health products. – View reference 30 10 2014. 28 9 2016.