Product License Amendments – Natural Health Products
In order to sell natural health products in Canada, a product license with an associated Natural Product Number (“NPN”) is required from Health Canada’s Natural and Non-prescription Health Products Directorate. An NPN is specific to a product’s brand name, ingredients, and recommended conditions of use. These elements may undergo changes during the time a natural health product (NHP) is marketed in Canada. Before making changes to natural health products, license holders should consult Regulations #11, #12 and #13 of the Natural Health Products Regulations to understand which type of post-license change is required to support the change.
Amendments are changes to NHPs that may have an impact on the safety or efficacy of the product. Therefore amendment submissions must include evidence to demonstrate that the product continues to be safe and effective once the changes have been implemented. The migration to the new amended product should not proceed until approval together with a revised product license is issued by the Natural and Non-prescription Health Products Directorate.
Some changes that require a post-license amendment include changes to a product’s recommended use, changes to the recommended dose, or modifications to risk statements that will appear on product labels. Amendment and notification applications must be submitted using the most recent version of the Natural health product licence amendment and notification form (hc-sc.gc.ca). An updated product label should be submitted with product license amendments. The Natural Product Number will remain unchanged throughout the amendment process.
If license holders are planning to make more significant changes to the product, such as a change to the level of medicinal ingredient per dose, change to the quantity of medicinal ingredient per dose, or addition/substitution of medicinal ingredients, filing of a new product license application rather than an amendment is required.
Company information may change over time as a result of location changes, product transfers, and mergers. These changes can be filed by an administrative pathway (post-license notifications) within 60 calendar days after the change has been made. Brand name changes can also be captured by way of a post-license notification. The Natural health product licence amendment and notification form (hc-sc.gc.ca) form should be used to submit notifications to Health Canada.
