Dosage Form Review – Natural Health Products
Canada has a unique licensing system in place for natural health products (NHPs) sold to Canadian consumers. A product license application must be submitted to Health Canada in order to receive a product license, along with a Natural Product Number (“NPN”) for listing on product labels.
The dosage form of the NHP is one of the critical elements of a natural health product application and its corresponding license. The dosage form can be defined as the physical manifestation containing medicinal and non-medicinal ingredients that deliver the dose of the product. The dosage form selected when completing a product license application should be an exact match for a dosage form listed on the Health Canada website.
Health Canada’s Natural and Non-Prescription Health Products Directorate maintains a list of acceptable dosage forms on the Natural Health Products Ingredient Database. Since the introduction of the Natural Health Product Regulations, the list of acceptable dosage forms has expanded significantly, mirroring recent advances in product delivery opportunities and consumer preferences. Unique and novel dosage forms such as film strips, patches, sublingual tablets and pouches have been added to the database to support applications for natural health products in these formats. Once a dosage form match has been identified on the listing, applicants should review Health Canada’s definition for the dosage form, to ensure complete alignment between applicants and Health Canada regarding how the natural health product will be used.
The dosage form of a product may dictate who can safely use the product (for example adults versus children), as well as provide insight to applicants on whether additional directions for use or risk statements are required for product labels. Given the impact a product’s dosage form may have on product safety and efficacy, Health Canada will pay close attention to this part of the product license application during their review.
While novel dosage forms are included in the database, this does not necessarily indicate that Health Canada will license all products combining novel formats with medicinal ingredients, especially if the ingredient is associated with safety concerns. Licensing times for these product applications may be stretched beyond the usual review timelines set by Health Canada. And addressing these potential delays in advance of setting launch dates can help set realistic timelines for marketing of NHPs in Canada.
