Canadian NPN Licensing
The situation
A client was developing an immune-support supplement in powder form, with an original product brief focused on nutrition before and after surgery. The project needed a Canadian licensing strategy that connected the finished formulation, intended use, and supporting evidence.
Kompete supported the formulation and Class III NPN application strategy, helping bring the product concept and regulatory submission into alignment.
What we found
The central challenge was translating a specialized nutrition concept into a clearly defined natural health product application. The ingredients, proposed benefits, directions for use, and scientific support needed to be considered together.
The intended use described in a development brief also needed to be distinguished from the claims ultimately authorized for the finished product.
What we did
Kompete supported the formulation and regulatory strategy for the Class III NPN application, connecting the product concept with the rationale presented in the submission.
The project resulted in an issued Natural Product Number, establishing a licensed route to the Canadian market. The issued product licence defines the authorized uses and conditions for the finished product.
The outcome
Health Canada issued a product licence following the Class III NPN application, establishing a licensed route to the Canadian market for the finished immune-support powder.
The project brought the formulation and regulatory strategy together, with the issued licence defining the product’s authorized uses and conditions.
A single review cycle is usually enough to establish whether the data in hand describes the product you intend to sell.