Aug 26, 2024

Getting an NPN Number Canada

The letters “NPN” followed by a number are on the packaging of many natural health products you may find in the Canadian marketplace, including Vitamin supplements, echinacea, and probiotics. It is a sign that they have been reviewed by our federal agency, Health Canada, and that their effectiveness and safety have been evaluated and approved. It is a much more regulated system than what exists in the US, where products are often sold without even being reviewed.

Getting an NPN Number in Canada is a significant step for a manufacturer of natural health products in order to be legally able to sell their product. The process is complex and requires detailed scientific and regulatory information. Our regulatory experts are here to guide you through the NPN process.

How to Obtain an NPN Number in Canada for Natural Health Products

In Canada, NHPs are regulated under a comprehensive framework outlined in the NHP regulations. Manufacturers of NHPs must apply to HC for a product license (NPN) for each NHP that they wish to market in Canada. For a NHP to be authorized for sale in Canada, it must meet stringent standards of quality and evidence, and must be produced and manufactured using good manufacturing practices. NHPs also have unique labelling requirements, as well as specific pharmacokinetic, safety and efficacy, and homeopathic medicine standards.

For NHPs to be licensed for sale, a product licensing application (PLA) must be submitted to HC, which includes a detailed submission of the product, its ingredients, dosage form(s), recommended use(s), and relevant scientific and traditional evidence. The PLA will undergo a thorough review by HC and can take up to several months.