Product Licences

Product Licences

In order to sell natural health products in Canada, companies must obtain a product license called a Natural Product Number (NPN). To obtain this NPN, detailed information must be provided to, and assessed by the Natural and Non-Prescription Health Product Directorate (NNHPD). Once NNHPD has determined that the product is safe, effective, and of high quality, an eight-digit NPN or DIN-HM (Homeopathic Medicine Number) will be granted.

There is no government fees for obtaining an NPN, and they do not expire.

Requirements of a Product Licence Application

Base Application Documentation

A multiple-page information document must be completed containing the following information:

  • The name and contact information of the company that will own the product licence
  • The type and class of application
  • Any associated manufacturers, packagers, labelers and importers
  • For each medicinal ingredient, the common name, proper name, source, quantity and potency/ratio (if applicable)
  • The name of each non-medicinal ingredient/excipient
  • The dosage form
  • Desired directions of use
  • Desired claims
  • Proposed cautions

Proposed Label Content

A proposed label (regulatory text, not artwork) is required.

Finished Product Specification

A Finished Product Specification sheet is submitted, showing the required tests (potency, micro, heavy metals, etc), limits and test methods.

Efficacy and Safety Documentation

Literature is required to be submitted to support the efficacy of all claims, and the safety of the product as a whole, when taken according to the directions of use.

The NPC-Corp Advantage

We use an extremely sophisticated electronic creation system to complete licence applications. This provides a more streamlined submission process, improves document and data management, and decreases the amount of time needed to produce an application by 35 to 50 percent.

This process significantly reduces the costs involved in completing a successful application.