1. What are Natural Health Products?

Natural Health Products are a sub-category of drugs in Canada and as such are products that are regulated under the Food and Drug Regulations. Natural Health Products are products that contain vitamins, minerals, botanicals, homeopathic ingredients, probiotics, amino acids and enzymes.

2. What is a regulated product?

A regulated product is a product that is governed by standards enforced through Canadian law. The laws detail how such products are sold in Canada. The laws address issues related to licensure of the actual product and activities related to how the product is brought to the marketplace. Specific regulations detail how these products can be manufactured, packaged, labeled, tested, and/or imported.

3.What licenses are involved?

The types of licenses required can be broadly classified as product licenses and Operational licenses.

Product Licenses

In order to sell a regulated product in Canada the formulation, proposed label, safety and efficacy must be reviewed and approved by qualified government reviewers. The amount of information required depends on the type of product and it level of risk.

Operational Licenses

In order to sell a regulated product in Canada an operational license depending on your business activity must be obtained. In the case of pharmaceuticals an Establishment License is required. In the case of Natural Health Products a Site License is required.

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