The Natural Health Product Approval Process Explained for Those in Regulatory Affairs

regulatory affairs
Across Canada, Natural Health Products (NHPs) are regulated to help protect consumers and provide
safe and effective products to the public. The Canadian government worked closely with consumers, academics, healthcare practitioners, and industry stakeholders to come up with the standard guidelines that are in effect today. As a future regulatory affairs professional, it is important to understand these regulations as they apply to each company and product within the industry. 

At AAPS, our Regulatory Affairs program helps students become familiar with regulatory systems, legislation, and practices that relate to the development, quality, and manufacture of pharmaceutical goods. With a course dedicated to Natural Health Products, students graduate with a well-rounded knowledge of the industry. Continue reading to discover a little more about the approval process for NHPs.

What to Know About Product Licenses for Regulatory Affairs

Before a product can be sold across Canada, it must obtain a number of licenses. One of these is the product license. The process involves completing an application with detailed information about the:

  • Medical ingredients
  • Ingredient sources 
  • Recommended dose
  • NHP potency
  • Non-medical ingredients
  • Recommended uses

After the application is submitted, Health Canada issues a product license if the safety, efficacy, and high-quality claims are supported by the assessment. Along with the product license, the product is given a specific eight-digit long Natural Product Number (NPN) or a unique Homeopathic Medicine Number (DIN-HM). 

regulatory affairs program

Regulatory affairs professionals need an understanding of product licensing

Understanding Site Licenses

On top of the product license, any manufacturer, packager, labeller, and importer needs a site license. If you’re looking to work in one of these environments after your regulatory affairs program, then becoming familiar with the process of site licenses is important.

A lot goes into obtaining and maintaining a site license, including the maintenance of distribution records as well as having proper procedures in place for product recall situations. On top of that, sites must reach industry standards when it comes to proper handling, storage, and delivery of their products. When training in regulatory affairs, you’ll become familiar with good manufacturing practices to look out for to ensure proper site licensing. 

regulatory affairs

Site processes and good manufacturing practices come into play when obtaining a site license

Required Labelling Information

In terms of labelling, products must meet the claims they make on their labels to comply with certain regulatory affairs standards. For example, if a product claims to aid in the maintenance of good health, there must be evidence of this in the assessments performed during the licensing process.

pharmaceutical regulatory affairs

Labelling requirements protect consumers by providing necessary information

Specific labelling requirements are in place to ensure that the public makes safe and informed choices about the NHPs they choose to purchase. Required information on NHP labels includes:

  • Product name
  • License number
  • Quantity in each product package
  • Complete list of ingredients (medical and non-medical)
  • Recommended uses
  • Cautionary statement
  • Storage condition specifications

The NHP course at AAPS will give you a complete understanding of all types of NHPs, as well as what it takes to sell them on the market today. 

Are you interested in pursuing pharmaceutical regulatory affairs?

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