Introduction

The Canadian market for natural health products (NHPs) has been growing steadily in recent years, with increasing demand from consumers for products that promote health and well-being. However, bringing a natural health product to the Canadian market requires navigating a complex regulatory process governed by Health Canada. Understanding the requirements of the Natural Health Products Regulations, including obtaining an NPN (Natural Product Number) from Health Canada, complying with NHP Site Licensing, and adhering to post-market obligations, is essential for getting your product approved for sale in Canada. In this blog, we will explore the step-by-step process for getting a product approved by Health Canada.
Navigating the Regulatory Process: How to Get Your Product Approved by Health Canada
Step 1: Understanding the Regulatory Framework
The first step in getting a product approved by Health Canada is to understand the regulatory framework for natural health products in Canada. Health Canada is the federal department responsible for regulating NHPs in Canada, and it has established the Natural Health Products Regulations to ensure that NHPs are safe, effective, and of high quality. These regulations apply to products that are sold or represented for use as NHPs in Canada, including herbal remedies, vitamins, minerals, probiotics, and other natural health products.
The Natural Health Products Regulations require that all NHPs sold in Canada have a valid NPN, unless exempted, which serves as evidence that the product has been assessed and authorized for sale by Health Canada. The regulations also specify requirements for product labeling, packaging, and advertising, as well as Good Manufacturing Practices (GMPs) for manufacturing, packaging, and labeling facilities. Understanding the regulatory framework and complying with the Natural Health Products Regulations is crucial for getting your product approved by Health Canada.
Step 2: Preparing and Submitting a Regulatory Submission

The next step in the approval process is to prepare and submit a regulatory submission to Health Canada. Regulatory submission is a comprehensive document that includes scientific and technical information about your product, including its safety, efficacy, quality, and proposed uses. The submission must be prepared in accordance with the requirements of the Natural Health Products Regulations and submitted to Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD).
The regulatory submission may include data from pre-clinical and clinical studies, information on the product’s ingredients, formulation, dosage form, and proposed uses, as well as evidence of safety and efficacy. It must also include information on the proposed label, packaging, and advertising for the product, as well as details on the manufacturing, packaging, and labeling facilities, if applicable. The regulatory submission must be complete, accurate, and supported by scientific evidence to increase the chances of approval by Health Canada.
Step 3: Review and Evaluation by Health Canada

Once the regulatory submission is received by Health Canada, it undergoes a review and evaluation process to determine if the product meets the safety, efficacy, and quality requirements of the Natural Health Products Regulations. The review and evaluation process involves a thorough assessment of the scientific and technical information submitted, as well as compliance with the regulatory requirements.
Health Canada may request additional information or clarification during the review process, and it’s important to respond promptly and accurately to any requests to avoid delays in the approval process. The length of the review process may vary depending on factors such as the complexity of the submission, the availability of data, and the workload of Health Canada. It’s important to be patient and proactive in providing any requested information to facilitate the review and evaluation process.
Step 4: Obtaining a Natural Product Number (NPN) from Health Canada

If the regulatory submission is deemed complete and meets the requirements of the Natural Health Products Regulations, Health Canada will issue a Natural Product Number (NPN) for the approved product. The NPN serves as evidence that the product has been authorized for sale in Canada and can be used on the product label, packaging, and advertising.
The NPN is a unique eight-digit number that identifies the specific product and its authorized uses. It provides consumers with assurance that the product has been reviewed and approved by Health Canada for safety, efficacy, and quality. It’s important to include the NPN on the product label, packaging, and advertising as it is a mandatory requirement for all NHPs sold in Canada, and failure to do so can result in regulatory non-compliance and potential penalties.
Step 5: NHP Site Licensing

In addition to obtaining an NPN for the approved product, some NHP manufacturers and importers may also need to obtain NHP Site Licensing from Health Canada. NHP Site Licensing is a separate requirement under the Natural Health Products Regulations for manufacturers, packagers, labelers, and importers of NHPs.
NHP Site Licensing involves submitting an application to Health Canada that includes information on the manufacturing, packaging, and labeling facilities, as well as evidence of compliance with Good Manufacturing Practices (GMPs). Once the site license is issued, it authorizes the manufacturer, packager, labeler, or importer to conduct activities related to the manufacturing, packaging, and labeling of NHPs in Canada.
It’s important to note that NHP Site Licensing is not required for all NHP manufacturers and importers, and it depends on factors such as the size of the operation, the types of products manufactured or imported, and the compliance history of the company. However, it’s crucial to ensure compliance with NHP Site Licensing requirements if applicable to your business to avoid regulatory non-compliance and potential penalties.
Step 6: Post-Market Obligations
Once a product has been approved and authorized for sale in Canada, there are ongoing post-market obligations that must be fulfilled to maintain compliance with Health Canada’s regulations. These obligations include, but are not limited to:
- Adverse Reaction Reporting: Manufacturers, importers, and distributors of NHPs are required to report any adverse reactions associated with the use of their products to Health Canada. This includes adverse reactions reported by consumers, healthcare professionals, or other sources. Timely and accurate reporting of adverse reactions is essential to monitor the safety of NHPs and ensure that any potential risks are addressed promptly.
- Labeling and Advertising Compliance: NHPs must continue to comply with the labeling and advertising requirements of the Natural Health Products Regulations. This includes accurate and up-to-date product labeling, packaging, and advertising that align with the approved NPN and comply with the regulatory requirements.
- Record Keeping: Manufacturers, importers, and distributors of NHPs are required to maintain records of their products, including information on the ingredients, formulation, dosage form, manufacturing, packaging, and labeling, as well as any adverse reactions reported. These records must be kept for a specified period of time and must be made available to Health Canada upon request.
- Compliance with GMPs: Manufacturers, packagers, labelers, and importers with NHP Site Licensing are required to comply with Good Manufacturing Practices (GMPs) on an ongoing basis. This includes regular inspections and audits of the manufacturing, packaging, and labeling facilities to ensure compliance with GMPs and maintain the site license.
Conclusion:
The process of getting a product approved by Health Canada can be complex and time-consuming, but it’s a necessary and important step for ensuring the safety, efficacy, and quality of natural health products (NHPs) in Canada. By following the Natural Health Products Regulations set by Health Canada, manufacturers, importers, and distributors can navigate the process successfully and bring their NHPs to market in compliance with the regulatory requirements.
It’s crucial to thoroughly understand the regulatory requirements and timelines for submitting a product for approval, as well as the ongoing post-market obligations for maintaining compliance. Working with regulatory experts or consultants can also be beneficial to ensure all requirements are met and the submission process is smooth.
In conclusion, the process for getting a product approved by Health Canada involves several key steps, including determining the product category, preparing and submitting a regulatory submission, obtaining a Natural Product Number (NPN), obtaining NHP Site Licensing if applicable, and fulfilling ongoing post-market obligations. It’s important to carefully follow Health Canada’s regulations and requirements to ensure the approval and ongoing compliance of NHPs in Canada.