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Importing Natural Health Products into Canada Commercially

Helping Canadian Businesses Get Licences, Stay Onside And Resolve Their Legal Challenges.

With the growing global interest in natural health products (NHPs), Canada has become a lucrative market for these goods. However, the process of importing NHPs into Canada commercially requires a thorough understanding of the regulatory landscape. This guide will provide you with the necessary steps and considerations to successfully navigate this process.

Understanding the Regulatory Framework

The Natural Health Products Regulations (NHPR) under the Food and Drugs Act governs the importation of NHPs into Canada. The NHPR ensures that Canadians have access to NHPs that are safe, effective, and of high quality. Understanding these regulations is the first step towards successful importation.

Under the NHPR, NHPs are defined as substances such as vitamins, minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, and other products like amino acids and essential fatty acids. These products must be safe for over-the-counter use and must be available in dosage forms such as capsules, tablets, powders, and liquids.

It’s important to note that the NHPR does not apply to natural health products for veterinary use, foods, or cosmetics. These products are regulated under different legislation.

Site Licensing

Before you can import NHPs into Canada, you must obtain a Site License (SL). The SL is issued by Health Canada and indicates that your business meets Good Manufacturing Practices (GMPs). GMPs ensure that products are consistently produced and controlled according to quality standards.

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To obtain an SL, you must provide detailed information about your business, including the location, activities, quality assurance personnel, and procedures for product recalls and adverse reaction reporting. Health Canada may also inspect your facilities before issuing an SL.

Product Licensing

Each NHP you intend to import must have a Product License (PL). The PL is issued by Health Canada and indicates that the product is safe, effective, and of high quality. To obtain a PL, you must provide detailed information about the product, including its ingredients, source, dosage form, and recommended use.

It’s important to note that obtaining a PL can be a lengthy process, as Health Canada reviews all the information provided and may request additional data. Therefore, it’s advisable to start the PL application process well in advance of your planned importation date.

Importation Process

Once you have obtained the necessary licenses, you can begin the importation process. This involves several steps, including arranging for transportation, ensuring compliance with import controls, and paying any applicable duties and taxes.

When your shipment arrives in Canada, it will be inspected by the Canada Border Services Agency (CBSA). The CBSA will verify that the shipment contains the products declared, that the products are properly labeled, and that all duties and taxes have been paid.

If the CBSA finds any issues with your shipment, it may be held at the border until the issues are resolved. Therefore, it’s important to ensure that your shipment complies with all requirements before it arrives in Canada.

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Labeling Requirements

Under the NHPR, all NHPs must be properly labeled. The label must include the product’s name, the list of ingredients, the quantity of each ingredient, the dosage form, the recommended use, and any cautionary statements. The label must also include the product’s PL number and the name and address of the licensee.

It’s important to note that all information on the label must be in both English and French, Canada’s official languages. Failure to meet these labelling requirements can result in your shipment being held at the border.

Import Controls

Canada has import controls on certain substances used in NHPs. These controls are in place to protect public health and safety. If your product contains a controlled substance, you may need to obtain an import permit from Health Canada.

It’s also important to note that Canada has trade agreements with many countries. These agreements can affect the duties and taxes you pay on your imported goods. Therefore, it’s advisable to consult with a customs broker or trade advisor to understand how these agreements may affect your importation.

Post-Importation Considerations

After your NHPs have been successfully imported, there are several post-importation considerations to keep in mind. These include monitoring for adverse reactions, maintaining records, and ensuring ongoing compliance with the NHPR.

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As a licensee, you are required to monitor for any adverse reactions to your products and report these to Health Canada. You are also required to maintain records of your importation activities for a period of six years. These records must be available for inspection by Health Canada upon request.

Finally, it’s important to ensure ongoing compliance with the NHPR. This includes maintaining your SL and PL, ensuring your products continue to meet quality standards, and keeping up-to-date with any changes to the regulations.

Importing NHPs into Canada commercially can be a complex process, but with careful planning and a thorough understanding of the regulatory landscape, it can also be a rewarding business venture. By following the steps and considerations outlined in this guide, you can navigate this process successfully and bring the benefits of natural health products to Canadian consumers.

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