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Registration Process for Food Supplement in Canada

Regulatory Authority

Health Canada

Regulatory Website

https://www.canada.ca/

License Validity

5 Years

Registration Timeline

1-3 Months

Registration Process for Food Supplement in Canada

The Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada is responsible for overseeing the regulation of food supplements in Canada.

Product Classification: Find out how your product is classified in accordance with Canadian laws. Generally, food supplements fall into two categories: “dietary supplements” or “natural health products” (NHPs). Factors including components, health claims, and intended use determine the classification.

Product Licensing or Notification: Based on the classification, you could have to apply to Health Canada for either a product license or a notification. Although certain dietary supplements might just need to be reported to Health Canada, NHPs normally need a product license.

Formulation and Labeling: Create a product that satisfies Canadian requirements by making sure its formulation is correct. Provide accurate and legally required labeling that includes ingredient lists, suggested dosages, any applicable health claims, and any necessary disclaimers or warning. Implement quality assurance procedures to guarantee the effectiveness, safety, and caliber of your goods. Product testing and adherence to Good Manufacturing Practices (GMP) may fall under this category.

Submission of Application or Notification: Follow the proper procedures to prepare and send Health Canada your application for a product license or notification. This could entail filling out forms and supplying supporting materials, like safety evaluations, product formulation specifications, and labeling data.

Review Process: To make sure that your application or notification complies with Canadian laws, Health Canada will review it. Evaluations of the product’s effectiveness, safety, labeling, and manufacturing procedures may be part of this examination.

Acceptance or Notification Acknowledgment: Following assessment of your application, Health Canada will either grant a product license or offer notification acknowledgment. This enables you to offer and sell your dietary supplement in Canada lawfully.

Post-Market Surveillance: After your product is sold, you could be required to comply with regulations pertaining to post-market surveillance, which include compliance monitoring and adverse event reporting. Health Canada has the authority to carry out audits and inspections to make sure that rules are being followed.

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