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  • Natural Health Product (NHP) Regulations Canada

    Natural Health Product (NHP) and NPN Services for Canada

    In Canada, Natural Health Products (NHPs) are products such as vitamins and minerals, probiotics and traditional medicines. Products must be safe to use over-the-counter to be classified as NHPs. These products must be assessed by Health Canada and a license must granted before they can be sold. 

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    Natural Health Supplements/Product Regulations in Canada

    The Canadian Food Inspection Agency enforces these regulations. Failure to meet safety and quality standards, or failure to correctly label food and beverage products will mean that these products cannot be sold in the Canadian market and could lead to legal action.

    NHP Product Licensing

    Health Canada required Natural Health Products to be assessed before they can be sold in Canada. The aim of the assessment is to determine if the product is safe, effective and of a high quality. Once this has been determined, the product is issued a license to be sold. Cosmereg can assist in the submission of licensing requests for Natural Health Products.

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    Health Claim Substantiation & Product Development

    Health Canada requires evidence that Natural Health Products are ‘effective’ before licenses can be issued for their sale in Canada. Cosmereg can assist in health claim substantiation by conducting a review of both published and unpublished information, to ensure that we access any information that exists to support your claim.

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    What is GMP Compliance

    Natural and Non-prescription Health Products in Canada are also subject to Good Manufacturing Practice (GMP) regulations. These regulations apply to any company responsible for manufacturing, packaging, labeling, importing or distributing these products. Cosmereg can help you to ensure that your entire supply chain complies with the GMP regulations.

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    FSMA Foreign Supplier Qualification

    As stipulated in the GMP regulations, all suppliers of ingredient for NHPs must be ‘qualified suppliers’. Manufacturers can ‘qualify’ suppliers by reviewing their certificate of analysis (CoA) and validating these certificates through testing. This can be a time-consuming process and is often the reason for non-compliance with GMP regulations. Cosmereg can help with the qualification and verification of foreign suppliers, ensuring that GMP regulations are met.

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    NHP Importation

    In Canada, NHPs are subject to import regulations, in accordance with the Food and Drugs Act. Natural Health Products must be authorized for sale in Canada before they can be imported. Cosmereg can assist in submitting the necessary information for approval to be granted, ensuring compliance with regulations.

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    NHP Clinical Trials

    The requirements for a Clinical Trial of a NHP in Canada are similar to those of a regular pharmaceutical trial. Any person or company that wishes to sell NHPs for the purpose of Clinical Trials in Canada must be authorized to do so. Cosmereg can assist in the process of authorization.

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    NHP Import & Border Control Issue Resolution

    Before NHPs can be exported to Canada, authorization for sale must be obtained, along with a unique Natural Product Number (NPN). This process can take anywhere between 10 days to several months. Cosmereg can assist you in this process, helping to ensure that authorization is granted as quickly as possible.

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    International Trade Certificates (ITC) & Certificates of GMP Compliance

    Certain documentation is required to trade NHPs between countries. Many countries require an International Trade Certificate – a document with information about the product, including its NPN. Certain countries also request a Certificate of GMP compliance, to ensure that the products being traded meet high manufacturing standards. These certificates are usually issued by third parties. Cosmereg can assist your company is obtaining certification.

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    FAQ

    What is defined as a natural health supplement/product in Canada?

    According to the Natural Health Product Regulations (2004), ‘Natural Health Products’ (NHPs) are products that are safe to use without a prescription and fall into one of the following categories:

    1. Vitamins and Minerals
    2. Herbal Remedies
    3. Homeopathic Medicines
    4. Traditional Medicines (i.e. Chinese Herbal Medicine)
    5. Probiotics
    6. Other natural products such as essential fatty acids.

    What is an NPN number Canada?

    In order to be sold in Canada, all ‘Natural Health Products’ must have a license. Manufacturers must provide a lot of information about each product to Health Canada for assessment. Once a product has been assessed and has been found to be high-quality, safe and effective, Health Canada issues a license, which is accompanied by an 8-digit ‘Natural Product Number’ (NPN) or, in the case of homeopathic medicine, a Homeopathic Medicine Number (DIN-HM). These numbers must appear on the label.

    We offer other Canada Services

    Cosmetics

    Cosmereg can assist you with all of Canadian’s cosmetic regulations and requirements, whether you’re manufacturing in Canada or importing products into Canada.

    food

    Any food or beverage products sold in Canada must meet Health Canada’s standards for safety and nutritional quality.

    Medical-Devices

    All Medical Devices are reviewed by Health Canada before authorization for their sale in Canada is granted.

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