Natural Health Products (NHP) Licensing Regulations & Solutions

NHP Health Canada

Navigating the Regulations for Natural Health Products
In Canada, natural health products (NHPs) play a significant role in promoting holistic wellness and complementing traditional healthcare practices. However, bringing NHPs to the market requires compliance with Health Canada's regulations. At Arora 297 Consultancy, we specialize in helping businesses navigate the regulatory landscape for NHPs. Our team of experts is well-versed in the Natural Health Products Regulations and can provide comprehensive guidance on the regulatory requirements, including product licensing, site licensing, and product classification. We understand the unique challenges faced by companies in the NHP industry and offer tailored solutions to ensure compliance with Health Canada's regulations. Whether you are a manufacturer, distributor, or importer of natural health products, our consultancy services will help streamline your journey towards obtaining the necessary approvals and licenses. Trust Arora 297 Consultancy to provide you with the knowledge and expertise you need to successfully navigate the NHP Health Canada regulations and bring your natural health products to the Canadian market with confidence. Visit our website to learn more about our services and schedule a consultation today.
Natural Health Product (NHP) Licensing Solutions
Need for NHP Consulting Regulations Solutions

Natural health products include goods like traditional medicines, probiotics, minerals and vitamins that are sold in Canada. To qualify as NHPs, a product must be safe for over-the-counter usage. Before these items with NPN health Canada number may be sold, Health Canada must evaluate them and provide a licence.

NHP Regulations apply to each natural health product (NHP) in Canada. You must adhere to NHP Regulations if you deal with the production, packing, labelling, or importationing NHPs for commercial sale in Canada. An NPN (Natural Product Number) or DIN-HM (Homeopathic Medicine Number) licence with an eight-digit identification number is given out following Health Canada's approval of the NHP. You can sell NHPs in Canada after an NPN licence registration. Do you want to know what are Natural Health Product Regulations in Canada are? call Arora Consultancy, Canada's best NHP consulting expert for licenced NHPs, right away to get your NPN.

Importance of NHP Licensing


    The NHP is evaluated by Health Canada to ascertain its efficacy and safety for use as an OTC product.


    To inform consumers that the NHP has been examined and approved by Health Canada, an NPN must be present on the label.


    Retailers who want to sell their NHPs on platforms and websites like Walmart, Amazon, and others, require Health Canada NPN license.


    Many nations acknowledge Canada's regulatory standards & NPN licence similar to or faster than a licence in their nations.

Requirements to Sell NHPs in Canada

In order to sell a natural health product legally in Canada, you must meet three standards.

Natural Product Number

You must obtain a Natural Product Number (NPN). Health Canada gives a product license and an eight-digit NPN, or homeopathic medicine number, after evaluating a product and concluding it is safe, effective, and of high quality (DIN-HM). This number informs you that Health Canada has examined and authorized the product. Depending on the kind of application, the time it takes to issue a license might range from 60 days to 7 months. The primary display screen of the NHP must display the NPN or DIN-HM.
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NHP Compliant Label

Before being sold in Canada, all Natural Health Products (NHPs) must be bilingual (English & French) and labeled/packaged in accordance with the Natural Health Products Regulations. Included are the NPN on the main display screen, a list of the active ingredients in medicine (in either tabular or linear style), usage instructions, a suggested use or use, dangers and warnings, and other information. In order to effectively calculate the amount of label space required to accommodate necessary product information, bilingual labelling should be taken into consideration early in the label and packaging creation process.
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Licensed Importer of Record

An importer of record with a current Health Canada site license is necessary for NHPs made outside of Canada. The NHP being imported has to arrive to a storage or warehouse location that is part of the importer's site license. Additionally, the foreign production facility must swear to following Good Manufacturing Practices and be attached to the importer's site license (GMP). NHPs made in Canada don't need to be imported, but they must be produced, packed, and labelled in a location that has a current site license for the required activities.
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NPN Canada (Natural Product number)

In Canada, the Natural Product Number (NPN) registration and licensing process is a requirement for companies that manufacture, distribute, or sell natural health products. The Health Canada NPN is a unique identification number that signifies that a natural health product has been assessed and approved by Health Canada for its safety, efficacy, and quality. To obtain an NPN, companies must submit a detailed application to Health Canada, which includes scientific evidence supporting the safety and efficacy of the product, as well as information on its manufacturing, ingredients, and proposed use. Health Canada reviews the application to ensure compliance with the Natural Health Products Regulations, and upon approval, issues an NPN to the company. NPN registration and licensing is crucial to ensure that natural health products available in the Canadian market are safe and of high quality, providing consumers with confidence in the products they purchase.
Contact us today to obtain your Health Canada Natural Product Number (NPN) and ensure compliance with Health Canada's regulations for natural health products. Our team is ready to assist you in the Health Canada's NPN registration process and help you bring your product to the Canadian market with confidence.

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Engage our NHP site licensing specialists to allay your site licensing worries, manage other tasks as required, and take care of any applicable importer of record duties.

Natural Health Products NHP Site Licensing

A current site license issued by the Natural and Non-Prescription Health Products Directorate is required if you are a Canadian business producing, packing, labelling, or importing natural health products for retail sale (NNHPD).
  • For four different sorts of operations, the NNHPD grants a site license (manufacturing, labeling, packaging, and importing)
  • Licenses are for Canada's activity only
  • It should be noted that the site license of a Canadian importer must be annexed by all packagers, international makers, and labelers of natural health products.

    Get NHP Consulting Regulations Solutions

    We have a 100% client satisfaction score and have helped numerous businesses obtain a site license for natural health products. In order to ensure that our clients can comply with the site licensing requirements and good manufacturing practices, we have assisted them in creating NHP license applications, SOPs, and supporting documentation. We help with:

    • creating and implementing quality systems that adhere to GMP
    • developing reports for quality assurance
    • conducting GMP audits for good manufacturing practices
    • extending site licenses for NHP
    • preparing site license dossiers for NHP
    • helping with NHP site license modifications
    • annexations of NHP site licenses for overseas sites

    Importance of NHP Site License

    • A site license is a proof that your site abides by GMP (Good Manufacturing Practices)

    • Site licensing demonstrates that the Canadian market only sells safe, superior NHPs.

    • With the license, you can rise to the top in your field.

    We offer the following solutions

    NHP Compliance Solutions

    We have 20 years of Experienced in Trusted NHP Regulatory Services

    Formula Development

    Based on published research, pre-cleared information, and market demand data, we create a variety of dosage forms, including bars, capsules, & powders. The formulas we created for your business are completely yours to keep!
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    NPN License Registration

    Since our founding, we have successfully registered more over 10,000 NPNs, and as a result, we have developed competence in creating all classes of Natural Health Product (NHP) License Applications in a time- and money-saving way.
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    New Ingredient submission (NHPID)

    If one of your ingredients is missing from the database or if a non-medicinal ingredient is present but not added to a function designated for usage in the product,new ingredient request submission is prepared by us.
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    French Translation

    We have French translators team with experience of 30 years. So package Includes both English and French language solutions.
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    NHP Master File Submission

    Don't stress about creating and submitting an application for a natural health product (NHP). On your behalf, our professionals will help you complete the Master File Application and submitting it to Health Canada.
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    Health Claims Substantiation

    We verify your evidence's ability to support your claims of structure-function, preventive, physiological advantage, etc. by reviewing published information, facts, unpublished data, and other information sources.
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    Advertisement and Media Compliance

    When you work with us, our specialists will examine your website, labels, television ads, and print ads to make sure they comply with Health Canada's advertising guidelines and labelling regulations.
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    International Trade Certificate (ITC)

    Our experts will work with you to quickly obtain an International Trade Certificate for your website or product that is accurate and available in either English or French.
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    Site Licensing

    Engage our NHP Compliance expertise to perform all relevant tasks, including as GMP, SOP Documentation, Quality Assurance and Import Licensing, to allay your worries regarding Site Licensing.
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    Clinical Trials Application

    We make sure the right kind of clinical trial is carried out on your NHPs. In addition, we help with the preparation and submission of Clinical Trials Applications (CTA) to the NHP Directorate.
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    Importer of Record

    You will have the freedom to make sure your NHPs cross the border without delays as a third party agency and a Health Canada approved import agent (via Quality IMPORT Solutions).
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    Amazon Seller Compliance

    We can help you comply with Amazon Canada's seller standards, including creating an official letter of confirmation of NPN issue, with your NHP license and compliant label.
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    Frequently Asked Questions - NHP (FAQ's) !
    What is the cost of registering Natural Health Products with Health Canada?
    Image of Faq on HACCP process

    The cost of registering Natural Health Products with Health Canada can vary depending on various factors such as the complexity of the product, the type of application being submitted, and any additional services required. It is recommended to consult with a regulatory consultancy firm like Arora 297 Consultancy for a personalized quote based on your specific needs.

    Can I get an NPN for a protein bar or beverage with herbs and vitamins?
    Image of Faq on HACCP purpose

    Yes, it is possible to obtain a Natural Product Number (NPN) for a protein bar or beverage that contains herbs and vitamins, provided that it meets the requirements set by Health Canada. The product must comply with the Natural Health Products Regulations and undergo a thorough review process.

    What are your costs for NPNs registration?
    Image of Faq on HACCP steps

    The costs for NPN registration can vary depending on the complexity of the product and the services required. Arora 297 Consultancy offers customized solutions and pricing options tailored to your specific needs. It is advisable to contact them for a detailed cost assessment based on your product requirements.

    Can I just acquire an NPN and start selling my current supplement package in English in Canada?
    Image of Faq on HACCP plan

    Acquiring an NPN is an essential step in ensuring the regulatory compliance of your supplement package in Canada. However, obtaining an NPN alone does not guarantee that you can start selling your product. You must also comply with other applicable regulations, such as labeling requirements and Good Manufacturing Practices (GMP), to legally sell your supplement package in Canada.

    Will Canada approve the sale of my dietary supplement?
    Image of Faq on HACCP process explanation

    Health Canada evaluates dietary supplements based on safety, efficacy, and quality criteria. While they strive to provide an efficient review process, the approval of a dietary supplement is determined on a case-by-case basis. It is crucial to ensure that your product meets all regulatory requirements and undergoes the necessary assessment to obtain approval for sale in Canada. Working with a regulatory consultancy firm like Arora 297 Consultancy can help you navigate the process and increase your chances of approval.