What is needed to sell a Natural Health Product in Canada?

Several key pieces are required to sell an NHP in Canada: A Natural Health Product Number or NPN, a compliant and bilingual label, your foreign or domestic manufacturing/packaging/labeling site to be annexed to a Canadian NHP Site License. Quality Smart Solutions and Quality Import Solutions offers turn-key solutions for all these activities. Reach out to our team to inquire about the range of services we can offer.

Does my Natural Health Product need to be tested?

Yes, Health Canada expects all finished products to be tested. Some items to test are: microbiological contaminants, solvent residues, pesticides, and medicinal ingredient amounts (if applicable). Different types of NHPs may require different testing protocols. For further information on testing please reach out to our team or consult the Quality of NHPs Guide.

Is there a fee associated with licensing for Natural Health Products?

Currently, there is no cost recovery issued by Health Canada for the licensing of Natural Health Products. Health Canada has considered this in the past, but nothing has been finalized.

How long will it take to receive my Natural Product Number (NPN)?

Once the application is submitted, the standard review timelines for Health Canada are as follows: Class I – 60 days, Class II – 90 days, Class III – 210 days. Health Canada’s backlog of applications and the pandemic has impacted these timelines, so their reviews may take considerably longer for all classes.

My Natural Health Product is manufactured outside of Canada. What do I need to do to import the product to Canada?

You will need an NPN and a compliant/bilingual label. You will also need to annex your foreign site to a domestic NHP Site License. Depending on what kind of quality documentation your site already carries, you may qualify for a pre-cleared annexation stream. Otherwise, you will have to complete a full QAR form and submit additional records and SOPs to support the GMP activities conducted at your site. Please reach out to our team if you have any further questions or if you would like any of your documentation, formulas or labels reviewed by our staff! We’re happy to help!

What is the Natural Health Product Licensing process?

The first step of Natural Health Product licensing is to perform an in-depth formula review. The formula review will address any questions or concerns around the product’s ingredients. After that, a Product License Application form will need to be drafted, along with the necessary accompanying documents (e.g. cover letter, attestation forms, evidence and safety summary report, etc.). Finally, when the application package is prepared, it can be submitted to Health Canada for review and approval.

Why should I get a Natural Health Product (NHP) License?

A Natural Health Product (NHP) License, otherwise known as a Product License, is needed in order to sell your NHP in Canada. Selling your product without this number may results in a stop sale, detainment, or forfeiture of your natural health products by Health Canada and/or the Canada Border Services Agency.

What are the licensing requirements for Natural Health Products in Canada?

All natural health products (NHPs) sold in Canada must be issued a Natural Product Number (NPN). In order to receive an NPN, the product must be licensed with Health Canada. To obtain a license, you must submit an application and supporting documentation. The application will be reviewed by Health Canada, who will determine if the product can be marketed in Canada. Licensing fees vary depending on the type of product being sold.

What are the Natural Health Products labelling standards and guidance documents?

All natural health products must follow the labelling requirements outlined in the Natural Health Products Regulations. In addition, Health Canada has published a number of labelling standards and guidance documents to help with label design and content. These guidelines outline the information that must be included on labels, including product name, active ingredients, dosage form, caution statements, dosage instructions and storage conditions. It is important to ensure that all labels comply with these regulations and documents in order to be sold in Canada.

What are the Quality System Regulations for Canadian Natural Health Products?

Quality System Regulations (QSR) requirements are necessary to ensure the safety and efficacy of natural health products in Canada. Companies, who distribute or manufacture natural health products, must be familiar with their responsibilities related to the QSR such as testing and making sure facilities meet labelling standards. Health Canada also has some specific Good Manufacturing Practices (GMP) requirements that specify how companies must manage their operational aspects such as production, storage, labelling and distribution. Companies should be familiar with GMP in order to comply with Canadian regulations when manufacturing or distributing natural health products.

What are the advertising guidelines and claims attached to Natural Health Products in Canada?

Advertising and labeling claims for natural health products must comply with the Food and Drugs Act. All promotional labeling materials must have accurate, non-misleading information about the product's ingredients, use, dosages, routes of administration, indications, side effects/warnings, quantity or strength of active ingredient, risk information, shelf life and safety. In addition to this, any claims that relate to the uses of a natural health product must be evaluated and authorized by Health Canada prior to being expressed in advertising.

How to report serious adverse reactions from consumer use of Natural Health Products?

Companies must report serious adverse reactions of a Natural Health Product (NHP) to Health Canada. Adverse reactions that could result in death, life-threatening illness, hospitalization or disability must be reported within 15 days of the company becoming aware of it. Any other adverse reaction which is deemed serious enough in the opinion of the company, should also be reported within 15 days via an Adverse Reaction Report form. All reports must include detailed information and be submitted on an official reporting form available on the Government of Canada website.

NHP Consulting to Save You Time & Money on NPN Number Registration

Quality Smart Solutions has registered over 9000 Natural Health Products (NHP) serving over 2000 clients since 2007 across all categories with a stellar success record. We have emerged as a global leader in NHP consulting & compliance.

Beginers Guide

How to Sell NHPs/Dietary Supplements on Amazon

All health products that contain active ingredients of natural health products are called Natural Health Products (NHP) in Canada. These NHPs are used to restore or maintain your health. NHPs come in different dosage forms, such as tablets, capsules, and gels, to name a few. Many consumer products for everyday use, such as toothpaste, shampoos, mouthwashes, antiperspirants, and facial products are also classified as NHPs in Canada.

Fast Facts – More than 71% of people in Canada consume natural health products (NHPs), like herbal products, vitamins, and homeopathic medicines, according to the Government of Canada (canada.ca). NHPs in the country generate $5.5 billion in sales (Alive Magazine, June 19, 2023). Canada has become an appealing market for brands that meet product registration requirements and other provisions outlined by Health Canada to sell Natural Health Products (NHP).

The comprehensive video above by Andrew Parshad, Founder, of Quality Smart Solutions, explains the three legal requirements to sell NHPs in Canada and answers common questions about NHP regulations. Also, click here to read our blog on the Health Canada proposed fees for NHP registration.

How can I save money, time & effort with expert regulatory assistance?

All Natural Health Products (NHPs) sold in Canada are subject to NHP Regulations. Whether you deal with manufacturing, packaging, labeling, or importing NHPs for commercial sale in Canada, you need to meet NHP Regulations. Once the NHP is approved by Health Canada, an NPN (Natural Product Number) or DIN-HM (Homeopathic Medicine Number) license consisting of an eight-digit identifier is issued. The NPN license is your ticket to selling NHPs in Canada. Do you know the Natural Health Product (NHP) Regulations in Canada? If not, call us today and obtain your NPN with Quality Smart Solutions, Canada’s leading NHP consulting firm for licensed NHPs.

Health Canada Compliance

Health Canada assesses the NHP and determines whether it is effective and safe to be used as over-the-counter product.

Label Compliance

An NPN must appear on the label to let consumers know the NHP has been reviewed and approved by Health Canada.

Ecommerce Growth

Retailers such as Walmart, Amazon, and others ask for proof of the NPN license issuance to sell NHPs through their platforms and stores.

International Expansion

Many countries recognize Canada's regulatory standards and NPN license may be equivalent to or expedite licensing in their jurisdiction.

Types of NHPs we have licensed

We have licensed a wide range of Natural Health Products. Here are just some of the types of NHPs we’ve registered.

Sports Nutrition

Sunscreens

Hand Sanitizers

Multi Vitamins

Anti-Oxidants

Traditional Medicine

Gummies

Greens

Nootropics

Probiotics

Beauty Enhancers

Aromatherapy

From licensing to importation, your end-to-end NHP compliance partner

Quality Smart Solutions is committed to providing quick assistance in services related to NHP Regulations Compliance so that you can enter the industry and establish a compliant and profitable business. Contact us for NPN Licensing, Label Compliance, and Importer of Record consulting services.

Formula Development

We develop various dosage forms, such as capsules, bars, powders based on published studies, pre-cleared information, and market demand data. The formulas developed by us for you are fully owned by you!

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NPN License Registration

With successful registration of over 5,000 NPNs since inception, we have gained expertise in preparing all Classes of Natural Health Product (NHP) License Applications in a cost-effective and efficient manner.

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New Ingredient submission (NHPID)

We prepare new ingredient request submission in case one of your ingredients is not available in the database or the non-medicinal ingredient is in the database but not added to a function listed for use in your product.

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French Translation

We are backed by a team of French Translators with 25 years of experience. So, our package compliance solution ensures your packaging complies with both languages English and French.

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NHP Master File Submission

Don’t worry about preparing and submitting Natural Health Product (NHP) Master File Application. Our experts will help you prepare the Master File Application on your behalf and submit it to Health Canada.

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Health Claims Substantiation

We check published information, facts, unpublished data, and other information resources to ensure that your evidence can substantiate your claims of structure-function, prevention, or physiological benefit, etc.

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Advertisement and Media Compliance

When you partner with us, our experts will review your website, label, television, and print ads to ensure they adhere to the labeling standards and meet Health Canada policies as it relates to advertising requirements.

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International Trade Certificate (ITC)

Our experts will assist you in getting an International Trade Certificate for your site or product with accuracy, and the capability of either English or French versions of ITC sooner than expected.

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Site Licensing

Mitigate your concerns about Site Licensing by engaging our NHP Compliance experts to handle all necessary functions, such as GMP, SOP Documentation, Import Licensing, and Quality Assurance.

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Clinical Trials Application

We ensure the type of clinical trial should be conducted for your NHPs. We also assist in preparing Clinical Trials Application (CTA) and submission to the NHP Directorate.

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Importer of Record

As a Health Canada licensed import agent (through Quality IMPORT Solutions) and a third party agent you will have the flexibility of ensuring your NHPs cross the border without hold ups.

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Amazon Seller Compliance

With your NHP license and compliant label we can assist you with meeting Amazon Canada's seller requirements including preparing an official letter of confirmation of NPN issuance.

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More than 9000 NHPs successfully licensed

Some of the World’s Largest Brands have Trusted Quality Smart Solutions to License their Natural Health Product (NHP).

5 Star Google Reviews

Edward Ro Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael T MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Don Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!