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).
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 assesses the NHP and determines whether it is effective and safe to be used as over-the-counter product.
An NPN must appear on the label to let consumers know the NHP has been reviewed and approved by Health Canada.
Retailers such as Walmart, Amazon, and others ask for proof of the NPN license issuance to sell NHPs through their platforms and stores.
Many countries recognize Canada's regulatory standards and NPN license may be equivalent to or expedite licensing in their jurisdiction.
We have licensed a wide range of Natural Health Products. Here are just some of the types of NHPs we’ve registered.
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.
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!
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Some of the World’s Largest Brands have Trusted Quality Smart Solutions to License their Natural Health Product (NHP).
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.
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.
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.
Once the application is submitted, the standard review timelines for Health Canada are as follows: Class I – 60 days, Class II – 90 to 120 days, Class III – 210 to 310 days. These timelines are non-binding meaning licensing may take longer than stated performance standard targets.
You will need an NPN and a compliant/bilingual label.
Your foreign (ie. outside Canada) manufacturing site must be annexed to a Canadian Health Canada site license holder with the activity of importing natural health products. 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!
No. You must obtain a NPN license, have a compliant label and, if your dietary supplement is manufactured outside Canada, you must partner with a Health Canada site licensed importer.
If your NHP is being exported to Canada without an NPN it is subject to border enforcement by the Canada Border Service Agency (CBSA) who could detain the non-compliant product, destroy on-site or ship back to the exporter at their expense. If the NHP is discovered to be sold in retail (online or in brick-and-mortar) Health Canada would issue a stop sale and recall of the product.
Health Canada treats each NHP application separately. They do not reference previously licensed products in their evaluation (unless you have permission from the other product license holder and reference their NPN on your application). As such, another company that has an NPN for the same product formula as yours does not expedite or have any influence on the licensing of your product.
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