Dietary Supplements in Canada are called Natural Health Products or NHP as is the common acronym used.  In Canada Natural Health Products cover various types of formats like tablets, capsules, gels, gummy bears, powders, creams and gels.  Natural Health Products can be taken by ingestion and includes topical use.  Certain ingredients of sunscreens and hand sanitizers are also considered natural health products.   Some common categories of natural health products are  vitamins, minerals, herbals, homeopathics, traditional (chinese herbal medicine, ayurvedic products), sports nutrition but there are many supplements (some that are considered OTC drugs in the United States) that are classified as NHPs.

Natural Health Products in Canada require a Natural Product Number or NPN as it’s often called. It is a 8 digit unique identifier. If you are planning to sell online, for example, like on Amazon Canada (Amazon.ca)  the retailer will ask for proof that you have a NHP license before they will allow you sell on their platform or in their store. This is a legal requirement to sell NHPs in Canada. Only after you obtain the license can you beginning selling the NHP.

The time to obtain a NPN license varies based on the ingredients and claims made with the supplement.  As a general rule of thumb, the more common the ingredients are the faster the licensing. For example, Vitamin C 500 mg health product would be licensed in approximately 60 days. The more complex or unique the ingredient is the longer it would take which can be as long as 210 days.  Health Canada has created monographs which are prescriptive details of ingredients and claims. If products fall within the parameters of these monographs then licensing takes approximately 60 to 90 days  (Class 1 or 2 respectively). But if just one ingredient in the formula is not found in the NHP monograph or is in a monograph but is outside of its parameters the timeline changes to 210 days (class 3 NHP). Here is a link to the NHP monographs which are single ingredient or product:

NHP MONOGRAPH DATABASE BOX WITH HEALTH CANADA LOGO AND MAPLE LEAF FLAG

Keep in mind that you can mix and match ingredients from monographs which just affects the class which the NHP falls under. 

Your Canada NHP label will be considerably different than your USA dietary supplement label.  Some distinct differences include:

• French is Canada’s second official language so all text except trademarked words must be bilingual (both in English and French)
• Supplement Facts panel is called Medicinal Ingredients
• FDA disclaimer is not used in Canada. There are other things like directions of use, recommended use or purpose, risk statements that must also appear on your Canadian NHP label
• Your license number must appear on the front of the package. The license holder’s name and importer of record’s name must also appear on the label (we’ll get to importer of record shortly).
• At least one of the claims you are licensed for must appear on your label. The claims may be stronger than in the United States. For example, with Chondroitin Sulfate, if you have the appropriate daily dosage level, you may qualify for a claim that it reduces pain due to osteoarthritis.  This claim would be considered a drug claim and require a drug license in the United States but in Canada it would be allowed with a NHP license. 

It’s important that you work with an experienced NHP Consultant to ensure your labels are compliant and the translation is Quebecois French.

The third requirement to sell a dietary supplement in Canada is to work with a Health Canada licensed importer agent.  This import agent is responsible for the quality of your product.  This includes annexation of your manufacturer to the importer’s site license.  The product must be stored in a warehouse or storage site that meets all the storage practice requirements that Health Canada has outlined.  For startups or companies that are looking to test the Canadian market a cost effective approach would be to have the US storage site where the supplements are currently stored and consolidate the licensed NHPs at this same site.   Then a just-in-time approach to ship the smaller volumes to the retailer or e-tailer’s warehouse.  Eventually, if the business expands into larger retail outlets who require faster delivery based on inventory replenishment needs then a Canadian warehouse solution would be recommended.    Our sister company, Quality IMPORT Solutions serves all your import needs and with the flexibility of using our Canadian warehouse partners as you grow.

The NHP license has been utilized in countries around the world to help expedite approval in those jurisdictions or seen as an equivalent to the country’s regulations and allow for immediate importation.  This is anecdotal and it is best to check with the country you plan to export to on the benefits and value of having an NPN license for your dietary supplements.  Quality Smart Solutions is Health Canada approved to issue International Trade Certificates (ITC) attesting to the NPN license or GMP requirements (if supplements are manufactured in Canada) to add another layer of confirmation and attestation.

INFO COLLECT –  We collect all the necessary information related to your dietary supplements

FORMULA REVIEW –  We conduct a formula feasiblity review evaluating the evidence to support the safety and, where applicable, the safety of each of your medicinal ingredients. We confirm if your non-medicinal ingredients are in the ingredient database and meet the requirements.

APPLICATION PREP –  Depending on the class we will prepare an electronic product license application (PLA), an Efficacy and Safety Technical Dossier and a Finished Product Specification Form.

QA CHECK – Another team member who has not seen the application will check over the completeness and accuracy of the application.

CLIENT REVIEW – We will pass the application back to you to look over on a high level, administrative basis before we finalize to submit.

SUBMISSION AND ACKNOLWEDGEMENT –  Through a secure government electronic portal we submit the application to Health Canada.  For class 2 and 3 applications, in approximately 30 to 45 days Health Canada will issue an acknowledgment letter.   The clock starts (non-binding) when the acknowledgement letter is received (90 days for class 2, 210 days for class 3).

APPLICATION ASSESSMENT (IRN) –  Health Canada will review the application and may come back with questions called Information Request Notices (IRN).  We will answer these IRNs on your behalf.

LICENSE ISSUANCE –  Your final NPN license containing 8 digits issued to you is permanent and never expires. The license issuance letter may be requested by retailers for confirmation of your NPN issuance.H

• Over 6000 NHPs Registered and Over 750 Clients Served
• Our Clients are from every continent
• Expert Assistance with troubleshooting regulatory requirements with AMAZON.CA 
• Over 50 years of combined NHP Regulatory Licensing Experience 
• NHP licensing and consulting expertise with former health canada officers, regulatory experts from Canada’s Biggest health product companies.