The following information is needed for a Natural Health Product (NHP) licence application:

• The name and contact information of the company that will own the product licence

• The type and class of application

• Any associated manufacturers, packagers, labellers, and importers

• For each medicinal ingredient, the common name, proper name, source, quantity, and potency/ratio (if applicable)

• The name of each non-medicinal ingredient/excipient

• The dosage form

• Desired directions of use

• Desired claims

• Proposed cautions

Proposed Label Content:

• A proposed label (regulatory text, not the artwork) is required.

Finished Product Specifications:

• A Finished Product Specification sheet is submitted, showing the required tests (potency, micro, heavy metals, etc.), limits, and test methods.

Efficacy and Safety Documentation

• Literature is required to be submitted to support the efficacy of all claims, and the safety of the product as a whole, when taken according to the directions of use.

We have simplified the process of completing a natural product licence application and obtaining a natural product license from the Natural Health Products Directorate (NHPD) into seven steps.

Step 1:

First, we sign a non-disclosure agreement with you (ours or yours), assuring you that anything we discuss remains strictly confidential. Eventually, some of the information will need to be included on the application submitted to Health Canada but they are the only people outside of ourselves to which anything will be disclosed.

Step 2:

We would then have you send us the formulations that you wish to have licensed by Health Canada. In order to assess the formula and provide a quote we will require the following information:

• The official brand name of the product;

• Dosage directions and dosage form;

• The formula with the amounts of each medicinal ingredient and the non-medicinal ingredients. Please include the source materials (i.e. leaf, root) for your medicinal ingredients.

• For extracts, please ensure that they have a ratio (e.g. 4:1), and for standardized extracts, please ensure they have constituents and potencies.

Step 3:

We will review the documents and let you know if the product is a candidate for licencing in its present form or if some small changes would make it acceptable. The changes could be as simple as doubling the dose or adding/subtracting an ingredient. If the product cannot comply with Canadian regulations, we will advise you that there is little or no chance of success.

Step 4:

Once this basic review is completed, we will send you an all-inclusive, comprehensive written quotation for the work required. There are no hidden or additional charges. What we quote is all that you will pay.

Step 5:

If the quote is acceptable, we will send you a Health Canada document to sign known as a Designated Party Authorization (DPA) Form. This form gives us permission to submit applications and speak on your behalf to Health Canada.

We will then complete and compile the application package, which we will then submit to Health Canada.

Step 6:

Once the application is submitted to Health Canada we will issue an invoice to you, which will be the same as the quote, and ask that it be honoured upon receipt.

Step 7:

Once the Natural Product Number (NPN) has been granted, we will complete a label compliance review. Since Canada is a bi-lingual country certain regulatory label text must be in French, such as directions of use, recommended use/purpose, risk statement, etc. Therefore we will translate the required regulatory label text into French.

An NPN (Natural Product Number) is a license issued by Health Canada, signifying that your Natural Health Product (NHP) meets stringent safety, quality, and efficacy standards. This license is mandatory for selling NHPs in Canada.

The NPN application process can be complex and involve navigating various regulations. Our team of NPN specialists possesses in-depth knowledge of Health Canada requirements and can streamline the process for you. We can help you avoid costly errors, ensure faster application review, and maximize your chances of successful approval.

Testing requirements vary depending on the specific ingredients and classification of your NHP. We can help you identify the essential tests needed for your product license application, ensuring compliance with Health Canada regulations.

The NPN application processing time can vary depending on the complexity of your product and Health Canada's workload. However, we can work efficiently to prepare your application and expedite the review process. Generally, it can range from a few months to a year.

The duration of product licence application assessment by Health Canada will depend on the application’s class:

• Class I - 60 days

• Class II - 90 days

• Class III - 310 days

Yes, all NHPs sold in Canada must obtain an NPN prior to the product’s sale. Amazon will frequently check their product offering and flag any non-compliant products.