Natural Health Products & Site Licensing
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In order to sell natural health products in Canada, companies must obtain a product license called a Natural Product Number (NPN). To obtain this NPN, detailed information must be provided to, and assessed by the Natural and Non-Prescription Health Product Directorate (NNHPD). Once NNHPD has determined that the product is safe, effective, and of high quality, an eight-digit NPN or DIN-HM (Homeopathic Medicine Number) will be granted.
There is no government fees for obtaining an NPN, and they do not expire.
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Requirements of a Product License Application
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Base Application Documentation
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A multiple-page information document must be completed containing the following information:
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The name and contact information of the company that will own the product license
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The type and class of application
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Any associated manufacturers, packagers, labelers and importers
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For each medicinal ingredient, the common name, proper name, source, quantity and potency/ratio (if applicable)
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The name of each non-medicinal ingredient/excipient
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The dosage form
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Desired directions of use
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Desired claims
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Proposed cautions
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Proposed Label Content
A proposed label (regulatory text, not artwork) is required.
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Finished Product Specification
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A Finished Product Specification sheet is submitted, showing the required tests (potency, micro, heavy metals, etc), limits and test methods.
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Efficacy and Safety Documentation
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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.
Steps to Obtaining a Natural Product License
We have simplified the process of completing a natural product license application and obtaining a natural product license from the Natural Health Products Directorate (NHPD) into seven steps.
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Step 1:
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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.
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Step 2:
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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:
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The official brand name of the product;
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Dosage directions and dosage form;
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The formula with the amounts of each medicinal ingredient and the non-medicinal ingredients. Please include the source materials (ie. leaf, root) for your medicinal ingredients.
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For extracts, please ensure that they have a ratio (e.g. 4:1), and for standardized extracts, please ensure they have constituents and potencies.
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Step 3:
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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. Please note there is no charge for this regulatory evaluation and discussions of registration feasibility.
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Step 4:
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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.
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Step 5:
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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.
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Step 6:
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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.
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Step 7:
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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.
Site Licenses
A “Site License” is issued to CANADIAN importers, manufacturers, packagers and labelers, when they can provide sufficient evidence of procedures or processes that comply with Canadian Good Manufacturing Practices.
The company must provide evidence through Standard Operating Procedures (SOPs) that proper processes are in place; including receiving natural health products, a clean premises with a good sanitation program, an up to date recall system in place, among others, all with good records and GMP procedures.
In the case of manufacturers, packagers and labelers, equipment and a record of their maintenance and calibration is required (if appropriate).
Natural Products Consulting Corp has obtained and maintains well over 100 Site Licenses for our clients. If your company requires acceptable SOPs, we can supply ones that fit your individual company needs.
Site Licenses are presently renewed annually for the first three years. After that, they are renewed and valid for two years. The third cycle is that once the first seven years have passed, they are valid for three years.
There is no government fee for obtaining a Site License or for renewing one.
Steps to Obtaining a Site License
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We have simplified the process of completing a site license application and obtaining a site license from the Natural and Non-Prescription Health Products Directorate (NNHPD) into eight steps.
More detail on each follows:
Step 1:
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We sign a non-disclosure agreement with you (yours or ours) so that you can be assured that anything we discuss remains strictly confidential. Eventually some of the information will be part of the application process to Health Canada but they are the only people outside of ourselves to which anything will be disclosed.
Step 2:
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You identify who your Canadian importer is – and if they do not already have a site license, we work with the company to obtain one. This involves proving GMP compliance, usually through a Quality Assurance Report providing Standard Operating Procedures (SOPs) and executed records. If your importer does not have SOPs, we can provide them for you.
Step 3:
You identify any other entities that will deal with the product (i.e. foreign manufacturers, foreign warehouses, fulfillment centres, etc.). Each of these will have to be annexed onto the importer’s site license so that Health Canada can ensure the product has been manufactured/packaged/labeled/stored in GMP compliant facilities.
Step 4:
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Once we understand your site licensing requirements, 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:
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If your quote is acceptable, we then submit the application to NNHPD for assessment.
Step 6:
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We will then issue you an invoice for the amount quoted.
Step 7:
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We work with NNHPD and your sites to answer any questions raised during the assessment of the site license.
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Step 8:
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You get a site license and are now eligible to ship any Licensed Products (products that have been granted a Natural Product Number/NPN) from your manufacturing and/or warehousing sites to your Canadian importer.
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MedTech Guys Advantage
We use an extremely sophisticated electronic creation system to complete license applications. This provides a more streamlined submission process, improves document and data management, and decreases the amount of time needed to produce an application by 35 to 50 percent.
This process significantly reduces the costs involved in completing a successful application
