ALPHAGREEN RESOURCES INC
NATURAL HEALTH PRODUCTS (NHPs) LICENCING
Workout supplements
Multi Vitamins
Herbal products
Traditional medicines such as ayurvedic and traditional Chinese medicines
Probiotics
Amino acids and essential fatty acids
Antioxidants
Greens
Aromatherapy
Sunscreens
Hand Sanitizer
Homeopathic medicines
If so, you’re probably familiar with the complexities of obtaining a Health Canada NPN number. Complying with Health Canada regulations is essential for marketing your product in Canada, but the application process can be overwhelming and time-consuming. Ease the burden and simplify the process by utilizing expert regulatory services. Our team excels in assisting businesses with the intricate steps of acquiring licenses for their products, helping you save time, effort, and money while ensuring that your product aligns with all necessary requirements for Canadian sales.
What is considered an NHP in Canada?
Under the Natural Health Products Regulations, which came into effect on January 1, 2004, Natural Health Products ( NHPs ) are defined as: Probiotics, Herbal remedies, Vitamins and minerals, Homeopathic medicines, Traditional Medicines such asTraditional Chinese Medicines, other products like Amino Acids and Essential Fatty Acids.
I want to sell a natural health product in Canada, what do I have to do?
- Product License: Obtain a product license from Health Canada, typically in the form of a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). This license indicates that the product has been reviewed and approved for safety, efficacy, and quality.
- Labeling Requirements: Create product labels that adhere to Health Canada’s guidelines, featuring bilingual labeling (English and French), precise ingredient listings, dosage instructions, and any risk information as specified on your product license.
- Site License: The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labelled, packaged, distributed, and/or stored to have a site license. Businesses can choose to have a single site license for all their operations (i.e. multiple sites) or an individual license for each site. Site licenses are obtained by demonstrating that the above mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs.
Why should I get a Natural Health Product (NHP) License?
Every natural health product (NHP) sold in Canada needs a product license before it can be marketed. Failure to have this license may lead to your products being stopped from sale, detained, or confiscated by Health Canada and/or the Canada Border Services Agency.
How long does it take to obtain an NPN number?
Once the application is submitted, the standard review timelines for Health Canada are as follows Class I Applications – 60 calendar days, Class II Applications – 90 calendar days, Class III Applications – 210 calendar days. These timelines are non-binding meaning licensing may take longer than stated performance standard targets.
What is the cost of obtaining an NPN number?
There’s a fee associated with submitting a product license application to Health Canada, and it varies depending on the number of medicinal ingredients and the complexity of the application.
Can I market my product without an NPN or DIN-HM?
No, all products must have valid a NPN or a DIN-HM before you are allowed to sell in Canada.
What is the process to import a natural health product into Canada?
- Ensure Compliance: Verify that your product complies with Canadian regulations for natural health products (NHPs).
- Appoint a Canadian Representative: If you’re not based in Canada, you’ll need to appoint a Canadian representative who can act on your behalf for regulatory matters.
- Obtain an NPN Number: If your product doesn’t already have a Natural Product Number (NPN), you’ll need to apply for one through Health Canada. This involves submitting an application with supporting documentation, such as evidence of safety, efficacy, and quality.
- Ensure that the product labels meet Canadian regulatory standards. This includes bilingual labeling, proper ingredient listing, and compliance with specific labeling requirements for natural health products.
- Register with the Canada Border Services Agency (CBSA): Ensure that your company is registered with the CBSA and has a business number.
- Prepare for Customs Clearance: Ensure that your shipment complies with Canadian customs regulations, including labeling requirements and importation documentation.
- Arrange for Importation: Coordinate with your chosen shipping method (air, sea, land) and arrange for the importation of your product into Canada.
- Clear Customs: Your shipment will undergo customs clearance upon arrival in Canada. Ensure that all required documentation is provided and that any applicable duties or taxes are paid.
- Distribution: Once your product has cleared customs, it can be distributed and sold in Canada through authorized channels.
Can I import my natural health product without an NPN in Canada?
No. If your natural health product (NHP) is imported into Canada without a Natural Product Number (NPN), it is subject to border enforcement by the Canada Border Services Agency (CBSA). The non-compliant product could be detained, destroyed on-site, or shipped back to the exporter at their expense. If the NHP is found to be sold online, Health Canada may issue a stop sale and recall of the product.
Does my Natural Health Product need to be tested?
Yes. Each of your products must go through quality testing for microbial and heavy metal contaminants. Pesticides testing is required only if a particular ingredient is not organic. Testing of raw materials can be done at the raw material stage, and you can also quantify ingredients by input on the Finished Product Specification form and lab test. This testing can be done outside of Canada if your company imports products into Canada. Note that the Canadian importer will be required to do yearly purity tests on each dosage form they import.
Can I sell a Natural Health Products on Amazon without a NPN?
No. In September 2018 Amazon.ca notified every Natural Health Product vendor (whether they had an NPN or not) that, effective in October 2018 they will be removing all products that don’t have a Natural Health Product Number. Here’s the email they sent to sellers:
AMAZON NOTICE TO SELLERS OF NATURAL HEALTH PRODUCTS
Dear Seller,
Pursuant to Canadian laws and regulations, all non-prescription drugs, supplements, and natural health products (“NHPs“) that are sold in Canada must be assigned a registration number by Health Canada.
We are updating our product registration templates to require either a Natural Product Number, Drug Identification Number or a Homeopathic Medicine Number to list these products on our site.
From October 2018, Amazon will remove drugs, supplements, and NHPs that do not have registration numbers associated with them in the catalog from the site. If your product is impacted, you can identify the ASINs and contact Seller Support.To back-fill the required compliance information for your existing products, you can do so through the single item setup in Seller Central or through an Inventory Template file. More information about listing drugs, supplements and NHPs can be found here: https://sellercentral.amazon.ca/gp/help/external/200164490
Alphagreen Resources Inc. is your one-stop destination for NHP compliance needs, providing comprehensive solutions from product licensing and labeling to site licensing and importation.
Under our Natural Health Products regulatory services, we offer a range of comprehensive solutions, including:
- Company registration
- Formula development
- Health claims substantiation
- Submission of new ingredients
- Registration for NPN licenses
- Site licensing
- Compliance with NHP labeling requirements
- Development of finished product specifications and formulations
- Management of complaints and recalls
- GMP training
- Quality and stability programs
- Need consulting support?
- Need training?
- Need a promptness audit?
- Have a question?
Phone: +1 519 996-3735
Email: info@alphagreenresources.com
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