NATURAL HEALTH PRODUCTS (NHPs) LICENCING

1. 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.
2. 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.
3. 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.

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.

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.

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.

No, all products must have valid a NPN or a DIN-HM before you are allowed to sell in Canada.

1. Ensure Compliance: Verify that your product complies with Canadian regulations for natural health products (NHPs).
2. 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.
3. 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.
4. 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.
5. Register with the Canada Border Services Agency (CBSA): Ensure that your company is registered with the CBSA and has a business number.
6. Prepare for Customs Clearance: Ensure that your shipment complies with Canadian customs regulations, including labeling requirements and importation documentation.
7. Arrange for Importation: Coordinate with your chosen shipping method (air, sea, land) and arrange for the importation of your product into Canada.
8. 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.
9. Distribution: Once your product has cleared customs, it can be distributed and sold in Canada through authorized channels.

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.

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.

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