Important: If you supply products for sale on Amazon, you must comply with all
federal, provincial, and local laws and Amazon policies applicable to those products and
product listings.
This page covers products regulated as drugs or natural health products (“NHPs”) by Health
Canada and are intended for human use. It also covers Drug Paraphernalia.
Note:
All drugs and NHPs listed in our stores must have a valid Drug Identification Number
(“DIN”) or Natural Health Product Number (“NPN”) issued by Health Canada. The images of the
product label on the detail page must include the DIN or NPN, as applicable. The DIN or NPN
also needs to be submitted to the license information section in Seller Central. To do this
you will need to backfill the license information through the single item setup in Seller
Central or through an Inventory Template file. If you require assistance providing any
of this information, please contact Selling Partner Support.
Drugs
In general, drugs are substances or mixtures of substances that are manufactured, sold or
represented for use in:
-
The diagnosis, treatment, mitigation or
prevention of a disease, disorder or abnormal physical state, or its symptoms;
-
Restoring, correcting or modifying organic
functions of the body; or
-
Disinfectants and sanitizers with disinfectant claims.
Please use the checklist below to ensure that your product complies with the requirements
of Canadian law and can be sold on Amazon.ca.
Compliance Checklist of Drugs
Licensing
Before drug products are authorized for sale in Canada, Health Canada reviews them to
assess their safety, efficacy and quality. Once approved, licensed drug products are issued
with a DIN. All drugs listed for sale on Amazon.ca are required to have a DIN. More
information on Health Canada’s licensing can be found here and here.
Labelling
With limited exceptions, drug products must be labelled in French and English with all the
information required by applicable Canadian law, including but not limited to:
-
DIN issued by Health Canada
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Brand name
-
Intended use
-
Active ingredients
-
Warnings
-
Dose
For more information, see Health Canada's Nonprescription Drugs: Labelling
Standards.
Marketing
All claims made by a drug must comply with the terms of the product’s market authorization.
Drugs may not be illegally marketed. Examples of illegal marketing include:
-
Making statements outside of the product’s market authorization
-
Making false or misleading statements
-
Using misleading endorsements, including the claim “Health Canada Approved” or similar
language
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Overstating effectiveness
-
Promoting unauthorized (off-label) use
For more information on illegal marketing, see this Health Canada guidance.
Prohibited Listings
Amazon.ca prohibits certain drugs in its stores, including drugs that are illegal for sale
in Canada, are administered by injection, require a prescription, require a pharmacist’s
intervention before sale, or are required to be sold at a pharmacy.
Drug Paraphernalia
Amazon.ca policy prohibits certain drug paraphernalia from being sold in our stores,
including products intended for illicit drug use, bongs, pipes and dab kits. Other drug
paraphernalia, such as syringes or hypodermic needles, are regulated by Health Canada as
medical devices. For more information about listing a medical device on Amazon, please see
our Medical Devices and Accessories Page.
Natural Health Products
In general, NHPs are either products that contain substances like minerals, probiotics,
amino acids, fatty acids or certain vitamins (for more information see this list) or are a homeopathic or traditional medicine
that is manufactured, sold or represented for use in:
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The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal
physical state;
-
Restoring or correcting organic functions; or
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Modifying organic functions, including in a way that promotes or maintains health.
It can be difficult to distinguish between food products and NHPs. Indicators that a
product is a food include:
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Compliant Nutrition Facts Table
-
Ingredient list that does not differential between “medicinal” and “non-medicinal”
ingredients
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No claims to modify, correct or restore body function, promote health, or maintain
health
Some foods may have added NHP substances. This may be allowed where the
substance is added for taste, is added as a preservative, or the addition is authorized
under a temporary marketing authorization. Please use the
checklist below to ensure that your product complies with the requirements of Canadian law
and can be sold on Amazon.ca
Compliance Checklist of NHPs
Licensing
Once Health Canada has assessed a product and decided it is safe, effective and of high
quality, it issues a product license along with an eight-digit Natural Product Number (NPN)
or Homeopathic Medicine Number (DIN-HM), which must appear on the label. More information on
Health Canada’s licensing can be found here and here.
Labelling
NHPs must be labelled in French and English with all the information required by applicable
Canadian law, including but not limited to:
-
NPN issued by Health Canada
-
Name of the dietary supplement
-
Intended use
-
Net quantity or amount of the dietary supplement
-
Nutrition labelling
-
Ingredient list
-
Name and place of business of the manufacturer, packer, or distributor
For more information see Health Canada's Nonprescription Drugs: Labelling
Standards.
Marketing
All claims made by a NHP must comply with the terms of the product’s market authorization.
NHPs may not be illegally marketed. Examples of illegal marketing include:
-
Making statements outside of the product’s market authorization
-
Making false or misleading statements
-
Using misleading endorsements, including the claim “Health Canada Approved” or similar
language
-
Overstating effectiveness
-
Promoting unauthorized (off-label) use
For more information on illegal marketing, see this Health Canada guidance.
COVID-19 Interim Order
During the COVID-19 pandemic, Health Canada has authorized certain drugs and NHPs to be
sold in Canada even if they do not meet labeling requirements. The criteria for these
products are identified in an Interim Order. Health Canada maintains a list of products, currently hand sanitizers and
disinfectants, that are authorized for sale under the Interim Order.
Examples of Prohibited Drugs, Drug Paraphernalia Listings, and Natural Health
Products
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Cannabis, its preparations, derivatives and similar synthetic preparations.
-
Products containing a cannabidiol (CBD) or tetrahydrocannabinol (THC) presence, topical
or ingestible, regardless of concentration level (e.g., even with THC <0.3%).
-
Hemp products that include rich hemp, industrial hemp, full spectrum hemp or resin.
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Illegal substances, controlled substances, and narcotics, including products containing:
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Substances listed in Schedules I, II, III, IV, or V of the Controlled Drugs and
Substances Act and the Narcotic Control Regulations
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Substances listed in the Benzodiazepines and Other Targeted Substances
Regulations
-
Products containing substances that are
prohibited by or exceed the allowable amount set forth in the Precursor Control
Regulations
-
Radiopharmaceuticals, and products represented for use in the preparation thereof
-
Products that contain DMAA (1,3-dimethylamylamine)
-
Products that simulate the effects of any illegal drug
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Products intended for experiencing, or marketing for producing, an effect similar to
that caused by an anabolic steroids
-
Products intended to defeat a drug test
-
Certain drug paraphernalia, such as:
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Vaporizers
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Pill and tablet press machines
-
Pipes made from metal, most woods, acrylic, glass, stone, plastic or ceramic
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Wired cigarette papers
-
Bongs
-
Dab kits
-
Products intended for illicit drug use
-
Products that are not licensed by Health Canada
for sale as a drug or natural health product
-
Listings claiming that a product is a treatment, preventative or cure for any of the
diseases, disorders or abnormal physical states referred to in Schedule A of the Food and
Drugs Act
-
Products that Health Canada has determined present an unreasonable risk of injury or
illness.
-
Products that have passed their expiration or their "use-by" dates.
-
Products manufactured, prepared, preserved, packaged or stored under unsanitary
conditions.
-
Products that are not sealed in original manufacturer's packaging.
-
Products labelled as "tester" or "not intended for resale", such as drug samples.
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Products marketed to imitate a prescription drug or prescription drug brand.
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Products that are adulterated or misbranded.
-
Products that are not labelled or packaged as required by Health Canada regulations,
such as:
-
Products that do not meet bilingual
labelling requirements and are not otherwise excepted from these requirements
-
Products that are not labelled with a "drug identification number" or "natural
product number" as applicable
-
Products that have been the subject of a prior
regulatory action, such as:
-
Health Canada advisories, warnings or
recalls
-
Products that have been the Subject of
Recalls or Safety Alerts
-
Products that have been the subject of criminal
enforcement, injunctions, seizures or warning letters
-
Dietary supplements and Natural Health Products, such as weight loss products, that
contain undeclared or prohibited active pharmaceutical ingredients
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Last Updated: 02/28/2022