Regulatory Overview: Non-prescription drugs in Canada: About non-prescription drugs
On this page
Who this is for
Use the information in this page to understand more about how non-prescription drugs (NPDs) are regulated in Canada and to find additional resources on drug authorization requirements and post-authorization obligations.
This information is intended for:
- Manufacturers, packagers, importers, distributors, wholesalers, sponsors, retailers, and advertisers of non-prescription drugs
- Other interested parties and stakeholders
About non-prescription drugs
In Canada, NPDs are regulated under the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR), by demonstrating they are safe to use and the benefits outweigh the risks to people in Canada. Before a drug can be sold, it must be assigned a Drug Identification Number (DIN), and in some cases it must also be issued a Notice of Compliance (NOC). When a NPD holds a valid DIN which is displayed on the product's label, that means it has been authorized for sale in Canada. All authorized NPDs in Canada are listed on Health Canada's Drug Product Database. Please also note that a Drug Establishment License (DEL) is required to perform certain activities related to drugs (e.g., importation).
In July 2025, the Government of Canada launched a Red Tape Review that called on departments and agencies to review their regulations in order to reduce regulatory burden for industry and government while providing oversight that is proportionate to risk. Health Canada is planning to make changes in the future that will increase flexibility in requirements and facilitate easier market access in Canada.
For more information :
- Regulating Natural and Non-prescription Health Products: The Path Forward
- Food and Drugs Act
- Food and Drug Regulations
- Drug Product Database
Determining if a product is a non-prescription drug
Non-prescription drugs are available to consumers without a prescription from a healthcare professional. They are generally available for self-selection, but could also be recommended by a healthcare professional, or be available behind the counter in pharmacies. Although Health Canada determines if a drug requires a prescription, provinces and territories can further restrict how a drug is sold in their province or territory such as requiring an NPD to be sold behind the counter or to require a prescription for the drug instead. NPD examples include:
- Cough and cold remedies
- Pain relief medication
- Anti-itch medication
- Anti-nausea medication
- Allergy medication
- Emergency birth control drugs
Non-prescription drugs are not:
- Cosmetics (substance used to clean, improve or change the complexion of skin, hair, nails or teeth)
- Prescription drugs (a drug that is captured by a listing on the Prescription Drug List that requires supervision from a healthcare practitioner)
- Natural health products (naturally occurring substances that are used to restore or maintain good health and that only has ingredients on Schedule 1 but not Schedule 2 of the Natural Health Products Regulations)
- Radiopharmaceuticals (which include drugs either of chemical or biological origin which are intentionally made radioactive for the purpose of diagnosing illness, as well as kits that are used for the preparation of radiopharmaceutical and radionuclide generators and administered by a healthcare practitioner, see Schedule C of the Food and Drugs Act)
- Biologics (a drug derived from living organisms as listed on Schedule D of the Food and Drugs Act)
- Biocides (surface disinfectants and sanitizers as defined in the Biocides Regulations)
There are instances where the classification of a product is not immediately apparent. For example, "interface products" may meet elements of more than one definition. Common non-prescription drug interfaces include:
- Cosmetics
- Medical devices
- Prescription drugs
- Natural health products
For more information on Health Canada's classification criteria and other products: