Regulation of non-prescription drugs

Find out how non-prescription drugs are regulated and licensed.

On this page

• About non-prescription drugs
• List D: List of Certain Non-prescription Drugs for Distribution as Samples
• For more information

About non-prescription drugs

Non-prescription drugs, also called over-the-counter drugs, are health products that can be bought without a doctor's prescription.

Canada regulates non-prescription drugs to:

• make sure they're safe to use
• reduce health risks to Canadians

Identifying non-prescription drugs

Non-prescription drugs require a valid Drug Identification Number (DIN) to be sold in Canada. On a product label, this number indicates the drug has met our requirements for:

• safety
• quality
• effectiveness

The label lists the drug's ingredients, so Canadians can avoid those that may cause concern.

Canadian companies that manufacture, package, label and import non-prescription drugs must:

• be licensed for these activities
• provide the necessary documents and evidence

A licence is provided after a satisfactory inspection.

If a health and safety problem is reported after a drug is on the market, we will:

• investigate
• take corrective action

List D: List of Certain Non-prescription Drugs for Distribution as Samples

Amendments to regulations now permit the distribution of specific low risk non-prescription drugs  as samples under certain conditions. To view the lists of drugs that can be distributed directly to consumers, please visit the following link:

• List D: List of Certain Non-prescription Drugs for Distribution as Samples

For more information

• Non-prescription Drug Action Plan
• Calendar of engagement on the self-care framework priorities
• Recalls and safety alerts
• Report a health and safety concern
• How drugs are reviewed in Canada
• Licensing, authorizing and manufacturing drug and health products