Over-The-Counter (OTC) Drugs Regulatory in Canada

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

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.

There are several monograph categories for Over-the-Counter (OTC) Drugs in Canada. These include Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).

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

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

Any company (domestic or international) that manufactures, distributes, or imports OTC pharmaceuticals must provide proof that they adhere to Good Manufacturing Practices GMP and possess an Site License.