|Legislation:||Food and Drugs Act|
|Regulation:||Food and Drug Regulations|
|Regulatory Authority:||Therapeutic Products Directorate (TPD), Health Canada|
|Inspection Authority:||Health Products and Food Branch Inspectorate (HPFBI),
|Guidance Documents:||Guidance Documents|
|Licensed Product Database:||Drug Product Database|
What is an over-the-counter (OTC) medication?
Over-the-counter medications (also referred to as "nonprescription medications") are a subset of drugs, and drugs are defined in the Food and Drugs Act as including any substance or mixture of substances manufactured, sold or represented for use in:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
- restoring, correcting or modifying organic functions in human beings or animals, or
- disinfection in premises in which food is manufactured, prepared or kept.
Over-the-counter medications are used for the prevention, treatment, symptomatic relief, cure or risk reduction of diseases, injuries or chronic conditions that individuals can recognize and manage on their own behalf, either separately or in participation with professionals. Over-the-counter medications are regulated by the Food and Drug Regulations.
How does an over-the-counter medication get to market?
In order to market an over-the-counter medication in Canada, the product must receive a Drug Identification Number (DIN) from Health Canada.
Before an over-the-counter medication can be marketed in Canada, it must undergo pre-market review by Health Canada's Therapeutic Products Directorate where it will be assessed for safety, efficacy and quality. Evidence demonstrating this must be contained in a Drug Application form. Medicines that meet the required criteria will be authorized for sale and issued a DIN.
Submission fees are applicable for the registration and review of over-the-counter medications and must be paid upon filing of the application. Fees vary depending on the type of submission filed (see Form).
DIN owners are required to renew the DINs on their products on an annual basis (Authority to Sell Drug Fees apply).
The Health Products and Food Branch Inspectorate ensures the uniform, efficient, and effective enforcement of the requirement for all Canadian drug establishments and any foreign drug establishments providing drug products to the Canadian market, to comply with the Food and Drug Regulations. Canadian drug establishments must hold an establishment license to fabricate, package, label, distribute, import, wholesale, or test a drug in Canada. (Forms and instructions)
Establishment licenses must be renewed annually. Fees for the licenses reflect the cost of the Health Products and Food Branch Inspectorate activity required to inspect an establishment based on the type of facility and the scope and extent of activity, which will in turn be based on risk management principles.
How can Canadians know a product has been approved for sale by Health Canada?
Once assessed by Health Canada, the product label will bear an 8-digit drug identification number, preceded by the letters "DIN". The DIN on the label will inform the public that the product has been reviewed by Health Canada for safety, efficacy, health claims and quality.