Drug Identification Number (DIN) Registration

Obtaining a Drug Identification Number (DIN) is important because this number indicates the drug has met Health Canada’s requirements for safety, quality, and effectiveness.

A Drug Identification Number (DIN) is located on the label of prescription and OTC drugs and confirms that the product has been evaluated and authorized for sale in Canada.

To obtain a DIN for your drug products, a DIN submission must be filed with Health Canada. Prior to issuing DINs, Health Canada’s Drugs Directorate requires the submission of sufficient data to evaluate the safety and efficacy of a drug for its intended use. A submission for a DIN should contain the following information for review:

• a completed Drug Submission Application, including proposed Canadian labels and prescribing information or a package insert where applicable
• a completed DIN Submission Certification or Category IV Drug Submission Certification as appropriate
• specific product type information as requested by Health Canada

A Drug Identification Number (DIN) is a computer-generated digit number, assigned to a drug product prior to being sold in Canada. 

Health Canada regulates OTC (Over-the-counter medicines sold directly to consumers without a prescription) drugs to ensure they are safe to use and decrease the health risks for Canadians. In the USA, the FDA carries out a regulatory review of OTC drugs based on active pharmaceutical ingredients and labeling. More than 300,000 OTC drug products are available in the US market.

• DIN products must be manufactured in a facility that follows good manufacturing practices (GMP)
• If the facility is based in Canada, that business must obtain a drug establishment license
• Foreign sites must also show evidence that they are following GMP through a Health Canada licensed importer
• DIN products cannot be sold prior to license issuance
• Licensing timelines vary as fast as 45 days 
• Health Canada’s fees for drug license application submissions are due initially and annually thereafter
• The fee varies and increases annually based on the rate of inflation

• Celecoxib
• Diclofenac
• Ibuprofen
• Indomethacin
• Meloxicam
• Naproxen

• Labeling Standard
• TPD Category IV
• Non-steroidal Anti-Inflammatory Drugs (NSAIDS)

• Acne Therapy
• Sunscreen Monographs
• Medicated Skin Care Products
• Diaper Rash Products
• Anti-Dandruff Products
• Antiseptic Skin Cleansers
• Athlete’s Foot Treatments
• Throat Lozenges