Contact: Office of Submissions and Intellectual Property (OSIP )

What is a DIN ?

A Drug Identification Number ( DIN ) is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada.

A DIN uniquely identifies the following product characteristics: manufacturer; product name; active ingredient(s); strength(s) of active ingredient(s); pharmaceutical form; route of administration.

When is a DIN issued?

Once a drug has been authorized, Health Canada issues a DIN which permits the manufacturer to market the drug in Canada. For drugs where there is minimal market history in Canada, there is a more stringent review and the drug is required to have a Notice of Compliance ( NOC ) and a DIN in order to be marketed in Canada.

What purpose does a DIN serve?

A DIN lets the user know that the product has undergone and passed a review of its formulation, labeling and instructions for use. A drug product sold in Canada without a DIN is not in compliance with Canadian law.

The DIN is unique and serves as a tool to help in the follow-up of products on the market, recall of products, inspections, and quality monitoring.

Do DIN s only appear on prescription drugs?

No. A DIN is assigned to all authorized prescription and over-the-counter drugs.

Is there a significance or special meaning for the numbers in the DIN ?

No. Numbers are assigned randomly by a computer-generated system and have no particular meaning.

Can a product classified as a drug be sold without a DIN ?

No. If a product defined as a drug under the Food and Drugs Act is sold without a DIN , it is not in compliance with Canadian law and regulatory action will be taken.

Do I need a DIN to sell a drug product in Canada?

Yes. If a product defined as a drug under the Food and Drugs Act is sold without a DIN , it is not in compliance with Canadian law.

For further information or questions

Write:

Office of Submissions and Intellectual Property (OSIP)

Therapeutic Products Directorate

Health Canada

101 Tunney's Pasture Driveway

Address Locator 0201A1

Ottawa, Ontario

K1A 0K9

Email: OSIP-BPPI@hc-sc.gc.ca