Drug Identification Number

What is a DIN? 

The Drug Identification Number (DIN) is the number located on the label of prescription and over-the-counter drug products that have been evaluated by the Therapeutic Products Directorate (TPD) and approved for sale in Canada. 

When is a DIN issued?

Once a drug has been approved, the Therapeutic Products Directorate 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 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 also a tool to help in the follow-up of products on the market, recall of products, inspections, and quality monitoring. 

Do DINs only appear on prescription drugs?

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

Do medicinal herbs require a DIN?

Yes. If a manufacturer wants to sell a medicinal herb or market a herb with drug claims, the product requires a DIN.

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

No. Numbers are assigned sequentially and have no particular meaning.

Can a product defined 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.

What is a GP?

The Therapeutic Programme no longer issues General Public (GP) numerical identifiers. They have now been replaced by DINs. Similar to DINs, GPs were used to identify proprietary medicines - products that may be purchased without prescriptions in any retail outlet. An example is fluoride toothpaste.

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

Write:

Submission and Information Policy Division 
Bureau of Policy and Coordination
Therapeutic Products Directorate
Health Canada
Tunney's Pasture
Locator 0201A1
Ottawa, Ontario K1A 0L2

or visit our website:

http://www.hc-sc.gc.ca/dhp-mps/index_e.html