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Drug Identification Number (DIN)
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 109 K)
Contact: Submission and Information Policy Division - Mail
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 DINs 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:
Submission and Information Policy Division
Therapeutic Products Directorate
Health Canada
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, Ontario
K1A 0K9
Email: SIPDMail@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/dhp-mps/index_e.html
www.hc-sc.gc.ca
Skip to content | Skip to institutional links
Français
Home
Contact Us
Help
Search
canada.gc.ca
Home > Drugs & Health Products > Drug Products > Activities > Fact Sheets
Back to
Fact Sheets
Explore...
Main Menu
Healthy Canadians
Media Room
Site Map
Transparency
Completed Access to Information Requests
Proactive Disclosure
Drugs and Health Products
Print | Text Size: S M L XL Help | Share
Drug Identification Number (DIN)
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 109 K)
Contact: Submission and Information Policy Division - Mail
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 DINs 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:
Submission and Information Policy Division
Therapeutic Products Directorate
Health Canada
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, Ontario
K1A 0K9
Email: SIPDMail@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/dhp-mps/index_e.html
