Overview
Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product is marketed in Canada. A DIN is a unique, computer-generated, eight-digit number issued to the manufacturer and printed on the front of package labels. A DIN identifies the following product characteristics: manufacturer; product name; active ingredient(s); strength(s) of active ingredient(s); pharmaceutical form and route of administration.
A DIN indicates that the product has undergone an evaluation by Health Canada and has been determined to successfully meet relevant requirements of the Food and Drugs Act and its Regulations. A drug product sold in Canada without a DIN is not in compliance with Canadian law. While the authorization of a drug includes the issuance of a DIN to the manufacturer, the DIN is the property of Health Canada.
Why is a Drug Identification Number Important?
If a product has a DIN on the medication label, this indicates to consumers that Health Canada has approved the formulation, labeling, and instructions for use. Drug Identification Number’s are also important to the consumer for the following reasons:
- Safety and Efficacy
- Health Canada requires manufacturers to provide data ensuring product safety, effectiveness in satisfying label claims, potency, and purity. Once the manufacturer meets these criteria, Health Canada issues a registration number for the drug. These measures provide confidence that medicines have been adequately tested and are safe for the use intended when administered according to label directions.
- Manufacturing Standards
- Consumers can also be ensured that the DIN is manufactured at a site that has been authorized to conduct drug-related activities in compliance with Good Manufacturing Practices (GMP).
- As part of Health Canada’s ongoing commitment to openness and transparency, the Department is publishing information regarding emerging issues identified via their drug inspection program. The information is posted in the form of a tracker and provides an insight into the potential health and safety issues Health Canada is tracking with companies that produce drugs for sale in Canada.
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3. Quality Monitoring
- Continuous monitoring for adverse effects is required by DIN license holders while the product is on the market. Post-market monitoring is an important aspect that Health Canada has been increasingly focusing on over the last few years to improve health risks to the public. OTC Drugs
- Verification for Consumers and Healthcare Professionals
- Health Canada assigned DINs uniquely identifies each drug on the market in Canada, allowing both consumers and medical professionals the ability to verify drug products. Many products on the internet do not have DIN and consumers can be easily misled about the safety of the product. Drug Identification Numbers allow consumers to trust the product has been approved by Health Canada.
- Additionally, DINs are used by drug insurance companies to identify whether or not a drug is covered.
- Recall
- If a DIN is recalled, the responsible party must complete a series of actions outlined by Health Canada. Health Canada’s recall procedure ensures that the responsible parties act in a timely and effective manner to mitigate potential risks to consumers.
How can DIN numbers help with product management?
DIN numbers can be a useful tool for product management, allowing manufacturers to track and classify their products more easily. A DIN number helps to identify a specific product and its various attributes, making it easier to locate the right product when needed. They also enable manufacturers to keep track of production batches and other information related to each product they make. This makes sharing Product Data Sheets (PDS) more efficient because manufacturers don’t have to manually sort through large amounts of data!
How do DIN numbers aid certification processes?
DIN numbers play an important role in product certification processes, as they allow manufacturers to register products and obtain the right certificates. For example, many electrical products have to be tested and certified according to specific regulations. To ensure that the necessary certificates are obtained quickly and accurately, manufacturers bundle different tests under the same DIN number. This way, all relevant tests related to a product can be carried out at the same time instead of separately.
What other applications do DIN numbers have?
While the primary use of DIN numbers is in product certification, they are also extremely useful as identifiers for individual components, parts and materials during internal product management processes. Using a unique ID number to mark every part simplifies product tracking and inventory oversight, and drastically streamlines sales orders. By doing so, businesses can quickly locate required components in their inventory and dispatch them on time.
Where can I find a list of all valid DINs?
One of the best places to find a full list of valid DINs is on the German Institute for Standardization’s (DIN) website. There, you can browse through specific DIN categories and view appropriate individual DIN numbers. Alternatively, there are multiple independent websites that curate lists of valid DINs, thus making it easier for companies to quickly identify correct codes and proceed with product certification processes.
Further information
The Drug Product Database (DPD) contains product-specific information on drugs approved for use in Canada. The database is managed by Health Canada and includes human pharmaceutical and biological drugs, veterinary drugs, and, disinfectant products.
It contains approximately 23,000 products that companies have notified Health Canada as being marketed. The DPD, allows consumers to search for information on products that have a DIN.
Bibliography
Canada, H. (2022, January 14). Government of Canada. Canada.ca. Retrieved August 9, 2022, from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drug-identification-number.html
Din’s and NPN’s: What are they? Stafford Pharmacy. (n.d.). Retrieved August 9, 2022, from https://www.staffordpharmacy.com/pharmacy/rx-pad/rx-center/dins-and-npns-what-are-they/
Ministry of Agriculture, Food and Rural Affairs. The Need to Read – Drug Label Directions Enhance Health of Livestock and Bottom Line. (n.d.). Retrieved August 9, 2022, from http://omafra.gov.on.ca/english/livestock/dairy/facts/need.htm
Are you looking to have your drug product registered with Health Canada? Quality Smart Solutions has a team of experts who are skilled with DIN numbers and DIN applications. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.
