Drug Identification Number
What is DIN?
The Drug Identification Number (DIN) is a unique eight-digit number issued by Health Canada to identify prescription and over-the-counter drugs sold in Canada. It is a crucial regulatory requirement for pharmaceutical products.
Importance of DIN
Companies need a DIN to ensure compliance with Health Canada's regulations and to legally market their drugs in Canada. It assures North-American customers that the product has been authorized for sale and meets safety, quality, and efficacy standards.
Who needs a DIN?
Any enterprise involved in the production, importation, or distribution of drugs in Canada requires a DIN. This includes pharmaceutical manufacturers, wholesalers, distributors, and retailers.
Health Canada application fees for Drug Identification Number
The application process for obtaining a DIN involves certain fees, which may vary depending on the type an complexity of the drug being submitted for approval.
|
Fee |
Fee Amount in 2023-2024 |
|
New active substance |
565,465 |
|
Clinical or non-clinical data and chemistry and manufacturing data |
292,806 |
|
Clinical or non-clinical data only |
117,080 |
|
Comparative studies |
65,985 |
|
Chemistry and manufacturing data only |
40,597 |
|
Clinical or non-clinical data only, in support of safety upgrades to the labelling |
21,429 |
|
Labelling only |
5,901 |
|
Labelling only (generic drugs) |
2,217 |
|
Administrative submission |
933 |
|
Disinfectant - Full review |
12,297 |
|
Labelling only (disinfectants) |
2,764 |
|
Drug identification number application - Labelling standards |
1,782 |
Detailed information about the application fees can be obtained from the website: https://www.canada.ca/en/health-canada/
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