Non-new drug to be marketed in Canada: prepare the submission and obtain its DIN before sale
Non-new drug to be marketed in Canada: prepare the submission and obtain its DIN before sale
Another manufacturer’s DIN, an establishment licence or a natural product number does not cover your drug. Confirm the correct regulatory route first.
Confirm the scope
Confirm the product is a non-new drug eligible for a DIN application rather than a new drug submission or another pathway.
Prepare the information
Define the manufacturer, ingredients, strength, dosage form, route, indications, labels, sites and product-specific quality data.
Complete the process
Assemble forms, fees, administrative material, clinical or monograph support and required chemistry and manufacturing information.
Keep follow-up records
File in the accepted format, answer clarification requests and await an active DIN before import, advertising or sale.
Preparation of drug identification number submissions — Health Canada