Canada · Health Canada · Over-the-counter
Review target
210 days
performance goal
Legal time limit
-
Not published
Steps
5
7 requirements
Application fee
CA$319,282
From April 1, 2026
Drugs that are not new drugs, including many non-prescription products, get a drug identification number through a DIN application. When the product does not fit a labelling standard, the application includes supporting data. Non-prescription and other drugs that are not new drugs and do not fully meet a labelling standard or monograph.
The official review target is 210 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The din application with clinical or non-clinical and chemistry and manufacturing data is CA$319,282 for From April 1, 2026.
1. File the DIN application; 2. Screening (45 days); 3. Review (210 days); 4. Deficiency response; 5. DIN issued or refused.
Outcome: Drug identification number (DIN).
Legal basis: Food and Drug Regulations, Part C, Division 1 (sections C.01.014.1 and C.01.014.2)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 300 days end to end with the official step targets, of which up to 45 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Official target in calendar days for the agency's work. It is not an actual review time. Time the applicant takes to answer questions is not counted. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| DIN application with clinical or non-clinical and chemistry and manufacturing dataApplication · From April 1, 2026 · Small businesses (fewer than 100 employees, or gross revenue of $30,000 to under $5 million, counting affiliates) can get 50% off. A small business filing its first drug submission can get the full fee waived. | CA$319,282 |
Other routes in Canada: New drug submission (new active substance), New drug submission or supplement (known substance), Abbreviated new drug submission (generic), DIN application under a labelling standard or monograph, Priority review, Notice of compliance with conditions, Extraordinary use new drug submission, Public health emergency drug (rolling review), Ministerial reliance order (foreign decision deeming), Access Consortium work sharing, Project Orbis (cancer drugs), Special Access Program (drugs), Drug and device combination products. See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.