Canada · Health Canada · Over-the-counter
Review target
60 days
performance goal
Legal time limit
-
Not published
Steps
4
7 requirements
Application fee
CA$1,945
From April 1, 2026
Many non-prescription drugs that are not new drugs get a drug identification number (DIN) by attesting that they meet a labelling standard or Category IV monograph. No clinical or manufacturing data are filed. Non-prescription drugs that fully fit a published labelling standard or Category IV monograph.
The official review target is 60 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The din application, labelling standard or category iv monograph is CA$1,945 for From April 1, 2026.
1. File the DIN application with attestation; 2. Review (60 days); 3. DIN issued or refused; 4. Confirm first sale.
Outcome: Drug identification number (DIN).
Legal basis: Food and Drug Regulations, sections C.01.014 to 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 90 days end to end with the official step targets. 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. | 60 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Annual right to sell fee, non-prescription drugYearly · From April 1, 2026 · Small businesses can get 25% off. | CA$3,391 |
| DIN application, labelling standard or Category IV monographApplication · 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$1,945 |
Other routes in Canada: DIN application with supporting data. See all routes on the Canada page or explore them in the Regulatory section.
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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.