Brazil · Brazilian Health Regulatory Agency · Over-the-counter
Review target
-
Not published
Legal time limit
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Not published
Steps
4
5 requirements
Application fee
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A company asks Anvisa to classify a medicine as non-prescription. The decision is made by updating the official list of non-prescription medicines, approved by the agency board. Companies then update their registrations within 180 days. A prescription medicine with a long, safe marketing history that treats minor conditions the patient can recognize. Non-prescription status can also be requested in a new registration, but not for generics or similars.
1. Request for non-prescription status; 2. Technical opinions; 3. Board updates the list; 4. Registrations adapted (180 days).
Outcome: Inclusion in the official list of non-prescription medicines; registrations are then adapted.
Legal basis: Anvisa RDC 882/2024; Anvisa RDC 948/2024 (Art. 34)
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 180 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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Brazil: Registration of a new medicine, Registration of an innovative medicine, Registration of a generic medicine, Registration of a similar medicine, Notification of a low-risk medicine, Priority review of a registration petition, Special procedure for new medicines for rare diseases, Registration under a commitment term, Optimized analysis using an equivalent foreign authority, Good manufacturing practice certification (CBPF). See all routes on the Brazil 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.