Brazil · Brazilian Health Regulatory Agency · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
4 requirements
Application fee
R$3,514
Fee table in force when checked (2026-10-03)
Low-risk, non-prescription medicines on an official list are notified electronically instead of registered. After the fee is paid and the notification is activated, the medicine may be sold at once. There is no prior dossier review. Non-prescription medicines that appear on the official list of low-risk medicines subject to notification.
The fee for exemption from registration (notification), medicines is R$3,514 for Fee table in force when checked (2026-10-03). A reduced fee of R$351 applies in some cases (Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 175.72).
1. Company enabled in the notification system; 2. Electronic notification and fee; 3. Notification active.
Outcome: Notification declaration; the medicine may be sold without a registration number review. Valid for 10 years.
Legal basis: Anvisa RDC 576/2021; Anvisa RDC 948/2024 (Art. 35); Anvisa RDC 912/2024
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).
Official step durations
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 |
|---|---|
| Fee for exemption from registration (notification), medicinesProduct · Fee table in force when checked (2026-10-03) · Amount for the largest companies (annual revenue above 50 million reais). Lower amounts by size: 15 percent off for large group II, 30 percent off for medium group III, 60 percent off for medium group IV, 90 percent off for small and 95 percent off for micro companies. Reduced amount shown: small company. Micro companies pay 175.72. | R$3,514reduced R$351 |
Other routes in Brazil: Non-prescription status (MIP) for a registered medicine. 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.