Brazil · Brazilian Health Regulatory Agency · Generics
Review target
-
Not published
Legal time limit
365 days
law
Steps
6
11 requirements
Application fee
R$41,000
Fee table in force when checked (2026-10-03)
Registration of a branded copy of a medicine already registered with Anvisa. It has the same active ingredients, strength, dosage form, route, dosing and indication and must always carry a brand or trade name. The evidence package is the same as for generics. Copies of a registered medicine that will be sold under a brand name.
The registration fee, similar medicine is R$41,000 for Fee table in force when checked (2026-10-03). A reduced fee of R$4,100 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 2,050.02).
1. Optional pre-submission guidance; 2. File the registration petition; 3. Technical review (365 days); 4. Technical requirements (clock stopped); 5. Decision published; 6. Public assessment report.
Outcome: Registration published in the Official Gazette, valid for 10 years. Valid for 10 years.
Legal basis: Lei 6.360/1976; Anvisa RDC 948/2024; Anvisa RDC 753/2022
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 365 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitlaw. Official maximum time for the agency decision. It is a target in the rules, not an observed review time. Time the applicant spends answering questions is not counted. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Registration fee, similar medicineApplication · 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 2,050.02. | R$41,000reduced R$4,100 |
Other routes in Brazil: Registration of a new medicine, Registration of an innovative medicine, Registration of a generic medicine, Non-prescription status (MIP) for a registered 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.