Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Registration of a generic medicine

Brazil · Brazilian Health Regulatory Agency · Generics

Generic applicationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

365 days

law

Steps

11 requirements

Application fee

R$11,714

Fee table in force when checked (2026-10-03)

What is the Registration of a generic medicine in Brazil?

Registration of a copy of a reference medicine that is meant to be interchangeable with it. The generic is named by the Brazilian nonproprietary name. The company shows pharmaceutical equivalence and bioequivalence. Synthetic or semisynthetic medicines that copy a reference medicine, usually after patent or other exclusivity ends.

How much does the Registration of a generic medicine cost?

The registration fee, generic medicine is R$11,714 for Fee table in force when checked (2026-10-03). A reduced fee of R$1,171 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 585.72).

What are the steps of the Registration of a generic medicine?

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

How the pathway works

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).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 365 days end to end with the official step targets. Targets, not actual times.

Approvals per year, generic application in Brazil

From the official approvals data of this market, all products of this pathway type and segment

Steps

In order, with the official target for each step

1. Optional pre-submission guidanceonly in some casesBefore filing, the agency can give guidance through protocol reviews, meetings or its service channels. This guidance is not binding.
2. File the registration petitionThe company files the dossier electronically and pays the inspection fee.
3. Technical review365 daysThe agency reviews quality, safety and efficacy. The legal maximum for an ordinary registration decision is 365 days from filing. The agency may extend it once by up to one third.
4. Technical requirements (clock stopped)clock stopped, only in some casesQuestions are sent in one consolidated request. The clock stops until the company answers.
5. Decision publishedThe decision is published in the Official Gazette (Diário Oficial da União).
6. Public assessment reportAfter the decision, the agency publishes a public assessment report with confidential data removed.

Official time targets

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

Fees

Official amounts in the local currency

Fee	Amount
Registration fee, generic 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 585.72.	R$11,714reduced R$1,171

Fee

Amount

Registration fee, generic 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 585.72.

R$11,714reduced R$1,171

Other routes in Brazil: Registration of a new medicine, Registration of an innovative medicine, Registration of a similar 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.

Quality and manufacturing

Pharmaceutical equivalence and dissolutionA pharmaceutical equivalence certificate, a dissolution profile certificate and a dissolution method development report.
Quality dataQuality data for the active ingredient and finished product, including stability with 3 batches.

Clinical data

Bioequivalence study or biowaiverBioequivalence studies or biowaiver tests, done with the same batch used for pharmaceutical equivalence.

Eligibility

Product types that cannot be generic or similarBiological products, herbal medicines, specific medicines, homeopathic medicines, notified medicines, hospital antiseptics, diagnostic and contrast products, radiopharmaceuticals and medical gases cannot use this route.

Local presence

Brazilian company with an operating authorizationThe applicant must be a company in Brazil with an Anvisa operating authorization (AFE): to manufacture, when the medicine is made in Brazil, or to import, when it is made abroad. The applicant becomes the registration holder.

Inspection

Good manufacturing practice certificateEach manufacturing site needs a valid Anvisa GMP certificate, or a pending request for one. If only a request exists, the registration decision waits until the certificate decision is made. The law now ties medicine registration to proof of GMP certification for both domestic and foreign manufacture.

Other

Inspection fee paid before filingThe Health Surveillance Inspection Fee (TFVS) must be paid when the petition is filed.
Dossier format: CTD is allowed(optional)The technical dossier can be organized in the Common Technical Document (CTD) format. Where national rules are missing or incomplete, companies may follow ICH or WHO guidelines.

Language

Translations(in some cases)Certificates and other declarations in a foreign language need a sworn translation, except documents in English or Spanish.

After approval

PharmacovigilanceThe holder must monitor adverse events under good pharmacovigilance practice. Serious adverse events in Brazil must be reported within 15 calendar days, urgent safety issues within 72 hours, and the holder must prepare periodic benefit-risk reports.
Registration lasts 10 yearsMedicine registration is valid for 10 years. Renewal needs proof that the medicine was sold during at least the last two thirds of the validity period.

Registration of a generic medicine

What is the Registration of a generic medicine in Brazil?

How much does the Registration of a generic medicine cost?

What are the steps of the Registration of a generic medicine?

How the pathway works

Timeline with clock stops

Approvals per year, generic application in Brazil

Steps

Official time targets

Fees

Requirements

Quality and manufacturing

Clinical data

Eligibility

Local presence

Inspection

Other

Language

After approval