ANVISA
Brazil's federal health surveillance agency that regulates clinical trials, medicines, medical devices, and cosmetics.
Short answer
ANVISA is Brazil's health regulator. Every document in a clinical trial dossier (DDCM), registration, or post-approval submission must be in Brazilian Portuguese. Foreign public documents — GMP certificates, certificates of free sale, notarized agreements, powers of attorney — additionally require a tradução juramentada by a tradutor público matriculado at a Junta Comercial, with the apostille applied to the original before translation. Portuguese from Portugal is not a substitute for Brazilian Portuguese.
What it means
ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's federal health surveillance agency. It reviews clinical trial protocols, product registration dossiers, and post-market changes for medicines, medical devices, biologics, and cosmetics. Every submission to ANVISA must be in Brazilian Portuguese.
Why it matters for LATAM submissions
Brazil is the largest clinical trial market in Latin America. ANVISA's review timeline can be shortened when translations match its controlled vocabulary and formatting expectations from the first cycle.
Submission language rules
ANVISA reviews in Portuguese. Submissions go through the Solicita/peticionamento electronic system, and the record of the submission — the dossier itself — must read in Brazilian Portuguese. English source files are attached as supporting originals, never in place of the Portuguese version.
- Clinical trial dossier (DDCM), protocol, and amendments: full Brazilian Portuguese translation.
- Investigator brochure and safety reporting: Brazilian Portuguese, terminology consistent with the protocol.
- Termo de Consentimento Livre e Esclarecido (TCLE): Brazilian Portuguese in lay register, aligned with CNS Resolution 466/2012 and 466's successor guidance, and with the reviewing CEP/CONEP template.
- Foreign-issued legal and administrative certificates: apostille on the original, then tradução juramentada.
- Terminology must follow Brazilian usage — 'ensaio clínico', 'consentimento livre e esclarecido', 'notificação', 'petição' — not European Portuguese.
- Exigências (deficiency notices) are issued in Portuguese and answered in Portuguese within the stated deadline; the review clock restarts on your response.
Where translation errors surface in the review
Two bodies read the same dossier for different reasons: the CEP/CONEP ethics review reads the TCLE and subject-facing material, and ANVISA's technical area reads the scientific and legal record. Language findings from either one cost a cycle.
- TCLE written as a literal translation of the English consent: long sentences, legalistic register, and risk language that a CEP reads as unclear or coercive.
- Terminology drift between protocol, brochure, CRF, and the Portuguese summary — the reviewer sees two names for one procedure.
- A tradução juramentada whose entity name, batch reference, or date does not match the apostilled original.
- Missing or unlinked apostille: the original was apostilled after translation, so the sworn translation does not include the apostille text.
- Portugal-Portuguese spelling and vocabulary in an otherwise valid dossier, which triggers an editorial exigência.
- Untranslated annexes, figure captions, and table headers inside otherwise translated documents.
Tradução juramentada: who may sign
Only a tradutor público e intérprete comercial registered with a state Junta Comercial may issue a tradução juramentada in Brazil. The translation carries the translator's registration number, a sequential book and page reference, and a signed statement. A certificate of accuracy from a translation agency is not equivalent and does not satisfy the requirement for public documents.
- Sworn translation is required for foreign public documents, not for the scientific body of the dossier.
- The scientific dossier still requires verifiable, consistent Portuguese, typically with a certificate of accuracy and a locked project glossary.
- Brazil has been a Hague Apostille Convention party since 2016, so foreign documents from other member states take the apostille route rather than consular legalization.
Document checklist
Printable ANVISA submission checklist (PDF)
Two pages: the document-by-document table with tick boxes, the apostille and sworn-translation order of operations, common rejection triggers, and space for filing notes.
| Document | Language / certification requirement |
|---|---|
| Clinical trial dossier (DDCM) and protocol amendments | Brazilian Portuguese, terminology locked against a project glossary |
| Investigator brochure | Brazilian Portuguese; safety terminology consistent with the protocol |
| TCLE (informed consent) and assent | Brazilian Portuguese, lay register, CEP/CONEP content elements present |
| GMP certificate / certificate of free sale | Apostille on the original, then tradução juramentada |
| Power of attorney and legal representation documents | Notarized, apostilled, tradução juramentada |
| Labeling, bula, and IFU text | Brazilian Portuguese, aligned with approved product information |
| CMC and quality sections | Brazilian Portuguese; units, nomenclature, and specifications carried over exactly |
| Exigência responses and correspondence | Portuguese; reuse the terminology already filed in the dossier |
Frequently asked questions
Does ANVISA accept documents in English?
No. The dossier must be in Brazilian Portuguese. English originals may be attached as supporting source documents alongside the Portuguese version, but they do not replace it.
When is a tradução juramentada required?
For foreign public and legal documents — GMP certificates, certificates of free sale, notarized instruments, and powers of attorney. The scientific dossier does not require a sworn translator, but it does require consistent, verifiable Portuguese.
Does the apostille go on the original or the sworn translation?
On the original, issued by the competent authority in the issuing country. The tradutor público then translates the apostilled document, including the apostille text itself.
Is European Portuguese acceptable?
It is not a formal bar, but it reads as foreign to a Brazilian reviewer and to a CEP reading the TCLE. Spelling, vocabulary, and register differences routinely draw editorial exigências. Brazilian Portuguese is the safe default.
What is an exigência and how is it linked to translation?
An exigência is ANVISA's formal deficiency notice. Inconsistent terminology, a missing sworn translation, an unclear TCLE, or an untranslated annex are all issued as exigências, and answering one restarts the review clock.
Who approves the TCLE — ANVISA or the ethics committee?
The CEP, escalating to CONEP for certain study types, reviews and approves the TCLE. ANVISA reviews the regulatory and technical dossier. Both read Portuguese, and both can return the file over language.
How long does sworn translation add to the timeline?
Plan for the apostille first, then the sworn translation, then filing. Compressing that order is the single most common cause of a re-issue, because a translation produced before the apostille has to be redone.
Primary sources
- ANVISA — official portal (gov.br/anvisa) — Regulatory framework, peticionamento procedures, and current resolutions.
- RDC 945/2024 and the clinical trial dossier (DDCM) framework — Defines the clinical development dossier and submission expectations for drug trials in Brazil.
- CONEP / CNS Resolution 466/2012 — Ethics review framework and the required content elements of the TCLE.
- HCCH — Apostille Convention status table — Confirms Brazil's status as a contracting party and the competent authorities per country.
- Junta Comercial registries — tradutores públicos — State-level registers of sworn translators authorized to issue tradução juramentada.
Next step
The complete document-by-document breakdown, the sworn translation and apostille sequence, TCLE review expectations, exigência response patterns, and a downloadable checklist.
Read the full ANVISA translation requirements guideKeep going on this topic
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