Why can a grammatically correct translation still be rejected by ANVISA?

Because ANVISA's Controlled Vocabulary standardizes how specific terms (pharmaceutical forms, routes of administration, indications) must appear. A linguistically valid variation that falls outside this vocabulary isn't wrong in the everyday sense — but it's outside the standard the submission process expects.

Do the printed insert and the electronic label repository need the exact same text?

They need to be consistent. Small wording discrepancies between the printed version and the one published in ANVISA's electronic repository are spotted quickly in a side-by-side comparison and trigger a correction request.

Do adverse events on a package insert follow the same MedDRA terminology as a pharmacovigilance report?

Yes. The adverse reactions section of a package insert must use MedDRA terminology in Portuguese, consistent with the rest of the product's safety documentation.

Package Inserts: The ANVISA Vocabulary You Must Follow

The active ingredient name on a package insert isn’t “whichever translation you prefer” — in Brazil, it’s the DCB (Denominação Comum Brasileira), full stop. Regulatory documents submitted to ANVISA, Brazil’s health regulator, follow their own controlled vocabulary, and a translation that ignores it — even one that’s technically correct in everyday Portuguese — usually gets sent back for correction before review can continue.

This guide covers what ANVISA’s Controlled Vocabulary is, why the Brazilian drug nomenclature (DCB) isn’t negotiable, and what needs to stay identical between the package insert, the electronic label repository, and the rest of the regulatory dossier.

ANVISA’s Controlled Vocabulary — what it is and why it matters

ANVISA maintains a controlled vocabulary that standardizes how certain terms must appear in regulatory documents — from pharmaceutical form names to routes of administration and indication categories. Its purpose is to let the regulator itself, and automated screening systems, recognize the same concept the same way across any submission, regardless of sponsor or translator.

A translation that uses a linguistically valid variation, but one outside the controlled vocabulary, isn’t “wrong” in the everyday sense — but it falls outside the standard the submission process itself expects, which triggers a correction request before the review can move forward.

DCB: drug naming isn’t a matter of preference

In practice

A drug’s brand name changes from country to country; the active ingredient doesn’t. The Brazilian Common Denomination (DCB) is Brazil’s official drug nomenclature, and it — not a literal translation of the English name, nor the brand name — is what needs to appear in package inserts and regulatory documents.

When an international dossier arrives with the drug name in English, or in an international nonproprietary name (INN) that differs from the Brazilian one, the translation needs to convert it to the corresponding DCB — not assume the spelling that most resembles the original is the correct one.

Package insert vs. electronic label repository: consistency across formats

The same drug usually has regulatory content in more than one format — the printed insert that ships with the product and the version published in ANVISA’s electronic label repository (bulário eletrônico), plus reference material for healthcare professionals. A translation done without visibility into the other formats risks introducing small wording discrepancies between versions of the same content — discrepancies the regulator spots quickly in a side-by-side comparison.

An example of how this shows up in practice, sentence by sentence:

Tradução literal

This medicine shouldn't be taken by people with liver problems.

Tradução adequada

This medicinal product is contraindicated in patients with hepatic insufficiency.

The first version uses colloquial language (“liver problems”) in a document that requires standardized technical-regulatory register — the second uses the terminology ANVISA’s Controlled Vocabulary and package insert standards actually expect.

What can never change in package insert and regulatory document translation

Element	Why it can’t vary
Drug name (DCB)	It’s the official Brazilian nomenclature — not a literal translation nor the brand name.
ANVISA Controlled Vocabulary terms	Pharmaceutical forms, routes of administration, and indications follow their own nomenclature.
Dosage and units	A conversion error is a direct risk to the patient.
Contraindications and warnings	Reworded text can change the legal scope of the warning.
Consistency between insert and electronic repository	Discrepancies between formats of the same product trigger a correction request.

Checklist before submitting to ANVISA

Drug name converted to the corresponding DCB, not translated literally.
Terminology aligned with ANVISA’s Controlled Vocabulary (pharmaceutical forms, routes, indications).
Dosage, units, and contraindications checked term-by-term against the source.
Wording consistent between the printed insert and content already published in the electronic repository.
MedDRA terminology used for adverse events mentioned in the adverse reactions section.
Reviewed by a second professional before submission.

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Need to translate a package insert or regulatory document for ANVISA submission? SealScribe applies this checklist automatically, with an official glossary and review before delivery.

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How this works in practice

Every regulatory document processed by SealScribe runs through a glossary built from official sources (ANVISA’s Controlled Vocabulary, DCB, MedDRA in Portuguese), with the correct term locked across every occurrence in the document, and review before delivery. When the document contains sensitive identifying data, anonymization runs before anything reaches the cloud, without altering any technical data — included in every order, at no extra cost.

Frequently asked questions

DCB (Denominação Comum Brasileira) is Brazil's official drug nomenclature. An international dossier usually carries the name in English or in a different international nonproprietary name (INN) — the translation needs to convert it to the corresponding DCB, not translate it literally or keep the brand name.

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