Drugdu.com expert's response:

I. ANVISA Certification (Core Certification)

The Brazilian National Health Surveillance Agency (ANVISA) is the primary regulatory authority for the export of active pharmaceutical ingredients (APIs) to Brazil. Its certification requirements include:

1. Registration Application

Foreign companies must submit applications through a Brazilian-based registered agent (a qualified company or professional) responsible for document preparation, submission, and communication with ANVISA.

Application documents must include:

Drug composition, dosage form, dosage, pharmacological mechanism, manufacturing process, and quality management system (GMP).

Clinical trial data (for new drugs) or bioequivalence study data (for generic drugs).

Pharmacological and toxicological research data, stability data, etc.

2. Labeling and Packaging Insert

Labels must be in Portuguese and include the drug name, ingredients, dosage form, indications, usage instructions, dosage, and adverse reactions.

The packaging insert must provide detailed usage instructions, including indications, dosage, adverse reactions, contraindications, etc.

3. Review and Approval

ANVISA reviews the drug’s safety, efficacy, and manufacturing compliance (GMP).

Upon approval, a Drug Registration Certificate is issued, typically valid for 5 years, requiring periodic updates and quality reports.

II. GMP Compliance Requirements (Manufacturing Quality Certification)

1. Brazilian GMP Certification

API manufacturers must obtain GMP certification from a Brazilian-recognized certification body to demonstrate compliance with Brazilian quality management standards.

Required documents:

Original and copies of the GMP certificate.

Business license, pharmaceutical production license, and quality management system documentation.

Certification process:

Application submission → Document review → On-site audit (if applicable) → Certification issuance.

2. Apostille (Hague Convention Legalization)

If the target country’s official language is not Portuguese, the GMP certificate must undergo Apostille legalization to simplify cross-border document authentication.

Required documents:

Original and copies of the Brazilian GMP certificate.

Translated copies (if not in English or Portuguese).

Applicant’s identification documents.

Process:

Submit to the Chinese Ministry of Foreign Affairs or designated authority → Document review → Issuance of the Apostille-certified document (stamped with the Apostille seal).

III. Other Supporting Certifications and Documents

1. Certificate of Origin

General Certificate of Origin (GCO): Proves the country of manufacture or production, a fundamental import document for Brazilian customs.

Preferential Certificate of Origin: If eligible under free trade agreements (e.g., Mercosur, Brazil-China Bilateral Agreement), this certificate grants tariff preferences.

2. Import License and Customs Clearance Documents

Some APIs may require an import license, necessitating submission of product details and usage descriptions to Brazilian authorities.

Customs clearance documents include:

Commercial invoice, packing list, shipping documents, and certificate of origin.

Ensure completeness and accuracy to avoid delays.

IV. Certification Process and Key Considerations

1. Process Overview

Product classification → Selection of certification type → Preparation of application documents → Submission → Review and testing → Certificate issuance → Ongoing maintenance (periodic updates, quality reporting).

2. Critical Considerations

Language Requirements: Labels, packaging inserts, and application documents must be in Portuguese.

Agent Selection: Foreign companies must use a Brazilian-based registered agent for ANVISA applications.

Regulatory Compliance: Ensure adherence to Brazilian regulations and standards, staying updated on policy changes.

Timeline Planning: ANVISA certification typically takes 6–18 months, requiring early preparation.