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Brazil – Peptide Import & Customs Guide

ANVISA regulations, RDC 172/2017, labeling requirements, and customs broker tips for research peptides

Back to Customs Risk Overview

High-Risk Destination

Brazil enforces strict documentation requirements under ANVISA oversight. Customs success rate is approximately 60%. Working with a local Brazilian customs broker is strongly recommended.

1. Regulatory Framework

In Brazil, the regulatory process for medicinal products is structured as a life cycle-based system governed primarily by ANVISA (Agência Nacional de Vigilância Sanitária) through a detailed framework of Resolutions of the Board of Directors (RDCs). Any product subject to ANVISA oversight must be approved before entering the Brazilian market, whether through registration, notification, authorization, or other regulatory clearance.

2. Import Requirements

Brazil's customs regulations impose strict documentation requirements. Essential documents include:

  • Certifications (including Certificates of Analysis / COA)
  • Commercial invoices
  • Labeling that meets local standards

All regulated products must comply with Brazil's labeling rules when placed on the market. Labels must be in Brazilian Portuguese and meet specific formatting guidelines.

For products intended for scientific or technological research, imports must follow the provisions of RDC No. 172/2017.

3. Recent Regulatory Updates

On August 25, 2025, ANVISA set new rules for the importation of liraglutide, semaglutide, and tirzepatide for compounding purposes. Importers should stay informed about evolving ANVISA regulations affecting specific peptide classes.

4. Customs Clearance

Imports require a Single Administrative Document and accurate commercial paperwork
Working with a local customs broker is strongly recommended to manage tariff classification, duties, VAT advice, and required customs formalities
Clear COAs and manufacturer documentation significantly reduce the chance of inspection and release delays

5. Compliance Recommendations

Confirm product classification with ANVISA before ordering — classification determines whether import authorisation, registration, or other declarations are required
Request lot-specific Certificates of Analysis (COA) and GMP certificates from suppliers
Prepare export-grade packaging with batch numbers, manufacture/expiry dates, and product identifiers in English and Portuguese
Appoint a Brazilian customs broker to manage SAD filing and customs formalities
Share COA and GMP scans with your broker in advance — many release delays are caused by missing or unclear certificates

Shipping to Brazil?

We recommend working with a local customs broker and preparing ANVISA-compliant documentation.