Importing medicines into Brazil

The regulator

The Brazilian Health Regulatory Agency (ANVISA) registers medicines and controls imports of products under health surveillance at ports, airports and borders. Import licences are filed in the LPCO module of the single foreign trade portal, and ANVISA's RDC 977/2025 began moving import control onto the single import declaration (DUIMP), according to Emergo by UL. Medicines containing substances on the Portaria 344/1998 lists are controlled and follow stricter rules.

Legal routes for unregistered medicines

Health establishments, RDC 488/2021

ANVISA's exceptional authorisation service page names RDC 488/2021 as the rule for imports by a health unit for its exclusive use. The hospital files the import with a technical and medical justification showing that no equivalent product is available in Brazil, and it takes responsibility for the benefit and risk of use and for reporting adverse events. ANVISA's 2026 personal import manual says imports in a patient's name but paid for by a hospital, health plan or similar institution must follow RDC 488/2021.

Ministry of Health programmes, RDC 203/2017

RDC 203/2017 lets ANVISA authorise exceptional imports when a product and its registered alternatives are unavailable, in a public health emergency, for vaccines bought through the PAHO revolving fund or for donations from multilateral bodies. The product must be WHO prequalified or registered in an ICH member country with GMP certification. In 2025 ANVISA's board approved such an import of leprosy combination packs made in India and supplied through WHO and PAHO for the public health system (SUS). Requests that fall outside the written rules are filed in ANVISA's SEI system and decided by board vote, which the service page says takes about 30 working days on average.

Personal import by the patient

Under RDC 81/2008, ANVISA's manual says an individual may import a medicine not registered in Brazil for personal use if it is not prohibited, the quantity matches the treatment and a prescription supports it. The individual must be the importer, buyer and payer, and the goods may come by baggage, express courier, post or a licensed import. Most medicines need no prior ANVISA authorisation, but the shipment is still inspected. Controlled substances need prior exceptional authorisation, and list C3 products such as thalidomide and lenalidomide cannot be imported this way.

Court orders and clinical trials

Some patients obtain medicines through court orders against the public health system. The Supreme Federal Court's Tema 500 ruling holds that lack of ANVISA registration generally prevents court-ordered supply, with exceptions where ANVISA unreasonably delays a registration request, the medicine is registered by renowned foreign regulators and no registered substitute exists in Brazil. ANVISA's manual says public institutions importing unregistered products to comply with a court order use RDC 262/2019. Investigational products follow RDC 945/2024, in force since 1 January 2025, which lets a sponsor import before the trial dossier review ends, with use held until approval.

Documents a buyer usually needs

• ANVISA import licence approval or exceptional authorisation issued to the Brazilian consignee
• Prescription and medical report, plus the hospital's justification that no equivalent is available in Brazil
• Proof of registration in the country of origin and a GMP certificate for the manufacturing site
• Package insert and a certificate of analysis for each batch
• Proforma invoice, commercial invoice and packing list with matching names and quantities
• Air waybill and the import declaration filed by the customs broker
• Prior ANVISA authorisation for any controlled substance

Timeline: a worked example

A private hospital in São Paulo needs an orphan medicine made in India for a patient. No equivalent is registered or available in Brazil.

Total: roughly 5 to 12 weeks from request to delivery, most of it waiting for the import licence. These are planning estimates, not published service times.

Shipping lanes from India

There are no direct passenger flights between India and Brazil, so freight to São Paulo Guarulhos (GRU) or Viracopos (VCP) connects through Dubai, Doha, Addis Ababa or a European hub. Express courier service is typically 5 to 9 days door to door, and air cargo with clearance is typically 8 to 16 days. These are typical estimates that depend on the hub and on ANVISA inspection.

CIP and DAP to the hospital or its broker are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Brazilian consignee files the import with ANVISA and customs.

Practical tips for buyers

• Agree the route before freight is booked, since a hospital import, a programme import, a trial import and a personal import each use different filings.
• For a personal import, ANVISA expects the invoice to show that the patient paid, and an assisting company may handle paperwork only, not purchase, storage or transport.
• Import duty on HS 300490 ranges from 0 to 14 percent by tariff line in World Bank WITS data. Receita Federal applies 0 percent import tax to medicines an individual imports for personal use by post or courier up to US$10,000, excluding controlled substances.
• State ICMS applies to most imports, with exemptions under CONFAZ agreements for some cancer medicines and supplies to public bodies, and the new CBS and IBS consumption taxes are being phased in. Ask a Brazilian tax adviser for a full calculation.
• Keep the product name, strength, pack size and quantity identical across the licence, invoice, packing list and air waybill.