BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
comex. Goods originating in countries subject to UN Security Council measures, as internalised in Brazil, are captured through non-automatic licensing triggers in Siscomex and may be refused where the applica- ble resolution so requires. Finally, Secex may, on a risk-based, time-limited basis, subject an importer or defined classes of transactions to non-automatic licensing to combat fraud or to verify the authentic- ity and accuracy of commercial documents ( Portaria Secex No 249/2023 codifies that authority and sets notice, scope and duration parameters). 7.5 Trade Blocs and Free Trade Agreements Brazil is a founding member of Mercosur and a WTO member that has implemented the WTO Trade Facili- tation Agreement. In 2022, its modern bilateral Proto- col on Trade Rules and Transparency with the United States entered into force, covering customs and trade facilitation, good regulatory practices and anti- corruption, and providing for formal advance rulings, electronic documentation and risk-based controls. These frameworks are implemented through Bra- zil’s foreign trade e-system (Siscomex/ Portal Único ), which integrates licences and customs declarations, enables pre-arrival processing, and supports joint inspections and release-time measurement. Brazil’s Authorised Economic Operator ( Operador Econômico Autorizado – OEA) programme is now complemented by a 2022 OEA mutual recognition arrangement with the United States, improving reciprocal border facilita- tion for trusted traders. Mercosur’s external agreements with the EU and the European Free Trade Association (EFTA) have been signed but remain pending ratification and are not in force, so their trade facilitation and regulatory co- operation provisions are not yet operative. Within the bloc, the common external tariff (CET) still applies to most imports, tempered by established exception mechanisms such as the list of exceptions to the CET and the ex tarifário regime for capital and information and communication technology (ICT) goods not pro- duced domestically. On the regulatory side, ANVISA participates in global harmonisation fora including the International Coun- cil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Inter-
national Medical Device Regulators Forum (IMDRF), and it has aligned Brazil’s medical device framework through ANVISA RDC No 751/2022 and ANVISA RDC No 830/2023. Brazil accepts MDSAP audit reports to support Brazilian GMP (BGMP) certification for higher- risk devices, and since March 2024 BGMP certificates tied to MDSAP have four-year validity, which reduces life cycle frictions. Material caveats remain. There is no in-force mutual recognition agreement for pharmaceutical GMP with the United States or the EU. Brazil-specific steps are decisive, including appointing a Brazil-based registra- tion holder, obtaining BGMP certification for Class III and IV devices, and meeting product specific con- formity assessments such as INMETRO for electro- medical safety and the National Telecommunications Agency ( Agência Nacional de Telecomunicações – ANATEL) for wireless functionality. While exceptions exist, Mercosur’s CET continues to define duty expo- sure on most imported inputs and finished goods. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Price regulation is substantially more structured for pharmaceuticals than for medical devices in Brazil. Medicines are subject to binding statutory ceilings administered by CMED under Law No 10,742/2003. The framework establishes an ex-factory ceiling pric- es for manufacturers and importers ( preço fábrica – PF), a maximum retail ceiling price for pharmacies and drugstores ( preço máximo ao consumidor – PMC) and a specific ceiling for sales to public entities ( preço máximo de venda ao governo – PMVG), which applies a mandatory discount to PF for government- and court-ordered purchases. CMED has recently opened Public Consultation No 1/2026 to set criteria for pric- ing medicines supplied to public entities pursuant to court orders. Until that rule is finalised, PMVG and its mandatory discount logic remain the central reference for judicial and government-facing pricing. Commer- cial terms and discounts are negotiable, but prices may not exceed the applicable CMED ceilings.
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