A proximidade temporal entre os atos normativos evidencia uma atuação coordenada na Receita Federal e sinaliza uma clara diretriz de aceleração da modernização do OEA, com impactos diretos sobre a cadeia logística e portuária.

O que é o Programa OEA

O Programa OEA consiste em um modelo de certificação aduaneira que reconhece operadores com elevado nível de conformidade, segurança e confiabilidade na cadeia de suprimentos internacional. Os intervenientes elegíveis à certificação estão previstos no art. 6º da Instrução Normativa RFB nº 2.318/2026, incluindo importadores, exportadores, transportadores, agentes de carga, agências marítimas, depositários em recintos alfandegados e em Recintos Especiais para Despacho Aduaneiro de Exportação (Redex), operadores portuários e operadores aeroportuários.

Uma vez certificados, os operadores passam a usufruir de benefícios como redução de inspeções, maior previsibilidade nos fluxos aduaneiros, tratamento prioritário e potencial reconhecimento internacional, chegando até ao diferimento de tributos devidos na importação, a depender da modalidade de certificação.

Em especial, no contexto portuário e logístico, o OEA consolida-se como um instrumento central de eficiência operacional, gestão de riscos e competitividade.

IN nº 2.318/2026: reestruturação das modalidades e níveis de certificação

A Instrução Normativa promove alterações estruturais relevantes no OEA, com destaque para a reorganização das modalidades de certificação.

Nos termos do art. 7º, o programa passa a contemplar: (i) a modalidade OEA-Segurança (OEA-S); e (ii) a modalidade OEA-Conformidade (OEA-C), subdividida em três níveis progressivos: OEA-C Nível 1 (Essencial), OEA-C Nível 2 (Qualificado) e OEA-C Nível 3 (Referência).

A estruturação em níveis no âmbito do OEA-C reforça uma lógica evolutiva de certificação, permitindo que os operadores ingressem no programa com requisitos iniciais e avancem conforme o grau de maturidade de seus controles internos e de conformidade. Ademais, essa nova estrutura visa atender a uma demanda decorrente das alterações trazidas pela Reforma Tributária, considerando determinadas situações de certificação OEA para a fruição de desonerações tributárias.

A IN também aprimora a sistemática de benefícios, ao estabelecer a diferenciação entre benefícios gerais — aplicáveis aos operadores certificados — e benefícios específicos, vinculados à modalidade e ao nível de certificação, conforme previsto no art. 8º.

Na prática, tais benefícios se traduzem em ganhos relevantes de eficiência operacional, especialmente para operadores com cadeias logísticas complexas.

Adicionalmente, a Instrução Normativa detalha o processo de certificação (arts. 18 a 27), que passa a observar etapas estruturadas que envolvem o protocolo do requerimento, a análise documental, a validação pela Receita Federal e, quando aplicável, a realização de diligências, deixando claro que a certificação está sujeita a monitoramento contínuo quanto à manutenção dos requisitos.

Nesse contexto, a norma também disciplina hipóteses de exclusão do operador certificado (art. 34 e seguintes), especialmente em casos de descumprimento de requisitos, inconsistências nos controles, prestação de informações inexatas ou ocorrência de irregularidades que comprometam sua confiabilidade, evidenciando que o OEA exige a manutenção permanente de elevados padrões de governança e compliance.

Portaria Coana nº 187/2026: o principal marco operacional

A Portaria assume papel central ao regulamentar a aplicação prática do novo OEA, ao mesmo tempo em que estrutura regimes distintos conforme a data de protocolo dos requerimentos de certificação, assegurando tratamento adequado tanto para processos em curso quanto para novos pedidos.

Especificamente, a norma prevê três marcos temporais:

Ademais, a Portaria também prevê prazo para a conclusão do procedimento de validação (até 120 dias). Embora se trate de prazo já estabelecido anteriormente, espera-se que a previsão na nova Portaria seja observado e resolva a problemática relativa ao elevado tempo que o procedimento de validação apresentava, o que era objeto de críticas e é evidenciado pela própria Portaria ao tratar de requerimentos protocolados ainda antes de julho de 2024.

É importante destacar que, para requerimentos protocolados a partir de 15 de abril de 2026, a norma dispensa a apresentação de informações e documentos já disponíveis nas bases da Receita Federal — como CNPJ, regularidade fiscal e adesão ao DTE.

Considerações finais

A Instrução Normativa RFB nº 2.318/2026 também estabelece disposições específicas de adequação ao novo modelo do Programa OEA, com efeitos práticos relevantes para os operadores. Nos termos do art. 51, a certificação anteriormente concedida na modalidade OEA-Conformidade (OEA-C) passa, desde a publicação da norma, a ser automaticamente denominada OEA-C Qualificado, refletindo a nova estrutura em níveis e promovendo o enquadramento imediato dos operadores já certificados no novo regime, sem necessidade de novo requerimento.

Ademais, o art. 53 fixa marco temporal relevante para a operacionalização das novas categorias, ao estabelecer que os requerimentos de certificação nas modalidades OEA-C Essencial e OEA-C Referência somente poderão ser formalizados a partir de 15 de abril de 2026, o que delimita o início efetivo da aplicação prática da nova arquitetura do programa.

Por fim, o art. 57 dispõe que ficam revogadas: a Instrução Normativa RFB nº 2.154, de 26 de julho de 2023; e a Instrução Normativa RFB nº 2.200, de 12 de julho de 2024.

Nossas equipes de Aduaneiro e Marítimo & Portuário estão à disposição para esclarecer dúvidas sobre as recentes mudanças no Programa OEA e seus impactos práticos na cadeia logística e portuária.

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This initiative (i) is part of the implementation of Brazil’s new regulatory framework for research involving human participants, established by Law No. 14,874/2024 and Decree No. 12,651/2025, which transferred to INAEP competencies previously held by the National Commission for Research Ethics (Comissão Nacional de Ética em Pesquisa – “CONEP”) and (ii) seek to consolidate and update previously fragmented regulations, particularly National Health Council’s Resolution No. 441/2011 and Ministry of Health’s Ordinance No. 2,201/2011, in alignment with the new legal framework.

The draft resolution submitted for public consultation represents the continuation of a process initiated in 2023 under CONEP. The text was initially approved unanimously by CONEP’s board in 2024 and was subsequently reviewed and resubmitted by INAEP under the new institutional arrangement.

The draft addresses, in a structured manner, key issues such as:

The proposal introduces the concept of an accredited Research Ethics Committee (Comitê de Ética em Pesquisa – “CEP”), concentrating the ethical review of biobanks within committees that demonstrate adequate technical and operational capacity. It also expressly aligns the regulatory framework with the principles of the Brazilian General Data Protection Law and with international ethical standards, such as the World Medical Association’s Declaration of Taipei, thereby enhancing regulatory predictability and harmonization.

Contributions may be submitted until June 1, 2026, exclusively through the government platform.

Impacts on Industry and Research Institutions

If approved, the resolution is expected to have significant implications for sponsors, research institutions, biobank managers, and companies in the pharmaceutical, biotechnology, and medical devices sectors.

Key anticipated effects include greater specialization in ethical review, increased governance and transparency requirements, and enhanced clarity regarding conditions for future use, international transfer of human biological material, and cost reimbursement mechanisms. At the same time, the new regulatory framework has the potential to strengthen legal certainty and support the sustainability of large-scale research initiatives, particularly in fields involving innovation and international scientific cooperation.

The Life Sciences & Healthcare team at Souto Correa Advogados is available to address any questions you may have at lifesciences@soutocorrea.com.br.

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In the ruling published on Tuesday (10), the STF held that the TCU exceeded the limits of its constitutional authority by replacing ANTAQ in a regulatory decision that falls within the agency’s exclusive competence. In the leading opinion, Justice Dias Toffoli emphasized that courts of accounts cannot, under the guise of exercising their supervisory functions, assume the role of regulatory agencies. According to the rapporteur, it is not for the courts of accounts “to step into the shoes of regulatory agencies, making decisions on regulatory matters that have been entrusted to those agencies and not to the courts themselves,” also noting that ANTAQ has greater institutional and technical capacity to address the matter, having conducted a broad, transparent regulatory process based on public hearings, which resulted in Resolutions 2,864/12, 34/19, and 72/22.

The decision further highlighted that, over the past years, ANTAQ has consolidated consistent regulatory parameters for the sector, including mechanisms for competition protection and provisions enabling the agency to set maximum prices for the SSE in the event of indications of abusive practices. The Court observed that, by invalidating the possibility of charging the SSE, the TCU encroached upon powers belonging not only to ANTAQ, but also to CADE, whose mission includes safeguarding competition. The opinion adds that CADE itself considers that charging the SSE is not inherently unlawful in the abstract, with assessments of potential abuse requiring a case-by-case analysis.

The Shipping & Port team at Souto Correa Advogados is closely monitoring the developments related to the decision and remains available to address any questions on the matter.

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This report brings together analyses on nutrivigilance, medical device innovation, pricing of advanced therapies, health‑sector litigation, veterinary pharmacovigilance, and other highly relevant themes for regulated industries.

Explore the 17 topics we have identified for 2026:

Click here to download the full report and prepare for the key regulatory challenges ahead.

The Life Sciences & Healthcare team at Souto Correa Advogados is available for any questions on these topics via email: lifesciences@soutocorrea.com.br.

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The deadline for submitting contributions is 60 days and will end on March 9, 2026.

The draft resolution and other supporting documents can be accessed through this link.

The Life Sciences & Healthcare team at Souto Correa Advogados is available to answer any questions regarding the proposed resolution via email: lifesciences@soutocorrea.com.br.

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The final text of Resolution 3/2025 can be accessed at this link.

Hot Topics

Resolution 3/2025:

On the other hand, pricing criteria for advanced therapies and radiopharmaceutical products will be addressed in a specific resolution and, for the time being, such products will be considered omitted cases. In addition, the criteria for extraordinary price adjustments for medicines were not covered in the new framework and are expected to be defined in 2026.

The resolution provides for a 120‑day transition period and, during this interval, CMED’s Executive Secretary, Mateus Amâncio, stated that CMED “will act to clarify any questions and provide the necessary guidance for a safe and transparent implementation of the new rules.”

I. Preliminary Provisions of the New Framework

Resolution 3/2025 standardizes the concept of incremental innovation as a change relative to an originator medicine resulting from innovative activity, not considering as such mere variations in simple product characteristics, such as:

In this sense, the new framework also introduces the concept of a medicine with incremental innovation as a medicine that demonstrates innovative activity in relation to an originator medicine already registered in the country, consisting of a new combination, new monodrug, new route of administration, new strength, new dosage form, new packaging, or other incremental innovation, according to the following definitions:

i. New chronological sequence for price submission

The new framework determines that holders of the marketing authorization must submit a price request to CMED after submitting the marketing authorization application and before its publication. It will be the company’s responsibility to monitor the progress of the marketing authorization process with Anvisa and take the necessary steps to comply with Article 6 of Resolution 3/2025. If the marketing authorization holder does not submit the DIP by the time Anvisa publishes the marketing authorization, CMED must initiate ex officio proceedings to define the medicine’s Factory Price (“PF”).

This obligation was included in the regulation to comply with what was determined by the Federal Supreme Court under Theme 1234.

ii. Pre‑submission meeting

Resolution 3/2025 provides that interested parties may request a pre‑submission meeting with CMED for the presentation of the DIP.

iii. Criteria for Price Determination

iv. Categories of Medicines and Criteria for Setting the PF by Category

The table below summarizes the categories of medicines provided in the new framework and the respective criteria for defining the PF by category, without prejudice to the detailed explanation throughout the text:

The new framework provides eight (8) categories for classifying new products, namely:

To detail the table above, Resolution 3/2025 provides the following criteria for setting the PF:

v. Marketing Authorization Conditional Upon Submission of Additional Data and Evidence & Provisional Price

CMED may set a provisional price in cases where the marketing authorization is conditional upon the submission of additional data and evidence after the authorization has been granted, when the information necessary for the product’s definitive pricing is not yet available at the time the DIP is submitted.

In such cases:

vi. Documents in a Foreign Language

Documents accompanying the DIP must be submitted in Portuguese, but the new framework also states that documents in English and Spanish will be accepted.

If translation of documents originally submitted in English and Spanish is necessary, a request for clarification will be issued asking for the translation of the documents. Where a translation is required, and in the absence of a specific rule requiring sworn translation, a free (non‑sworn) translation may be accepted.

Documents accompanying the DIP, when submitted in a language other than Portuguese, English, or Spanish, must be submitted via sworn translation referring to the identification of the price or to the lack of a price in the reference countries.

vii. First‑Instance Decision and Deadlines

CMED’s Executive Secretariat (“SCMED”) is responsible for issuing first‑instance decisions on price requests for new products and new presentations submitted, and must observe the following deadlines, counted from the date of publication of the marketing authorization:

These deadlines may be extended once, for an equivalent period. In addition, SCMED must prioritize the analysis of DIPs whenever there is a formal and duly substantiated request from the Ministry of Health.

viii. Administrative Appeal

An appeal may be filed with the Technical‑Executive Committee (“CTE”) against SCMED’s decision within 30 (thirty) days from the notification of the decision. The appeal will be addressed to SCMED, which may reconsider the first‑instance decision within 90 (ninety) days.

If there is no reconsideration of the decision, or upon expiry of the reconsideration period, the case will be sent to the CTE for a decision on the appeal. If SCMED’s reconsideration only partially accepts the grounds of the appeal, the company will be notified so that, if it wishes, it may file an appeal with the CTE within 30 (thirty) days from the notification.

ix. Mandatory Reexamination

SCMED decisions will be subject to mandatory reexamination by the CTE when the company does not file an appeal, in the following cases:

The CTE’s decision in the mandatory reexamination may confirm the first‑instance decision or modify it to set a higher or lower price than that calculated by SCMED. In situations where the mandatory reexamination results in the definition of a price lower than that established by SCMED, a request for reconsideration may be filed with the CTE itself within 30 (thirty) days, and the case will be assigned to a new rapporteur.
CMED may review its decisions when it identifies:

X. Disclosure of Prices

CMED decisions on DIPs, at any level, will result in the disclosure of the approved prices in a list published monthly on its website and on Anvisa’s website, which may be amended if the decision is modified in reconsideration or appeal proceedings. The price list published on Anvisa’s website will include an indicator showing cases pending judgment by CMED.

XI. Final and Transitional Provisions

The PF obtained from the calculations provided for in the new framework will be expressed with two decimal places, with rounding from the third decimal place, as set out in item “7. Rounding of Numerical Data” of the publication Standards for Tabular Presentation of the IBGE (Brazilian Institute of Geography and Statistics).
Failure to comply with the provisions of Resolution 3/2025 will subject the violator to the sanctions set out in Law 10,742/2003. Doubts arising from the application of Resolution 3/2025 will be resolved by the CTE, after hearing SCMED.

XII. Five‑Year Review of the New Medicine Pricing Framework

The CTE will periodically coordinate evaluation processes of Resolution 3/2025, observing good regulatory practices, to assess the need for its amendment by the Council of Ministers. The evaluation processes will be carried out at intervals no longer than five (5) years.

XIII. Omitted Cases: Advanced Therapies and Radiopharmaceutical Products

The criteria for setting prices for advanced therapy products and radiopharmaceutical products will be regulated in specific acts of the Council of Ministers. Thus, advanced therapy products and radiopharmaceutical products will be considered omitted cases until the specific acts of the Council of Ministers are issued.

XIV. Transition Regime

The new regulatory framework for medicine pricing applies to:

Companies requesting pricing for medicines that fall under the situations above must submit the supplementary documentation required by Resolution 3/2025 within 30 (thirty) days from its effective date. In cases where the supplementary documentation is not submitted within the specified period, SCMED must notify the applicant company to comply with the determination within 30 (thirty) days. Failure to observe the 30‑day period will result in the initiation of ex officio proceedings to define the initial PF for the medicine.

Administrative appeals and mandatory reexaminations that are under review at the CTE, as well as appeals pending judgment by the Council of Ministers, will continue their course before those instances until judgment, observing the rules set out in Resolution 2/2004.

XV. Revoked Rules

The following Resolutions are revoked:

The Life Sciences & Healthcare team at Souto Correa is available to answer any questions about the new medicine pricing framework, its transition period, and its possible developments at lifesciences@soutocorrea.com.br.

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Dividend Taxation and High-Income Taxation:

Important Notes:

It is therefore advisable for companies to assess the existence of accumulated profits and consider distribution, in accordance with the law, to avoid additional taxation.

How to Prepare for 2026

With dividend taxation scheduled for 2026, it is essential for taxpayers and companies to evaluate tax optimization strategies, such as:

The Tax Law team at Souto Correa Advogados is available to clarify any questions related to this matter.

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Although public debate has focused on the impacts for insurers, the new law also introduces significant changes for policyholders, particularly regarding duties, disclosure requirements, and the consequences of omissions.

Below are some key points to consider under the new law:

Law No. 15,040/2024 represents a significant reform of the insurance contract regime in Brazil. While it consolidates rights, it also imposes greater responsibilities, requiring a more diligent approach to information exchange and ongoing risk management.

The Contracts team at Souto Correa Advogados is available to provide the technical support needed for policy negotiation, monitoring, and management.

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INAEP will be coordinated by Dr. Meiruze Sousa Freitas, currently director of the Department of Science and Technology at the Secretariat of Science, Technology and Innovation and of the Health Economic-Industrial Complex of the Ministry of Health.

Dr. Meiruze Sousa Freitas holds a degree in Pharmacy from UFMG, with a specialization in Pharmaceutical Technology from UFF. A career civil servant at Anvisa since 2007, she served as director of Anvisa’s Second Directorate (2020–2024) and acting president of the Agency (2020–2023). She played a strategic role in the emergency approval of COVID-19 vaccines and in implementing regulatory frameworks for clinical research. She currently leads science and technology policies at the Ministry of Health.

The ordinance also appoints representatives from the Ministry of Health, the National Health Council, the Ministry of Science, Technology and Innovation, the Ministry of Education, Anvisa, and Confap.

Is INAEP fully composed and functional?
The establishment of INAEP is an important step toward operationalizing the new regulatory framework for clinical research. Its responsibilities include:

However, INAEP is not yet fully functional.
Article 12, item VII, of Decree No. 12,651/2025 requires the inclusion of 15 expert representatives with recognized expertise and relevant experience in research ethics involving human subjects, to be selected through a public process. These specialists have not yet been appointed, which limits the full composition of the collegiate body.

We will continue to monitor developments in the implementation of INAEP, including:

The Life Sciences and Healthcare team at Souto Correa Advogados will continue to follow the next steps in INAEP’s implementation and remain available to provide guidance on legal and regulatory strategies.

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Considering the complexity and volume of information required, we recommend starting the data consolidation process as soon as possible to avoid delays and, consequently, non-compliance with this obligation.

Please note that the required document is not a simplified report, but a technical and comprehensive Annual Report that demonstrates the effectiveness of the policies, procedures, and controls implemented throughout 2025, in compliance with regulatory obligations and anti-money laundering measures established by SPA/MF.

The report should address, for example:

Compliance with this obligation is essential to confirm to the regulatory authority the Operator’s commitment to regulatory compliance and its efforts throughout 2025 to contribute to building an ethical and sustainable sector.

The Compliance team at Souto Correa Advogados is available to provide technical support for structuring, gap identification, and drafting and/or reviewing the Report, ensuring that the document fully meets SPA/MF requirements.

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