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09/06/2026

The 45th Ordinary Meeting of the Genetic Heritage Management Council (CGen) Will Take Place This Week

The Genetic Heritage Management Council (CGen) will hold its 45th Ordinary Meeting on June 10 and 11, 2026, to discuss developments concerning SisGen (system for registering access to genetic heritage and associated traditional knowledge) and proposals for regulatory adjustments with potentially relevant impact on regulated sectors. The main topics are outlined below. Harmonization of the …
Client Alert

05/06/2026

Betting Advertising Under Heightened Enforcement During the 2026 FIFA World Cup

Summary. The Secretariat of Prizes and Betting of the Ministry of Finance (SPA/MF) has issued Technical Note SEI No. 3620/2026, dated June 3, 2026, addressed to authorized fixed-odds betting operators, concerning communication, advertising and marketing activities during the 2026 FIFA World Cup (June 11 to July 19, 2026). The Note does not create new obligations, …
Client Alert

09/04/2026

Portaria Coana nº 187/2026 e Instrução Normativa RFB nº 2.318/2026 reformulam o Programa Brasileiro de Operador Econômico Autorizado (OEA)

A Receita Federal do Brasil publicou, em 26 de março de 2026, a Instrução Normativa RFB nº 2.318/2026, que reformula o Programa Brasileiro de Operador Econômico Autorizado (OEA). Poucos dias depois, em 7 de abril de 2026, foi publicada a Portaria Coana nº 187/2026, responsável por detalhar e viabilizar sua aplicação prática, a partir da …
Client Alert

06/04/2026

INAEP: Public Consultation on new guidelines applicable to biobanks

Public Consultation No. 1/2026 has been published by the National Research Ethics Authority (Instância Nacional de Ética em Pesquisa – “INAEP”), inviting public participation on the proposed new guidelines applicable to biobanks of human biological material, within the scope of the National System for Research Ethics Involving Human Beings (Sistema Nacional de Ética em Pesquisa …
Client Alert

11/03/2026

STF reaffirms ANTAQ’s regulatory authority and restores the legal effect of Resolution 72/22 on the SSE

The Second Panel of the Federal Supreme Court (STF) unanimously denied the internal appeal filed by the Brazilian Federal Court of Accounts (TCU) and fully reinstated the legal effect of ANTAQ Resolution No. 72/22, reaffirming the possibility of charging the Container Segregation and Delivery Service (SSE). The controversy centered on the actions of the TCU, …
Client Alert

04/02/2026

Regulatory Trends for the Life Sciences Sector in 2026: 17 Key Topics for Companies Regulated by Anvisa, ANS, and MAPA

As 2026 begins, companies regulated by Brazilian Health Regulatory Agency (Anvisa), the National Supplementary Health Agency (ANS), and the Ministry of Agriculture and Livestock (MAPA) face a dynamic regulatory landscape. To support organizations in anticipating risks and preparing for strategic decision‑making, our Life Sciences & Healthcare team has identified 17 regulatory topics that will shape …
Client Alert

08/01/2026

Healthcare Judicialization: CMED opens Public Consultation on pricing rules for Government purchases

On January 8, 2026, the Brazilian Drug Market Regulation Chamber (CMED) published in the Federal Register the Public Consultation No. 1/2026, which aims to gather contributions from civil society and the regulated sector on criteria for setting and adjusting prices of medicines sold to government entities to comply with court-ordered demands. The regulation of this …
Client Alert

29/12/2025

CMED publishes new regulatory framework for pricing medicines in Brazil

On December 24, 2025, the Brazilian Drug Market Regulation Chamber (“CMED”) published Resolution 3/2025 in the Federal Register, establishing criteria for the definition of prices for new products and new presentations of medicines, as provided in Article 7 of Law 10,742/2003, and setting out the procedure for filing the Price Information Document (“DIP”). Resolution 3/2025was …
Client Alert

19/12/2025

Law No. 15,270/2025 Published – Taxation of Dividends

Law No. 15.270/2025, resulting from the approval of Bill No. 1.087, was published on November 27, 2025. The main provisions of the Law, which will take effect as of January 1, 2026, are as follows: Dividend Taxation and High-Income Taxation: Taxation of dividends received by individuals residing in Brazil at a 10% rate, when the …
Client Alert

12/12/2025

Law 15,040/2024: What Changes Under the New Insurance Legal Framework

This week, Law No. 15,040/2024, known as the “Insurance Legal Framework,” came into effect, establishing a specific legal regime for insurance contracts in Brazil. The new law aims to modernize rules, consolidate interpretations, and enhance legal certainty in relationships between insurers and policyholders. Although public debate has focused on the impacts for insurers, the new …

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