29/12/2025
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 …
19/12/2025
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 …
12/12/2025
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 …
09/12/2025
On December 4, 2025, Ordinance GM/MS No. 1,283 was published, appointing full and alternate members to compose the National Authority for Research Ethics (INAEP), a collegiate body regulated by Decree No. 12,651/2025 within the National System of Research Ethics Involving Human Subjects. INAEP will be coordinated by Dr. Meiruze Sousa Freitas, currently director of the …
02/12/2025
As the end of the year approaches, please note that there are only two months left to submit the Annual Anti-Money Laundering and Counter-Terrorism Financing (AML/CFT) Compliance Report to the Secretariat of Prizes and Betting (SPA/MF), as established in Article 11 of SPA/MF Ordinance No. 1,143 (February 1, 2026). Considering the complexity and volume of …
25/11/2025
Publication of Technical Note No. 43/2025 – Department of Science and Technology (“DECIT”) / Secretariat of Science, Technology, and Innovation in Health (“SECTICS”) / Ministry of Health (“MS”) The Ministry of Health has published Technical Note No. 43/2025, providing guidance for the processing and risk classification of research involving human subjects within the National System …
09/10/2025
On October 8, 2025, Decree No. 12,651/2025 came into force, regulating Law No. 14,874/2024 and establishing the National System of Ethics in Research with Human Subjects (SNEP). The regulation consolidates guidelines for ethical approval, governance, and accreditation of Institutional Review Boards (IRBs, known as CEPs in Portuguese), bringing greater legal certainty to the sector. Topics …
01/08/2025
On July 31, 2025, the President of Brazil sanctioned Law No. 15.183/2025 (originating from Bill No. 3,062/2022), which prohibits the use of live vertebrate animals in testing ingredients or finished products intended for personal care, cosmetics, and perfumes. The new law amends Law No. 11,794/2008 (the “Arouca Law”) and Law No. 6,360/1976, establishing new regulatory …
31/07/2025
Em 29 de julho de 2025, foi publicada a Lei Complementar nº 216, que institui o Programa Acredita Exportação e altera diversos dispositivos legais, com impactos significativos para empresas exportadoras, especialmente para as micro e pequenas empresas optantes pelo Simples Nacional e para as empresas beneficiárias dos regimes Recof e drawback. Entre as principais alterações …
09/07/2025
On July 2, 2025, the Brazilian Federal Senate approved the United Nations Convention on International Settlement Agreements Resulting from Mediation, known as the Singapore Convention on Mediation (PDL 228/2024). For the Convention to enter into force in Brazil, it must now be promulgated by the President of the Republic — a formal act that will …