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12/01/2024

New law requires pharmaceutical companies to warn about doping in medicines

On January 12, 2024, Law 14.806/2024 was published, amending Law 6.360/1976 to oblige pharmaceutical laboratories to include warnings on the labels, leaflets and advertising materials of their products about the presence of substances whose use is considered doping. The new law establishes that medicines containing substances banned by the World Anti-Doping Code must carry these warnings. This is an effort …
Client Alert

12/01/2024

Criteria for environmental compensation have been updated in the state of São Paulo, effective from february onwards

Resolution No. 02/2024 was published on January 2nd, 2024, by the State Department of Environment, Infrastructure, and Logistics (“SEMIL”), updating the criteria and parameters for environmental compensation for the removal of native vegetation, cutting of isolated trees, or for interventions in Permanent Preservation Areas (“APP”) in both rural and urban areas of the State. The …
Client Alert

05/01/2024

Bets Law: law regulating the sector in Brazil comes into force

On December 30, 2023, the “Bets Law” (Law Nº 14.790/2023) entered into force, which regulates the lottery method known as fixed-odds betting. The Bets Law changes several Brazilian laws, including Law Nº 5,768/1971, Provisional Measure Nº 2,158-35/2001 and specially on Law Nº 13,756/2018, which created the modality commonly known as bets. As we reported in …
Client Alert

04/01/2024

Biodiversity: Brazil promulgates the Nagoya Protocol

In the last week of 2023, Brazil promulgated the Nagoya Protocol, an international agreement on access to genetic resources and the benefit-sharing arising to their utilization. The Protocol – which came into force internationally in 2014, and was ratified by Brazil in 2021 -, had its promulgation through Federal Decree No. 11,865 on December 27th, 2023, …
Client Alert

04/01/2024

Anvisa publishes Regulatory Agenda for 2024-2025

On December 15, 2023, the Brazilian Health Regulatory Agency (“Anvisa”) approved the Regulatory Agenda for the 2024-2025 cycle. Published in the Federal Register of December 18, 2023, through Ordinance 1409/2023, the 2024-2025 Agenda has 172 regulatory topics distributed in 16 macro-themes, aligned with the strategic objectives of the Strategic Plan 2024-2027 and feasible to implement during the biennium. …
Client Alert

02/01/2024

Ministry of Health has extended the deadline for submission of contributions to the new PDP regulation

The Ministry of Health (“MoH”) extended the deadline for contributions to the Public Consultation #54/2023 (“PC #54/2023”) until February 08, 2024, regarding the draft of the Interinisterial Ordinance which regulates Product Development Partnerships – PDPs. The documents covered by PC # 54/2023 and the address for sending contributions are available through this link. Highlight: the registration is exclusive to …
Client Alert

29/12/2023

Published Decree No. 11,856/2023 establishing the National Cybersecurity Policy and the National Cybersecurity Committee

On December 27, Decree No. 11,856/2023 was published, establishing the National Cybersecurity Policy and the National Cybersecurity Committee. The purpose of these entities is to guide cybersecurity activities in the country through the National Cybersecurity Strategy and the National Cybersecurity Plan. According to the decree, the National Cybersecurity Policy will be guided by the following …
Client Alert

27/12/2023

Federal Law assigns powers to the military police and fire department to issue environmental infraction notices

On December 13, 2023, the Federal Law No. 14,751/2023 was published, legislating on the organic law of the Military Police and Fire Department of the States, Federal District and Territories. Said legislation amplifies the Military Police and Fire Department powers, both now expressly authorized to issue, respectively, environmental infraction notices in general and environmental infraction …
Client Alert

26/12/2023

CMN RESOLUTION NO. 5,111/2023 – Definition of investment entity and credit rights for the purposes of the exception to the “come-cotas” taxation regime

The Brazilian Monetary Council (Conselho Monetário Nacional) published Resolution No. 5,111 to regulate the concept of “investment entity” and “credit rights” applicable to the exceptions to the periodic income taxation (“come-cotas”) introduced by Law No. 14,754/23. Investment Entities Investment funds in the Brazil with a professional management structure, represented by agents or service providers with powers to …
Client Alert

21/12/2023

Published federal act that creates the national policy for the prevention and control of cancer and brings relevant changes in the procedure for incorporation of oncological medicines into the SUS

On December 12, 2023, Federal Law 14,758/2023 (“Law”) was published in the Federal Register, which amends Federal Law 8,080/1990 (Organic Health Law), and creates the National Policy for Prevention and Control (“Policy”) of within the scope of the Brazilian Unified System of Health (“SUS”). Under the terms of the Law – which comes into force on June 18, 2024 …

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