24/11/2023
Souto Correa announces the addition of Luciana Sakamoto to bolster the Life Sciences & Healthcare team. With 17 years of experience at Pinheiro Neto Advogados, Luciana has advised national and international clients, and participated in some of the largest M&A transactions involving health insurance providers, including UHG and Amil, AON and Admix, and Bupa and …
17/11/2023
The Brazilian National Electric Energy Agency (ANEEL) has opened Public Consultation No. 39/2023, through the exchange of documents, to develop regulatory adjustments necessary for integrating storage systems, including Reversible Hydroelectric Plants, in the context of the Brazilian electric sector’s energy transition. The issue, considered strategic because of its potential direct or indirect impact in government entities and agencies, as …
30/10/2023
On October 27, 2023, the Brazilian Health Regulatory Agency (Anvisa) published Public Consultation 1,210/2023, which aims to revise RDC 38/2013, which regulates expanded access programs, compassionate use and post-study medicine supply. The Public Consultation will be open from November 3, 2023 to January 2, 2024 for contributions. During the 10 years that the standard has …
25/10/2023
In late September, Souto Correa appointed two new partners. Tiago Figueiró, former Vice President of Renewable Power and Transition at Brookfield Asset Management, has joined the firm to lead the Energy team and boost the firm’s M&A practice. Mariana Guenka now heads the Capital Markets team and the brand-new Banking & Fintech area. Tiago has …
24/10/2023
On October 23, 2023, the Brazilian Health Regulatory Agency (Anvisa) published in the Federal Official Gazette (DOU) RDC 823/2023, which establishes the pilot project for implementing the optimized evaluation procedure, based on risk criteria in applications for registration and post-registration changes of medicines. The Resolution comes into force on November 1, 2023. The RDC’s draft …
16/10/2023
Nossa equipe multidisciplinar de Soluções Climáticas mapeou as atualizações regulatórias recentes de 2023 que, em síntese, impactam em maior necessidade de análise e monitoramento de critérios socioambientais e climáticos no setor financeiro (e, em especial, para o agronegócio). As alterações (Atualização MCR nº 722 de 30 de agosto de 2023) envolvem novas normas do Conselho …
05/10/2023
Anvisa’s Public Consultation 1.206/2023 was published in the Official Federal Gazette (DOU) on October 4, 2023. The main objective is to amend the current regulation on biosimilar medicines, as well as to completely revoke Chapter V of RDC 55/2010, which establishes the registration of biological products through comparability – Biosimilars. In general terms, the goal …
03/10/2023
On September 5, 2023, Clube Atlético Mineiro (CAM) filed with the Brazilian antitrust authority (CADE, the Portuguese acronym) the first merger control case involving a Soccer Corporation (SAF, the Portuguese acronym). It is the Merger Case No. 08700.006273/2023-87, through which Galo Holding S.A. (Galo Holding) acquired the corporate control of Atlético Mineiro S.A.F. (Atlético SAF), …
27/09/2023
On September 26, 2023, Brazil’s Federal Government published the Brazilian Strategy for the Development of the Health Economic-Industrial Complex (CEIS). Through Decrees No. 11.714/2023 and No. 11.715/2023, the President of the Republic, Luiz Inácio Lula da Silva, established the main objectives of the initiative and created the Deliberative Committee and the Technical Evaluation Commission to …
06/09/2023
The National Health Surveillance Agency (Anvisa) has been striving to promote regulatory harmonization in recent years. In this regard, the Collegiate Board Resolution RDC 741/2022 has introduced authorization for optimized analysis through reliance mechanisms. However, RDC 741/2022 stipulates that each technical area of the Agency must define specific requirements for these optimized procedures, indicating the documents to …