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14/12/2023

Brazilian Ministry of Health open Public Consultations on frameworks to foster the national economy-industrial health complex.

The current Brazilian federal administration is re-routing the destination of the country’s general healthcare industrial policy to tackle several deficiencies, especially the high dependence on imports of all sorts of healthcare related products (e.g. pharmaceuticals, APIs & medical devices), which was aggravated during the Covid-19 pandemic, and a huge trade balance deficit. The Ministry of …
Client Alert

14/12/2023

Published the law that alters the taxation of financial investments abroad, Offshore Structures, and investment funds

The Law No. 14,754/2023 was published on December 13, 2023. The Law alters the taxation rules for individuals regarding financial investments held abroad, and for controlled foreign entities (offshores) and trusts. The Law also alters the taxation rules for closed-end investment funds in Brazil, introducing, among other changes, the periodic income tax (“come-cotas”) for such …
Client Alert

04/12/2023

Approved Bill that changes the taxation of financial investments abroad, Offshore Structures, and Investment Funds

On November 29, 2023, the Brazilian Federal Senate approved the Bill No. 4.173/2023, which changes the taxation rules for individuals regarding financial investments held abroad, as well as for controlled foreign entities (offshores) and trusts. The Bill also changes the taxation rules for closed-end investment funds in Brazil, introducing, among other changes, the periodic income …
Client Alert

17/11/2023

ANEEL opens a Public Consultation concerning the regulation of electricity storage, including reversible hydroeletric power plants

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 …
Client Alert

30/10/2023

Expanded access programs, compassionate and post-study medicine supply: review of regulations

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 …
Client Alert

24/10/2023

Brazil: Pilot project of optimized assessment for pharmaceutical products

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 …
Client Alert

16/10/2023

ESG: Novidades sobre critérios sociais, ambientais e climáticos no setor financeiro

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 …
Client Alert

05/10/2023

Public Consultation on biosimilars medicines opened

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 …
Client Alert

27/09/2023

National strategy for the development of the health economic-industrial complex (CEIS) published by the Federal Government

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 …
Client Alert

06/09/2023

Anvisa’s public consultation is open until 10/25 to receive comments about the procedure to adopt reliance for medical devices

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 …

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