20/12/2023
On December 18, 2023, the Brazilian Health Regulatory Agency (Anvisa) published in the Federal Register Resolution RDC 839/2023, which provides for safety proof and authorization for the use of novel foods and novel ingredients. The new regulation was approved after Public Consultation 1,158/2023, which remained open for 120 days for comments from society and the regulated sector, …
15/12/2023
On December 13, 2023, Anvisa opened the Public Consultation 1,224/2023, about the draft of new regulation for transitional guidelines for providing labels in digital format and dispensing printed labels on the packaging of certain medicines. This proposal, approved during Anvisa’s Board of Directors Meeting # 20/2023, is part of the 2021-2023 Regulatory Agenda and will extend to 2024-2025 due to its …
14/12/2023
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 …
14/12/2023
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 …
04/12/2023
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 …
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 …
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 …