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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 …
Client Alert

21/12/2023

Rio Grande do Sul regulates take-back system of packaging

The Environmental Council of the State of Rio Grande do Sul published on December 5th, 2023 Resolution No. 500/2023 (Portuguese only), which sets forth the guidelines for implementation and operationalization of take-back systems of packaging in general in the State of Rio Grande do Sul. The Resolution applies to manufactures, importers, distributors, and sellers of products …
Client Alert

20/12/2023

ANVISA approves regulatory framework for novel foods and novel ingredients

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, …
Client Alert

15/12/2023

ANVISA publishes Public Consultation on digital labels for medicines

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 …
Client Alert

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 …

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