Client Alerts Archive - Page 6 of 11 - Souto Correa Advogados

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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 …
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 …

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