04/01/2024
In the last week of 2023, Brazil promulgated the Nagoya Protocol, an international agreement on access to genetic resources and the benefit-sharing arising to their utilization. The Protocol – which came into force internationally in 2014, and was ratified by Brazil in 2021 -, had its promulgation through Federal Decree No. 11,865 on December 27th, 2023, …
04/01/2024
On December 15, 2023, the Brazilian Health Regulatory Agency (“Anvisa”) approved the Regulatory Agenda for the 2024-2025 cycle. Published in the Federal Register of December 18, 2023, through Ordinance 1409/2023, the 2024-2025 Agenda has 172 regulatory topics distributed in 16 macro-themes, aligned with the strategic objectives of the Strategic Plan 2024-2027 and feasible to implement during the biennium. …
02/01/2024
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 …
29/12/2023
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 …
27/12/2023
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 …
26/12/2023
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 …
21/12/2023
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 …
21/12/2023
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 …
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 …