01/10/2024
CGen, the ABS Authority in Brazil, published today resolution No. 45/2024 that defines the methodology for determining whether an exotic species — i.e., not native to Brazil — has developed distinctive characteristics once it is introduced into the country and used in agricultural activities. The final assessment will be made by the Ministry of Agriculture, …
26/09/2024
Two new patent prosecution guidelines have been issued by the Brazilian PTO and are scheduled to take effect in October. The first guideline governs the format and content of patent applications. It enhances the process by streamlining electronic filings and providing greater transparency through clearer guidelines on specific requirements. This guideline addresses the formalities and …
24/09/2024
Brazil Approves New Legal Framework For Clinical Trial With Humans. Federal Law Establishes Rights And Duties For Researchers, Sponsors, And Participants In Clinical Trials With Humans On May 29, 2024, the President of the Republic sanctioned Federal Law 14,874/2024, which established the principles, guidelines, and rules for conducting clinical trials with humans by public or …
17/09/2024
SPA/MF Edict nº 1475, published on September 17, 2024, establishes that only companies that have submitted a license application to the Secretariat of Prizes and Betting by the date of its publication will be allowed to continue operating fixed quota bets in the national territory from October 1, 2024. As a consequence: Companies that have …
02/09/2024
Known as the Clinical Research Law, Federal Law # 14.874/2024 came into force on August 28th, 2024. 1. Main Objectives of the Clinical Research Law: Foster technical-scientific development. Improve legal security for those involved in clinical research. Reduce approval times for conducting clinical research in Brazil. Protect the dignity, safety, and well-being of research participants. …
29/08/2024
On August 23, 2024, the National Data Protection Authority (ANPD) published Resolution CD/ANPD No. 19/2024, which approves the International Data Transfer Regulation and establishes the content of the standard contractual clauses (Regulation). The Regulation establishes procedures and rules to authorize international transfers of personal data, including contractual mechanisms and guidelines for the recognition of adequacy …
22/08/2024
On August 20th, the 90-day period for submitting applications for the federal license to operate fixed-odds betting, which would guarantee approval by the Prizes and Betting Secretariat of the Ministry of Finance (SPA/MF), in accordance with Article 23 of SPA/MF Ordinance No. 827/2024, ended. A total of 113 applications were submitted. On August 21st, SPA/MF …
09/08/2024
Cetesb Board Decision No. 056/2024/E (DD), published on July 30, 2024, regulated the grouping into blocks of the stages of contaminated areas management. Also, a detailed procedure was established for requesting Technical Opinions and submitting the corresponding reports, seeking greater efficiency and clarity in the process of rehabilitating contaminated areas. The stages of the environmental …
09/08/2024
On July 30, 2024, Cetesb published its new Board Decision No. 051/2024/P (DD), which revoked DD No. 127/2021/P and established a new procedure for demonstrating compliance with waste take-back system within the scope of environmental licensing in the state of São Paulo. The procedure covers all manufacturers, importers, distributors and traders of the products detailed …
09/08/2024
Resolution No. 50, published on July 3, 2024, within the scope of the São Paulo State Department of Agriculture and Supply (“SAA”), establishes the steps to be observed in the Rural Environmental Registry System of the State of São Paulo (SICAR-SP) by the owner or possessor of the rural property, in order to obtain Environmental …