CLIENT ALERT
Resolution No. 3/2025: Structural Changes to Brazil’s Drug Pricing Framework
by mariana.cuzziol, Viviane Kunisawa | Jan 7, 2026 | Client Alert, Regulatory
The Drug Market Regulation Chamber (CMED) has published Resolution CM/CMED No. 3/2025, which establishes a new regulatory framework for the pricing of medicines in Brazil, replacing rules that had been in force for more than two decades. The resolution introduces...
14-days countdown to Ecuador’s deadline for DPO registration
by Nuria López, Martin Daniel-Shores, Juliana de Lopes Dória | Dec 17, 2025 | Client Alert, Technology
The deadline for registering Data Protection Officers (DPOs) with Ecuador's Superintendency of Personal Data Protection is now two weeks away, on December 31, 2025. Resolution No. SPDP-SPD 2025-0028-R regulates the responsibilities of DPOs in Ecuador, supplementing...
Last Chance for Fast-Track Examination of H04 Telecom Patents in Brazil
by Gustavo Sartori, Pedro Altoé | Dec 16, 2025 | Client Alert, Patent
The Brazilian Patent and Trademark Office (BPTO) published today an ordinance establishing that, as of January 1, 2026, it will suspend the acceptance of all priority and fast-track examination requests, including the Patent Prosecution Highway (PPH), for patent...
Argentina Publishes New Rules for Trademark Registration – INPI Resolution 583/2025
by Cecília Delgado | Dec 16, 2025 | Client Alert, Trademark
The Argentine National Institute of Industrial Property (INPI) has published Resolution 583/2025, introducing a new and comprehensive overhaul of the country’s trademark registration procedure. This initiative reflects another step by the Argentine authority toward...
Chile approves Standard Contractual Clauses for international transfers
by Nuria López, Martin Daniel-Shores, Juliana de Lopes Dória | Dec 15, 2025 | Client Alert, Technology
In approving Standard Contractual Clauses for international transfers, Chile follows with the standard set by other data protection regulations in the European Union and Latin America. The country’s new personal data protection law (Law No. 21,719/24) allows...
ANVISA reinforces deadline for labeling compliance for simplified-notification medicines
by mariana.cuzziol, Viviane Kunisawa | Dec 10, 2025 | Client Alert, Regulatory
The Brazilian Health Regulatory Agency (“ANVISA”) has published a communication reminding companies of the need to fully align the labeling of medicines subject to simplified notification with the requirements established under RDC 768/2022, as updated by RDC...
Brazilian Federal Revenue Issues New Act Strengthening Border Measures Against Counterfeit Goods
by Rafael Rocha, Lays Serpa | Dec 5, 2025 | Client Alert, Trademark
The Brazilian Federal Revenue (RFB) has published a new Interpretative Declaratory Act (ADI No. 03/2025), marking a significant advancement in Brazil’s efforts to combat the entry of counterfeit products and strengthen the protection of intellectual property rights at...
Paraguay’s Personal Data Protection Law published
by Nuria López | Dec 3, 2025 | Client Alert, Technology
On November 27, Paraguay published Law No. 7593/2025, the country’s first general personal data protection law. Until now, the matter was governed by sparse legislation, such as the Credit Data Protection Law (Law No. 6534/2020). With the new legislation, Paraguay...
Overturning of the vetoes to the new Environmental Licensing Framework: impacts on agribusiness and the productive sector
by Viviane Kunisawa, mariana.cuzziol | Nov 28, 2025 | Client Alert, Regulatory
On November 27, 2025, the National Congress overturned most of the presidential vetoes to the new environmental licensing framework. The decision reinstates provisions that simplify steps and expedite licensing procedures, particularly for activities classified as low...
ANVISA Publishes RDC 998/2025 on Occupational and Non-Dietary Exposure Risk Assessment for Pesticides
by mariana.cuzziol, Viviane Kunisawa | Nov 27, 2025 | Client Alert, Regulatory
The Brazilian Health Surveillance Agency (“ANVISA”) has published Resolution 998/2025, which establishes technical and procedural requirements for assessing occupational, residential, and bystander risks related to the use of pesticides and related products. The...
BPTO proposes regulation of alternative claim sets in patents to streamline examination and align with international practices
by Gustavo Sartori, Elaine Moraes | Nov 25, 2025 | Client Alert, Regulatory
A public event on December 2 will discuss the new regulation, which aims to offer greater flexibility to users and reduce the average time for patent grants. The Brazilian Patent and Trademark Office (BPTO) will hold an event on December 2 to discuss the regulation...
Technological Litigation and Judicial Sovereignty: reflections of the OAB-RJ ICT Commission on the limits of anti-suit injunctions
by Viviane Kunisawa, Vanessa Aguiar, Isabel Milman | Nov 25, 2025 | Client Alert, Regulatory
On November 4, the Information and Communication Technologies Commission of the Brazilian Bar Association - Rio de Janeiro Section (OAB-RJ) held a lecture titled “Maintaining the sovereignty of Brazilian courts over ICTs registered in national territory”, bringing...
STJ Sets New Deadline for Regulation of Hemp Cultivation for Medical and Pharmacological Purposes
by Viviane Kunisawa, mariana.cuzziol | Nov 12, 2025 | Client Alert, Regulatory
On November 6, the Superior Court of Justice (STJ) approved a new timeline submitted by the Federal Government and established an additional 145 days for the publication of the regulatory act governing the cultivation of hemp for medical and pharmacological purposes....
Brazilian Supreme Court to Review Constitutionality of New Clinical Research Law
by Viviane Kunisawa, mariana.cuzziol | Nov 11, 2025 | Client Alert, Regulatory
The Brazilian Society of Bioethics (SBB) has filed a Direct Action of Unconstitutionality (ADI 7875) before the Federal Supreme Court (STF), assigned to Justice Cristiano Zanin, seeking a preliminary injunction and subsequent annulment of key provisions of Law No....
Anvisa opens Public Consultations to revise nutrition labeling requirements for packaged foods
by mariana.cuzziol | Nov 5, 2025 | Client Alert, Regulatory
Anvisa has published Public Consultations No. 1,357/2025 and 1,358/2025, launching a comprehensive review of Brazil’s nutrition labeling regulation, a major development for the food, beverage, and supplements industries. The proposal introduces a new RDC that...