Expertise
The growing Brazilian population has a huge desire for innovative, safe, and efficient products.
To meet such demand, the Brazilian companies are expanding, and the international companies are establishing subsidiaries in Brazil. With the progress of biotechnology, the agricultural sector, already well established, also offers new progress opportunities.
Where there are opportunities, there are challenges. The Brazilian regulation scenario may be complex and subject to conflicting interpretations. Registration procedures may take time and precious resources. The intellectual property rights are protected; however, they require surveillance and a proactive strategy.
Trench Rossi Watanabe offers the legal, technical, and commercial know-how that your company needs to operate in the Brazilian market and thrive. We are a law firm that provides full services with experience in and knowledge of all the traditional areas of corporate law and of the industry segments. Our associates represent foreign investors as ease as they represent Brazilian investors.
We assist companies in registering and protecting patents, as well as carrying out clinical trials to obtain approval for new drugs and products. We keep good relations with local, state, and federal public bodies. We anticipate regulatory subjects that may affect your business.
In case of disputes, we defend your interests through judicial or administrative procedures. We have experience with rejected products, and we defend or prosecute the accusations of disloyal business practices. In many cases, we settle precedents in how the health sector laws are interpreted.
ANVISA published on October 9, in the Official Gazette the new Resolution of the Collegiate Board – RDC nº 430/2020 providing for the Good Practices of Distribution, Storage and Transport of Drugs. This new Resolution revokes Resolution No. 304/2019, which was published almost a year ago, but had not yet entered into force. ANVISA maintained the […]
The Federal Decree No. 10,388/2020, which regulates the take-back system for medicines nationwide, was published last Friday (June 5th, 2020) on an extra edition of the Federal Official Gazette. The regulation will come into force a hundred and eighty (180) days after its publication. The system will cover the structuring, implementation and operationalization of the […]
ANVISA published (May 28) the Resolution RDC No. 392/2020 for defining extraordinary and temporary criteria and procedures for flexing certain specific requirements applicable to the Good Manufacturing Practices and Import of Pharmaceutical Inputs, due to the Coronavirus pandemic. According to the RDC, exceptional and temporally, manufacturers and importers of drugs and pharmaceutical inputs may disregard […]
Market access (a) How has the regulator in charge been addressing the urgent needs for medicines, medical devices and medical supplies? Has the focus been faster review and grant of marketing authorization, or exceptions to or relaxation of import / use / licensing restrictions, or any other available mechanisms? The Brazilian Federal Health Agency (ANVISA) […]
