BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Pharmaceuticals and medical devices in Brazil are regulated by Federal Laws and Resolutions (known as Resoluções or RDCs) issued by ANVI- SA, the National Health Regulatory Agency. Key legislation for pharmaceuticals includes: • Law 5,991/1973, known as the Law of Sani- tary Control of the Distribution and Sale of Medicines, which regulates the distribution, sale and control of medicines and related products; • Law 6,360/1976, the primary statute for pharmaceutical products, covering produc- tion, commercialisation, advertising, labelling, quality control and penalties; • Law 6,437/1977, which outlines penalties for violating federal sanitary statutes and regula- tions; and • Law 9,294/1996, which imposes restrictions on the use and advertising of specific prod- ucts. Key legislation for medical devices includes: • RDC 751/2022, amended by RDC 810/2023, which establishes rules for risk assessment, notification procedures, registration, labelling and use of medical devices; • RDC 850/2024, which sets the validity term for medical device marketing approvals; • RDC 830/2023, which establishes rules for in vitro diagnostic devices, including its instru- ments, complemented by IN 320/2024; • RDC 657/2022, which regulates software as a medical device (SaMD); and
• Normative Instruction 290/2024, under the terms of RDC 741/2022, which establishes a procedure for analysing medical device registration petitions, utilising analyses by an Equivalent Foreign Regulatory Authority (AREE). ANVISA operates independently within the Min- istry of Health as the primary regulatory author- ity. It oversees the production, marketing and utilisation of health-related products and ser- vices, as well as supervising ports, airports and borders. ANVISA functions as a semi-autono- mous agency, with administrative and financial autonomy but linked to the federal government (Ministry of Health). Oversight and budget- ary control are provided by the Ministry, while ANVISA’s board of directors, composed of tech- nical experts, makes science-based decisions regarding regulations and approvals. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Regulatory decisions in the pharmaceutical and medical field can be contested through adminis- trative appeals, either directly to the relevant reg- ulatory authority or via lawsuits in federal courts. The process for filing administrative appeals against ANVISA’s decisions is governed by Law 9,784/1999, which regulates administrative pro- cedures within the Federal Public Administra- tion, and RDC 266/2019. ANVISA’s decisions undergo a maximum of three instances: • first instance – decisions by Organisational Units; • second instance – Appeals Division ( Gerên- cia-Geral de Recursos or GGREC); and • final instance – Collegiate Board of Directors ( Diretoria Colegiada or DICOL)
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