Brazilian Drug and Medical Device Regulation:

Brazilian Drug and Medical Device Regulation: A Practical Guide Edited by Carlos T. Angulo and Areta L. Kupchyk

COPYRIGHT 2012 FDLI All Rights Reserved. ISBN 978-1-935065-55-5 Disclaimer This Practical Guide is intended to provide direction to those interested in learning about Brazil s drug and medical device regulatory regimes. It contains summaries of the key Brazilian legal authority in these areas written by experts in these fields. These summaries, including any opinions, observations or recommendations expressed by the authors, do not constitute legal advice, and do not represent the opinions, policies or positions of their respective institutions, companies, organizations or firms. For specific guidance on particular matters, including regulatory and legal advice on the application of Brazilian law to particular drug and device issues and products, you should consult directly with Brazilian counsel who is familiar with the specific legal issues you face. FDLI is a nonprofit, educational organization founded in 1949. Its mission is to advance the public health by providing high-quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities. FDLI s role is strictly educational, and the organization does not lobby. Our activities benefit attorneys; corporate officials; regulatory affairs professionals; students and academics; research, quality control, manufacturing and marketing personnel; government officials; and consumer organizations. Authorization to photocopy items for internal or personal use of specific clients is granted by the Food and Drug Law Institute, provided that the base fee of US $.75 per page is paid directly to the Copyright Clearance Center (CCC), 222 Rosewood Drive, Danvers, MA 01923, USA. For those organizations that have been granted a photocopy license by CCC, a separate system of payment has been arranged. For additional information or to order copies of this publication, contact: FDLI Customer Service Department 1155 15th Street, NW, Suite 800 Washington, D.C. 20005 (800) 956-6293 or (202) 371-1420 www.fdli.org

Table of Contents About This Book...v About the Editors...vi About the Authors...vii Introduction...viii Chapter 1. Overview of Regulatory Framework and Governmental Oversight in Brazil...1 Chapter 2. Drugs: Classification...5 Chapter 3. Drugs: Process for Entering the Market...7 Chapter 4. Drugs: Post-Approval Requirements...11 Chapter 5. Drugs: Advertising and Promotion...15 Chapter 6. Drugs: Import Requirements and Restrictions...17 Chapter 7. Drugs: Enforcement...19 Chapter 8. Annex I...21 Chapter 9. Medical Devices: Classification...27 Chapter 10. Medical Devices: Process for Entering the Market...31 Chapter 11. Medical Devices: Post-Approval Requirements...35 Chapter 12. Medical Devices: Advertising and Promotion...37 Chapter 13. Medical Devices: Import and Export Requirements and Restrictions...39 Chapter 14. Medical Devices: Enforcement...41 5

About This Book This Practical Guide is intended to provide information about Brazil s drug and medical device regulatory regimes for anyone considering doing business in Brazil or with a Brazilian company. This Guide is authored by Brazilian experts in the drug and medical device fields. The contents of this Guide, including any opinions, observations or recommendations expressed by the authors, do not constitute legal advice, and do not represent the opinions, policies or positions of their respective institutions, companies, organizations or firms. For specific guidance on particular matters, including regulatory and legal advice on the application of Brazilian law to particular drug and device issues and products, you should consult directly with Brazilian counsel who is familiar with the specific legal issues you face. Brazil is one of the world s largest countries, with one of its fastest growing economies. This Practical Guide is intended to help multinational drug and medical device companies better understand Brazil s regulatory framework, requirements and accepted practice in such areas as product classifications, import requirements, clinical trials, product approvals, advertising and product recalls. This volume contains concise summaries of critical legal authorities written by Brazilian experts in the drug and device areas. We thank these authors for their invaluable assistance in this effort. This is only an entry point to what is a vast body of legal authority, and we of course encourage those with greater interest in this area to engage Brazilian counsel and to enter into a direct dialogue with the relevant regulatory authorities in that country. We also thank the Food and Drug Law Institute for its support in preparing this new tool to help manage the challenging environment of Brazil s complex and evolving drug and device law regime.

About the Editors Carlos T. Angulo is a Partner in the law firm of Zuckerman Spaeder LLP in Washington, DC. His practice focuses on food and drug litigation in state and federal courts, administrative practice before the Food and Drug Administration and policy counseling on matters before Congress. Mr. Angulo joined Zuckerman Spaeder in 1999 and was a partner from 2003 to 2007. From 2007 to 2010, when he returned to the firm, he served as Legislative Director for Senator Sheldon Whitehouse. Before joining Zuckerman Spaeder, Mr. Angulo served as a staff attorney in the U.S. Department of Justice s Civil Division; clerked for the Honorable Phyllis A. Kravitch, U.S. Court of Appeals for the Eleventh Circuit; and served as counsel for Senators Paul Simon and Paul Sarbanes. Mr. Angulo graduated from Haverford College (magna cum laude, Phi Beta Kappa) in 1986 and received his law degree from Yale University in 1989. Areta L. Kupchyk is a Partner with Nixon Peabody LLP in Washington, DC, where she counsels clients on drug, biologics, medical device and biotechnology matters. Previously, she served for nearly ten years in the Food and Drug Administration s (FDA s) Office of the Chief Counsel as Associate Chief Counsel for Drugs and Biologics, as well as Assistant General Counsel for Litigation. While at FDA, Ms. Kupchyk provided legal counsel to the Commissioner s Office, the Center for Biologics Evaluation and Research, and the Center for Drug Evaluation and Research on a wide range of pre-approval and post-approval issues, including clinical trial requirements and good manufacturing practice regulations. Ms. Kupchyk worked extensively on a number of special topics, such as FDA s Good Tissue Practice regulations, cellular and gene therapy, bioengineered plants grown to produce pharmaceutical materials, pharmacogenomics and drug codevelopment with in vitro diagnostics, xenotransplantation, medical errors, BSE and thimerosol-related issues, women subjects in clinical trials and the application integrity policy. She received numerous honors while at the agency, including the FDA Commissioner s Special Recognition Award and the Health and Human Services General Counsel s Award for Leadership. Ms. Kupchyk received her JD, with honors, from the University of Maryland School of Law, where she was inducted into the Order of the Coif. vi

About the Authors Marcelo França Brisolla is Managing Director of Emergo South America and Emergo Brazil Import. His areas of expertise include health law and medical device consulting services. Previously, he served as Founding Partner of Brazil Import and Brisa Consultants, and before that as an Associate Attorney at Brisolla Advogados Associados. Mr. Brisolla s experience includes serving as Director of Regulatory Affairs, offering consulting and representation services for foreign companies operating in Brazil, negotiating in meetings on behalf of clients with the Ministry of Health, CEO and Board Director of ANVISA (the Brazilian Health Surveillance Agency), and INMETRO and negotiating and consulting for the legalization of companies and products. He is also responsible for strategic planning to form and manage teams working in regulatory affairs throughout South America as Managing Director of Emergo South America and is responsible for all regulatory processes related to regulatory authorities in Brazil as Managing Director of Emergo Brazil Import. He also serves as a consultant to Senior Management Staff in the analysis and interpretation of country quality and regulatory issues and requirements as well as consequences to business and budget. Mr. Brisolla received a post-graduate degree in marketing by Escola Superior de Propaganda e Marketing ESPM (Executive MBA) and a degree in Law at Centro Universitário do Distrito Federal UDF MBA. Angela Fan Chi Kung, Brazilian attorney, is a Partner in the life sciences and intellectual property areas of Pinheiro Neto Advogados. She received her LLB from the University of Sao Paulo School of Law, Brazil; LLM in Common Law Studies from Georgetown University; and Specialist in Sanitary Law from the University of São Paulo School of Public Health. She is professor of pharmaceutical industry and clinical trials regulation at Fundação Getúlio Vargas Business School in São Paulo, IDISA/UNICAMP and Faculdade de Medicina da Santa Casa de Misericórdia and also a member of the Research Ethics Committee of UNIFESP Federal University in Sao Paulo. Camila Martino Parise, Brazilian attorney, practices in the regulatory area with emphasis in life sciences, and is a Senior Associate of the litigation area of Pinheiro Neto Advogados, where she has worked since 1998. She received her LLB degree from the Universidade Paulista UNIP (2000) and holds a specialization degree in public law from the Getúlio Vargas Foundation (2006). She is a member of the Sanitary Law Committee of the Brazilian Bar Association. Benny Spiewak is Senior Partner at the law firm of Zancaner Costa, Bastos e Spiewak Advogados in São Paulo, Brazil. He focuses his practice on legal, regulatory and legislative policy challenges affecting highly regulated, IP-intensive industries, including pioneer and follow-on pharmaceuticals, biologics and medical devices; beverages, food, functional foods and vitamins; chemicals and industrial technology. Presently, Mr. Spiewak chairs the International Law Committee of the Brazilian Intellectual Property Association and the Latin American Biotechnology Law Subcommittee of the American Intellectual Property Association. Mr. Spiewak was admitted in Brazil (OAB/SP, 2002) and has an LLB from Mackenzie Law School in São Paulo. His academic record includes a certification in intellectual property and technology law from Fundação Getúlio Vargas in São Paulo, a certification in intellectual property from Franklin Pierce Law Center in Concord, New Hampshire and an LLM in intellectual property from George Washington University. vii

Introduction The Food and Drug Law Institute (FDLI) is pleased to provide Brazilian Drug and Medical Device Regulation: A Practical Guide as a companion product to our pioneering conference, U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device, and Food Law and Regulation. With this practical book and the groundbreaking 2012 Brazil conference, FDLI is continuing its role as a leading provider of publications and programming in the area of global food and drug law. Brazil is a fast-growing economy and of great interest to U.S. and international drug, medical device and food companies. Brazil is currently the eighth largest goods trading partner with $75 billion in total (twoway) goods trades during 2011. Exports were valued at $65 billion while imports were valued at $39 billion. U.S. goods and services trade with Brazil was estimated at $103 billion in 2011. In March 2011, Brazil and the U.S. signed an agreement on trade and economic cooperation and established the United States-Brazil Commission on Economic and Trade Relations, with the objective of promoting bilateral economic and trade cooperation, including intellectual property rights and regulatory issues affecting trade and investment. The U.S. Food and Drug Administration has opened offices outside of the United States and specifically in Latin America, where it is collaborating with its counterpart, the Brazilian Health Surveillance Agency (ANVISA). U.S. drug and medical device companies wanting to do business in Brazil need to understand ANVISA procedures in administering the regulatory scheme for drugs and medical devices, as well as FDA requirements. This Practical Guide, written by experienced Brazilian lawyers and regulatory specialists, provides summaries of Brazil s requirements for the development, approval and marketing of drugs and medical devices. This Guide also includes English translations of many relevant laws and directives. This Guide is intended to help you to take advantage of various marketing pathways and enable successful partnerships in Brazil. viii

The Food and Drug Law Institute 1155 15th Street, NW Suite 800 Washington, DC 20005 p: 202-371-1420 www.fdli.org ISBN 978-1-935065-55-5