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ARTICLE · 11 FEBRUARY 2016

Brazilian Drug Approval Considerations

Dannemann Siemsen
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The Brazilian patent system is ruled by Brazilian Patent Office created by Federal Law nº 5.648/70 and its authority is defined by Brazilian Industrial Property Law.

BrazilIntellectual Property
Gustavo De Freitas Morais
Gustavo De Freitas Morais
Rodrigo Rocci
Rodrigo Rocci
Vyctor Taddeucci De Araujo
Vyctor Taddeucci De Araujo

Introduction

The Brazilian patent system is ruled by Brazilian Patent Office created by Federal Law nº 5.648/70 and its authority is defined by Brazilian Industrial Property Law (no. 9.279/96). On the Brazilian health regulatory system introduced by Act no 6.360/76, any drug may be marketed only if it has been previously registered with the pertinent authority of the Ministry of Health; such competence was attributed to Brazilian Agency of Sanitary Surveillance ("ANVISA") by Law no 9.782/99.

As can be noticed, pharmaceuticals in Brazil are governed by a comprehensive and complex regime of legislation and regulations spanning many different areas of law. The legislative and regulatory landscapes are very dynamic, as patent laws are constantly under review and government authorities constantly update regulatory processes and policies.

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