Legal & Regulatory > Brazil

For more than 20 years, Ordinance No. 802/1998 (“Ordinance No. 802/1998”), issued by the Brazilian Ministry of Health, used to regulate the distribution of pharmaceutical products in Brazil. Needless to say that such rule, although very extensive, became outdated and stopped reflecting the dynamics and needs of those involved in the drugs supply chain.   For this reason and for a period of more than two years, the update of Ordinance No. 802/1998 was discussed by the Brazilian National Health…

Biosimilars & biologics in Brazil – a comprehensive legal overview. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, a biosimilar drug is not considered to be the same as a generic drug. There are specific rules governing generic and similar drugs, and they…

Want to know more about localization in Brazil? Read on! Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes, there are rules encouraging localization in Brazil, such as the Federal Law No.…

The key facts about orphan drugs & rare diseases in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What is the definition of Rare Diseases in your country? According to Resolution RDC No. 205/2017 issued by the National Health of Surveillance Agency (“ANVISA”), “rare diseases” are defined as diseases with incidence of up to 65…

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The National Health Surveillance Agency (“ANVISA”) recently approved (on December 11, 2019) the Resolution RDC No. 327/19 defining the procedure for granting the Sanitary Authorization for manufacturing and…

A brief insight into upcoming regulatory reforms in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are there proposals for reform or significant change to the healthcare system? There are plenty of Law projects under discussion. Before ANVISA there are two relevant rules under public consultation, one to regulate Good Practices for Pharmacovigilance and other…

An overview of the legal framework for patents and trademarks for pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.    1. What are the basic requirements to obtain patent and trademark protection? Industrial Property Rights are regulated in Brazil through Federal Law No. 9,279/1996 (“IP Law”). Under its Article 8, the main requirements for the grant…

The ins and outs of product liability in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What types of liability are recognized in your jurisdiction? The scope of liability for suppliers and the standards for consumer protection in Brazil are, in some cases, more severe than the consumer rules applicable in other countries. The Brazilian…

A guide to the state-of-play regarding traditional medicines and over-the-counter (OTC) products in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.    1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Resolution RDC No. 26/2014 provides for traditional and herbal drugs requirements. These drugs are subject to registration, simplified registration…

Everything you need to know about the marketing, manufacturing, packaging & labeling and advertising of pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The company should be licensed before ANVISA (at the…

The requirements for conducting preclinical and clinical trials in Brazil.  Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No.   2. How are clinical trials funded? Clinical trials are funded by sponsor (individual or legal entity, public or private,…

A brief legal overview of the situation regarding the regulation, pricing and reimbursement of pharmaceuticals in Brazil.  Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Brazil, the authorities are the National Health of Surveillance Agency (“ANVISA”),…