Regulatory Framework for Pharmaceutical Products in Brazil

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Brazil is one of the largest economies in the world. The value of its pharmaceutical market is about 30,670 million USD. The Health Sanitary Inspection in Brazil estimates that 5-7% of drugs are counterfeit - this means losses of about USD 500 million per year for the pharmaceutical industry there. To counteract this development, Brazil has also introduced a Track & Trace solution that is intended to create transparency across the entire pharmaceutical supply chain, from production and distributors to the dispensing of drugs in the pharmacy. 

Brazil's serialization requirements have been realized in three phases. The Agência Nacional de Vigilância Sanitária (Anvisa) has just confirmed the last step - the Go-live of the nationwide Track & Trace solution for April 2022. All stakeholders of the supply chain – like Pharmaceutical Marketing Authorization Holders (MAHs), Contract Manufacturers (CMOs), wholesalers and distributors -  that import to Brazil or produce there are now facing procedural and logistical challenges in order to be able to act according to Brazilian serialization requirements & guidelines in the future.