BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
To secure marketing authorisation for medicinal products, the applicant must be an authorised manufacturer or importer. ANVISA authorisation is mandatory for manufacturing/selling pharma- ceuticals and/or importing them before market entry. Various government agencies enforce import regulations for pharmaceuticals and medical devices. • National Health Regulatory Agency (ANVISA): (a) oversees health product import/export; and (b) sets specific technical requirements/pro- cedures via resolutions/directives. • Federal Revenue Department ( Secretaria da Receita Federal do Brasil ): (a) manages customs control at Brazilian borders; and (b) collaborates with ANVISA to verify import documents, classify goods and collect duties/taxes. • Ministry of Agriculture, Livestock and Supply (MAPA): (a) participates in importing specific agricul- tural/veterinary medical devices; and (b) collaborates with ANVISA on import pro- cedures for these products. • National Institute of Metrology, Standardisa- tion and Industrial Quality (INMETRO): (a) involved in importing certain medical devices meeting technical standards; and (b) may require additional certifications/ conformity assessments to meet Brazilian specifications. 7.2 Importer of Record of Pharmaceuticals and Medical Devices In Brazil, only a local legal entity can serve as the importer of record for pharmaceuticals and
medical devices. Specific requirements must be met. Eligible importer of record: • Brazilian legal entity – registered with the relevant commercial registry. This includes subsidiaries of foreign companies or wholly Brazilian-owned companies; and • foreign company with a branch office – a for- eign company can be the importer if it has a duly established and registered branch office in Brazil. Importer of record requirements: • valid CNPJ (National Registry of Legal Enti- ties) – the company must possess a valid CNPJ, a unique identification number for Brazilian legal entities; • qualified technical professional – the importer must employ a qualified technical profes- sional responsible for the imported products, possessing relevant qualifications; • permanent establishment – maintaining a physical establishment in Brazil with proper infrastructure for storage and distribution to ensure supply chain traceability; and • ANVISA registration – the importer must be registered with ANVISA, allowing verification of regulatory compliance and import manage- ment capacity. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In Brazil, importing pharmaceuticals and medi- cal devices requires prior authorisation from ANVISA. Key regulations, including RDC 810/2023 amending RDC 751/2022 (in force with amend- ments), cover risk classification, notification,
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