BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
• the RFB manages customs and tax control, includ- ing post-clearance audits; and • the Ministry of Development, Industry, Trade, and Services ( Ministério do Desenvolvimento, Indús- tria, Comércio Exterior e Serviços – MDIC)/Foreign Trade Secretariat ( Secretaria de Comércio Exterior – Secex) administers import licensing within the foreign trade framework. Depending on the product, other consenting authori- ties such as the Ministry of Agriculture, Livestock, and Supply ( Ministério da Agricultura, Pecuária e Abasteci- mento – MAPA), the Brazilian Institute of Environment and Renewable Natural Resources ( Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Reno- váveis – IBAMA) and the National Institute of Metrol- ogy, Quality, and Technology ( Instituto Nacional de Metrologia, Qualidade e Tecnologia – INMETRO) may also be involved. 7.2 Importer of Record of Pharmaceuticals and Medical Devices The importation of pharmaceutical products and med- ical devices into Brazil is restricted to legal entities established in the country that possess a compatible corporate purpose, are registered with the National Registry of Legal Entities ( Cadastro Nacional da Pes- soa Jurídica – CNPJ), hold habilitation within the Inte- grated Foreign Trade System ( Sistema Integrado de Comércio Exterior – SISCOMEX), and maintain cumu- lative compliance with applicable sanitary, regulatory and customs requirements. Importing companies must obtain AFE from ANVISA in accordance with product-specific rules. For cer- tain products, importation is further restricted to the marketing authorisation holder or entities acting on its behalf. Additional authorisations apply where medi- cines or inputs subject to special control are con- cerned. Importers must also adhere to good practice require- ments, maintain an appropriate technical infrastruc- ture, including a legally qualified technical officer, and bear ongoing responsibility for product conformity and compliance with applicable traceability, storage and distribution standards.
In exceptional circumstances, such as clinical research, compassionate use, donation or experi- mental use, importation may be conducted by enti- ties expressly authorised by ANVISA, subject to the conditions established in the relevant regulations. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Importation of pharmaceutical products and medi- cal devices into Brazil requires prior authorisations, primarily sanitary controls administered by ANVISA, alongside standard customs requirements. Under Law No 9,782/1999 and ANVISA RDC No 81/2008, ANVI- SA clearance is mandatory and processed through Siscomex/ Portal Único . Products must be regularised with ANVISA through registration, listing or notification per Law No 6,360/1976 and applicable ANVISA RDCs, with medicines under special control requiring addi- tional specific authorisation. Simplified or differenti- ated procedures apply to certain categories, including clinical research, compassionate use, donations and non-commercial imports, each governed by relevant specific regulations. 7.4 Non-Tariff Regulations and Restrictions Brazil operationalises non-tariff import controls within the government’s foreign trade single window, Portal Único , which is built on the Siscomex platform. The system exposes an administrative treatment for each Mercosur Common Nomenclature ( Nomenclatura Comum do Mercosul – NCM) subheading and, where needed, refines the trigger through product “attrib- utes”, technical descriptors, declared end use or the type of import operation. The administrative treatment entry tells the importer whether a licence is required, whether it is automatic or non-automatic, which con- senting authority will analyse it and the legal basis for the requirement. The overarching import licensing framework today is set by Portaria Secex No 249/2023, as amended, and Portaria Secex No 65/2020 on how agencies insert, alter or remove administrative treat- ments in Siscomex. Under the current framework, import licensing is processed either through the legacy import licence module tied to the Import Declaration ( Declaração Imposed Upon Imports Key Regulatory Framework
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