BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
• Registration – the company and product must be registered with ANVISA. • Documentation – detailed documentation should be submitted describing manufactur- ing processes, quality control measures and plant layout, complying with Good Manu- facturing Practices (GMP) regulations (RDC 658/2022 for pharmaceuticals and specific RDCs for medical devices). • Inspection – ANVISA conducts a facility inspection to verify compliance. • Approval – If compliant, ANVISA issues the AFE. Activities authorised by the AFE include manu- facturing, storage of raw materials and finished products, and quality control procedures. The AFE has no expiry date. Additional notes: • while a GMP certificate is not mandatory for the AFE, facilities must adhere to ANVISA’s Good Manufacturing Practices. • documentation requirements and inspections may vary based on product complexity and risk classification; and • for certain products such as electrical medi- cal devices, breast implants, rubber gloves and sterile disposable syringes, an INMETRO certificate confirming compliance with Brazil- ian standards is necessary. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesale distributors of pharmaceuticals and medical devices in Brazil must be licensed by
ANVISA. The Authorisation to Operate Pharma- cies and Drug Stores (AFE) permits the sale of industrialised medicines, including those under special control per Regulation SVS/MS 344/1998 and updates. The application process, outlined in RDC 16/2014, Article 28, requires the submission of technical and formal documentation. Once granted, the AFE for Wholesale allows commercialisation of various products such as medicines, pharmaceutical inputs, health prod- ucts, cosmetics, personal hygiene items, per- fumes and disinfectants between legal entities or to professionals. The AFE has no expiry date. 6.2 Different Classifications Applicable to Pharmaceuticals As mentioned in 1.3 Different Categories of Pharmaceuticals and Medical Devices , ANVISA categorises pharmaceutical products based on their API and innovative characteristics, as out- lined in RDC 753/2022. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies Law 6,360/1976 is the primary pharmaceutical law, governing production, marketing, advertis- ing, labelling, inspection, quality control, penal- ties, importation and marketing authorisation of medicines, drugs, active ingredients and medi- cal devices. Decree 8,077/2013 regulates it.
51
CHAMBERS.COM
Powered by FlippingBook