BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
cal registration, fee payment and an inspection report or current sanitary licence from the local VISA dem- onstrating compliance with applicable distribution and storage good practices. For device wholesalers, because AFE is per establishment, each warehouse or distribution centre must obtain its own AFE. For pharmaceuticals, the matrix-level AFE covers branch- es, but each branch must still hold the local sanitary licence, maintain compliant operations and appear in ANVISA’s records. The AFE for wholesale covers distribution and stor- age as petitioned and published. Companies may add related activities such as transport, export, import or packing/repacking through alteration petitions when permissible for the class and scope. If wholesale involves handling controlled substances, the estab- lishment must also hold an AE covering the controlled activities. The AFE takes effect on publication and, like manu- facturing AFEs, does not require renewal. It remains valid while the company maintains compliance and updates registered information. A certificate of good distribution and storage prac- tices (cGDSP) exists but is not a legal prerequisite for operation. Nonetheless, adherence to applicable distribution and storage good practices is required and may be assessed during inspections (including ANVISA RDC No 430/2020 for medicines and ANVISA RDC No 665/2022 for medical devices). 6.2 Different Classifications Applicable to Pharmaceuticals Brazil’s ANVISA classifies medicines primarily by dis- pensing category, identified through package colour stripes and label requirements. The three main categories are as follows. • Non-prescription (OTC/MIP): No stripe, and it may be dispensed without a prescription for non-severe conditions and self-care. • Prescription-only (red stripe): Requires a valid prescription. This category further distinguishes between medicines dispensed without prescription retention and those requiring retention, where the
pharmacy must keep the prescription for inspec- tion. Medicines under special control (per Portaria SVS/MS No 344/1998) typically fall within the red stripe category with retention requirements. • Stricter control (black stripe): Subject to reinforced controls and stricter prescribing rules. Prescrip- tions must be retained by the pharmacist, reflecting heightened safety concerns. This dispensing-based classification differs from other ANVISA categorisations such as regulatory status or authorisation pathway (reference, generic, similar, new or biological medicines). Those categorisations concern how a product is authorised and its market positioning, including interchangeability rules, rather than whether a medicine requires a prescription. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies Brazil’s import and export of medicines, pharmaceuti- cal inputs and health products are governed by both sanitary and customs regulations. On the sanitary side, Law No 6,360/1976 and Law No 9,782/1999 apply, with the latter granting ANVISA regulatory authority over these operations. The primary secondary regu- lation is ANVISA RDC No 81/2008, which establishes general import/export procedures and is supplement- ed by product-specific rules, including ANVISA RDC No 753/2022 for medicines, specific ANVISA RDCs for APIs and ANVISA RDC No 751/2022 for medical devices. On the customs side, Decree No 6,759/2009 (the “Customs Regulation”) applies, along with several Normative Instructions from the Brazilian Federal Revenue Service ( Receita Federal do Brasil – RFB) governing import clearance, export clearance and the Siscomex/ Portal Único , through which ANVISA’s sani- tary clearance operates. Three main authorities oversee these operations: • ANVISA handles sanitary control at entry points and post-importation enforcement;
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