BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
parability safeguards. Even where reliance applies, ANVISA may request additional information, conduct local checks or revert the application to the ordinary route, remaining solely responsible for the outcome, in line with ANVISA RDC No 741/2022 and Law No 14,313/2022. Where prior authorisations from recognised foreign regulatory authorities exist, ANVISA may expedite review under an optimised procedure if eligibility criteria are met. For medicines, vaccines, biologi- cal products and active pharmaceutical ingredients (APIs), Normative Instruction 289/2024 establishes the requirements and designates a broad group of refer- ence authorities, including the EMA, Swissmedic and the UK’s Medicines and Healthcare products Regula- tory Agency (MHRA). For higher-risk medical devices (Classes III and IV), Normative Instruction 290/2024 establishes an analogous regulatory reliance pathway, though with a narrower list of AREEs: Australia’s Ther- apeutic Goods Administration (TGA), Health Canada, the FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW). Under both pathways, ANVISA pre- serves its discretion to apply ordinary review where appropriate and clarifies that reliance does not alter petition chronology. Reliance also applies to GMP certification and inspec- tions, allowing ANVISA to rely on inspections or audit reports from recognised partners under ANVISA RDC No 741/2022 and implementing instruments, such as Normative Instruction No 292/2024 (medicines and APIs) and Normative Instruction No 687/2022 (medi- cal devices), including Medical Device Single Audit Program (MDSAP)-recognised auditing bodies and, in specific cases, Southern Common Market ( Mercado Comum do Sul – Mercosur) authorities. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Manufacturing plants for pharmaceuticals and medi- cal devices require AFE before operations commence. ANVISA grants AFE upon a successful electronic peti- tion that includes the identification of product classes
and activities, responsible personnel credentials, cor- porate information, proof of payment of the sanitary surveillance fee, and an inspection report or current sanitary licence from the local municipal health sur- veillance service ( Vigilância Sanitária Municipal – VISA) documenting technical compliance. For medicines and APIs, GMP is a practical prerequisite for product registration and commercialisation. ANVISA issues certificates of good manufacturing practice (cGMPs) per manufacturing unit based on inspections and risk- based review. For devices, cGMP is likewise issued per unit, with ANVISA able to rely on MDSAP audit outputs to issue cGMP more efficiently. The AFE authorises the set of activities petitioned and published, which can include manufacturing and activities inherent to manufacturing, such as storing, distributing, packing, repacking, fractioning, expedi- tion and importing for own use. Companies can later expand AFE to add importing, exporting or transport- ing if not covered inherently. If work involves con- trolled substances or medicines containing them, AE is additionally required, with the scope matching the controlled activities and substances handled. AFE effectiveness begins on publication in the Federal Official Gazette. Renewal of AFE is no longer required following statutory change. It remains valid while the establishment upholds requirements and files altera- tion petitions for changes in activities, scope, address, responsible personnel or corporate data. cGMP for pharmaceuticals and devices is generally valid for two years from publication. For medical device manufac- turers operating under MDSAP, ANVISA has extended cGMP validity to four years, contingent upon contin- uous programme participation and ongoing surveil- lance audits. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesale distributors and warehouses for phar- maceuticals and medical devices also require AFE. ANVISA grants the AFE upon electronic petition sup- ported by corporate documents, responsible techni-
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