BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
procedures for utilising these assessments. IN 289/2024 applies to medicines, biological prod- ucts, vaccines and active pharmaceutical ingre- dients, while IN 290/2024 specifically addresses medical devices. The applicable AREEs for each sector are as fol- lows. Medicines, biological products and vaccines: • European Medicines Agency (EMA); • Health Canada; • Swissmedic; • Medicines and Healthcare products Regula- tory Agency (MHRA); • US Food and Drug Administration (FDA); • Therapeutic Goods Administration (TGA); and • World Health Organization (OMS) Active Pharmaceutical Ingredients: • World Health Organization (OMS); and • European Directorate for the Quality of Medi- cines & HealthCare (EDQM) Medical Devices: • Australian Therapeutic Goods Administration (TGA); • Health Canada (HC); • US Food and Drug Administration (FDA); • Japan Ministry of Health, Labour and Welfare (MHLW). Brazil makes use of regulatory decisions of other jurisdictions to optimise its product regis- tration procedures. Therefore, if a company has already obtained authorisations from interna - tionally recognised jurisdictions, the issuance of ANVISA’s authorisations can be expedited. The analysis conducted by AREE can be accepted
for the purpose of implementing an optimised analytical procedure facilitated by regulatory trust practices, such as collaborative work and mutual or unilateral recognition. The practice of the optimised analysis procedure will be based on the instructional documentation prepared by the Equivalent Foreign Regulatory Authority, as established in specific normative acts. For the purposes of adopting the optimised anal- ysis procedure, the instructional documentation of the Equivalent Foreign Regulatory Authority must: • prove that the product subject to the instruc- tional documentation is essentially identical to the one submitted for evaluation by ANVISA; • have been prepared using standards consist- ent with those used by ANVISA, to ensure it has the same scope; and • be presented in its complete form, including the questions and guidelines that were made during the analysis by the Equivalent Foreign Regulatory Authority, unless excepted in spe- cific normative acts. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Both pharmaceutical and medical device man- ufacturing facilities in Brazil need a licence to operate, known as an Autorização de Funciona- mento (AFE), issued by ANVISA. The procedure for obtaining an AFE is outlined in RDC 16/2014 (in force but amended by RDC 860/2024).
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