BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
The primary avenue for challenge is usually adminis- trative review within the competent authority. In the case of ANVISA, regulated parties may file adminis- trative appeals within the relevant proceeding, seek- ing review by higher internal instances and, depend- ing on the decision and applicable procedural rules, potentially by ANVISA’s Collegiate Board ( Diretoria Colegiada da ANVISA – DICOL). In sanctioning pro- ceedings, challenges generally begin with a formal defence or impugnation in the administrative case file, followed by successive appeals as the proceed- ing advances. While ANVISA applies sector-specific procedural rules, general federal administrative law principles also apply, including due process, reasoned decisions and the right to be heard. For an administrative challenge to be admissible and effective, it generally requires: (i) standing (the chal- lenger must be directly affected by the act); (ii) timely filing, in accordance with the applicable deadline; and (iii) a reasoned submission clearly identifying the con- tested act and setting out legal and technical grounds (such as illegality, procedural flaws, insufficient rea- soning, inconsistency with applicable regulations or disproportionality), supported by appropriate docu- mentation and technical evidence. Where administrative relief is insufficient or inade- quate, decisions may also be challenged through judi- cial review, often combined with requests for urgent injunctive relief in cases of immediate operational impact or risk of irreparable harm. These challenge mechanisms are largely consistent across other ANVISA-regulated product categories (such as food), as they derive from general administra- tive due process and sanitary enforcement principles, with differences arising mainly from sector-specific technical standards, rather than from the availability of review pathways. 1.3 Categories of Pharmaceuticals and Medical Devices In Brazil, both pharmaceuticals and medical devices are subject to tiered regulatory categories, and the applicable requirements (such as the market authori- sation pathway, dispensing and supply chain controls,
labelling and post-market obligations) vary depending on the product’s classification and risk profile. For pharmaceuticals, the most practical “regulatory split” is based on dispensing status. A key category is over-the-counter (OTC)/non-prescription medi- cines ( medicamentos isentos de prescrição – MIPs). ANVISA explains that MIPs are medicines that do not require a prescription and are generally available for self-selection in pharmacies and drugstores, and they do not carry the classic red or black stripes on the outer packaging. ANVISA periodically updates the official list of MIPs (LMIP), and recent rules set criteria for a product to be classified as non-prescription. By contrast, prescription medicines must display a red or black stripe and the wording Venda sob prescrição médica (“prescription-only medicines”), under ANVI- SA’s labelling rules. Within prescription medicines, there is a further sub-category of controlled/special substances, governed by Ordinance of the Secretar- iat of Health ( Portaria SVS/MS ) No 344/1998, which establishes lists and stricter controls for dispensing, record-keeping and prescription handling. Beyond dispensing status, Brazil also classifies medi- cines by regulatory type, which affects the applicable dossier and evidence requirements. In practice, the main categories are reference (innovator) products, generic medicines and similar medicines, each sub- ject to specific rules on quality documentation and, where applicable, BE/interchangeability standards. In addition, biological products are regulated under a distinct framework from small-molecule drugs, and biosimilars are generally assessed through a compa- rability pathway. For medical devices, the core differentiator is risk clas- sification. ANVISA classifies devices into Classes I–IV (from low to maximum risk) under Collegiate Board Resolution ( Resolução da Diretoria Colegiada – RDC) No 751/2022, and this classification drives the regula- tory route and intensity of review: lower-risk products typically follow lighter regularisation mechanisms, while higher-risk devices are subject to more robust pre-market review, stricter technical documentation expectations and reinforced post-market surveillance obligations.
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