BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
3.3 Period of Validity of Marketing Authorisations Definition of Marketing Authorisation
gravity. This is one element within the broader device framework and does not replace the full definition of “medical device” set out in the applicable device regu- lations. In some circumstances, the main characteristics of health products, such as composition, mode of action, indications for use or presentation, do not clearly determine their classification. Such products fall into a grey area (often referred to as “borderline products”) and require an in-depth technical assess- ment to ensure appropriate classification, resulting in the designation of a specific regulatory pathway in accordance with the applicable laws and regulations. Companies responsible for these hybrid products, which do not clearly fall within a single regulatory category, must submit a classification request using ANVISA’s Product Classification or Determination of Whether a Product Is Subject to Sanitary Regulation Form ( Formulário de Classificação de Produtos ou Determinação de Sujeição à Vigilância Sanitária ). The classification is then determined by the participation of the Committee for the Classification of Products Subject to Sanitary Surveillance ( Comitê de Classi- ficação de Produtos Sujeitos à Vigilância Sanitária – COMEP), which supports ANVISA’s board of directors ( Diretoria Colegiada da ANVISA – DICOL) in borderline determinations. 3.2 Marketing Authorisation for Biologic Medicinal Products The primary ANVISA regulation governing biological product registration is RDC No 55/2010. To obtain authorisation, a company must submit comprehen- sive documentation to ANVISA demonstrating the product’s safety, efficacy and quality prior to com- mercialisation. In practice, marketing authorisation for biological medicinal products in Brazil requires compliance with regulatory obligations that are more stringent than those that apply to non-biological (chemical/synthetic) medicines, due to the biological complexity and inherent risks associated with their production and use.
Under Brazilian sanitary law, a marketing authorisa- tion is the administrative act by which ANVISA permits commercialisation of a product in Brazil after verifying compliance with legal, technical and sanitary require- ments. This authorisation is granted through sanitary registration or, where applicable, product notification, pursuant to Law No 6,360/1976, Law No 9,782/1999 and implementing ANVISA RDCs. For non-low-risk medicinal products, registration certifies compliance with quality, safety and efficacy requirements and is an indispensable prerequisite for manufacture, importation, distribution and commer- cialisation. For medical devices, authorisation takes two forms: Classes III and IV (higher risk) require registration, while Classes I and II require notification. Both confirm compliance with essential safety, performance, qual- ity and user information requirements under ANVISA RDC No 751/2022. Validity Periods For medicines that are not classified as low risk, the registration is valid for a period of ten years, as estab- lished by Law No 6,360/1976 and ANVISA RDC No 912/2024. ANVISA RDC No 912/2024 also provides for variations depending on the nature of the approv- al. Specifically, for drugs approved with preliminary evidence under a commitment term ( termo de com- promisso ), the marketing authorisation is initially valid for three years. Upon the first renewal, the validity extends to five years, and after the second renewal, it extends to ten years, consecutively. By contrast, for low-risk medicines subject to notification rather than registration ( medicamentos de baixo risco sujeitos à notificação ), the notification is valid for ten years from the date of activation, as established by ANVISA RDC No 576/2021, and holders must submit a declaration of interest in continuing commercialisation every ten years through ANVISA’s electronic system For medical devices subject to registration (Classes III and IV), the validity period is also ten years under ANVISA RDC No 751/2022. Notifications applicable
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