BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
throughout their product life cycle, aimed at maintain- ing quality, safety and performance standards. Medicines: Pharmacovigilance Authorisation holders must implement and maintain a pharmacovigilance system under ANVISA RDC No 406/2020 and linked instruments. This includes adverse event reporting, periodic safety reports and Authorisation holders must maintain a technovigilance system governed by ANVISA RDC No 67/2009, cov- ering detection, assessment, understanding and pre- vention of adverse incidents related to product use. Additional Post-Marketing Obligations Both product categories require: • compliance with GMP; • compliance with good distribution and storage practices (GDSP); risk mitigation measures as needed. Medical Devices: Technovigilance • adherence to post-registration requirements (medi- cines) or post-regularisation change requirements (medical devices); and • continuous updating of regulatory information and labelling. Conditional Requirements ANVISA may impose additional obligations as condi- tions for granting or maintaining authorisation for: • medicines – post-marketing studies such as Phase IV clinical trials, particularly when uncertainties exist regarding safety, efficacy or use in specific populations; and • medical devices – post-market monitoring or clini- cal studies for high-risk devices under ANVISA RDC No 751/2022, and field actions. These additional requirements stem from ANVISA’s sanitary police powers. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations In Brazil, third-party access to information on mar- keting authorisation procedures (registration or noti- fication before ANVISA) is generally limited to public,
high-level regulatory data. Technical dossiers and sup- porting documentation remain non-public. Disclosure to third parties is constrained by confidentiality and personal data protection rules, notably the Access to Information Law (Law No 12,527/2011) and the General Data Protection Law (Law No 13,709/2018), which protect personal data and industrial or com- mercial secrecy. Pending Applications For pending applications, ANVISA’s public databases disclose primarily status and identification data, not the content of dossiers under review. Technical files, correspondence and evidence submitted are typically accessible only to the applicant and ANVISA. Granted Authorisations Once an authorisation is granted, third parties may verify key non-confidential information through ANVI- SA’s public consultation systems, including product name, holder, type of regularisation and identifiers. For medical devices under the registration regime, regis- tration is time-limited and subject to revalidation, sup- porting public traceability of status over time. Refused Applications Where an application is refused, third parties may become aware of the outcome through updated pub- lic records, but the reasons for refusal and the techni- cal assessment are not disclosed in full. Practical Implications Third parties may generally confirm whether a product has been regularised and consult limited non-confi- dential identifiers but should not expect access to underlying technical dossiers or personal data, except where disclosure is legally justified and appropriately redacted. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes The Brazilian regulatory framework provides expedit- ed review mechanisms, particularly for medicines and biological products, through priority review and regu- latory reliance–based procedures, as well as stream-
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