Health, Safety and Environment (HSE) in Brazil
The National Health Regulatory Agency (Anvisa) has taken a significant step towards modernizing healthcare information by approving a pilot project for digital medication leaflets. This initiative aims to enhance patient access to medication information while ensuring accuracy and convenience. Key Read More …
Brazilian Health Regulatory Agency (Anvisa) has enacted a ban on the sale and use of phenol-based products in both general health and aesthetic procedures. This prohibition was formalized under Resolution No. 2384, issued on June 24, 2024. The decision comes Read More …
The National Health Regulatory Agency (Anvisa) has issued a critical safety report highlighting the adverse reactions associated with cosmetic products. This is part of Anvisa’s ongoing cosmetovigilance efforts to ensure consumer safety and to monitor the cosmetic market effectively. Key Read More …
Brazilian Health Regulatory Agency (Anvisa) has updated its guidelines to simplify regulatory procedures and recude costs for the sanitation product sector. The new measure simplifies the process of altering labels on sanitation products meant for donation. This decision is encapsulated Read More …
The Brazilian Health Regulatory Agency (Anvisa) issued Normative Instruction (IN) 292/2024, outlining the criteria and specific procedures for defining Equivalent Foreign Regulatory Authorities (AREEs) in sanitary inspections. This norm also establishes an optimized analysis procedure for Good Manufacturing Practices (GMP) Read More …
Brazil’s National Health Regulatory Agency (Anvisa) published RDC 876/2024, which modifies the existing regulation on registration changes and the cancellation of biological products, previously governed by RDC 413/2020. This update aims to streamline the protocol process for updating the registration Read More …
The Brazilian Health Regulatory Agency (ANVISA) has recently announced the publication of Resolution of the Collegiate Board (RDC) 860/2024. This new regulation updates RDC 16/2014, which outlines the criteria for obtaining Authorization to Operate (ATO) and Special Authorization for companies. Read More …
Brazilian Health Regulatory Agency (Anvisa) has approved a new regulation establishing the National Prescription Control System (SNCR) to enhance the management and numbering of prescriptions for controlled medications in Brazil. This measure aims to improve the tracking and security of Read More …
Brazilian Health Regulatory Agency (Anvisa) has recently published a regulatory framework for the medicinal gases sector. The Collegiate Board Resolution (RDC) 870/2024 and the Normative Instruction (IN) 301/2024 aim to enhance technical requirements and ensure the safety, efficacy, and quality Read More …
Brazil’s National Health Surveillance Agency (ANVISA), has announced an upcoming update to regulations concerning in vitro diagnostic devices (IVD). This move aims to modernize and enhance the regulatory framework to ensure the safety, efficacy, and quality of these crucial healthcare Read More …