QR Group Explica as Mudanças na RDC 954/2024 e Seu Impacto no Registro de Medicamentos
New ANVISA resolution updates criteria for simplified registration and brings greater clarity to the regulatory process With official publication in April and expected to come into force in October 2024, RDC No. 954/2024 brings an important update to the drug registration process with ANVISA. The new rule repeals RDC No. 199/2006 and redefines the criteria […]
RDC 954/2024 Updates Simplified Medication Registration
QR Group analyzes the impacts of ANVISA’s new rule and guides companies on how to adapt to changes in the regularization process ANVISA published RDC No. 954/2024, which updates the criteria and procedures for the simplified registration of medicines. The new rule repeals the old RDC No. 199/2006 and comes into force as of October […]
ANVISA Begins Review of RDC 81/2008: Impacts on Imported Products
QR Group analyzes the effects of the proposal to update the main rule that regulates the import of products subject to health surveillance in Brazil In 2024, ANVISA began the process of revising RDC No. 81/2008, a rule that for more than 15 years has established the requirements for importing products subject to health surveillance, […]
ANVISA Receives Top Score for Good Regulatory Practices
QR Group analyzes the impact of agency performance for companies seeking registration of health products in Brazil ANVISA was rated 10 in the OECD Index of Good Regulatory Practices, according to a report released in April 2024. The index, prepared by the Organization for Economic Cooperation and Development, measures the quality of standard-making processes in […]
ANVISA Updates Cosmetics Regulations in Brazil
QR Group explains the main changes and guides companies on how to maintain compliance safely and quickly In April 2024, ANVISA published the new Normative Instruction (IN) No. 280/2024, which changes relevant aspects of the regulation of cosmetics and personal care products in Brazil. The measure updates the technical requirements for regularization, with a focus […]
Regulation of Medications for Rare Diseases Advances in Brazil
QR Group analyzes the regulatory impacts of ANVISA’s new guidelines and the challenges for the pharmaceutical industry In recent years, the regulation of medicines for rare diseases in Brazil has undergone significant advances. ANVISA has been working to make registration processes more flexible and faster, especially for innovative drugs aimed at treating conditions with a […]
ANVISA Updates Rules for Importing Medical Device Components
QR Group explains regulatory impacts and guides companies on how to maintain compliance safely ANVISA has published a new technical statement on the regulatory framework for medical device components, bringing important clarifications for manufacturers, importers and distributors. The update reinforces the need to evaluate, on a case-by-case basis, the destination and risk of the components, […]
QR Group Explains ANVISA Updates on Smoking Product Registration
Changes require attention from companies to maintain regulatory compliance and avoid penalties In July 2024, the National Health Surveillance Agency (ANVISA) published an update on the criteria for registration and renewal of tobacco-derived smoking products, such as cigarettes, cigars, and cigarillos. The measure reinforces the need for attention on the part of companies in the […]
Understand the Requirements of IN 242/2023 and How to Ensure Regulatory Compliance
QR Group Explains ANVISA’s New Labeling Rules: How to Adapt Your Products Normative Instruction IN No. 242/2023, published by ANVISA, brought significant changes to the labeling of personal care products, cosmetics, perfumes, and disposables. Now, whenever there is a formula modification, the “NEW FORMULA” or “NEW COMPOSITION” statement must be included in the label. If […]
QR Group Explains the Classification of Odor Neutralizers: Cosmetics or Sanitizers? Enviar feedback Resultados de tradução disponíveis
Understand how ANVISA’s regulation impacts the classification of odor neutralizers and QR Group’s role in adapting to standards. The classification of odor neutralizers has raised doubts in the market, especially about whether they should be treated as cosmetics or sanitizers. RDC Resolution No. 752, of 2022, and RDC No. 59, of 2010, provide the guidelines […]
