Notice to pharmacy professionals: the mandatory use of SNGPC will return in 2025.
Pharmacies’ participation is essential to detecting possible areas for improvement and making adjustments before the system becomes mandatory again. Anvisa reinforces the importance of SNGPC and guides pharmacies towards a mandatory return in 2025 The Brazilian Health Surveillance Agency (Anvisa) informs that …
Anvisa provides clarification on importing components for medical devices
Check out the Agency’s guidelines on the new flows and frameworks. Anvisa revises rules on operating authorization for warehousers and importers of medical components. Anvisa has updated the guidelines regarding the need for an Operating Authorization (Autorização de Funcionamento—AFE) for warehousers in …
Difference between Registration and Notification of Health Products at Anvisa: Understand the Processes and Rules
Regulating medical materials and equipment is essential in the health sector to guarantee product safety and efficacy. In Brazil, Anvisa establishes the requirements necessary for these products to be authorized for sale, classifying them according to the risks they pose to the …
The integration of the payment of the health surveillance fee into the Single Foreign Trade Portal is scheduled. Check the implementation schedule.
Anvisa is promoting the integration of the payment of the Health Surveillance Inspection Fee (TFVS) and the import process protocol (LI/LPCO) into the Centralized Payment for Foreign Trade (PCCE) module, available on the Single Foreign Trade Portal (Siscomex ) This initiative …
Anvisa updates form for Business Operation Authorization and Special Authorization
Since last Thursday, October 3rd, the forms used to request the Business Operating Authorization (AFE) and Special Authorization (AE) in the Solicita system will undergo an update. This change will affect requests for the granting of authorizations provided for in Collegiate Board …
Anvisa clarifies that phosphoethanolamine is not approved for cancer treatment.
The substance is not permitted or registered as a food supplement or medicine in Brazil. Anvisa informs the population that phosphoethanolamine is not authorized or registered as a food supplement or medicine in Brazil. The commercialization of this substance can only …
Anvisa changes regulations and reduces regulatory costs for the sanitizing industry
The measure makes it easier to modify labels on sanitizers intended for donation. To facilitate donations of sanitizing products, Anvisa decided to simplify the rules for modifying the labeling of these products when they are destined for donation. To achieve this, …
ANVISA Clarifies the Use of Smartwatches for Measuring Blood Glucose
These devices are not suitable for glycemic control. ANVISA Clarifies the Use of Smartwatches for Measuring Blood Glucose and Oximetry ANVISA has published a technical note regarding the use of smartwatches for measuring parameters such as blood glucose (blood sugar level) and …
List of Irregular Weight Loss Products
Published on 03/25/2022 at 11:48 AM Updated on 12/18/2023 at 10:49 AM The list of irregular weight loss products aims to facilitate the identification and the efforts to combat the sale of these unauthorized products. These weight loss products included in …
Anvisa revises rules for electronic cigarettes and continues with the ban.
Restrictions on producing, importing, selling, distributing, storing, and transporting, as well as advertising all electronic smoking devices, remain. The Brazilian Health Surveillance Agency (Anvisa) confirmed the continued ban on electronic smoking devices, also referred to as electronic cigarettes. This decision, taken on …