Anvisa Expands e-Notivisa to Include Technical Complaints Related to Medicines
As of November 9, 2026, the Brazilian Health Regulatory Agency (Anvisa) will expand the scope of e-Notivisa to allow the submission of technical complaints related to medicines. This change represents another step toward strengthening post-marketing surveillance mechanisms and may have relevant implications for manufacturers, importers, and other companies responsible for medicines in Brazil.
Until now, the system has been used for notifications involving medical devices, cosmetics, personal hygiene products, sanitizing products, and food products. With the new functionality, patients, caregivers, and healthcare professionals will also be able to report suspected quality deviations in medicines directly through the platform.
What are technical complaints related to medicines?
According to Anvisa, technical complaints are notifications concerning potential issues related to the quality, presentation, storage conditions, or safety of a product, even when no harm to the user’s health has occurred.
Examples highlighted by the Agency include:
- broken, crumbled, or discolored tablets;
- leaks or defects in packaging;
- unusual odor, taste, or appearance;
- the presence of particles or impurities in solutions;
- problems involving devices associated with the medicine, such as applicators and dosing devices; and
- discrepancies between the contents of the package and the information provided on the labeling.
In cases where there is suspicion of health damage resulting from the use of the medicine, the report will be directed to Vigimed, the system designated for pharmacovigilance notifications.
Expansion of Monitoring Capabilities
This development reinforces a regulatory trend observed in recent years: the strengthening of post-market data collection tools and increased user participation in the health surveillance system.
In practice, the inclusion of medicines in e-Notivisa is expected to significantly increase the volume of information available to Anvisa regarding potential quality deviations. This may enable faster identification of patterns, recurring failures, and potential risks associated with specific products or batches.
In addition, suspected counterfeit products will initially be registered as technical complaints for investigation purposes, which may contribute to improving monitoring and oversight activities.
Impacts on the Pharmaceutical Sector
The expansion of e-Notivisa reflects Anvisa’s efforts to strengthen post-marketing surveillance of medicines and increase user participation in health surveillance mechanisms.
In practice, the new functionality is expected to increase the volume of information available regarding potential quality deviations, allowing for faster identification of issues and recurring patterns. In this context, it becomes particularly important for companies to maintain adequate quality management, pharmacovigilance, and traceability structures.
The Life Sciences & Healthcare team at Souto Correa Advogados is available to assist with any questions regarding these topics through the following email address: lifesciences@soutocorrea.com.br.