Brazil- Anvisa


This new tool enables faster and easier notification of drugs and vaccines.


Pharmacovigilance is defined as the science and activities relating to the identification, assessment, understanding, and prevention of adverse effects or any problems related to the use of drugs.

Pharmacovigilance is responsible for identifying and monitoring the occurrence of adverse events related to the use of drugs marketed in the Brazilian market, aiming to ensure that the benefits related to the use of these products are greater than the risks they cause.

In addition to adverse drug reactions, the following issues are relevant for pharmacovigilance: adverse events caused by deviations in drug quality, therapeutic ineffectiveness, medication errors, use of drugs for indications not approved in the registration, abuse, poisoning, and drug interactions.


Anvisa informed that the new form for reporting adverse events related to drugs and vaccines is now available. The measure aims to make it easier and faster for citizens to report suspected adverse events.  

The form has a more user-friendly format and can also be accessed via cell phone.  The Agency points out that by reporting suspected adverse events, you contribute to improving the monitoring and safety of medicines and vaccines used in the country. 

To access the form, click here. (Available only in Portuguese language).


* Vigimed: Anvisa’s system for citizens, health professionals and drug registration holders to report suspected adverse events to drugs and vaccines.

* Notivisa: is the Health Surveillance Notification System, developed by Anvisa, to receive notifications of incidents and technical complaints related to the use of products and services under health surveillance.

* Sentinel Hospital Project: It is a project developed by ANVISA, with the objective of expanding and systematizing the surveillance of health products and thus promoting better services and working conditions. It is implemented in the country’s main hospitals, which form an integrated network, acting in three major areas: Technovigilance, Pharmacovigilance, and Hemovigilance.


Ministry of Health – Anvisa Section. For the link, click here.

Webinar Desafios da Farmacovigilância no Brasil (Challenges of Pharmacovigilance in Brazil). For the link, click here.

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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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