ANMAT launches online platform to report drug adverse reactions

On July 10th, 2013, ANMAT implemented a system for electronic submission of reports on adverse reactions to drug products.  The system consists on an online form accessible from the website of the National System of Pharmacovigilance. You can access the online form here.

Healthcare professionals, the regulated sector (pharmaceutical companies, etc.) and patients can use this new system to notify adverse reactions.

This tool has been developed considering ICH standards. (E2B-ICH guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports) Its purpose is to minimize mistakes, make the data submission more complete and efficient, improve the quality, precision and consistency of reports and establish a common methodology for the presentation of clinical information.

Reports can still be submitted using the previous methodology of downloading the form from the ANMAT website and sending it to the Department of Pharmacovigilance via email, (  fax (0054-11-4340-0866) or regular mail (Av. de Mayo 869, piso 11º -CP AAD1084- Buenos Aires, Argentina) once completed.

The online reporting system is not yet available for notifications of ESAVI (Adverse Reactions Supposedly Caused by Vaccination and Immunization).


About Maria I. Guaia
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