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Processing and evaluation of reports
 
Once the report is entered into the system, it is evaluated by ANMAT Pharmacovigilance Department. First, the quality of the data reported is assessed and then the causality and intensity degree of the event occurred are determined. Then, the drug and adverse event are classified according to the WHO-UMC code, (WHO Drug Dictionary) based on the International Nonproprietary Names scheme and the Anatomical Therapeutic Chemical – ATC classification, for the drug; and the WHO adverse reaction dictionary (Adverse Reaction Directory - ARD-WHO-ART) for the adverse event. These data, as arranged above, can be added into the database of the Pharmacovigilance Department, where the necessary information for monitoring and control actions will be found. Reports unable to be evaluated due to incomplete data or those not eligible to be defined as an adverse event are filed and labeled as disallowed.
 
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