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Pharmacovigilance

It is a set of rules or recommendations aimed at ensuring:

1) The authenticity and quality of the collected data in order to assess the risks attributable to a drug.

2) The confidentiality related to the identity of persons who may have reported adverse reactions.

3) The use of uniform criteria to assess the notifications and generate warning signals to health authorities.

Data of notification agent

Data of patient

Suspect drug product(s)

Adverse effect(s)